Premique 0.625mg / 5mg Coated Tablets
PREMIQUE 0.625mg/5mg Coated Tablets
Conjugated Estrogens and Medroxyprogesterone Acetate
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Premique is and what it is used for 2. Before you take Premique 3. How to take Premique 4. Possible side effects 5. How to store Premique 6. Further information What Premique Is And What It Is Used ForPremique is one of a group of medicines known as Hormone Replacement Therapy (HRT). It is used to treat some of the symptoms and conditions associated with the menopause. Premique is a period-free HRT (an HRT product where you do not have a monthly bleed).
Your periods will stop once menopause is reached. This change is due to lowered levels of the hormones estrogen and progesterone. You may experience a number of unpleasant symptoms, including hot flushes, night sweats and vaginal dryness, around the time of menopause. Premique can relieve some of these symptoms by replacing some of the lost estrogen.
After the menopause some women may develop bone thinning (osteoporosis). If you are at an increased risk of fractures due to osteoporosis but are unable to take other treatments or if other therapies prove to be ineffective, Premique may also be used for this purpose. Your doctor should discuss all the available options with you.
Before You Take Premique 1 Do not take Premique if: you are allergic (hypersensitive) to conjugated estrogens or medroxyprogesterone acetate or any of the other ingredients of Premique; the ingredients are listed in Section 6 of this leaflet you have or have had breast cancer you have endometrial cancer (cancer of the lining of the womb) or have been told you have another type of estrogen-dependent cancer you have been told you have a blood circulation disorder or have had a blood clot you have a heart condition such as angina or have had a heart attack you have porphyria (a rare inherited metabolic disorder) you have recently had unexpected or very heavy vaginal bleeding you have been told that you have endometrial hyperplasia (abnormal growth of the lining of the womb) you have or have previously had liver disease you are pregnant, or you are breast-feeding.Before you start taking HRT, your doctor should ask about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination — but only if these examinations are necessary for you, or if you have any special concerns.
Once you’ve started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.
You are advised to:
go for regular breast screening and cervical smear tests regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.Some diseases may be made worse by HRT. Therefore, if you have or have ever had any of the following remind your doctor as he or she may want to monitor you more closely:
uterine fibroids or endometriosis risk factors for blood clots (see section 2.2 - Blood Clots for more detail) a close relative who has had breast cancer or an estrogen dependent cancer, such as cancer of the womb or ovaries (see section 2.3 – Effects on your risk of developing cancer for more detail) high blood pressure heart disease (see section 2.2 – Heart Disease for more detail) liver disease (e.g. liver adenoma) kidney disease diabetes gallbladder disease or gallstones migraine systemic lupus erythematosus (SLE – a rare chronic inflammatory disease) epilepsy asthma otosclerosis (hearing loss due to a problem with the bones in your ear) low blood calcium levels (hypocalcaemia) high levels of fatty substances in the blood (hypertriglyceridaemia).If there is a change in any of the above conditions whilst taking Premique tell your doctor.
As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.
2 Effects on your heart or circulation:Heart Disease
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing conjugated estrogens plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.
If you get:
a pain in your chest that spreads to your arm or neck See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.Stroke
Recent research suggests that HRT slightly increases the risk of having a stroke.
Other things that can increase the risk of stroke include:
getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat.If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.
Looking at women in their 50s who are not taking HRT — on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the figure would be 4 in 1000.
Looking at women in their 60s who are not taking HRT — on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.
For women in their 60s who are taking HRT, the figure would be 15 in 1000.
If you get:
unexplained migraine-type headaches, with or without disturbed vision See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.Blood Clots
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.
These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism, or VTE.
You are more likely to get a blood clot:
if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if you’re off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE (systemic lupus erythematosus).If any of these things apply to you, talk to your doctor to see if you should take HRT.
Looking at women in their 50s who are not taking HRT — on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT, the figure would be 7 in 1000.
Looking at women in their 60s who are not taking HRT — on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.
For women in their 60s who are taking HRT, the figure would be 17 in 1000.
If you get:
painful swelling in your leg sudden chest pain difficulty breathing See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.
3 Effects on your risk of developing cancer:Breast Cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestogen HRT is higher than for estrogen-only HRT (but estrogen plus progestogen HRT is beneficial for the endometrium, see Endometrial Cancer below).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping.
Your risk of breast cancer is also higher:
if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are seriously overweight.Looking at women aged 50 who are not taking HRT – on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).
If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).
For women who start taking estrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).
If they take estrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).
If you notice any changes in your breast, such as:
dimpling of the skin changes in the nipple any lumps you can see or feel Make an appointment to see your doctor as soon as possible.Endometrial Cancer (cancer of the lining of the womb)
Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the estrogen helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestogen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.
If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestogen.
If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an estrogen.
Your product, Premique, contains a progestogen.
Looking at women who still have a uterus and who are not taking HRT – on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women who take estrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long they take it.
The addition of a progestogen to estrogen-only HRT substantially reduces the risk of endometrial cancer.
If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
carries on for more than the first few months starts after you’ve been on HRT for a while carries on even after you’ve stopped taking HRT Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.Ovarian Cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that taking estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
4 Other ConditionsHRT will not help prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.
Women with hypertriglyceridaemia (high levels of fatty substances in the blood) may experience large increases of their plasma triglycerides, which can lead to inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis include sudden sharp abdominal pains, abdominal swelling, fever and feeling or being sick.
If you are taking thyroid hormone replacement therapy (e.g. thyroxine), your doctor may monitor your thyroid function more often when you start treatment.
HRT may affect some medical tests. If you visit a hospital or clinic for any medical tests, you should tell the doctor concerned that you are taking HRT.
5 Taking other medicinesPlease tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular tell your doctor if you are taking:
an anticonvulsant (used to treat epilepsy e.g. phenobarbital, phenytoin, carbamazepine) an anti-infective (e.g. rifampicin, rifabutin, nevirapine, efavirenz, erythromycin, ketoconazole, ritonavir, nelfinavir) a herbal preparation such as St. John’s wort (Hypericum perforatum) metyrapone (most commonly used in the treatment of Cushing’s syndrome) aminoglutethimide (most commonly used in the treatment of breast cancer and Cushing’s syndrome).The way that Premique works may be altered if other medicines are used at the same time.
6 Pregnancy and breast-feedingYou should stop taking Premique and tell your doctor immediately if you know or suspect you are pregnant, or if you are breast-feeding.
Premique is not a contraceptive. It is important that you use a reliable form of non-hormonal contraception (e.g. condom or diaphragm) if there is any possibility that you may still become pregnant. You should discuss this with your doctor.
7 Driving and using machinesThere is no evidence to suggest that Premique will affect your ability to drive or to operate machinery.
8 Important information about some of the ingredients in PremiquePremique contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Premique 1 Instructions for proper useAlways take Premique exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.
The usual dose is one tablet every day.
Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms.
Take your tablet at the same time each day as this will help to remind you to take your medicine.
If you are not currently taking HRT or you are taking another period-free HRT, you may start your first pack of Premique at any convenient time.
If you are changing from an HRT product that gives you a monthly bleed, start Premique the day after you finish the course of the previous product, unless instructed otherwise by your doctor.
Begin your pack of Premique by taking the first tablet marked for that day of the week. Continue to take one tablet each day following the arrows until all 28 tablets have been taken.
While you are taking Premique you will have no tablet-free days. You should start your next pack the day after you finish the previous one.
Premique does not cause periods. However, you may experience some irregular bleeding or light bleeding (spotting) during your first few months of taking Premique. If the bleeding is troublesome, or continues beyond the first 3 months of treatment you should discuss this with your doctor (see section titled Endometrial Cancer above).
Do not try to take off the coating, divide or crush the tablets as this could affect the way Premique works.
2 If you take more Premique than you shouldIf you take too many tablets don’t worry. You may feel some nausea (sickness), breast tenderness, dizziness, abdominal pain, drowsiness, fatigue or experience a short period of vaginal bleeding, but it is unlikely that serious problems will result. If you are concerned talk to your doctor or pharmacist.
3 If you forget to take PremiqueIf you forget to take a tablet don’t worry. Take it as soon as you remember and then carry on taking the remaining tablets at the usual time.
If more than one tablet has been forgotten, do not take extra to try to make up for the missed tablets.
Missed tablets may cause a short period of light bleeding in women who have not had a hysterectomy.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side EffectsLike all medicines, Premique can cause side effects, although not everybody gets them.
1 Serious side effectsStop taking Premique and tell your doctor immediately if you:
have an allergic reaction, signs of which include rash, itching, shortness of breath, difficulty breathing and a swollen face experience a migraine type headache (typically a throbbing headache and nausea preceded by visual disturbances) for the first time develop signs of jaundice (yellowing of the skin or the whites of the eyes) become pregnant experience a significant increase in your blood pressure develop a contraindication i.e. circumstances which make treatment inadvisable (see Section 2 - Before you take Premique).Do not take any more tablets until your doctor says you can.
HRT can also increase the risk of heart disease, stroke, blood clots, breast cancer, endometrial cancer and ovarian cancer. Please see Section 2 - Before you take Premique.
2 Other side effectsVery common (affect more than 1 in 10 women)
breast painCommon (affect less than 1 in 10 women)
breakthrough bleeding or spotting, vaginal inflammation, period pain breast tenderness, swollen breasts, nipple discharge depression muscle and joint aches, leg cramps weight change (increase or decrease) changes in your triglyceride levels (fatty substances in the blood)Uncommon (affect less than 1 in 100 women)
changes in menstrual flow, vaginal discharge thrush nausea, bloating, abdominal pain headache, migraine blood clots in the veins dizziness changes in mood including anxiety changes in your interest in sex (increased or decreased libido) visible swelling of the face or ankles itchiness, acne difficulty wearing contact lenses gallbladder disease (e.g. gallstones) hair lossRare (affect less than 1 in 1000 women)
vomiting changes in breast tissue, milky secretion from the breasts irritability allergic reactions including swelling, rash or red patches on the skin increase in hair growth an intolerance to glucose a worsening of asthma increased size of fibroids ovarian cancer worsening of epilepsy heart attack, stroke inflammation of veins just under the skin inflammation of the pancreas irregular dark spots (usually on the face)Very rare (affect less than 1 in 10000 women)
jaundice (e.g. yellowing of the skin) a worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body) a worsening of hypocalcaemia (low blood levels of calcium) blurred vision or loss of vision worsening of porphyria (a rare inherited metabolic disorder) growth of benign liver tumoursThese side effects are usually temporary and should get better over time.
Other side effects that may occur while taking an estrogen-progesterone combined HRT are:
memory loss (dementia)If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store PremiqueKeep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Do not store above 25°C. Keep the blister in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information 1 What Premique contains The active ingredients are an estrogen (conjugated estrogens) and a progestogen (medroxyprogesterone acetate).Each blister pack contains 28 oval coated tablets, each tablet contains 0.625mg of conjugated estrogens and 5mg of medroxyprogesterone acetate (MPA). The tablets are light blue coloured and marked with “ 0.625/5”.
The other ingredients are calcium phosphate tribasic, calcium sulphate, microcrystalline cellulose, carnauba wax, glyceryl mono-oleates, lactose, magnesium stearate, methylcellulose, macrogol, pharmaceutical glaze, povidone, sucrose, titanium dioxide (E171), stearic acid and colour (E132, indigo carmine) and edible ink containing iron oxide black (E172), shellac, N-Butyl alcohol, propylene glycol and ethyl acetate. The inks and dyes used to coat your tablets are approved for use as food colourings. 2 What Premique looks like and contents of the packYour Premique carton contains either one or three blisters, each containing 28 tablets.
Not all pack sizes may be marketed.
The marketing authorisation holder is
John Wyeth & Brother Ltd trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PHThe manufacturer is
Wyeth Medica Ireland Little Connell Newbridge County Kildare Republic of IrelandThis leaflet applies to Premique tablets only.
This leaflet was last approved in 04/2010
Doc ID 60103 (combined from doc id56233 and 51576)
Premique Cycle 0.625mg / 10mg Coated Tablets
1. Name Of The Medicinal Product
Premique Cycle® 0.625mg/10mg Coated Tablets.
2. Qualitative And Quantitative CompositionPremique Cycle is a combination of conjugated estrogens* USP and medroxyprogesterone acetate (MPA) Ph.Eur.
Premique Cycle is composed of 14 tablets containing 0.625mg conjugated estrogens and 14 combination tablets containing 0.625mg conjugated estrogens and 10mg MPA.
*Conjugated estrogens contain sodium estrone sulphate, sodium equilin sulphate, 17?
3. Pharmaceutical FormPremique Cycle is available for oral administration as conjugated estrogens 0.625mg tablets and conjugated estrogens/MPA (0.625mg/10mg) combination tablets. Conjugated estrogens 0.625mg tablets are white, oval, biconvex sugar-coated tablets marked “0.625”. Conjugated estrogens/MPA (0.625mg/10mg) combination tablets are green, oval, biconvex sugar-coated tablets marked “0.625/10”.
4. Clinical Particulars 4.1 Therapeutic Indications• Hormone replacement therapy for estrogen deficiency symptoms in menopausal and postmenopausal women
• Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
4.2 Posology And Method Of AdministrationAdults:
Premique Cycle is available for oral use in a sequential regimen for treatment of women with a uterus. That is, for the first 14 days of each cycle (days 1-14), one white tablet containing conjugated estrogens 0.625mg is taken daily, and for the last 14 days (days 15-28), one green tablet containing conjugated estrogens 0.625mg and MPA 10mg is taken daily. There should be no break between packs.
For most post-menopausal women, therapy may be commenced at any convenient time, although if the patient is still menstruating, commencement on the first day of bleeding is recommended. In women transferring from another sequential hormone replacement therapy regimen, treatment should begin the day following completion of the prior regimen.
Patients should be advised that a regular withdrawal bleed will usually occur at the end of one cycle of Premique Cycle and the beginning of the next.
For treatment of postmenopausal symptoms: Conjugated estrogens 0.625mg daily for the first 14 days of each cycle, followed by conjugated estrogens/MPA (0.625mg/10mg) combination tablet daily on days 15 to 28.
For prevention and treatment of osteoporosis associated with estrogen deficiency: Conjugated estrogens 0.625mg daily for the first 14 days and conjugated estrogens/MPA (0.625mg/10mg) combination tablet taken daily on days 15 to 28. (See section 5.1 Pharmacological Properties)
Maintenance/Continuation/Extended Treatment:
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4 Special warnings and special precautions for use) should be used. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.
The benefits of the lower risk of endometrial hyperplasia and endometrial cancer due to adding a progestogen should be weighed against the increased risk of breast cancer (see sections 4.4 Special Warnings and Precautions for Use and 4.8 Undesirable Effects).
Forgotten tablet: If a tablet is forgotten, it should be taken as soon as the patient remembers, therapy should then be continued as before. If more than one tablet has been forgotten only the most recent tablet should be taken. The patient should not take double the usual dose to make up for the missed tablet.
Missed pills may cause breakthrough bleeding.
Elderly:
There are no special dosage requirements for elderly patients, but, as with all medicines, the lowest effective dose should be used.
Children:
Not recommended.
4.3 Contraindications1. Known, past or suspected cancer of the breast.
2. Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer)
3. Undiagnosed abnormal genital bleeding.
4. Untreated endometrial hyperplasia
5. Active or past history of venous thromboembolism (e.g. deep vein thrombosis, pulmonary embolism)
6. Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
7. Acute liver disease or history of liver disease where the liver function tests have failed to return to normal.
8. Known hypersensitivity to the active substances or to any of the excipients of Premique Cycle tablets.
9. Porphyria
4.4 Special Warnings And Precautions For UseFor the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
1. Medical examination/Follow up
Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual women. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see 'Breast Cancer' below). Investigations, including mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
2. Conditions that need supervision
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with Premique Cycle, in particular:
? Leiomyoma (uterine fibroids) or endometriosis
? A family history of, or other risk factors for, thromboembolic disorders (see below)
? Risk factors for estrogen dependent tumours (e.g. 1st degree heredity for breast cancer)
? Hypertension
? Liver disorders (e.g. liver adenoma)
? Diabetes mellitus with or without vascular involvement
? Cholelithiasis
? Migraine or (severe) headaches
? Systemic lupus erythematosus (SLE)
? A history of endometrial hyperplasia (see below)
? Epilepsy
? Asthma
? Otosclerosis
3. Reasons for immediate withdrawal of therapy
Therapy should be discontinued if a contra-indication is discovered and in the following situations:
? Jaundice or deterioration in liver function
? Significant increase in blood pressure
? New onset of migraine-type headache
? Pregnancy
4. Endometrial Hyperplasia
The risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods (see section 4.8 Undesirable effects). The addition of a progestogen for at least 12 days of the cycle in non-hysterectomised women greatly reduces this risk. Unless there is a previous diagnosis of endometriosis it is not recommended to add a progestogen in hysterectomised women.
The reduction in risk to the endometrium should be weighed against the increase in the risk of breast cancer of added progestogen (see 'Breast cancer' below and Section 4.8 Undesirable effects).
Break-through bleeding and spotting may occur during the first months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
5. Breast Cancer
A randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and epidemiological studies, including the Million Women Study (MWS), have reported an increased risk of breast cancer in women taking estrogens, estrogen-progestogen combinations or tibolone for HRT for several years (see Section 4.8 Undesirable effects). For all HRT, an excess risk becomes apparent within a few years of use and increases with the duration of intake but returns to baseline within a few (at most five) years after stopping treatment.
In the MWS, the relative risk of breast cancer with conjugated equine estrogens (CEE) or estradiol (E2) was greater when a progestogen was added, either sequentially or continuously, and regardless of type of progestogen. There was no evidence of a difference in risk between the different routes of administration.
In the WHI study, the continuous combined conjugated equine estrogen and medroxyprogesterone acetate (CEE + MPA) product used was associated with breast cancers that were slightly larger in size and more frequently had local lymph node metastases compared to placebo.
HRT, especially estrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
6. Venous thromboembolism
Hormone replacement therapy (HRT) is associated with a higher relative risk of developing venous thromboembolism (VTE) i.e. deep vein thrombosis or pulmonary embolism. One randomised controlled trial and epidemiological studies found a two to threefold higher risk for users compared with non-users. For non- users it is estimated that the number of cases of VTE that will occur over a 5-year period is about 3 per 1000 women aged 50-59 years and 8 per 1000 women aged between 60-69 years. It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5-year period will be between 2 and 6 (best estimate 4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate = 9) per 1000 women aged 60-69 years. The occurrence of such an event is more likely in the first year of HRT than later.
Generally recognised risk factors for VTE include a personal or family history and severe obesity (Body Mass Index>30kg/m2) and systemic lupus erythematosus (SLE). There is no consensus about the possible role of varicose veins in VTE.
Patients with a history of VTE or known thrombophilic states have an increased risk of VTE. HRT may add to this risk. Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition. Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of HRT in such patients should be viewed as contraindicated. Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery. As in all postoperative patients, scrupulous attention should be given to prophylactic measures to prevent VTE following surgery. Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4-6 weeks earlier, if this is possible. Treatment should not be restarted until the woman is completely mobilised.
If venous thromboembolism develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they are aware of potential thromboembolic symptoms (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
7. Coronary Artery Disease (CAD)
There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated estrogens and MPA. Two large clinical trials (WHI and HERS i.e. Heart and Estrogen/progestin Replacement Study) showed a possible increased risk of cardiovascular morbidity in the first year of use and no overall benefit. For other HRT products, there are only limited data from randomised controlled trials examining effects in cardiovascular morbidity or mortality. Therefore, it is uncertain whether these findings also extend to other HRT products.
8. Stroke
One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated estrogens and MPA. For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years. It is estimated that for women who use conjugated estrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate =1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years. It is unknown whether the increased risk also extends to other HRT products.
9. Ovarian Cancer
Long term (at least 5-10 years) use of estrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRT confers different risk than estrogen-only products.
Other Conditions
10. Estrogens/progestogens may cause fluid retention and therefore patients with cardiac or renal dysfunction should be carefully observed. Patients with terminal renal insufficiency should be closely observed, since it is expected that the level of circulating active ingredients in Premique Cycle is increased.
11. The use of estrogen may influence the laboratory results of certain endocrine tests and liver enzymes.
Estrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radio-immunoassay) or T3 levels (by radio-immunoassay). T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered.
Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, ceruloplasmin).
Some patients dependent on thyroid hormone replacement therapy may require increased doses in order to maintain their free thyroid hormone levels in an acceptable range. Therefore, patients should have their thyroid function monitored more frequently when commencing concurrent treatment in order to maintain their free thyroid hormone levels in an acceptable range.
12. There is an increase in the risk of gallbladder disease in women receiving HRT (see conditions that need supervision)
13. A worsening of glucose tolerance may occur in some patients on estrogen/progestogen therapy and therefore diabetic patients should be carefully observed while receiving hormone replacement therapy.
This product contains lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
14. Women with pre-existing hypertriglyceridemia should be followed closely during estrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with estrogen therapy in this condition.
15. Estrogens should be used with caution in individuals with severe hypocalcaemia.
16. There is no conclusive evidence of improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger post-menopausal women or other HRT products.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionThe metabolism of estrogens and progestogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of estrogens and progestogens.
Clinically, an increased metabolism of estrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile.
The response to metyrapone may be reduced.
Aminogluthimide administered concomitantly with MPA may significantly depress the bioavailiablity of MPA.
4.6 Pregnancy And LactationPregnancy:
Premique Cycle is not indicated during pregnancy. If pregnancy occurs during medication with Premique treatment should be withdrawn immediately.
Clinically, data on a limited number of exposed pregnancies indicate no adverse effects of MPA on the foetus.
The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of estrogens and progestogens indicate no teratogenic or foetotoxic effect.
Lactation:
Premique Cycle is not indicated during lactation.
4.7 Effects On Ability To Drive And Use MachinesPremique Cycle should not affect the ability to drive or use machines.
4.8 Undesirable EffectsSee also 4.4 Special warnings and special precautions for use.
Adverse drug reactions (ADRs)
The adverse reactions listed in the table are based on post-marketing spontaneous (reporting rate), clinical trials and class-effects. Breast pain is a very common adverse event reported in
System Organ Class
Very Common ADRs
(>1/10)
Common ADRs
(>1/100, < 1/10)
Uncommon ADRs
(>1/1000, <1/100)
Rare ADRs
(>1/10000, <1/1000)
Very Rare ADRs
(<1/10000), isolated reports
Infections and infestations
Vaginitis
Vaginal candidiasis
Neoplasms benign and malignant (including cysts and polyps)
Fibrocystic breast changes
Ovarian cancer
Enlargement of hepatic hemangiomas
Immune system disorders
Anaphylactic/ anaphylactoid reactions, including urticaria and angioedema
Metabolism and nutrition disorders
Glucose intolerance
Exacerbation of porphyria; hypocalcemia
Psychiatric disorders
Depression
Changes in libido; Mood disturbances;
Irritability
Nervous system disorders
Dizziness; Headache; Migraine; Anxiety
Stroke; Exacerbation of epilepsy;
Exacerbation of chorea
Eye disorders
Intolerance to contact lenses
None
Retinal vascular thrombosis
Cardiac disorders
Myocardial infarction
Vascular disorders
Pulmonary embolism
Superficial thrombophlebitis
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
Gastrointestinal disorders
Nausea; Bloating; Abdominal pain
Vomiting; Pancreatitis
Hepatobiliary disorders
Gallbladder disease
None
Cholestatic jaundice
Skin and subcutaneous tissue disorders
Alopecia; acne; Pruritis
Chloasma/melasma; Hirsutism; Pruritus; Rash
Musculoskeletal, connective tissue and bone disorders
Arthralgias; Leg cramps
Reproductive system & breast disorders
Breast pain
Breakthrough bleeding/spotting dysmenorrhea, breast, tenderness, enlargement, discharge
Change in menstrual flow; Change in cervical ectropion and secretion
Galactorrhoea; Increased size of uterine leiomyomata
General disorders and administration site conditions
Oedema
Investigations
Changes in weight (increase or decrease) Increased triglycerides
Increase in blood pressure
Breast cancer
According to evidence from a large number of epidemiological studies and one randomised placebo-controlled trial, the Women's Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users.
For estrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which>80% of HRT use was estrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 – 1.49) and 1.30 (95%CI 1.21 – 1.40), respectively.
For estrogen plus progestogen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with estrogens alone.
The MWS reported that, compared to never users, the use of various types of estrogen-progestogen combined HRT was associated with a higher risk of breast cancer (RR = 2.00, 95%CI: 1.88 – 2.12) than use of estrogens alone (RR = 1.30, 95%CI: 1.21 – 1.40) or use of tibolone (RR=1.45; 95%CI 1.25-1.68).
The WHI trial reported a risk estimate of 1.24 (95%CI 1.01 – 1.54) after 5.6 years of use of estrogen-progestogen combined HRT (CEE + MPA) in all users compared with placebo.
The absolute risks calculated from the MWS and the WHI trial are presented below:
The MWS has estimated, from the known average incidence of breast cancer in developed countries, that:
• For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.
• For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will be
• For users of estrogen-only replacement therapy
• between 0 and 3 (best estimate = 1.5) for 5 years’ use
• between 3 and 7 (best estimate = 5) for 10 years’ use.
• For users of estrogen plus progestogen combined HRT
• between 5 and 7 (best estimate = 6) for 5 years’ use
• between 18 and 20 (best estimate = 19) for 10 years’ use.
The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to estrogen-progestogen combined HRT (CEE + MPA) per 10,000 women years.
According to calculations from the trial data, it is estimated that:
• For 1000 women in the placebo group.
• About 16 cases of invasive breast cancer would be diagnosed in 5 years.
• For 1000 women who used estrogen plus progestogen combined HRT (CEE + MPA), the number of additional cases would be
• Between 0 and 9 (best estimate = 4) for 5 years’ use.
The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65) (see section 4.4 Special warnings and special precautions for use).
Endometrial Cancer
In women with an intact uterus, the risk of endometrial hyperplasia and endometrial cancer increases with increasing duration of use of unopposed estrogens. According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT, about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65. Depending on the duration of treatment and estrogen dose, the reported increase in endometrial cancer risk among unopposed estrogen users varies from 2-to 12-fold greater compared with non-users. Adding a progestogen to estrogen-only therapy greatly reduces this increased risk.
Other adverse reactions reported in association with estrogen/progestogen treatment including Premique:
• Estrogen-dependent neoplasms benign and malignant, e.g. endometrial hyperplasia, endometrial cancer
• Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users. For further information, see section 4.3 Contra-indications and 4.4 Special Warnings and Precautions for Use.
• Myocardial infarction
• Stroke
• Skin and subcutaneous disorders: erythema multiforme, erythema nodosum, vascular purpura
• Probable dementia (see section 4.4 Special warnings and special precautions for use)
• Exacerbation of otosclerosis
4.9 OverdoseSymptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in females. There is no specific antidote, and further treatment should be symptomatic.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesATC Code: GO3F A12
Conjugated Estrogens
The active ingredients are primarily the sulphate esters of estrone, equilin sulphates, 17?-estradiol and 17?-estradiol. These substitute for the loss of estrogen production in menopausal women, and alleviate menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy.
Progestogen:
As estrogens promote the growth of the endometrium, unopposed estrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestogen reduces but does not eliminate the estrogen-induced risk of endometrial hyperplasia in non-hysterectomised women.
Relief of estrogen-deficiency symptoms
In a 1-year clinical trial (n=2,808), vasomotor symptoms were assessed for efficacy during the first 12 weeks of treatment in a subset of symptomatic women (n=241) who had at least 7 moderate or severe hot flushes daily or 50 moderate to severe hot flushes during the week before randomisation. Premique 0.625mg/2.5mg (conjugated estrogens/medroxyprogesterone acetate) was shown to be statistically better than placebo at weeks 4, 8 and 12 for relief of both frequency and severity of moderate to severe vasomotor symptoms.
In two clinical trials, the incidence of amenorrhoea (no bleeding or spotting) increased over time in women treated with Premique 0.625mg/2.5mg. Amenorrhoea was seen in 68% of women at cycle 6 and 77% of women at cycle 12. Breakthrough bleeding and/or spotting appeared in 48% during the first 3 months, and in 24% of women during months 10-12 of treatment.
Prevention of osteoporosis
Epidemiological studies suggest a number of individual risk factors which contribute to the development of post-menopausal osteoporosis. These include: early menopause; family history of osteoporosis; thin, small frame; cigarette use; recent prolonged systemic corticosteroid use.
Estrogen deficiency at menopause is associated with an increasing bone turnover and decline in bone mass. The effect of estrogens on the bone mineral density is dose-dependent. Protection appears to be effective for as long as treatment is continued. After discontinuation of HRT, bone mass is lost at a rate similar to that in untreated women.
Evidence from the WHI trial and meta-analysed trials shows that current use of HRT, alone or in combination with a progestogen – given to predominantly healthy women – reduces the risk of hip, vertebral and other osteoporotic fractures. HRT may also help prevent fractures in women with low bone density and/or established osteoporosis, but the evidence for that is limited.
After 3 years of treatment with Premique 0.625mg/2.5mg, the increase in lumbar spine bone mineral density (BMD) was 4.87% ± 0.66. The percentage of women who maintained (less than 1% BMD loss per year) or gained BMD in lumbar zone during treatment was 92%.
Premique 0.625mg/2.5mg also had an effect on hip BMD. The increase after 3 years was 1.94% ± 0.44 at total hip. The percentage of women who maintained (less than 1% BMD loss per year) or gained BMD in hip zone during treatment was 88%.
5.2 Pharmacokinetic PropertiesAbsorption
Conjugated estrogens are soluble in water and are well absorbed from the gastrointestinal tract after release from the drug formulation. However Premique contains a formulation of medroxyprogesterone acetate (MPA) that is immediately released and conjugated estrogens that are slowly released over several hours. MPA is well absorbed from the gastrointestinal tract. Table 1 summarises the mean pharmacokinetic parameters for unconjugated and conjugated estrogens, and medroxyprogesterone acetate following administration of 2 Premique 0.625/2.5mg and 2 Premique 0.625/5mg tablets to healthy postmenopausal women.
Distribution
The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin. MPA is approximately 90% bound to plasma proteins but does not bind to SHBG.
Metabolism
Exogenous estrogens are metabolised in the same manner as endogenous estrogens. Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulphate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption. In postmenopausal women a significant proportion of the circulating estrogens exists as sulphate conjugates, especially estrone sulphate, which serves as a circulating reservoir for the formation of more active estrogens. Metabolism and elimination of MPA occur primarily in the liver via hydroxylation, with subsequent conjugation and elimination in the urine.
Excretion
Estradiol, estrone and estriol are excreted in the urine along with glucuronide and sulphate conjugates. Most metabolites of MPA are extracted as glucuronide conjugates with only minor amounts secreted as sulphates.
Table 1 – Pharmacokinetic parameters for Premique
Pharmacokinetic parameters for unconjugated and conjugated estrogens (CE) and medroxyprogesterone acetate (MPA)
Drug
2 x 0.625mg CE/2.5mg MPA Combination Tablets
(n=54)
2 x 0.625mg CE/5mg MPA Combination Tablets
(n=51)
PK Parameter
Arithmetic Mean
(%CV)
Cmax
(pg/mL)
tmax
(h)
t1/2
(h)
AUC
(pg.h/mL)
Cmax
(pg/mL)
tmax
(h)
t1/2
(h)
AUC
(pg.h/mL)
Unconjugated Estrogens
Urispas 200
Urispas 200mg Film-coated tablets
Flavoxate hydrochloride
Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What is Urispas 200mg Film-coated Tablets?Urispas 200mg Film-coated Tablets contain the active ingredient flavoxate hydrochloride.
Flavoxate hydrochloride is one of a group of drugs called antispasmodics which relieve or prevent muscle spasms including spasms of the urinary tract. Urispas has also been shown to relieve pain.
Urispas 200mg Film-coated Tablets also contain the ingredients lactose, sodium starch glycollate, povidone, talc, cellulose microcrystalline, magnesium stearate, hypromellose, macrogol, macrogol stearate and titanium dioxide (E171).
Each white, film coated tablet is embossed with 'F 200' and contains 200mg flavoxate hydrochloride.
The pack contains 90 tablets, which is enough for about 4 weeks treatment at the normal dose of one tablet three times a day.
The Marketing Authorisation holder is
Recordati PharmaceuticalsIsis House
43 Station Rd
Henley on Thames
OXON
RG9 1AT
Tel: 01491 576336
What is Urispas 200mg Film-coated Tablets used for?
Urispas is used to treat conditions which cause muscle spasms of the urinary tract. These muscle spasms may be due to inflammation of the bladder, prostate gland or urethra (tube from bladder to outside). In addition, Urispas can be used to treat the symptoms which may occur as a result of surgery, cystoscopy or catheterisation such as painful urination, excessive urination at night and the inability to control urine flow.
If you have a urine infection as well, your doctor will probably also prescribe medicine to treat this at the same time.
When must Urispas not be used?If you have a condition which causes a blockage of the stomach, bowel or urinary tract or if you suffer from bleeding from the stomach or bowel.
If you are allergic to Urispas 200mg Film-coated Tablets or any of the ingredients they contain.
In children under 12 years of age.
When should you be extra careful while taking Urispas 200mg Film-coated Tablets?Make sure your doctor knows if you have, or suspects you have, the eye condition glaucoma.
This medicine may cause drowsiness, blurred vision or dizziness. If it does you should not operate a motor vehicle or machinery.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
May Urispas be used during pregnancy or while breast feeding?Before starting treatment, tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should take the medicine.
Many drugs pass into breast milk, therefore, if you are breast feeding, this medicine should be avoided. Your doctor will be able to discuss this with you.
How should Urispas 200mg Film-coated Tablets be taken?Always take the tablets as your doctor tells you to. A normal dose is one tablet three times a day for as long as is required.
If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
If you forget to take your tablets:Take the normal dose when you remember unless it is almost time for your next dose.
DO NOT TAKE A DOUBLE DOSE OF TABLETS TO MAKE UP FOR A MISSED DOSE.
What are the possible unwanted effects of Urispas 200mg Film-coated Tablets?In addition to the beneficial effects of Urispas, it is possible that unwanted effects will occur during treatment such as:
feeling or being sick, dry mouth or diarrhoea. indigestion or difficulty swallowing. vertigo, headache, confusion (especially in the elderly), drowsiness, tiredness, dizziness or nervousness. allergic reaction such as rash, itching, skin redness, sneezing, difficulty in breathing and swelling of the throat. if any of these occur stop taking the tablets and see your doctor immediately. heart beat irregularities. disturbances to your vision or eye pain. painful urination. low white blood cell count.If you are concerned about these or any other unwanted effects, talk to your doctor.
How should Urispas 200mg Film-coated Tablets be stored?Do not store above 30°C. In order to protect your medicine from light, keep the blister strips in the outer carton.
Keep this medicine out of the reach and sight of children.
This medicine must not be used after the expiry date printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.
REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.
Further InformationYou can get more information on Urispas 200mg Film-coated Tablets from your doctor or pharmacist.
Date of Preparation: April 2007
41894313 A
Nucleoside reverse transcriptase inhibitors (NRTIs)
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
Nucleoside reverse transcriptase inhibitors (NRTIs) are active inhibitors of reverse transcriptase found in retroviruses such as the human immunodeficiency virus (HIV). The different nucleoside reverse transcriptase inhibitors may be activated differently but they have the same mechanism of action. NRTIs are activated generally by phosphorylation to the triphosphate form by cellular enzymes. It then competes with cellular triphosphates, which are substrates for proviral DNA by viral reverse transcriptase. NRTI
See alsoMedical conditions associated with nucleoside reverse transcriptase inhibitors (NRTIs):
Hepatitis B HIV Infection Nonoccupational Exposure Occupational Exposure Reduction of Perinatal Transmission of HIV Drug List: Baraclude Hepsera Videx-Chewable-Dispersible-Buffered-Tablets Viread Ziagen Epivir Retrovir Zerit Emtriva Epivir-Hbv Hivid Tyzeka Videx-Ec-Delayed-Release-Enteric-Coated-CapsulesSpondylolisthesis Medications
Definition of Spondylolisthesis: Spondylolisthesis is a condition in which a bone (vertebra) in the lower part of the spine slips forward and onto a bone below it.
Drugs associated with SpondylolisthesisThe following drugs and medications are in some way related to, or used in the treatment of Spondylolisthesis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Learn more about SpondylolisthesisMedical Encyclopedia:
SpondylolisthesisDrug List: A-G-Profen Actiprofen Addaprin Advil Children-S-Advil-Chewable-Tablets Advil-Infants-Concentrated-Drops Advil-Junior-Strength Advil-Liqui-Gels Advil-Migraine Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Anaprox Anaprox-Ds Caldolor Children-S-Motrin-Chewable-Tablets Childrens-Ibuprofen-Berry Comfort-Pac-With-Naproxen Ec-Naprosyn-Enteric-Coated-Tablets Genpril Haltran Ibu Ibu-200 Leader-Naproxen-Sodium Lyrica Midol-Extended-Relief Midol-Ib Midol-Maximum-Strength-Cramp-Formula Motrin Motrin-Childrens Motrin-Ib Motrin-Infant-Drops Motrin-Junior-Strength-Chewable-Tablets Motrin-Migraine-Pain Naprelan-Sustained-Release-Tablets Naprosyn Neoprofen-Intravenous Nuprin Q-Profen
Naproxen Enteric-Coated Tablets
Pronunciation: na-PROX-en
Generic Name: Naproxen
Brand Name: EC-Naprosyn
Naproxen Enteric-Coated Tablets are a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take Naproxen Enteric-Coated Tablets for a long time. Do not use Naproxen Enteric-Coated Tablets right before or after bypass heart surgery.
Naproxen Enteric-Coated Tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Naproxen Enteric-Coated Tablets are used for:
Treating rheumatoid arthritis, osteoarthritis, juvenile arthritis, and ankylosing spondylitis. It may also be used for other conditions as determined by your doctor.
Naproxen Enteric-Coated Tablets are an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
Do NOT use Naproxen Enteric-Coated Tablets if: you are allergic to any ingredient in Naproxen Enteric-Coated Tablets you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib) you have recently had or will be having bypass heart surgery you are in the last 3 months of pregnancy you are taking an H2 blocker (eg, ranitidine), sucralfate, or another medicine that contains naproxenContact your doctor or health care provider right away if any of these apply to you.
Before using Naproxen Enteric-Coated Tablets:Some medical conditions may interact with Naproxen Enteric-Coated Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers) if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk of any of these diseases if you have poor health, dehydration or low fluid volume; low blood sodium levels; you are on a low-salt (sodium) diet; or you drink alcohol, smoke, or have a history of alcohol abuseSome MEDICINES MAY INTERACT with Naproxen Enteric-Coated Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, corticosteroids (eg, prednisone), heparin, other NSAIDs (eg, ibuprofen), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased Probenecid because it may increase the risk of Naproxen Enteric-Coated Tablets's side effects H2 blockers (eg, ranitidine) or sucralfate because they may decrease Naproxen Enteric-Coated Tablets's effectiveness Bisphosphonates (eg, alendronate), cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Naproxen Enteric-Coated Tablets Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Naproxen Enteric-Coated TabletsThis may not be a complete list of all interactions that may occur. Ask your health care provider if Naproxen Enteric-Coated Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Naproxen Enteric-Coated Tablets:Use Naproxen Enteric-Coated Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Naproxen Enteric-Coated Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen Enteric-Coated Tablets refilled. Take Naproxen Enteric-Coated Tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset. Swallow Naproxen Enteric-Coated Tablets whole. Do not break, crush, or chew before swallowing. Take Naproxen Enteric-Coated Tablets with a full glass of water (8 oz/240 mL) as directed by your doctor. If you take antacids or cholestyramine, ask your doctor or pharmacist how to take them with Naproxen Enteric-Coated Tablets. If you miss a dose of Naproxen Enteric-Coated Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.Ask your health care provider any questions you may have about how to use Naproxen Enteric-Coated Tablets.
Important safety information: Naproxen Enteric-Coated Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Naproxen Enteric-Coated Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Serious stomach ulcers or bleeding can occur with the use of Naproxen Enteric-Coated Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Naproxen Enteric-Coated Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Naproxen Enteric-Coated Tablets has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist. Do not take aspirin while you are using Naproxen Enteric-Coated Tablets unless your doctor tells you to. Do not switch between different forms of Naproxen Enteric-Coated Tablets (eg, tablets, suspension) unless your doctor tells you to. They may not provide the same amount of medicine to your body. Naproxen Enteric-Coated Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Naproxen Enteric-Coated Tablets. Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Naproxen Enteric-Coated Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Naproxen Enteric-Coated Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems. Naproxen Enteric-Coated Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Naproxen Enteric-Coated Tablets may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Naproxen Enteric-Coated Tablets while you are pregnant. Naproxen Enteric-Coated Tablets should not be used during labor. Naproxen Enteric-Coated Tablets are found in breast milk. Do not breast-feed while taking Naproxen Enteric-Coated Tablets. Possible side effects of Naproxen Enteric-Coated Tablets:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset; stuffy nose.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mental or mood changes; numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Naproxen side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.
Proper storage of Naproxen Enteric-Coated Tablets:Store Naproxen Enteric-Coated Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Naproxen Enteric-Coated Tablets out of the reach of children and away from pets.
General information: If you have any questions about Naproxen Enteric-Coated Tablets, please talk with your doctor, pharmacist, or other health care provider. Naproxen Enteric-Coated Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is summary only. It does not contain all information about Naproxen Enteric-Coated Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Naproxen resources Naproxen Side Effects (in more detail) Naproxen Use in Pregnancy & Breastfeeding Drug Images Naproxen Drug Interactions Naproxen Support Group 131 Reviews for Naproxen - Add your own review/rating Compare Naproxen with other medications Ankylosing Spondylitis Aseptic Necrosis Back Pain Bursitis Costochondritis Diffuse Idiopathic Skeletal Hyperostosis Dysautonomia Fever Frozen Shoulder Gout, Acute Headache Juvenile Rheumatoid Arthritis Muscle Pain Osteoarthritis Pain Period Pain Rheumatoid Arthritis Sciatica Spondylolisthesis TendonitisAseptic Necrosis Medications
Definition of Aseptic Necrosis: Aseptic necrosis is bone death caused by poor blood supply to the area. It is most common in the hip, knee, and shoulder.
Drugs associated with Aseptic NecrosisThe following drugs and medications are in some way related to, or used in the treatment of Aseptic Necrosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Drug List: A-G-Profen Actiprofen Addaprin Advil Advil-Liqui-Gels Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Anaprox Anaprox-Ds Arthritis-Pain Aspergum-Gum Aspirin-Lite-Coat Aspiritab Bayer Bayer-Plus Bayer-Aspirin-With-Calcium Buffered-Aspirin Bufferin Bufferin-Arthritis-Strength Bufferin-Extra-Strength Cataflam Comfort-Pac-With-Naproxen Easprin Ec-Naprosyn-Enteric-Coated-Tablets Ecotrin-Delayed-Release-Tablets Ecotrin-Adult-Low-Strength Ecotrin-Maximum-Strength Empirin Fasprin Fosamax Genacote Genpril Halfprin Haltran Ibu Ibu-200 Leader-Naproxen-Sodium Litecoat-Aspirin Medi-Seltzer-Effervescent-Tablets Midol-Extended-Relief Midol-Ib Motrin Motrin-Ib Naprelan-Sustained-Release-Tablets Naprosyn Norwich-Aspirin Nuprin Q-Profen Stanback-Analgesic Tri-Buffered-Aspirin Voltaren Voltaren-Xr-Extended-Release-Tablets Ysp-Aspirin Zorprin-Controlled-Release-Tablets
EC-Naprosyn Enteric-Coated Tablets
Pronunciation: na-PROX-en
Generic Name: Naproxen
Brand Name: EC-Naprosyn
EC-Naprosyn Enteric-Coated Tablets are a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take EC-Naprosyn Enteric-Coated Tablets for a long time. Do not use EC-Naprosyn Enteric-Coated Tablets right before or after bypass heart surgery.
EC-Naprosyn Enteric-Coated Tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
EC-Naprosyn Enteric-Coated Tablets are used for:
Treating rheumatoid arthritis, osteoarthritis, juvenile arthritis, and ankylosing spondylitis. It may also be used for other conditions as determined by your doctor.
EC-Naprosyn Enteric-Coated Tablets are an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
Do NOT use EC-Naprosyn Enteric-Coated Tablets if: you are allergic to any ingredient in EC-Naprosyn Enteric-Coated Tablets you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib) you have recently had or will be having bypass heart surgery you are in the last 3 months of pregnancy you are taking an H2 blocker (eg, ranitidine), sucralfate, or another medicine that contains naproxenContact your doctor or health care provider right away if any of these apply to you.
Before using EC-Naprosyn Enteric-Coated Tablets:Some medical conditions may interact with EC-Naprosyn Enteric-Coated Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers) if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk of any of these diseases if you have poor health, dehydration or low fluid volume; low blood sodium levels; you are on a low-salt (sodium) diet; or you drink alcohol, smoke, or have a history of alcohol abuseSome MEDICINES MAY INTERACT with EC-Naprosyn Enteric-Coated Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, corticosteroids (eg, prednisone), heparin, other NSAIDs (eg, ibuprofen), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased Probenecid because it may increase the risk of EC-Naprosyn Enteric-Coated Tablets's side effects H2 blockers (eg, ranitidine) or sucralfate because they may decrease EC-Naprosyn Enteric-Coated Tablets's effectiveness Bisphosphonates (eg, alendronate), cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by EC-Naprosyn Enteric-Coated Tablets Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by EC-Naprosyn Enteric-Coated TabletsThis may not be a complete list of all interactions that may occur. Ask your health care provider if EC-Naprosyn Enteric-Coated Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use EC-Naprosyn Enteric-Coated Tablets:Use EC-Naprosyn Enteric-Coated Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
EC-Naprosyn Enteric-Coated Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get EC-Naprosyn Enteric-Coated Tablets refilled. Take EC-Naprosyn Enteric-Coated Tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset. Swallow EC-Naprosyn Enteric-Coated Tablets whole. Do not break, crush, or chew before swallowing. Take EC-Naprosyn Enteric-Coated Tablets with a full glass of water (8 oz/240 mL) as directed by your doctor. If you take antacids or cholestyramine, ask your doctor or pharmacist how to take them with EC-Naprosyn Enteric-Coated Tablets. If you miss a dose of EC-Naprosyn Enteric-Coated Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.Ask your health care provider any questions you may have about how to use EC-Naprosyn Enteric-Coated Tablets.
Important safety information: EC-Naprosyn Enteric-Coated Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use EC-Naprosyn Enteric-Coated Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Serious stomach ulcers or bleeding can occur with the use of EC-Naprosyn Enteric-Coated Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking EC-Naprosyn Enteric-Coated Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. EC-Naprosyn Enteric-Coated Tablets has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist. Do not take aspirin while you are using EC-Naprosyn Enteric-Coated Tablets unless your doctor tells you to. Do not switch between different forms of EC-Naprosyn Enteric-Coated Tablets (eg, tablets, suspension) unless your doctor tells you to. They may not provide the same amount of medicine to your body. EC-Naprosyn Enteric-Coated Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take EC-Naprosyn Enteric-Coated Tablets. Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use EC-Naprosyn Enteric-Coated Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use EC-Naprosyn Enteric-Coated Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems. EC-Naprosyn Enteric-Coated Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: EC-Naprosyn Enteric-Coated Tablets may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using EC-Naprosyn Enteric-Coated Tablets while you are pregnant. EC-Naprosyn Enteric-Coated Tablets should not be used during labor. EC-Naprosyn Enteric-Coated Tablets are found in breast milk. Do not breast-feed while taking EC-Naprosyn Enteric-Coated Tablets. Possible side effects of EC-Naprosyn Enteric-Coated Tablets:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset; stuffy nose.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mental or mood changes; numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: EC-Naprosyn side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.
Proper storage of EC-Naprosyn Enteric-Coated Tablets:Store EC-Naprosyn Enteric-Coated Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep EC-Naprosyn Enteric-Coated Tablets out of the reach of children and away from pets.
General information: If you have any questions about EC-Naprosyn Enteric-Coated Tablets, please talk with your doctor, pharmacist, or other health care provider. EC-Naprosyn Enteric-Coated Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is summary only. It does not contain all information about EC-Naprosyn Enteric-Coated Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More EC-Naprosyn resources EC-Naprosyn Side Effects (in more detail) EC-Naprosyn Use in Pregnancy & Breastfeeding Drug Images EC-Naprosyn Drug Interactions EC-Naprosyn Support Group 0 Reviews for EC-Naprosyn - Add your own review/rating Compare EC-Naprosyn with other medications Ankylosing Spondylitis Aseptic Necrosis Back Pain Bursitis Costochondritis Diffuse Idiopathic Skeletal Hyperostosis Dysautonomia Fever Frozen Shoulder Gout, Acute Headache Juvenile Rheumatoid Arthritis Muscle Pain Osteoarthritis Pain Period Pain Rheumatoid Arthritis Sciatica Spondylolisthesis TendonitisLipram UL Capsules (Enteric-Coated)
Pronunciation: PAN-kree-LYE-pase
Generic Name: Pancrelipase
Brand Name: Examples include Pancrecarb MS and Ultrase MT
Lipram UL Capsules (Enteric-Coated) is used for:
Improving food digestion in patients who cannot digest food properly because they have a pancreas problem (exocrine pancreatic insufficiency) caused by cystic fibrosis or certain other conditions.
Lipram UL Capsules (Enteric-Coated) is a digestive enzyme combination. It works by helping the body to digest protein, starch, and fat.
Do NOT use Lipram UL Capsules (Enteric-Coated) if: you are allergic to any ingredient in Lipram UL Capsules (Enteric-Coated) or to pork you have inflammation of the pancreas (acute pancreatitis) or a flare-up of long-term pancreas problemsContact your doctor or health care provider right away if any of these apply to you.
Before using Lipram UL Capsules (Enteric-Coated):Some medical conditions may interact with Lipram UL Capsules (Enteric-Coated). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have gout, high uric acid levels, or a history of kidney problems if you have a history of pancreas problems, stomach or bowel problems (eg, blockage, inflammation, short bowel syndrome, Crohn disease), or intestinal surgery if you have trouble swallowing capsulesSome MEDICINES MAY INTERACT with Lipram UL Capsules (Enteric-Coated). However, no specific interactions with Lipram UL Capsules (Enteric-Coated) are known at this time.
Ask your health care provider if Lipram UL Capsules (Enteric-Coated) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Lipram UL Capsules (Enteric-Coated):Use Lipram UL Capsules (Enteric-Coated) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Lipram UL Capsules (Enteric-Coated) by mouth with each meal or snack as directed by your doctor. Swallow Lipram UL Capsules (Enteric-Coated) whole. Do not crush, chew, or hold Lipram UL Capsules (Enteric-Coated) in your mouth before swallowing. Doing so may increase the risk of mouth irritation from Lipram UL Capsules (Enteric-Coated). Drink a glass of water or juice immediately after you take Lipram UL Capsules (Enteric-Coated). If you cannot swallow Lipram UL Capsules (Enteric-Coated) whole, open it and sprinkle the contents over a small amount of acidic soft food (eg, applesauce, gelatin) that does not need to be chewed. Do not crush or chew the contents of the capsule. Mix the medicine with the food and swallow the entire mixture right away. Follow with a glass of water or juice. Be sure that none of the medicine is left in your mouth. Check with your doctor if you are unsure which foods you may mix with Lipram UL Capsules (Enteric-Coated). Drinking extra fluids while you are taking Lipram UL Capsules (Enteric-Coated) is recommended. Check with your doctor for instructions. If you miss a dose of Lipram UL Capsules (Enteric-Coated), skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or take a dose without a snack or a meal.Ask your health care provider any questions you may have about how to use Lipram UL Capsules (Enteric-Coated).
Important safety information: Do NOT take more than the recommended dose without checking with your doctor. Do not switch between brands of Lipram UL Capsules (Enteric-Coated) without checking with your doctor. Lipram UL Capsules (Enteric-Coated) may increase the risk of developing a rare, serious condition called fibrosing colonopathy. When this occurs, it is usually with high doses over a long period of time. It has been most commonly reported in children with cystic fibrosis. Contact your doctor right away if you experience unusual or severe nausea, vomiting, or stomach pain, or severe or persistent loose stools, constipation, or diarrhea. Lipram UL Capsules (Enteric-Coated) comes from pork (pig) pancreas tissue. There is an extremely rare risk of developing a viral disease from this product. No cases of viral disease from pork pancreas products have been identified. Caution is advised when using Lipram UL Capsules (Enteric-Coated) in CHILDREN; they may be more sensitive to its effects, especially fibrosing colonopathy. PREGNANCY and BREAST-FEEDING: It is not known if Lipram UL Capsules (Enteric-Coated) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lipram UL Capsules (Enteric-Coated) while you are pregnant. It is not known if Lipram UL Capsules (Enteric-Coated) is found in breast milk. If you are or will be breast-feeding while you use Lipram UL Capsules (Enteric-Coated), check with your doctor. Discuss any possible risks to your baby. Possible side effects of Lipram UL Capsules (Enteric-Coated):All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Bloating; constipation; diarrhea; gas; headache; nausea; stomach pain; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); painful, swollen joints; severe or persistent loose stools, diarrhea, or constipation; severe or unusual nausea, vomiting, or stomach pain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Lipram UL (Enteric-Coated) side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Lipram UL Capsules (Enteric-Coated):Store Lipram UL Capsules (Enteric-Coated) at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store in the original container, away from heat, moisture, and light. Do not refrigerate. Do not store in the bathroom. Keep Lipram UL Capsules (Enteric-Coated) out of the reach of children and away from pets.
General information: If you have any questions about Lipram UL Capsules (Enteric-Coated), please talk with your doctor, pharmacist, or other health care provider. Lipram UL Capsules (Enteric-Coated) is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Lipram UL Capsules (Enteric-Coated). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lipram UL Capsules (Enteric-Coated) resources Lipram UL Capsules (Enteric-Coated) Side Effects (in more detail) Lipram UL Capsules (Enteric-Coated) Use in Pregnancy & Breastfeeding Lipram UL Capsules (Enteric-Coated) Drug Interactions 0 Reviews for Lipram UL (Enteric-Coated) - Add your own review/rating Compare Lipram UL Capsules (Enteric-Coated) with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine DysfunctionBursitis Medications
Definition of Bursitis: Bursitis involves the inflammation of the fluid-filled sac (bursa) that lies between tendon and skin and/or between tendon and bone. The condition may be acute or chronic.
Drugs associated with BursitisThe following drugs and medications are in some way related to, or used in the treatment of Bursitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Learn more about BursitisMedical Encyclopedia:
BursitisHarvard Health Guide:
Symptoms and treatment for BursitisDrug List: Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Anaprox Anaprox-Ds Aristocort Aspercreme-Cream Baycadron Celestone-Solution Celestone-Soluspan Clinacort-Injection Clinalog-Injection Comfort-Pac-With-Naproxen Cortone-Acetate De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Ec-Naprosyn-Enteric-Coated-Tablets Indocin Indocin-Iv Indocin-Sr-Sustained-Release-Capsules Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Leader-Naproxen-Sodium Meticorten Midol-Extended-Relief Myoflex-Cream Naprelan-Sustained-Release-Tablets Naprosyn Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Tac-3-Injection Triam-Forte Triamcot-Injection Triamonide-40-Injection U-Tri-Lone-Injection Zema-Pak-10-Day
Premarin Tablets
1. Name Of The Medicinal Product
Premarin 0.3mg Coated Tablets
Premarin 0.625mg Coated Tablets
Premarin 1.25mg Coated Tablets
2. Qualitative And Quantitative CompositionTablets containing 0.3mg, 0.625mg or 1.25mg Conjugated Estrogens USP.
3. Pharmaceutical FormCoated Tablet
Premarin 0.3mg tablets are green oval biconvex, sugar-coated tablets marked with “0.3” in white ink.
Premarin 0.625mg tablets are maroon oval biconvex sugar-coated tablets marked with “ 0.625” in white ink.
Premarin 1.25mg tablets are yellow oval biconvex sugar-coated tablets marked with “1.25” in black ink.
4. Clinical Particulars 4.1 Therapeutic IndicationsPremarin 0.3mg, 0.625mg and 1.25mg:
- Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women.
Premarin 0.625mg and 1.25mg:
- Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
4.2 Posology And Method Of AdministrationAdults:
Premarin is an estrogen only HRT.
Treatment of Postmenopausal Symptoms
Premarin 0.3-1.25mg daily is the usual starting dose for women without a uterus. Continuous administration is recommended.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4 Special warnings and precautions for use) should be used. Treatment to control menopausal symptoms should be initiated with Premarin 0.3mg. If symptoms are not adequately controlled, higher doses of Premarin may be prescribed. Once treatment is established the lowest effective dose necessary for the relief of symptoms should be used. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.
Treatment of osteoporosis
The minimum effective dose is 0.625mg daily for most patients. (See section 5.1 Pharmacodynamic properties).
Starting or Changing Treatment
In women who are not taking hormone replacement therapy or women who switch from a continuous combined hormone replacement therapy product, treatment may be started on any convenient day. In women transferring from a sequential hormone replacement therapy regimen, treatment should begin the day following completion of the prior regimen.
Concomitant progestogen use for women with a uterus
In women with a uterus, where the addition of a progestogen is necessary it should be added for at least 12-14 days every 28 day cycle to reduce the risk to the endometrium.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
The benefits of the lower risk of endometrial hyperplasia and endometrial cancer due to adding progestogen should be weighed against the increased risk of breast cancer (see sections 4.4 Special warnings and precautions for use and 4.8 Undesirable effects).
Forgotten tablet: If a tablet is forgotten, it should be taken as soon as the patient remembers, therapy should then be continued as before. If more than one tablet has been forgotten only the most recent tablet should be taken, the patient should not take double the usual dose to make up for missed tablets.
Missed pills may cause breakthrough bleeding in women with a uterus.
Elderly
There are no special dosage requirements for elderly patients, but as with all medicines, the lowest effective dose should be used.
Children
Not recommended.
4.3 Contraindications1. Known, past or suspected breast cancer
2. Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer)
3. Undiagnosed genital bleeding
4. Untreated endometrial hyperplasia
5. Previous or current venous thromboembolism (e.g. deep vein thrombosis, pulmonary embolism)
6. Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4)
7. Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
8. Acute liver disease or history of liver disease where the liver function tests have failed to return to normal
9. Known hypersensitivity to the active substances or to any of the excipients of Premarin tablets
10. Porphyria
4.4 Special Warnings And Precautions For UseFor the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
1. Medical examination/Follow up
Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual women. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see 'Breast Cancer' below). Investigations, including mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
2. Conditions that need supervision
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with Premarin, in particular:
? Leiomyoma (uterine fibroids) or endometriosis
? A family history of, or other risk factors for, thromboembolic disorders (see below)
? Risk factors for estrogen dependent tumours (e.g. first degree heredity for breast cancer)
? Hypertension
? Liver disorders (e.g. liver adenoma)
? Diabetes mellitus with or without vascular involvement
? Cholelithiasis
? Migraine or (severe) headaches
? Systemic lupus erythematosus (SLE)
? A history of endometrial hyperplasia (see below)
? Epilepsy
? Asthma
? Otosclerosis
3. Reasons for immediate withdrawal of therapy
Therapy should be discontinued if a contra-indication is discovered and in the following situations:
? Jaundice or deterioration in liver function
? Significant increase in blood pressure
? New onset of migraine-type headache
? Pregnancy
4. Endometrial Hyperplasia
The risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods (see section 4.8 Undesirable effects and section 5.1 Pharmacodynamic Properties). The addition of a progestogen for at least 12 days of the cycle in non-hysterectomised women greatly reduces this risk.
The reduction in risk to the endometrium should be weighed against the increase in the risk of breast cancer of added progestogen (see 'Breast Cancer' below and section 4.8 Undesirable effects).
Break-through bleeding and spotting may occur during the first months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Unopposed estrogen stimulation may lead to pre-malignant or malignant transformation in the residual foci of endometriosis. Therefore, the addition of progestogens to estrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis, if they are known to have residual endometriosis (but see above).
5. Breast Cancer
A randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and epidemiological studies, including the Million Women Study (MWS), have reported an increased risk of breast cancer in women taking estrogens, estrogen-progestogen combinations or tibolone for HRT for several years (see Section 4.8 Undesirable effects). For all HRT, an excess risk becomes apparent within a few years of use and increases with the duration of intake but returns to baseline within a few (at most five) years after stopping treatment.
In the MWS, the relative risk of breast cancer with conjugated equine estrogens (CEE) or estradiol (E2) was greater when a progestogen was added, either sequentially or continuously, and regardless of type of progestogen. There was no evidence of a difference in risk between the different routes of administration.
In the WHI study, the continuous combined conjugated equine estrogen and medroxyprogesterone acetate (CEE + MPA) product used was associated with breast cancers that were slightly larger in size and more frequently had local lymph node metastases compared to placebo.
HRT, especially estrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
6. Venous thromboembolism
Hormone replacement therapy (HRT) is associated with a higher relative risk of developing venous thromboembolism (VTE) i.e. deep vein thrombosis or pulmonary embolism. One randomised controlled trial and epidemiological studies found a two to threefold higher risk for users compared with non-users. For non- users it is estimated that the number of cases of VTE that will occur over a 5-year period is about 3 per 1000 women aged 50-59 years and 8 per 1000 women aged between 60-69 years. It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5-year period will be between 2 and 6 (best estimate = 4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate = 9) per 1000 women aged 60-69 years. The occurrence of such an event is more likely in the first year of HRT than later.
Generally recognised risk factors for VTE include a personal or family history and severe obesity (Body Mass Index >30kg/m2) and systemic lupus erythematosus (SLE). There is no consensus about the possible role of varicose veins in VTE.
Patients with a history of VTE or known thrombophilic states have an increased risk of VTE. HRT may add to this risk. Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition. Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of HRT in such patients should be viewed as contraindicated. Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery. As in all postoperative patients scrupulous attention should be given to prophylactic measures to prevent VTE following surgery. Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4-6 weeks earlier, if this is possible. Treatment should not be restarted until the woman is completely mobilised.
If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they are aware of potential thromboembolic symptoms (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
7. Coronary Artery Disease (CAD)
There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated estrogens and MPA. Two large clinical trials (WHI and HERS i.e. Heart and Estrogen/progestin Replacement Study) showed a possible increased risk of cardiovascular morbidity in the first year of use and no overall benefit. For other HRT products, there are only limited data from randomised controlled trials examining effects in cardiovascular morbidity or mortality. Therefore, it is uncertain whether these findings also extend to other HRT products.
8. Stroke
One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated estrogens and MPA. For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years. It is estimated that for women who use conjugated estrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate =1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years. It is unknown whether the increased risk also extends to other HRT products.
9. Ovarian Cancer
Long-term (at least 5-10 years) use of estrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRT confers different risk than estrogen-only products.
Other Conditions
10. Estrogens may cause fluid retention and therefore patients with cardiac or renal dysfunction should be carefully observed. Patients with terminal renal insufficiency should be closely observed, since it is expected that the level of circulating active ingredients in Premarin is increased.
11. The use of estrogen may influence the laboratory results of certain endocrine tests and liver enzymes.
Estrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radio-immunoassay) or T3 levels (by radio-immunoassay). T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered.
Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, ceruloplasmin).
Some patients dependent on thyroid hormone replacement therapy may require increased doses in order to maintain their free thyroid hormone levels in an acceptable range. Therefore, patients should have their thyroid function monitored more frequently when commencing concurrent treatment in order to maintain their free thyroid hormone levels in an acceptable range.
12. A worsening of glucose tolerance may occur in patients taking estrogens and therefore diabetic patients should be carefully observed while receiving hormone replacement therapy.
This product contains lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
13. There is an increase in the risk of gallbladder disease in women receiving HRT (see conditions that need supervision).
14. Women with pre-existing hypertriglyceridemia should be followed closely during estrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with estrogen therapy in this condition.
15. Estrogens should be used with caution in individuals with severe hypocalcaemia.
16. There is no conclusive evidence for improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger post-menopausal women or other HRT products.
17. Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionThe metabolism of estrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of estrogens.
Clinically, an increased metabolism of estrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile.
The response to metyrapone may be reduced.
4.6 Pregnancy And LactationPremarin is not indicated during pregnancy.
For women with a uterus
If pregnancy occurs during medication with Premarin treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to estrogens indicate no teratogenic or foetotoxic effects.
Lactation:
Premarin is not indicated during lactation.
4.7 Effects On Ability To Drive And Use MachinesNone known.
4.8 Undesirable EffectsSee also 4.4 Special warnings and precautions for use.
Adverse drug reactions (ADRs)
The adverse reactions listed in the table are based on post-marketing spontaneous (reporting rate), clinical trials and class-effects.
System Organ Class
Common ADRs
(>1/100, < 1/10)
Uncommon ADRs
(>1/1000, <1/100)
Rare ADRs
(>1/10000, <1/1000)
Very Rare ADRs
(<1/10000), isolated reports
Infections and infestations
Vaginitis, including vaginal candidiasis
Neoplasms benign and malignant (including cysts and polyps)
Fibrocystic breast changes; Ovarian cancer; Growth potentiation of benign meningioma
Enlargement of hepatic haemangiomas
Immune system disorders
Hypersensitivity
Anaphylactic/ anaphylactoid reactions, including urticaria and angioedema
Metabolism and nutrition disorders
Glucose intolerance
Exacerbation of porphyria; Exacerbation of Hypocalcaemia
Psychiatric disorders
Depression
Changes in libido; Mood disturbances;
Irritability
Nervous system disordersDizziness; Headache; Migraine; Anxiety
Stroke; Exacerbation of epilepsy
Exacerbation of chorea
Eye disorders
Intolerance to contact lenses
Retinal vascular thrombosis
Cardiac disorders
Myocardial infarction
Vascular disorders
Venous thrombosis; Pulmonary embolism
Superficial thrombophlebitis
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
Gastrointestinal disorders
Nausea; Bloating; Abdominal pain
Vomiting; Pancreatitis; Ischaemic colitis
Hepatobiliary disorders
Gallbladder disease
Cholestatic jaundice
Skin and subcutaneous tissue disorders
AlopeciaChloasma/melasma; Hirsutism; Pruritus; Rash
Musculoskeletal, connective tissue and bone disorders
Arthralgias; Leg crampsReproductive system & breast disorders
Abnormal uterine bleeding (Breakthrough bleeding/spotting); Breast pain, tenderness, enlargement, discharge; Leukorrhoea
Change in menstrual flow; Change in cervical ectropion and secretion
Dysmenorrhoea /pelvic pain; Galactorrhoea; Increased size of uterine leiomyomata
General disorders and administration site conditions
Oedema
Investigations
Changes in weight (increase or decrease); Increased triglycerides
Increases in blood pressure
Breast Cancer
According to evidence from a large number of epidemiological studies and one randomised placebo-controlled trial, the Women's Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users.
For estrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which >80% of HRT use was estrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 – 1.49) and 1.30 (95%CI 1.21 – 1.40), respectively.
For estrogen plus progestogen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with estrogens alone.
The MWS reported that, compared to never users, the use of various types of estrogen-progestogen combined HRT was associated with a higher risk of breast cancer (RR = 2.00, 95%CI: 1.88 – 2.12) than use of estrogens alone (RR = 1.30, 95%CI: 1.21 – 1.40) or use of tibolone (RR=1.45; 95%CI 1.25-1.68).
The WHI trial reported a risk estimate of 1.24 (95%CI 1.01 – 1.54) after 5.6 years of use of estrogen-progestogen combined HRT (CEE + MPA) in all users compared with placebo.
The absolute risks calculated from the MWS and the WHI trial are presented below:
The MWS has estimated, from the known average incidence of breast cancer in developed countries, that:
• For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.
• For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will be
• For users of estrogen-only replacement therapy
• between 0 and 3 (best estimate = 1.5) for 5 years' use
• between 3 and 7 (best estimate = 5) for 10 years' use.
• For users of estrogen plus progestogen combined HRT
• between 5 and 7 (best estimate = 6) for 5 years' use
• between 18 and 20 (best estimate = 19) for 10 years' use.
The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to estrogen-progestogen combined HRT (CEE + MPA) per 10,000 women years.
According to calculations from the trial data, it is estimated that:
• For 1000 women in the placebo group.
• About 16 cases of invasive breast cancer would be diagnosed in 5 years.
• For 1000 women who used estrogen plus progestogen combined HRT (CEE + MPA), the number of additional cases would be
• Between 0 and 9 (best estimate = 4) for 5 years' use.
The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65) (see section 4.4 Special warnings and special precautions for use).
Endometrial Cancer
In women with an intact uterus, the risk of endometrial hyperplasia and endometrial cancer increases with increasing duration of use of unopposed estrogens. According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT, about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65. Depending on the duration of treatment and estrogen dose, the reported increase in endometrial cancer risk among unopposed estrogen users varies from 2-to 12-fold greater compared with non-users. Adding a progestogen to estrogen-only therapy greatly reduces this increased risk.
Other adverse reactions reported in association with estrogen/progestogen treatment including Premarin:
• Estrogen-dependent neoplasms benign and malignant, e.g. endometrial hyperplasia, endometrial cancer
• Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users. For further information, see section 4.3 Contraindications and 4.4 Special warnings and precautions for use.
• Myocardial infarction
• Gallbladder disease
• Skin and subcutaneous disorders: erythema multiforme, erythema nodosum, vascular purpura
• Probable dementia (see section 4.4 Special warnings and special precautions for use)
• Exacerbation of otosclerosis
• Gynecomastia in males
4.9 OverdoseSymptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/ fatigue and withdrawal bleeding may occur in females. There is no specific antidote, and further treatment should be symptomatic.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesATC Code: G03C A57
Conjugated Estrogens
The active ingredients are primarily the sulphate esters of estrone, equilin sulphates, 17?-estradiol and 17?-estradiol. These substitute for the loss of estrogen production in menopausal women, and alleviate menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy.
Relief of estrogen-deficiency symptoms
In a 1-year clinical trial (n=2,805), vasomotor symptoms were assessed for efficacy during the first 12 weeks of treatment in a subset of symptomatic women (n=241, 0.625mg n=27, 0.3mg n=30) who had at least 7 moderate or severe hot flushes daily or 50 moderate to severe hot flushes during the week before randomisation. Premarin 0.3mg and 0.625mg tablets were shown to be statistically better than placebo at weeks 4, 8 and 12 for relief of both frequency and severity of moderate to severe vasomotor symptoms.
The incidence of endometrial hyperplasia with Premarin, ie unopposed estrogen, at cycle 13 for 0.625mg (n=249) and 0.3mg (n=269) was assessed. The number of patients with hyperplasia was 20 (8.03%) for 0.625mg and 1 (0.37%) for 0.3mg.
Prevention of osteoporosis
At present there is no established screening programme for determining women at risk of developing osteoporotic fracture. Epidemiological studies suggest a number of individual risk factors which contribute to the development of postmenopausal osteoporosis. These include: early menopause; family history of osteoporosis; thin, small frame; cigarette use; recent prolonged systemic corticosteroid use.
Estrogen deficiency at menopause is associated with an increasing bone turnover and decline in bone mass. The effect of estrogens on the bone mineral density is dose-dependent. Protection appears to be effective for as long as treatment is continued. After discontinuation of HRT, bone mass is lost at a rate similar to that in untreated women.
Evidence from the WHI trial and meta-analysed trials shows that current use of HRT, alone or in combination with a progestogen – given to predominantly healthy women – reduces the risk of hip, vertebral and other osteoporotic fractures. HRT may also help prevent fractures in women with low bone density and/or established osteoporosis, but the evidence for that is limited.
In the HOPE study, prevention of bone loss was assessed by measurement of bone mineral density (BMD), at the final on-therapy evaluation (cycle 26 or the last available evaluation for those who discontinued early), primarily at the anteroposterior lumbar spine (L2 to L4 BMD). Secondarily, BMD measurements of the total body, femoral neck and trochanter were analysed.
The mean increase in anteroposterior lumbar spine bone mineral density (L2 to L4 BMD) after 2 years treatment was 2.46% ± 0.37 with Premarin 0.625mg.
Premarin also has an effect of the other BMD parameters. The mean increase in total femoral neck BMD was 1.82% ± 0.45 with Premarin 0.625mg. The mean increase in femoral trochanter BMD was 3.82% ± 0.58 with Premarin 0.625mg.
5.2 Pharmacokinetic PropertiesAbsorption
Conjugated estrogens are soluble in water and are well absorbed from the gastrointestinal tract after release from the drug formulation. The Premarin tablets release conjugated estrogens slowly over several hours. The pharmacodynamic profile of unconjugated and conjugated estrogens following doses of 3 x 0.3mg and 2 x 0.625mg are provided in Table 1.
Distribution
The distribution of exogenous estrogen is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin.
Metabolism
Exogenous estrogens are metabolised in the same manner as endogenous estrogens. Circulating estrogens exist in dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulphate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut following reabsorption. In post-menopausal women a significant proportion of the circulating estrogens exists as sulphate conjugates, especially estrone sulphate, which serves as a circulating reservoir for the formation of more active estrogens.
Excretion
Estriol, estrone and estradiol are excreted in the urine along with glucuronide and sulphate conjugates.
Table 1 – Pharmacokinetic parameters for Premarin
Pharmacokinetic profile for unconjugated estrogens following a dose of 3 x 0.3mg or 2 x 0.625mg
Premarin 0.3mg
Premarin 0.625mg
Drug
PK Parameter
Arithmetic Mean
(%CV)
Cmax
(pg/mL)
tmax
(h)
t1/2
(h)
AUC
(pg.h/mL)
Cmax
(pg/mL)
tmax
(h)
t1/2
(h)
AUC
(pg.h/mL)*
estrone
82 (33)
7.8 (27)
54.7 (42)
5390 (50)
139 (37)
8.8 (20)
28.0 (13)
5016 (34)
baseline-adjusted estrone
58 (42)
7.8 (27)
21.1 (45)
1467 (41)
120 (42)
8.8 (20)
17.4 (37)
2956 (39)
equilin
31 (47)
7.2 (28)
18.3 (110)
652 (68)
66 (42)
7.9 (19)
13.6 (52)
1210 (37)
Pharmacokinetic profile for conjugated estrogens following a dose of 3 x 0.3mg or 2 x 0.625mg
Premarin 0.3mg
Premarin 0.625mg
Drug
PK Parameter
Arithmetic Mean
(%CV)
Cmax
(ng/mL)
tmax
(h)
t1/2
(h)
AUC
(ng.h/mL)
Cmax
(ng/mL)
tmax
(h)
t1/2
(h)
AUC
(pg.h/mL)*
total estrone
2.5 (32)
6.5 (29)
25.4 (22)
61.0 (43)
7.3 (41)
7.3 (51)
15.0 (25)
134 (42)
baseline-adjusted total estrone
2.4 (32)
6.5 (29)
16.2 (34)
40.8 (36)
7.1 (41)
7.3 (25)
13.6 (27)
122 (39)
total equilin
Renacet 950mg Tablets
1. Name Of The Medicinal Product
Renacet 950 mg, film-coated tablets
2. Qualitative And Quantitative CompositionActive substance: Calcium acetate
Each film-coated tablet contains:
950 mg calcium acetate (anhydrous) equivalent to 240.50 mg calcium.
Excipients: Contains sucrose, see section 4.4.
For a full list of excipients see section 6.1.
3. Pharmaceutical FormFilm-coated tablet
white, oval, convex film-coated tablets scored on both sides.
4. Clinical Particulars 4.1 Therapeutic IndicationsHyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis.
4.2 Posology And Method Of AdministrationThe tablet can be divided into equal halves. Dosage should be effected individually. Unless a different dose has been prescribed, adults should take no more than 7 Renacet 950 mg film-coated tablets daily.
To achieve optimal efficacy, Renacet 950 mg should be taken during or immediately after meals.
The usual dose is:
with breakfast:
? to 1 film-coated tablet Renacet 950 mg,
with a snack:
? to 1 film-coated tablet Renacet 950 mg,
with a main meal:
1 to 3 film-coated tablets Renacet 950 mg,
with supper:
1 to 2 film-coated tablets Renacet 950 mg.
Renacet 950 mg film-coated tablets should be taken with some liquid during or immediately after meals and must not be chewed.
Experience with children is not available.
4.3 ContraindicationsRenacet 950 mg must not be used in patients with:
Hypersensitivity to the active substance or to any of the excipients.
Hypophosphatemia, severe hypophosphatemia, hypercalcemia, hypercalciuria associated with calcium-containing kidney stones, decalcifying tumors and skeletal metastases; severe renal failure without dialysis treatment; constipation; known stenosis of the large intestine, osteoporosis due to immobilisation.
4.4 Special Warnings And Precautions For UseTreatment with Renacet 950 mg film-coated tablets requires regular measurement of the serum calcium and serum phosphate levels. Under no circumstances should the calcium concentration multiplied by the phosphate concentration exceed 5.3 mmol/l since the frequency of extraosseous calcification increases if this value is exceeded.
To avoid an increase in serum calcium level beyond the normal range the intake of Renacet 950 mg film-coated tablets should be monitored regularly when patients are already on preparations which contain calcium.
Patients with the rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionConcomitant intake of Renacet 950 mg film-coated tablets with other medicinal products may impair their absorption.
For numerous anionic medicinal agents, e.g. tetracyclines and doxycycline, quinolones (gyrase inhibitors), biphosphonates, fluorides and anticholinergics changes in absorption may occur. Interaction may also occur with vitamin D preparations.Therefore it is recommended that there should be an interval of 1-2 hours between the intake of Renacet 950 mg film-coated tablets and other medicinal products.
An increased effect may occur with cardiac glycosides, a reduced effect may occur with calcium antagonists.
Concomitant administration of thiazides results in an increased risk of hypercalcemia. If the calcium level is increased, use of adrenaline may lead to severe cardiac arrhythmia.
Intake of larger quantities of calcium salts may cause a precipitation of fatty or bile acids as calcium soaps. This may impair the absorption of ursodeoxycholic acid and chenodeoxycholic acid as well as fats and fat soluble vitamins.
4.6 Pregnancy And LactationHarmful effects on humans due to calcium taken during pregnancy and lactation have not been reported.
However, the likelihood of hypercalcaemia is increased in pregnant women in whom calcium and vitamin D are co-administered.
4.7 Effects On Ability To Drive And Use MachinesRenacet 950 mg has no effect on the ability to drive or use machines.
4.8 Undesirable EffectsThe following definitions apply to the incidence of undesirable effects:
Very common (
Common (
Uncommon (
Rare (
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
General disorders:
Uncommon:
Soft tissue calcification (e.g in the fatty tissue under the skin) usually occurring only after many years of intake and frequently associated with increased blood calcium levels.
Cardiac/vascular disorders:
Uncommon:
Hypercalcemia, especially following overdosage.
Gastrointestinal disorders:
Rare:
Gastrointestinal disorders such as nausea and constipation, especially in case of too high dosages.
If gastrointestinal side effects occur, treatment should be changed to calcium carbonate as appropriate.
4.9 OverdoseOverdose would not be expected to cause gross hypercalcaemia except in patients taking excessive doses of vitamin D.
Measures in case of overdose: Discontinuation of the medicinal product and symptomatic treatment including lowering calcium levels e.g. administration of oral phosphates and non-saline laxatives such as lactulose.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group:
Drug for treatment of hyperphosphatemia
ATC-Code:
A12AA12
Calcium is an endogenous ion of the body essential for the maintenance of a number of physiologic processes. It participates as an integral factor in the maintenance of the functional integrity of the nervous system, in the contractile mechanisms of muscle tissue, in the clotting of blood, and in the formation of the major structural material of the skeleton.
A dynamic equilibrium occurs between blood calcium and skeletal calcium, homeostasis being mainly regulated by the parathyroid hormone, by calcitonin and by vitamin D.
Variations in the concentration of ionised calcium are responsible for the symptoms of hyper/hypocalcaemia. Soluble calcium salts are commonly used in the treatment of calcium deficiency.
5.2 Pharmacokinetic PropertiesThe pharmacokinetics of calcium and its salts are well known. Bioavailability of calcium acetate depends on the dissolution rate which is normally completed after 15 minutes. After 15 minutes the calcium acetate is released. The serum concentration of phosphate may decrease after interaction with calcium resulting in the formation of the less soluble calcium phosphate salts.
5.3 Preclinical Safety DataPreclinical studies with calcium acetate are very limited and reveal no special additional risks to those already mentioned in other sections of the SPC. Preclinical effects were observed only at doses considered in excess of the maximum human dose.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsTablet core
Maize starch
Sucrose
Gelatin
Sodium starch glycolate (Type A)
Croscarmellose sodium
Magnesium stearate
Film coat
Hypromellose
Refined castor oil
Saccharin sodium
Talc
Orange flavour
6.2 IncompatibilitiesNot applicable.
6.3 Shelf Life3 years
6.4 Special Precautions For StorageDo not store above 30 °C.
6.5 Nature And Contents Of ContainerPack sizes:
100 film-coated tablets
200 film-coated tablets
PVDC-coated PVC / aluminium foil blisters
6.6 Special Precautions For Disposal And Other HandlingNo special requirements.
7. Marketing Authorisation HolderRenaCare NephroMed GmbH
Werrastr. 1 a
35625 H?ttenberg
Germany
Phone:
Fax:
E-mail:
+49 (0) 64 03 9 21 60
+49 (0) 64 03 9 21 63
mail@renacare.com
8. Marketing Authorisation Number(S)PL 36032/0002
9. Date Of First Authorisation/Renewal Of The Authorisation30/06/2010
10. Date Of Revision Of The Text30/06/2010
HIV Infection Medications
Definition of HIV Infection: HIV infection is a viral infection caused by the human immunodeficiency virus (HIV) that gradually destroys the immune system, resulting in infections that are hard for the body to fight.
Drugs associated with HIV InfectionThe following drugs and medications are in some way related to, or used in the treatment of HIV Infection. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Learn more about HIV InfectionMicromedex Care Notes:
Human Immunodeficiency Virus And Acquired Immune Deficiency SyndromeSexually Transmitted DiseasesSexually Transmitted Diseases In AdolescentsMedical Encyclopedia:
AIDSHIV infectionDrugs.com Health Center:
HIV/AIDS CenterDrug List:Accesspak-For-Hiv-Pep-BasicAccesspak-For-Hiv-Pep-Expanded-With-KaletraAccesspak-For-Hiv-Pep-Expanded-With-ViraceptAgeneraseAptivusAtriplaCarimune-IgivCombivirCompleraCrixivanEdurantEmtrivaEpivirEpivir-HbvEpzicomFlebogammaFortovaseFuzeonGamimuneGamimune-N-10-IgivGammagardGammagard-S-D-IgivGammaplex-IgivGammar-PivHividIntelenceInviraseIsentressIveegam-En-IgivKaletraLexivaNorvirOctagamPanglobulin-NfPolygam-S-D-IgivPrezistaPrivigenRescriptorRetrovirReyatazSandoglobulin-IgivSelzentrySustivaTrizivirTruvadaVidex-Chewable-Dispersible-Buffered-TabletsVidex-Ec-Delayed-Release-Enteric-Coated-CapsulesViraceptViramuneViramune-Xr-Extended-Release-TabletsVireadZeritZiagen
Zanidip 10 mg and 20 mg tablets
Zanidip 10 mg film-coated tablets
Zanidip 20 mg film-coated tablets
lercanidipine hydrochloride
Please read this leaflet before taking your medicine and keep it in a safe place just in case you require it again. This leaflet contains only the most essential information on your medicine. If you have any other questions about your medicine or if you are unsure about anything, ask your doctor or your pharmacist.
Zanidip 10 mg: 1 tablet contains 10 mg of lercandipine hydrochloride, which is equivalent to 9.4 mg of lercanidipine.
Zanidip 20 mg: 1 tablet contains 20 mg of lercanidipine hydrochloride, which is equivalent to 18.8 mg of lercanidipine.
The following inactive ingredients are also included in Zanidip tablets, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate, hypromellose, talc, titanium dioxide (E171), macrogol 6000, and ferric oxide (E172).
Zanidip is available in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets*.
Lercanidipine belongs to a group of medicines called calcium channel blockers (of the dihydropyridine group) which are used to treat high blood pressure.
Marketing Authorisation Holder and Manufacturer of the product: Manufactured for
Recordati PharmaceuticalsIsis House
43 Station Rd
Henley on Thames
OXON
RG9 1AT
Tel: 01491 576336
by the Marketing Authorisation holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali 1 20148 Milan Italy Why has Zanidip been prescribed for me ?Zanidip has been prescribed by your doctor to treat your high blood pressure, also known as hypertension.
Who can take Zanidip tablets?Adults over 18 years old can take the tablets. They are not recommended for children under 18 years old.
When should I NOT take Zanidip?Do not take Zanidip tablets if:
You are sensitive or allergic to lercanidipine You are allergic to any of the ingredients in Zanidip tablets You have had allergic reactions to drugs closely related to Zanidip tablets ( such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) You are pregnant or breast-feeding, or you wish to become pregnant or do not use any contraceptive method If you are taking Zanidip and think that you may be pregnant, consult your doctor You are suffering from certain heart diseases: Uncontrolled cardiac failure Obstruction to flow of blood from the heart Unstable angina (angina at rest or progressively increasing) Within one month of heart attack You have severe liver or kidney problems What other cautions should be observed when taking Zanidip?Also tell your doctor or pharmacist if you have any condition in the list below:
Certain other heart conditions, or if you have a pacemaker Problems with your liver or kidney, or you are on dialysis You have an intolerance to lactose, galactosaemia or glucose/galactose malabsorption syndrome, as the Zanidip 20 mg tablet contains 60 mg of lactose and the Zanidip 10 mg tablet contains 30 mg of lactose. What if I am taking other drugs?If you take Zandip tablets with some other medicines, the effect of Zanidip tablets or the other medicine may be increased. Tell your doctor or pharmacist if:
You are taking drugs that are inhibitors of CYP3A4 isoenzyme (medicines that will increase the absorption of lercanidipine): Antifungal medicines (such as ketoconazole or itraconazole) Macrolide antibiotics (such as erythromycin or troleandomycin) Antivirals ( such as ritonavir) You are taking beta-blockers, diuretics or ACE-inhibitors (medicines to treat high blood pressure), although these may be safely taken with Zanidip You are taking cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn) You are taking digoxin (a medicine to treat a heart problem) You are taking midazolam (a medicine that helps you sleep) You are taking rifampicin (a medicine to treat tubercolosis) You are taking astemizole (a medicine for allergies) You are taking terfenadine (a medicine for allergies) You are taking amiodarone or quinidine (medicines to treat a fast heart beat) You are taking phenytoin or carbamazepine (medicines for epilepsy) You are taking medicines which lower the body’s resistance to disease (such as ciclosporin/cyclosporin You are taking grapefruit or grapefruit juiceDrinking alcohol during your treatment with Zanidip tablets may increase the effect of Zanidip tablets, you are therefore advised to stop or strictly limit your consumption of alcoholic drinks.
When and how do I take Zanidip ?Take Zanidip as prescribed by your doctor. Usually this will be one Zanidip 10 mg film-coated tablet daily at the same time each day, preferably in the morning at least 15 minutes before breakfast, because a high fat meal significantly increases blood levels of the drug. Your doctor may advise you to increase the dose to one Zanidip 20 mg film-coated tablet daily, if needed.
The tablets should preferably be swallowed whole with some water.
Do not exceed the prescribed dose
If you take more than the prescribed dose or in the event of overdose, seek medical advice immediately and, if possible, take your tablets and/or the container with you.
Exceeding the correct dosage may cause blood pressure to become too low, and the heart to beat irregularly or faster. It may also lead to unconsciousness.
What should I do if I forget to take my Zanidip ?Take your normal dose immediately and continue as prescribed the next day.
If you forget to take your tablet, take it as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose.
Driving and using machinesZanidip should not affect your ability to drive or use machines but caution should be exercised because of the possibility of dizziness, weakness and tiredness. Do not drive or use machines until you know how Zanidip affects you.
What undesirable effects may occur ?Like all medicines, Zanidip can cause side effects. The most commonly reported side effects in the clinical trials were:
Headache, dizziness, ankle swelling, faster heart beats, awareness of the beating of the heart, and transient episodic redness of the face and neck.
Uncommon (affecting less than 1 out 100 patients): headache, dizziness, faster heart beats, awareness of the beating of the heart, transient episodic redness of the face and neck, ankle swelling.
Rare (affecting less than 1 out 1, 000 of patients): sleepiness, chest pain, nausea, vomiting, rash, muscle pain, passage of large amounts of urine, tiredness.
Very rare (affecting less than 1 out 10, 000 of patients): fainting, allergic reaction, swelling of gums, increase in blood test values which show changes in the way the liver is working, fall in blood pressure which can cause dizziness, light-headedness or fainting, increase in the usual number of times one urinates, and chest pain.
If you experience any of these problems with Zanidip, please tell your doctor immediately.
If you experience any other side effects, tell your doctor immediately.
When reporting any undesirable effects, remember to mention any other drugs you may be taking, even those for occasional use.
How should I store my Zanidip tablets ?It is best if you keep your Zanidip tablets in the original container supplied. The package should be kept in a dry place. Do not store above 25° C
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
Do not use tablets after the expiry date, which is marked on both the outer carton and on each blister strip of tablets.
Remember: this medicine has been prescribed for you. Do not give it to anyone else under any circumstances.
PL 04595/0005 (Zanidip 10 mg film-coated tablets).
PL 04595/0010 (Zanidip 20 mg film-coated tablets).
Date of review of this leaflet: May 2006
For any further information about this product, please ring: 0044 (0) 1784 898300
*The printed leaflet will refer to the marketed pack size of 28 tablets only.
Famciclovir 125mg, 250mg, 500mg, 750mg Film-coated Tablets
Famciclovir 125mg, 250mg, 500mg, 750mg film-coated tablets
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What famciclovir is and what it is used for 2. Before you use famciclovir 3. How to use famciclovir 4. Possible side effects 5. How to store famciclovir 6. Further information What Famciclovir Is And What It Is Used ForFamciclovir belongs to a group of medicines called antiviral agents. These are medicines used in the treatment of infections caused by viruses.
Famciclovir is used in patients with a normal immune system to treat attacks of genital herpes. Genital herpes is a viral infection which is normally spread by sexual contact. It causes blisters and burning around your genitals, which may be painful.
It is also sometimes used to prevent further episodes of genital herpes in patients with a normal immune system.
Famciclovir is used in the treatment of shingles in both patients with a normal immune system and in patients with a weakened immune system. Shingles is caused by a virus called herpes zoster or varicella zoster.
It is used in the treatment of herpes zoster infections of the eye in patients with a normal immune system.
Famciclovir is used in patients with a weakened immune system for the treatment of infections caused by herpes simplex virus, such as genital herpes or fever blisters (herpes labialis).
Before You Use Famciclovir Do not use famciclovir if you are allergic (hypersensitive) to famciclovir, penciclovir or any of the other ingredients of famciclovir. Take special care with famciclovir if you have kidney problems. You should talk with your doctor before you begin treatment with famciclovir, as it may be necessary to adjust your dosage.As genital herpes is a sexually transmitted disease, you should avoid sexual activity if you have any symptoms of herpes, even if you have started treatment, to reduce the risk of spreading the disease to your partner. You should also take appropriate steps for protected intercourse if you are on long-term treatment with famciclovir for the same reason. Patients should therefore take appropriate steps for protected intercourse (i.e. use condoms).
Consult your doctor if one of the above-mentioned warnings applies to you, or has applied to you in the past.
Using other medicinesPlease tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are taking other medicines at the same time as famciclovir, these medicines may interfere with each other. This might be harmful. The effects of the medicines could be increased or diminished and side effects could occur more easily.
In particular this applies to:
probenecid, a medicine against viruses and gout some painkillers such as acetylsalicylic acid and ibuprofen Using famciclovir with food and drinkFamciclovir can be taken with or without food. Swallow the tablets with water.
Pregnancy and breast-feedingPregnancy
It is not known if it is safe to use famciclovir during pregnancy. Famciclovir must not be used during pregnancy, unless it is absolutely necessary and only in accordance with your doctor's instructions.
Breast-feeding
There is limited experience with famciclovir in breast-feeding women. Therefore, it should not be used during breast-feeding unless you are directly instructed to do so by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machinesIn rare instances, use of famciclovir may have side effects, such as dizziness, drowsiness and confusion.
If you experience any such side effects then do not drive or operate machinery.
How To Use FamciclovirAlways use famciclovir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Treatment with famciclovir should start as soon as possible after the symptoms of eruption/rash appear.
You should keep taking the medicine even if there is no improvement, as it may take several days for the medicine to work.
Keep taking the tablets until you have used the whole pack, unless your doctor has given you other instructions. Use lower dosage strength tablets, where these are available.
Adults
Recurrent genital herpes infection in patients with a normal immune system: 250mg twice daily.
In the treatment of genital herpes, you should start taking famciclovir as soon as possible after the occurrence of the first symptoms (pain, burning sensation, blisters).
First outbreak of genital herpes in patients with a normal immune system: 250mg three times daily.
In the treatment of genital herpes, you should start taking famciclovir as soon as possible after the occurrence of the first symptoms (pain, burning sensation, blisters).
Prevention of further recurrences of genital herpes in patients with a normal immune system: one 250mg tablet twice daily.
Prevention of recurring outbreak of genital herpes in HIV patients: 500mg twice daily.
Genital herpes infection in patients with a weakened immune system: 500mg twice daily.
In the treatment of genital herpes, you should start taking famciclovir as soon as possible after the occurrence of the first symptoms (pain, burning sensation, blisters).
Fever blisters in patients with a weakened immune system: 500mg twice daily.
In the treatment of a fever blister (herpes labialis), you should start taking famciclovir as soon as possible after the occurrence of the first symptoms of the infection (pain, burning sensation, blisters).
Shingles in patients with a normal immune system: 500mg three times daily.
In the treatment of shingles (herpes zoster), you should start taking famciclovir as soon as possible (within 48 hours) after the occurrence of the first symptoms of the infection (rash).
Herpes zoster infection of the eye in patients with a normal immune system: 500mg three times daily or 750mg twice daily* for 7 days.
* Only relevant for the 750mg strength.
Shingles in patients with a weakened immune system: 500mg three times daily.
In the treatment of shingles (herpes zoster), you should start taking famciclovir as soon as possible (within 48 hours) after the occurrence of the first symptoms of the infection (rash).
Patients with kidney problems
Depending on how severely the function of your kidneys is affected, your doctor may reduce the dose of famciclovir you must take.
Elderly patients
Your doctor may adjust your dosage of famciclovir according to your kidney function.
Children
Famciclovir is not recommended for use in children below 18 years of age due to lack of data on safety and efficacy.
Duration of treatmentTreatment of genital herpes in patients with a normal immune system: 5 days.
Treatment of genital herpes in patients with a weakened immune system: 7 days.
Prevention of recurrence of genital herpes in patients with a normal immune system: 6-12 months. You should only take famciclovir for as long as your doctor has told you.
Shingles in patients with a normal immune system: 7 days.
Shingles in patients with a weakened immune system: 10 days.
Fever blisters in patients with a weakened immune system: 7 days.
If you use more famciclovir than you shouldContact your doctor or pharmacist if you have taken more famciclovir than stated in this leaflet, or more than the doctor has prescribed.
Rarely, acute kidney failure has occurred in patients with existing kidney disease when the dose of famciclovir was not adjusted accordingly.
If you forget to use famciclovirIf you forget to take the medicine, take it as soon as you remember, or skip the forgotten tablet if it is time for your next dose. Then continue taking the tablets as normal.
Do not take a double dose to make up for a forgotten dose. If you have forgotten several doses, you should contact your doctor.
If you stop using famciclovirDo not stop taking famciclovir without consulting your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side EffectsLike all medicines, famciclovir can cause side effects, although not everybody gets them.
The following side effects may occur:
Common side effects (occur in 1 to 10 users in 100)
Headache Nausea, diarrhoea, vomiting, abdominal pain, constipation Increased sweating ItchingRare side effects (occur in 1 to 10 users in 10,000)
Confusion (mainly in elderly patients)Very rare effects (occur in less than 1 user in 10,000)
Blood disorders (shortage of blood cells, called blood platelets that help blood to clot) accompanied by bruises and proneness to bleeding (so-called thrombocytopenia) Hallucinations (seeing and hearing things that are not really there) Dizziness, fatigue (tiredness), drowsiness (primarily in elderly patients) Yellowing of the skin and eyes (jaundice) Abnormal liver function tests Severe skin reactions, such as serious allergic reactions (hypersensitivity) with (high) temperature, dark red patches on the skin, joint pains and/or eye infections (so-called Stevens-Johnson syndrome), acute severe (hypersensitivity) reactions associated with fever and blisters on the skin, shedding of skin (so-called toxic epidermal necrolysis) or rash with reddish (weeping) irregular patches (so-called erythema multiforme); rash, nettle rashNot known (cannot be estimated from the available data)
FeverIf any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store FamciclovirKeep out of the reach and sight of children.
Do not store above 30°C.
Store in the original package to protect from moisture.
Do not use famciclovir after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information What Famciclovir Tablets containThe active substance is famciclovir.
125mg tablet: each tablet contains 125mg of famciclovir.
250mg tablet: each tablet contains 250mg of famciclovir.
500mg tablet: each tablet contains 500mg of famciclovir.
750mg tablet: each tablet contains 750mg of famciclovir.
The other ingredients are:
Tablet core: Starch Pregelatinised, Sodium Laurilsulfate, Cellulose, Microcrystalline, Croscarmellose Sodium, Silica Colloidal Anhydrous, Stearic acid.
Film-coating:
Hypromellose (E464), Titanium Dioxide (E171), Macrogol 4000, Macrogol 6000.
What Famciclovir Tablets look like and contents of the pack125mg film-coated tablets: white, round, biconvex, film-coated tablets with diameter of 7.6mm approximately.
250mg film-coated tablets: white, round, biconvex, film-coated tablets, scored on one side with diameter of 10.6mm approximately.
500mg film-coated tablets: white, oval, film-coated tablets, scored on both sides with dimensions of 18.2 x 8.6mm approximately.
750mg film-coated tablets: white, oval, film-coated tablets with dimensions of 20.5 x 9.8mm approximately.
250mg and 500mg film-coated tablets: The tablet can be divided into equal halves. Use lower strength tablets where these are available.
Famciclovir Tablets are available in blister packs of:
125mg: 10 tablets
250mg: 15, 21, 56 tablets
500mg: 14, 30, 56 tablets
750mg: 7 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Winthrop Pharmaceuticals PO Box 611 Guildford Surrey GU1 4YS UK Specifar S.A 1, 28 Octovriou str. 12351 Ag. Varvara Athens GreeceThis leaflet was last revised in June 2009
5664 (Specifar’s Item No.)
PC 3261
MYFORTIC film coated gastro-resistant tablets
MYFORTIC
Film-coated gastro-resistant tablets (mycophenolic acid)
Myfortic 180mg and 360mg film-coated gastro-resistant tablets
mycophenolic acid (as mycophenolate sodium)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicineKeep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
In this leaflet 1. What Myfortic is and what it is used for 2. Before you take Myfortic 3. How to take Myfortic 4. Possible side effects 5. Storing Myfortic 6. Further information Myfortic 180mg and 360mg film-coated gastro-resistant tabletsThe active substance in Myfortic is mycophenolic acid. Myfortic 180mg film-coated gastro-resistant tablets contain 180mg mycophenolic acid (as mycophenolate sodium). Myfortic 360mg film-coated gastro-resistant tablets contain 360mg mycophenolic acid (as mycophenolate sodium).
The other ingredients of the tablet are: maize starch, povidone, crospovidone, lactose anhydrous, silica colloidal anhydrous, magnesium stearate. The tablet coating contains: hypromellose phthalate, titanium dioxide (E171), iron oxide yellow (E172).
The 180mg tablets also contain indigo carmine (E132).
The 360mg tablets also contain iron oxide red (E172).
Marketing Authorisation Holder Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Manufacturer responsible for release onto the market Novartis Pharma S.A.S. 26 rue de la Chapelle 68330 Huningue France What Myfortic is and what it is used forMyfortic film-coated gastro-resistant tablets belong to the class of drugs known as immunosuppressants. Immunosuppressants reduce your body's response to anything that it sees as "foreign" - which includes transplant organs.
Myfortic 180mg film-coated gastro-resistant tablets are lime green, film-coated round tablets, with the imprint "C" on one side. Myfortic 360mg film-coated gastro-resistant tablets are pale orange/red, film-coated ovoid tablets, with the imprint "CT" on one side.
Myfortic comes in the following pack sizes:
180mg tablets: cartons containing 20,50,100,120 or 250 tablets. 360mg tablets: cartons containing 50, 100, 120 or 250 tablets.Not all pack sizes may be marketed.
Myfortic is used to prevent your body from rejecting your kidney transplant. Myfortic is used together with other drugs known as ciclosporin and corticosteroids.
If you have any questions about how Myfortic works or why this medicine has been prescribed for you, ask your doctor.
Before you take MyforticMyfortic will only be prescribed for you by a doctor with experience in transplantation medicine. Follow your doctor's instructions carefully.
Do not take Myfortic:If you are allergic (hypersensitive) to mycophenolic acid, mycophenolate sodium or mycophenolate mofetil or to any of the ingredients of Myfortic listed at the beginning of this leaflet.
Take special care with Myfortic:If the answer to any of the following questions is 'yes', talk to your doctor before you start to take Myfortic:
Do you now, or have you ever had any problems with your digestive system, e.g., stomach ulcers? Do you need to receive vaccines (especially live vaccines)? It is important to seek your doctor's advice first. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose). If you know that you have a hereditary enzyme deficiency such as Lesch-Nyhan or Kelley-Seegmiller syndrome.In case of any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding you should inform your doctor immediately.
Myfortic reduces your body's defence mechanism. Because of this, there is an increased risk of skin cancer. You should therefore limit your exposure to sunlight and UV light by covering exposed areas as much as possible, wearing a hat when there is a risk of burning, and using sunscreen with a high protection factor.
Myfortic and older peopleMyfortic can be given to older people.
Myfortic in children and adolescentsThere is not enough experience to recommend the use of Myfortic in children and adolescents.
Pregnancy and Breast-feedingIf you are a woman you should make sure that you are not pregnant e.g. by means of a negative pregnancy test, before you start taking Myfortic. Your doctor should advise you about contraception before starting Myfortic, whilst taking it and for six weeks after you have stopped taking it. This is because Myfortic may cause damage to your unborn baby.
Tell your doctor straight away if you are pregnant, breast feeding, become pregnant, or plan to start a family in the near future.
Driving and using machines:Myfortic is unlikely to affect your ability to drive or use machines.
Taking other medicines:Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you have bought without a prescription.
In particular, you should inform your doctor if you are taking any of the following:
Azathioprine (another immunosuppressant) Tacrolimus (another immunosuppressant) Any other immunosuppressive agents other than ciclosporin and corticosteroids. Colestyramine (used to treat patients with high blood cholesterol and certain other disorders) Antacids Aciclovir or ganciclovir (used for viral infections).Your dose of Myfortic may need to be adjusted if your doctor considers it necessary for you to interrupt or stop taking ciclosporin therapy. Your doctor should discuss this with you.
You should tell your doctor if you plan to receive any vaccinations (see Take Special Care with Myfortic section)
How to take MyforticFollow your doctor's instructions carefully. Do not exceed the recommended dosage.
Do not stop taking Myfortic unless your doctor tells you to.
How much to takeIf you have just had your transplant, then the first dose of 720mg will be given to you within 72 hours of your transplant operation.
The recommended daily dose is 1440mg. This is taken as two separate doses of 720mg each.
If you are taking 180mg tablets : This means taking 4 tablets each morning and 4 tablets each evening.
If you are taking 360mg tablets : This means taking 2 tablets each morning and 2 tablets each evening.
How to take MyforticSwallow the tablets whole with a glass of water. Do not break or crush them and do not take any tablets that are broken or split.
You can take Myfortic either with food or without food. You should choose one of these options and continue to take it in this way to make sure that absorption of your medication is consistent.
How long to take MyforticUsually treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplant. You should follow the advice of your doctor.
If you take more Myfortic than you should:If you take more tablets than you have been told to take, or if someone else accidentally takes your medicine, tell your doctor immediately or go straight to your nearest Casualty Department.
If you forget to take Myfortic:If you forget to take Myfortic, take it as soon as you remember unless it is almost time for your next dose. Then continue to take your tablets at the usual times.
Effects when treatment with Myfortic is stopped:Stopping your treatment with Myfortic may increase the chance of rejection of your transplant. Do not stop taking your medicine unless your doctor tells you to.
Possible side effectsLike all medicines, Myfortic can have side effects, even when used as directed. Most of these are similar to those you would have with other mycophenolic acid compounds such as mycophenolate mofetil. Some of the more usual problems include diarrhoea and fewer white cells in your blood.
Your doctor will do regular blood tests to monitor any changes in the number of your blood cells or changes in the levels of any of the substances carried in your blood, e.g. sugar, fat, and cholesterol.
Myfortic reduces your body's own defence mechanisms to stop you rejecting your transplant. Consequently your body will not be as good as normal at fighting infections. So if you are taking Myfortic you may be at increased risk of infections caused by bacteria, viruses or fungi. These may include infections of wounds, blood, bones, chest, heart or brain. Some infections may be life threatening.
As with other immunosuppressive medications, there is an increased risk of developing certain types of cancer whilst taking Myfortic. Skin cancer may become apparent as unexpected growths that may be shiny or ulcerating, and cancer of the white blood cells may appear as swollen glands (lymph nodes).
Other effects may include:
General symptoms including tiredness, fever, flu-like illness, swelling in your lower limbs, thirst, chills, pain and weakness.
Disorders of the mouth such as bad breath, tongue discolouration, dry mouth and gum overgrowth.
Disorders of the digestive system including loose stools, constipation, nausea, vomiting, abdominal swelling, pain or tenderness, heartburn, indigestion, flatulence, inflammation, bleeding, lip and stomach ulcers, salivary gland blockage and inflammation of the pancreas.
Disorders of the nervous system including headache, tremor and difficulty sleeping.
Disorders of the skin including hair loss and bruising.
Urinary disorders such as kidney problems, blood in the urine or difficulty passing urine.
Disorders of the blood and vascular disorders including reduced numbers of white cells, red cells and platelets and swollen glands.
Metabolic disorders such as weight loss, high levels of lipids or cholesterol in your blood, low levels of phosphate or diabetes.
Disorders of the lung or respiratory system including cough, wheezing, fluid on the lungs, infections and pneumonia.
Disorders of the heart including abnormal heart beat.
Other side effects that have been reported include abnormal tests of liver function, blurred vision, conjunctivitis, impotence, back pain, muscle cramps, strange dreams, delusions and arthritis.
If any of these affects you, tell your doctor. If you notice any other side effects not mentioned in this leaflet, please inform your doctor. However, do not stop taking your medicine unless you have discussed this with your doctor first.
Storing Myfortic Do not store Myfortic above 30°C. Store Myfortic in the original package in order to protect from moisture and light. Do not use Myfortic after the expiry date printed on the box. Do not use any Myfortic pack that is damaged or shows signs of tampering. Keep Myfortic out of the reach and sight of children. If your doctor decides to stop your treatment, return any leftover medicine to the Pharmacist. Only keep it if your doctor tells you to. Further InformationLeaflet approved: November 2007
Myfortic 180mg film-coated gastro-resistant tablets: PL 00101/0664
Myfortic 360mg film-coated gastro-resistant tablets: PL 00101/0665
Arimidex 1mg Film-Coated Tablet
Arimidex 1 mg Film-coated Tablets
anastrozole
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Arimidex is and what it is used for 2. Before you take Arimidex 3. How to take Arimidex 4. Possible side effects 5. How to store Arimidex 6. Further information What Arimidex is and what it is used forArimidex contains a medicine called anastrozole. This belongs to a group of medicines called 'aromatase inhibitors'. Arimidex is used to treat breast cancer in women who have gone through the menopause.
Arimidex works by cutting down the amount of the hormone called oestrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called 'aromatase'.
Before you take Arimidex Do not take Arimidex if: You are allergic (hypersensitive) to anastrozole or any of the other ingredients of Arimidex (see Section 6: Further information). You still have menstrual periods and have not yet gone through the menopause. You have moderate or severe liver problems. You have severe kidney problems. You are taking a medicine called tamoxifen or medicines that contain oestrogen. (See the section called 'Taking other medicines' overleaf.) You are pregnant or breast-feeding. (See the section called 'Pregnancy and breast-feeding' overleaf.)Do not take Arimidex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Arimidex.
Arimidex should not be given to children.
Take special care with ArimidexCheck with your doctor or pharmacist before taking Arimidex if:
You have ever had a condition that affects the strength of your bones (osteoporosis). You have problems with your liver or kidneys.If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Arimidex.
If you go into hospital, let the medical staff know you are taking Arimidex.
Taking other medicinesPlease tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Arimidex can affect the way some medicines work and some medicines can have an effect on Arimidex.
Do not take Arimidex if you are already taking any of the following medicines:
Tamoxifen. This is because tamoxifen may stop Arimidex working properly. Medicines that contain oestrogen, such as hormone replacement therapy (HRT).If this applies to you, ask your doctor or pharmacist for advice.
Tell your doctor or pharmacist if you are taking the following:
A medicine known as an 'LHRH analogue'. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin.These medicines are used to treat breast cancer, certain female health (gynaecological) conditions, and infertility.
Pregnancy and breast-feedingDo not take Arimidex if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.
Driving and using machines Arimidex is not likely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel weak or sleepy while taking Arimidex. If this happens to you, ask your doctor or pharmacist for advice. Important information about some of the ingredients of ArimidexArimidex contains lactose which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
How to take ArimidexAlways take Arimidex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Arimidex should not be given to children.
Taking Arimidex The usual dose is one tablet once a day. Try to take your tablet at the same time each day. Swallow the tablet whole with a drink of water. It does not matter if you take Arimidex before, with or after food.Keep taking Arimidex for as long as your doctor tells you to. It is a long-term treatment and you may need to take it for several years.
If you take more Arimidex than you shouldIf you take more Arimidex than you should, talk to a doctor straight away.
If you forget to take Arimidex If you forget to take a dose, just take your next dose as normal. Do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking ArimidexDo not stop taking your tablets unless your doctor tells you to.
Possible side effectsLike all medicines, Arimidex can cause side effects, although not everybody gets them.
Serious allergic reactions
If any of the following happen to you, call an ambulance or see a doctor straight away - you may need urgent medical treatment:
Swelling of the face, lips, tongue or throat. This may cause difficulty in swallowing or breathing (rare, affects less than 1 in 1000 people). An extremely severe skin reaction with ulcers or blisters on the skin. This is known as 'Stevens-Johnson syndrome' (the frequency of this side effect is unknown).Liver effects (uncommon, affect less than 1 in 100 people)
The signs may include:
Yellowing of your skin or eyes, dark coloured urine, a loss of appetite and a general feeling of being unwell.If this happens to you, see a doctor straight away - you may need medical tests or treatment.
Other possible side effects (usually not severe):
Very common (affects more than 1 in 10 people)
Hot flushes. Feeling weak. Pain or stiffness in your joints. Skin rash (this can include a type of rash called 'hives' or 'nettle rash'). Feeling sick (nausea). Headache.Common (affects less than 1 in 10 people)
Vaginal dryness. Bleeding from the vagina (usually in the first few weeks of treatment - if the bleeding continues, talk to your doctor). Thinning of your hair (hair loss). Diarrhoea. Loss of appetite. Raised or high levels of a fatty substance known as cholesterol in your blood. This would be seen in a blood test. Being sick (vomiting). Feeling sleepy. Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand). Changes in blood tests that show how well your liver is working.Uncommon (affects less than 1 in 100 people)
Trigger finger (a condition in which your finger or thumb catches in a bent position).Effects on your bones
Arimidex lowers the amount of the hormone called oestrogen that is in your body. This may lower the mineral content of your bones. Your bones may be less strong and may be more likely to fracture. Your doctor will manage these risks according to treatment guidelines for managing bone health in women who have gone through the menopause. You should talk to your doctor about the risks and treatment options.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Arimidex Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them. Do not take your tablets after the expiry date which is stated on the container. The expiry date refers to the last day of that month. Keep your tablets below 30°C. Keep your tablets in the container they came in. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further information What Arimidex containsThe active substance is anastrozole. Each tablet contains 1 milligram (mg) of anastrozole.
The other ingredients are lactose monohydrate, macrogol, magnesium stearate, hypromellose, povidone, sodium starch glycolate and titanium dioxide.
What Arimidex looks like and contents of the packArimidex comes as film-coated tablets. The tablets are white and round.
Arimidex comes in blister packs of 28 tablets.
Marketing Authorisation Holder and ManufacturerThe Marketing Authorisation for Arimidex 1 mg Film-coated Tablets is held by
AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU UKArimidex is manufactured by
AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA UKTo listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Arimidex 1 mg Tablets
Reference number 17901/0002
This is a service provided by the Royal National Institute of Blind People.
Leaflet prepared: March 2009
© AstraZeneca 2009
Arimidex is a trade mark of the AstraZeneca group of companies.
ONC 08 0049b
P026587
Ethmozine
Generic Name: moricizine (more IH sih zeen)
Brand Names: Ethmozine
Moricizine affects the way that your heart beats.
Moricizine is used to treat seriously irregular heartbeat patterns.
Moricizine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Ethmozine (moricizine)?Call your doctor immediately if you experience chest pain, chest discomfort, worsening irregular heartbeats, or a fever.
Do not skip doses or change your dosing schedule without first talking to your doctor. Changing your schedule could make your condition much worse. It is important to take this medication exactly as directed by your doctor. Use caution when driving, operating machinery, or performing other hazardous activities. Moricizine may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. What should I discuss with my healthcare provider before taking Ethmozine (moricizine)?Before taking moricizine, tell your doctor if you have
any other type of heart disease or heart problems,
liver disease, or kidney disease.You may not be able to take moricizine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
Moricizine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take moricizine without first talking to your doctor if you are pregnant. Moricizine passes into breast milk. It is not known whether moricizine will affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. How should I take Ethmozine (moricizine)?Take moricizine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Do not skip doses or change your dosing schedule without first talking to your doctor. Changing your schedule could make your condition much worse. It is important to take this medication exactly as directed by your doctor. Store moricizine at room temperature away from moisture and heat.See also: Ethmozine dosage (in more detail)
What happens if I miss a dose?Try not to miss any doses of this medication. Missing doses could be very dangerous.
If you do miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication. A double dose could be dangerous.
What happens if I overdose? Seek emergency medical attention.Symptoms of a moricizine overdose include vomiting, tiredness, dizziness, an irregular heartbeat, severe chest pain, a heart attack, difficulty breathing, and coma.
What should I avoid while taking Ethmozine (moricizine)? Use caution when driving, operating machinery, or performing other hazardous activities. Moricizine may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. Ethmozine (moricizine) side effects If you experience any of the following serious side effects, stop taking moricizine and seek emergency medical attention:an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
a new or a worsening irregular heartbeat pattern;
fever; or
chest pain or chest discomfort.
Other, less serious side effects may be more likely to occur. Continue to take moricizine and talk to your doctor if you experience
dizziness or tiredness;
anxiety;
upset stomach, vomiting, or diarrhea;
dry mouth;
headache; or
blurred vision.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Ethmozine (moricizine)?Before taking moricizine, tell your doctor if you are taking any of the following drugs:
cimetidine (Tagamet, Tagamet HB);
cisapride (Propulsid);
diltiazem (Cardizem, Dilacor, Diltia XT, Tiazac);
propranolol (Inderal);
theophylline (Theo-Dur, Slo-Bid, Elixophyllin, Slo-Phyllin, Aerolate, Theolair, others);
warfarin (Coumadin); or
dofetilide (Tikosyn), procainamide (Procan SR, Procanbid, Pronestyl, Pronestyl-SR), sotalol (Betapace, Betapace AF), or another medicine used to treat irregular heartbeats.
You may not be able to take moricizine or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with moricizine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
More Ethmozine resources Ethmozine Side Effects (in more detail) Ethmozine Dosage Ethmozine Use in Pregnancy & Breastfeeding Drug Images Ethmozine Drug Interactions Ethmozine Support Group 1 Review for Ethmozine - Add your own review/rating Ethmozine Prescribing Information (FDA) Ethmozine Advanced Consumer (Micromedex) - Includes Dosage Information Ethmozine MedFacts Consumer Leaflet (Wolters Kluwer) Compare Ethmozine with other medications Ventricular Tachycardia Where can I get more information? Your pharmacist has more information about moricizine written for health professionals that you may read. What does my medication look like?Moricizine is available with a prescription under the brand name Ethmozine. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Ethmozine 200 mg--light-green, oval, film-coated tablets
Ethmozine 250 mg--light-orange, oval, film-coated tablets
Ethmozine 300 mg--light-blue, oval, film-coated tablets
See also: Ethmozine side effects (in more detail)
JANUVIA 100mg film-coated tablets
Januvia 100 mg film-coated tablets
Sitagliptin
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Januvia is and what it is used for 2. Before you take Januvia 3. How to take Januvia 4. Possible side effects 5. How to store Januvia 6. Further information What Januvia Is And What It Is Used ForJanuvia is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
Januvia helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body. It is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when Januvia is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur.
Your doctor has prescribed Januvia to help lower your blood sugar, which is too high because of your type 2 diabetes. Januvia can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.
What is type 2 diabetes?Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Before You Take Januvia Do not take Januvia if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of Januvia. Take special care with JanuviaTell your doctor if you have or have had:
type 1 diabetes diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting) any kidney problems, or any past or present medical problems. If you have kidney problems, Januvia may not be the right medicine for you. an allergic reaction to Januvia.If you are taking a sulphonylurea or insulin with Januvia you may experience low blood sugar. Your doctor may reduce the dose of your sulphonylurea or insulin medication.
Taking other medicinesJanuvia may be taken with most medicines. Tell your doctor or pharmacist about all the medicines you take or have recently taken. This includes prescription and non-prescription medicines, and herbal supplements.
Taking Januvia with food and drinkYou can take Januvia with or without food and drink.
Pregnancy and breast-feedingWomen who are pregnant or plan to become pregnant should consult their doctor before taking Januvia. You should not use Januvia during pregnancy.
It is not known if Januvia passes into breast milk. You should not use Januvia if you are breast-feeding or plan to breast-feed.
Driving and using machinesJanuvia is not expected to interfere with your ability to drive or to use machines. However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
How To Take JanuviaAlways take Januvia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
one 100 mg film-coated tablet once a day by mouthYour doctor may prescribe Januvia alone or with certain other medicines that lower blood sugar.
Continue to take Januvia as long as your doctor prescribes it so you can continue to help control your blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking Januvia.
If you take more Januvia than you shouldIf you take more than the prescribed dosage of Januvia, contact your doctor immediately.
If you forget to take JanuviaIf you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of Januvia.
Possible Side EffectsLike all medicines, Januvia may cause side effects, although not everybody gets them.
Very common side effects (more than 1 per 10 patients)
Common side effects (less than 1 per 10 but more than 1 per 100 patients)
Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Common: nausea
Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.
Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.
Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea:
Common: low blood sugar
Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea and metformin:
Very common: low blood sugar
Common: constipation
Some patients have experienced the following side effects while taking Januvia and pioglitazone:
Common: low blood sugar and flatulence. In addition, some patients have reported foot swelling while taking Januvia and pioglitazone. These side effects may be seen with sitagliptin and any glitazone (e.g., rosiglitazone).
Some patients have experienced the following side effects while taking Januvia in combination with rosiglitazone and metformin:
Common: headache, cough, diarrhoea, vomiting, low blood sugar, fungal skin infection, upper respiratory infection, swelling of the hands or legs.
Some patients have experienced the following side effects while taking Januvia in combination with insulin (with or without metformin):
Common: headache, low blood sugar and flu
Uncommon: dry mouth, constipation
Some patients have experienced the following side effects while taking Januvia alone:
Common: low blood sugar, headache
Uncommon: dizziness, constipation
In addition, some patients have reported the following side effects while taking Januvia:
Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
During post-marketing experience the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking Januvia and call your doctor right away. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes. Inflammation of the pancreas has also been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store JanuviaKeep out of the reach and sight of children.
Do not use Januvia after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information What Januvia contains The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin. The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), and sodium stearyl fumarate. The tablet film coating contains: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172). What Januvia looks like and contents of the packRound, beige film-coated tablet with “277” on one side.
Opaque blisters (PVC/PE/PVDC and aluminum). Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and ManufacturerThe Marketing Authorisation Holder is:
Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU United KingdomThe Manufacturer is:
Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21 27100 - Pavia ItalyFor any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom Merck Sharp and Dohme Limited Tel: +44 (0) 1992 467272 Email:medinfo_uk@merck.comThis leaflet was last approved in November 2009.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
denotes registered trademark of
Merkc & Co Inc. Whitehouse Station NJ USA© Merck Sharp & Dohme Limited 2009. All rights reserved.
PIL.JAN.09.UK.3169 II-011 F.T.131109
Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UKZirtek Allergy Relief Tablets
Zirtek ALLERGY RELIEF
cetirizine hydrochloride
ONE A DAY
What You Should Know About Your TabletsPlease read this leaflet carefully before you start taking this medicine. It provides a summary of the information currently available on Zirtek Allergy Relief. For further information or advice ask your doctor or pharmacist.
What Is In Zirtek Allergy ReliefEach tablet contains 10 mg of cetirizine hydrochloride together with microcrystalline cellulose (E460), lactose, colloidal anhydrous silica and magnesium stearate (E572). The film coating hydroxypropylmethyl cellulose (E464), titanium dioxide (E171) and polyethylene glycol.
The tablets are small white oblong film-coated tablets, each scored and bearing the code Y/Y. Your medicine is supplied in blister packs of 7 tablets.
Your medicine belongs to the antihistamine group of drugs.
Product licence number: PL 00039 / 0561
This medicine is manufactured and licenced by:
UCB Pharma Ltd 208 Bath Road Slough SL1 3WE When Is Zirtek Allergy Relief UsedThis medicine treats people suffering from hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).
Antihistamines like Zirtek Allergy Relief relieve the unpleasant symptoms and discomfort associated with the above conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.
Before Taking ZirtekAllergy ReliefIf you are pregnant or if your doctor has told you that you have kidney problems, you should consult your doctor before taking these tablets. You should not take this medicine if you are breastfeeding or if you have ever had an allergic reaction to any of its constituents (see 'What is in Zirtek Allergy Relief).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
As with all antihistamines, you should avoid excessive alcohol consumption when taking your tablets.
If you have ever had a reaction to an antihistamine in the past consult your doctor or pharmacist before taking these tablets.
How To Take Your TabletsAdults and children aged 12 years and over should take one tablet daily.
Each dose should be taken with water.
REMEMBER... If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.
If you accidentally take a larger dose than recommended consult your doctor immediately.
You may feel drowsy or dizzy, taking half your dose twice a day may reduce this.
Zirtek Allergy Relief tablets are not for use in children under 12 years of age.
If symptoms persist consult your doctor.
After Taking Zirtek Allergy Relief TabletsThese tablets do not cause side-effects in most people. However, as with all medicines, some people can react differently. If you:
have frequent headaches have an upset stomach become agitated have diarrhoea get a dry mouth feel weak and/or unwell experience unusual touch sensation experience fatigue, dizziness or drowsiness experience itchiness and skin rashStop taking the tablets and tell your doctor.
Other rare side effects have been reported such as bleeding and bruising easily, rapid heart beat, difficulty focussing, blurred vision, swelling, allergic reaction/shock, changes in liver function, fits, confusion, depression, aggression, weight increase, unusual limb movements, experience a bad taste in the mouth, fainting, hallucination, insomnia, bed wetting, pain and/or difficulty passing water, red and/or blotchy skin rash.
If you notice anything unusual or have these or any other unexpected effects stop taking the tablets and tell you doctor. These tablets do not normally cause drowsiness. However, individuals can react differently to treatment. If you are affected you should not drive or operate machinery, but should persist with the tablets as any drowsiness doesn't usually last very long.
Storing Your Tablets.Keep your tablets out of reach and sight of children.
Do not use after the expiry date shown under EXP on the end panel of the carton.
LEGAL STATUS: GSL.
Date of preparation of this leaflet: October 2005
© UCB 2004 - UCB logo
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