Juvanesta Comp

Juvanesta Comp may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Juvanesta Comp Benzylpenicillin

Benzylpenicillin is reported as an ingredient of Juvanesta Comp in the following countries:

Norway Dihydrostreptomycin

Dihydrostreptomycin is reported as an ingredient of Juvanesta Comp in the following countries:

Norway Penethamate Hydriodide

Penethamate Hydriodide is reported as an ingredient of Juvanesta Comp in the following countries:

Norway

International Drug Name Search

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Jutacor comp.

Jutacor comp. may be available in the countries listed below.

Ingredient matches for Jutacor comp. Captopril

Captopril is reported as an ingredient of Jutacor comp. in the following countries:

Germany Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Jutacor comp. in the following countries:

Germany

International Drug Name Search

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Cozaar - Comp 50 / 12.5mg, 100 / 12.5mg, 100 / 25mg Film-Coated Tablets

COZAAR COMP 50mg/12.5mg Film-coated Tablets

COZAAR COMP 100mg/12.5mg Film-coated Tablets

COZAAR COMP 100mg/25mg Film-coated Tablets

losartan potassium and hydrochlorothiazide

Read all of this leaflet carefully before taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your 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 Cozaar Comp is and what it is used for
2. Before you take Cozaar Comp
3. How to take Cozaar Comp
4. Possible side effects
5. How to store Cozaar Comp
6. Further information

What Cozaar Comp Is And What It Is Used For

Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure.

Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure).

Before You Take Cozaar Comp Do not take Cozaar Comp if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients in this medicine if you are allergic (hypersensitive) to other sulfonamide-derived substances (e. g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure) if you are more than 3 months pregnant. (It is also better to avoid Cozaar Comp in early pregnancy - See Pregnancy.) if you have severely impaired liver function if you have severely impaired kidney function or your kidneys are not producing any urine if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment if you are suffering from gout. Take special care with Cozaar Comp

You must tell your doctor if you think you are (or might become) pregnant. Cozaar Comp is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

It is important to tell your doctor before taking Cozaar Comp:

if you have previously suffered from swelling of the face, lips, throat or tongue if you take diuretics (water pills) if you are on a salt-restricted diet if you have or have had severe vomiting and/or diarrhoea if you have heart failure if your liver function is impaired (see section 2 “Do not take Cozaar Comp”) if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function) if you have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle) if you are diabetic if you have had gout if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus) if you have high calcium or low potassium levels or you are on a low potassium diet if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland). Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Diuretic agents such as the hydrochlorothiazide contained in Cozaar Comp may interact with other medicines.

Preparations containing lithium should not be taken with Cozaar Comp without close supervision by your doctor.

Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins).

It is also important for your doctor to know if you are taking

other medicines to reduce your blood pressure steroids medicines to treat cancer pain killers drugs for treatment of fungal infections arthritis medicines resins used for high cholesterol, such as colestyramine medicines which relax your muscles sleeping tablets opioid medicines such as morphine ‘pressor amines’ such as adrenaline or other drugs from the same group oral agents for diabetes or insulins.

Please also inform your doctor you are taking Cozaar Comp if you will be undergoing a radiographic procedure and will be given iodine contrast media.

Taking Cozaar Comp with food and drink

You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Cozaar Comp tablets.

Cozaar Comp tablets may be taken with or without food.

Pregnancy and breast feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Cozaar Comp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Cozaar Comp. Cozaar Comp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast feeding. Cozaar Comp is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast feed. Especially if your baby is a newborn, or born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children and adolescents

There is no experience with the use of Cozaar Comp in children. Therefore, Cozaar Comp should not be given to children.

Use in elderly patients

Cozaar Comp works equally well in and is equally well tolerated by most older and younger adult patients. Most older patients require the same dose as younger patients.

Driving and using machines

When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.

Important information about some of the ingredients of Cozaar Comp

Cozaar Comp contains lactose. 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 Cozaar Comp

Always take Cozaar Comp exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Cozaar Comp depending on your condition and whether you are taking other medicines. It is important to continue taking Cozaar Comp for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

High Blood Pressure

The usual dose of Cozaar Comp for most patients with high blood pressure is 1 tablet of Cozaar Comp 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets

If you take more Cozaar Comp than you should

In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. Overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Cozaar Comp

Try to take Cozaar Comp daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

Possible Side Effects

Like all medicines, Cozaar Comp tablets can cause side effects, although not everybody gets them.

If you experience the following, stop taking Cozaar Comp tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Common (affecting less than one person in 10 but more than one person in 100):

Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder, Diarrhoea, abdominal pain, nausea, indigestion, Muscle pain or cramps, leg pain, back pain, Insomnia, headache, dizziness, Weakness, tiredness, chest pain, Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.

Uncommon (affecting less than one person in 100 but more than one person in 1,000):

Anaemia, red or brownish spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in white blood cells, clotting problems and bruising, Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels, Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment, Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting, Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow, Ringing, buzzing, roaring or clicking in the ears, Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up), angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations, Inflammation of blood vessels, which is often associated with a skin rash or bruising, Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion, Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache, Jaundice (yellowing of the eyes and skin), inflammation of the pancreas, Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss, Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness, Frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine, Decreased sexual appetite, impotence, Swelling of the face, fever.

Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients)

Hepatitis (inflammation of the liver), abnormal liver function tests

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

How To Store Cozaar Comp

Keep out of the reach and sight of children.

Do not use Cozaar Comp after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

Blisters

Store Cozaar Comp in the original package in order to protect from light and moisture. Do not store the package above 30°C. Do not open the blister pack until you are ready to take the medicine.

Bottle

Store in the original container. Keep the bottle tightly closed in order to protect from light and moisture. Do not store the bottle above 25 °C.

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 Cozaar Comp contains

The active substances are losartan potassium and hydrochlorothiazide.

Cozaar Comp 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.

Cozaar Comp 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.

Cozaar Comp 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.

Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg contain the following inactive ingredients:

microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose.

Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.

Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).

Cozaar Comp 100 mg/12.5 mg also contains: titanium dioxide (E171) and carnauba wax (E903).

What Cozaar Comp looks like and contents of the pack

Cozaar Comp 50 mg/12.5 mg is supplied as yellow, oval film-coated tablets marked 717 on one side and plain or scored on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Cozaar Comp 100 mg/12.5 mg is supplied as white, oval film-coated tablets marked 745 on one side and plain on the other.

Cozaar Comp 100 mg/25 mg is supplied as light yellow, oval film-coated tablets marked 747 on one side and plain on the other.

Cozaar Comp is supplied in the following pack sizes:

Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.

Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets. HDPE bottles of 100 tablets.

Cozaar Comp 100 mg/25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets and unit-dose packages of 28,56 and 98 tablets for hospital use.. HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder in the UK and Malta is

Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

Manufacturers:

50mg/12.5mg strength:

Merck Manufacturing Division Shotton Lane Cramlington Northumberland NE23 3JU UK

100mg/12.5mg and 100mg/25mg strengths:

Merck Sharp & Dohme BV Waarderweg 39 2031 BN Haarlem Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Cosaar Plus – Filmtabletten, Fortzaar-Filmtabletten
Belgium COZAAR PLUS FORTE, COZAAR PLUS, LOORTAN PLUS FORTE, LOORTAN PLUS
Bulgaria Hyzaar
Cyprus FORTZAAR, HYZAAR
Denmark Cozaar Comp, . Cozaar Comp Forte, Fortzaar
Estonia HYZAAR, FORTZAAR
Finland Cozaar Comp, Cozaar Comp Forte
France Fortzaar, Hyzaar
Germany LORZAAR PLUS, CARDOPAL PLUS, LORZAAR VARIPHARM PLUS, FORTZAAR, FORTZAAR VARIPHARM< LORZAAR PLUS FORTE
Greece HYZAAR
Hungary Hyzaar, Hyzaar Forte.
Ireland ‘Cozaar’ Comp
Italy HIZAAR, FORZAAR, NEOLOTAN PLUS, LOSAZID
Latvia HYZAAR, Fortzaar
Lithuania FORTZAAR, HYZAAR
Luxembourg COZAAR PLUS FORTE , COZAAR PLUS, LOORTAN PLUS< LOORTAN PLUS FORTE
Malta "Cozaar Comp"
Netherlands Cozaar Plus, Fortzaar, Hyzaar
Poland HYZAAR, HYZAAR FORTE
Portugal COZAAR Plus, FORTZAAR, SIAARA, LORTAAN PLUS, Losartan + Hidrochlorotiazide Fross
Romania HYZAAR, FORTZAAR
Slovenia HYZAAR, FORTZAAR
Spain Cozaar Plus, Fortzaar
Sweden Cozaar Comp, Cozaar Comp Forte
United Kingdom COZAAR-COMP
Iceland COZAAR-COMP , COZAAR COMP FORTE
Norway Cozaar Comp, Cozaar Comp Forte

This leaflet was last approved in (07/2010)

PIL.HYZ.10.UK.3278.REN

Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

Registered trademark of EI du Pont de Nemours and Company, Wilmington, Delaware, USA.

© Merck Sharp & Dohme Limited 2010. All rights reserved.

Read More:

COZAAR 12.5mg, 25 mg, 50 mg and 100 mg Film-Coated Tablets

Cozaar 12.5 mg film-coated tablets

Cozaar 25 mg film-coated tablets

Cozaar 50 mg film-coated tablets

Cozaar 100 mg film-coated tablets

Losartan potassium

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 Cozaar is and what it is used for 2. Before you take Cozaar 3. How to take Cozaar 4. Possible side effects 5. How to store Cozaar 6. Further information What Cozaar Is And What It Is Used For

Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Cozaar is used

to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age. to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ? 0.5 g per day (a condition in which urine contains an abnormal amount of protein). to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan. in patients with high blood pressure and a thickening of the left ventricle, COZAAR has been shown to decrease the risk of stroke (“LIFE indication”). Before You Take Cozaar Do not take Cozaar if you are allergic (hypersensitive) to losartan or to any of its other ingredients, if your liver function is severely impaired, if you are more than 3 months pregnant. (It is also better to avoid Cozaar in early pregnancy-see "Pregnancy".). Take special care with Cozaar

You must tell your doctor if you think you are (or might become) pregnant. Cozaar is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)

It is important to tell your doctor before taking Cozaar:

if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 ‘Possible side effects’), if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body, if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special patient groups’), if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently, if your liver function is impaired (see sections 2 "Do not take Cozaar" and 3 "Dosage in special patient groups"), if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ?-blocker concomitantly, if you have problems with your heart valves or heart muscle, if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain), if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland). Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.

Take particular care if you are taking the following medicines while under treatment with Cozaar:

other blood pressure lowering medicines as they may additionally reduce your blood pressure. Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine, medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin), non-steroidal anti-inflammatory drugs such as indometacin, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood lowering effect of losartan.

If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.

Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Cozaar with food and drink

Cozaar may be taken with or without food.

Pregnancy and breast feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Cozaar before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Cozaar. Cozaar is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast Feeding

Tell your doctor if you are breast feeding or about to start breast feeding. Cozaar is not recommended for mothers who are breast feeding, and your doctor may choose another treatment for you if you wish to breast feed. Especially if your baby is a newborn, or born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children and adolescents

Cozaar has been studied in children. For more information,, talk to your doctor.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Cozaar is unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.

Important information about some of the ingredients of Cozaar

Cozaar contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Cozaar

Always take Cozaar exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Cozaar, depending on your condition and whether you are taking other medicines.

It is important to continue taking Cozaar for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

Adult Patients with high blood pressure

Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg) once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to 100 mg losartan (two tablets Cozaar 50 mg) once daily. If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.

Use in children or adolescents (6 to 18 years old)

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of Cozaar). The doctor may increase the dose if blood pressure is not controlled.

Adult Patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg) once a day. The dose may later be increased to 100 mg losartan (two tablets Cozaar 50 mg) once daily depending on your blood pressure response.

Losartan tablets may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

Adult Patients with heart failure

Treatment usually starts with 12.5 mg losartan (one tablet Cozaar 12.5 mg) once a day. Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week) up to the usual maintenance dose of 50 mg losartan (one tablet Cozaar 50 mg) once daily, according to your condition.

In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker.

Dosage in special patient groups

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Cozaar").

Administration

The tablets should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Cozaar until your doctor tells you otherwise.

If you take more Cozaar than you should

If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.

If you forget to take Cozaar

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Cozaar can cause side effects, although not everybody gets them.

If you experience the following, stop taking losartan tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients. You may need urgent medical attention or hospitalisation.

The side effects of medicines are classified as follows:

very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon affects 1 to 10 users in 1,000
rare: affects 1 to in 10 users in 10,000
very rare: affects less than 1 user in 10,000 patients
not known: frequency cannot be estimated from the available data

The following side effects have been reported with Cozaar:

Common:

dizziness, low blood pressure, debility, fatigue, too little sugar in the blood (hypoglycaemia), too much potassium in the blood (hyperkalaemia).

Uncommon:

somnolence, headache, sleep disorders, feeling of increased heart rate (palpitations), severe chest pain (angina pectoris), low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics), dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position, shortness of breath (dyspnoea), abdominal pain, obstipation, diarrhoea, nausea, vomiting, hives (urticaria), itching (pruritus), rash, localised swelling (oedema).

Rare:

inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura), numbness or tingling sensation (paraesthesia), fainting (syncope), very rapid and irregular heartbeat (atrial fibrillation) brain attack (stroke), inflammation of the liver (hepatitis), elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.

Not known:

reduced number of red blood cells (anaemia), reduced number of thrombocytes, migraine, cough, liver function abnormalities, muscle and joint pain, changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure, flu-like symptoms, increase in blood urea, serum creatinine and serum potassium in patients with heart failure, back pain and urinary tract infection, increased sensitivity to the sun (photosensitivity), unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis), impotence, inflammation of the pancreas (pancreatitis), low levels of sodium in the blood (hyponatraemia), depression, generally feeling unwell (malaise), ringing, buzzing, roaring, or clicking in the ears (tinnitus).

Side effects in children are similar to those seen in adults.

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 Cozaar

Keep out of the reach and sight of children.

Do not use Cozaar after the expiry date which is stated on the carton or the bottle label. The expiry date refers to the last day of that month.

Blisters

Store Cozaar in the original package in order to protect from light and moisture. Do not open the blister pack until you are ready to take the medicine.

Bottles

Store Cozaar in the original package. Store the bottle below 25°C. Keep the bottle tightly closed in order to protect from light and moisture.

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 Cozaar contains

The active substance is losartan potassium.

Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.

Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.

Each Cozaar 50 mg tablet contains 50 mg of losartan potassium.

Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.

The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hyprolose (E463), hypromellose (E464).

Cozaar 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.

The Cozaar 12.5 mg tablets also contain
carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.

The Cozaar 25 mg tablets also contain Carnauba wax (E903), Titanium dioxide (E171).

The Cozaar 50 mg tablets also contain Carnauba wax (E903), Titanium dioxide (E171).

The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).

What Cozaar looks like and contents of the pack

Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.

Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.

Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium. The tablets can be divided into equal halves.

Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.

Cozaar is supplied in the following pack sizes:

Cozaar 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles of 100 tablets.

Cozaar 25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.

Cozaar 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets.

Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

Manufacturer:

12.5 mg:

Merck Sharp & Dohme BV/MMD Waarderweg 39 2031 BN Haarlem Netherlands

25mg, 50mg and 100mg:

Merck Manufacturing Division Merck Sharp & Dohme Limited Shotton Lane Cramlington Northumberland NE23 3JU UK

This medicinal product is authorised in the Member States of the EEA under the following names:

Member State : Invented name

Austria: COSAAR 12,5 mg, 50mg or 100mg Filmtabletten
Belgium: COZAAR 12.5 mg, 50 mg or 100 mg
Belgium: COZAAR 12.5 mg, 50 mg or 100 mg
LOORTAN 12.5 mg, 50 mg or 100 mg
Bulgaria: COZAAR
Cyprus: COZAAR
Denmark: COZAAR, COZAAR STARTPAKKE
Estonia: COZAAR, COZAAR 12,5 mg
Finland: COZAAR 50 or 100 mg
France: COZAAR 50 scored coated or 100 mg film-coated tablets
Germany: CARDOPAL START 12.5 mg Filmtabletten
Germany: LORZAAR 50 mg or 100 mg Filmtabletten
Germany: LORZAAR PROTECT 50 mg or 100 mg Filmtabletten
Germany: LORZAAR START 12,5 mg Filmtabletten
Germany: PINZAAR 50 mg or 100 mg Filmtabletten
Germany: LORZAAR VARIPHARMSTART 12,5 mg Filmtabletten
Greece: COZAAR
Hungary: COZAAR
Ireland: COZAAR 12.5 mg, 50 mg or 100 mg Film-coated Tablets
Italy: LORTAAN 12.5 mg, 50 mg or 100 mg compresse rivestite con film
Italy: NEO-LOTAN 12.5 mg, 50 mg or 100 mg compresse rivestite con film
Italy: LOSAPREX 12.5 mg, 50 mg, or 100 mg compresse rivestite con film
Latvia: COZAAR 50 mg or 100 mg film-coated tablets
Lithuania: COZAAR
(Losartan)
Luxembourg: COZAAR 12.5mg, 50 mg or 100 mg
Luxembourg: LOORTAN 12.5 mg, 50 mg or 100 mg
Malta: COZAAR 12.5 mg, 50mg or 100 mgfilm-coated tablets
Netherlands: COZAAR 50 or 100
Poland: COZAAR
Portugal: COZAAR, COZAAR 100 mg, COZAAR IC
Portugal: LORTAAN , LORTAAN 100mg , LORTAAN IC
Romania: COZAAR, comprimate filmate, 50 mg
Slovenia: COZAAR 12,5 , 50 mg or 100 mg filmsko oblo?ene tablete
Spain: COZAAR 12,5 mg Inicio, COZAAR 50 or 100 mg
Sweden: COZAAR 50 or 100 mg 12,5 mg, 50 mg, or 100 mg filmdragerade tabletter
United Kingdom: COZAAR 12.5 mg, 25 mg, 50 mg or 100 mg FILM-COATED TABLETS
Iceland: COZAAR
Norway: COZAAR

This leaflet was last approved (11/2009)

PIL.CZR.09.UK.3197 REN

LOGO MSD

Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire
EN11 9BU UK

Registered trademark of

EI du Pont de Nemours and Company Wilmington Delaware USA

Read More:

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 Pharmaceuticals
Isis 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 Information

You can get more information on Urispas 200mg Film-coated Tablets from your doctor or pharmacist.

Date of Preparation: April 2007

41894313 A

Read More:

Renacet 950mg Tablets

1. Name Of The Medicinal Product

Renacet 950 mg, film-coated tablets

2. Qualitative And Quantitative Composition

Active 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 Form

Film-coated tablet

white, oval, convex film-coated tablets scored on both sides.

4. Clinical Particulars 4.1 Therapeutic Indications

Hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis.

4.2 Posology And Method Of Administration

The 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 Contraindications

Renacet 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 Use

Treatment 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 Interaction

Concomitant 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 Lactation

Harmful 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 Machines

Renacet 950 mg has no effect on the ability to drive or use machines.

4.8 Undesirable Effects

The 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 Overdose

Overdose 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 Properties

Pharmacotherapeutic 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 Properties

The 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 Data

Preclinical 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 Excipients

Tablet 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 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30 °C.

6.5 Nature And Contents Of Container

Pack sizes:

100 film-coated tablets

200 film-coated tablets

PVDC-coated PVC / aluminium foil blisters

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

RenaCare 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 Authorisation

30/06/2010

10. Date Of Revision Of The Text

30/06/2010

Read More:

Surmontil 10mg and 25mg Tablets

1. Name Of The Medicinal Product

Surmontil 10mg tablets or Trimipramine 10mg Tablets

Surmontil 25mg tablets or Trimipramine 25mg Tablets

2. Qualitative And Quantitative Composition

Each 10mg tablet contains 14mg of trimipramine maleate equivalent to 10mg of trimipramine.

Each 25mg tablet contains 34.9mg of trimipramine maleate, equivalent to 25mg of trimipramine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

Surmontil 10mg Tablets

White to pale yellow, circular, biconvex, film coated tablet, one face impressed 'SURMONTIL' just inside the perimeter around a centrally impressed '10', scoreline on reverse.

Trimipramine 10mg Tablets

White to pale yellow, circular, biconvex, film coated tablet embossed 'TM' above '10' on one side, scoreline on reverse.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide the dose.

Surmontil 25mg Tablets

White to pale yellow, circular, biconvex, film coated tablet, one face impressed 'SURMONTIL' just inside the perimeter around a centrally impressed '25', reverse face plain.

Trimipramine 25mg Tablet

White to pale yellow, circular, biconvex, film coated tablet, embossed 'TM' above ''25' on one side, reverse side plain.

4. Clinical Particulars 4.1 Therapeutic Indications

Surmontil has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses pronounced sedative action. It is, therefore, indicated in the treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms. Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days.

4.2 Posology And Method Of Administration

Adults

For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day.

Elderly

10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response.

Children

Not recommended.

Route of administration is oral.

4.3 Contraindications

• Recent myocardial infarction

• Any degree of heart block or other cardiac arrhythmias

• Mania. Severe liver disease

• During breast feeding

• Hypersensitivity to trimipramine maleate or to any of the excipients

4.4 Special Warnings And Precautions For Use

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions for which Surmontil is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

The elderly are particularly liable to experience adverse reactions, especially agitation, confusion and postural hypotension.

Avoid if possible in patients with narrow angle glaucoma, symptoms suggestive of prostatic hypertrophy and a history of epilepsy.

Patients posing a high suicidal risk require close initial supervision. Tricyclic antidepressants potentiate the central nervous depressant action of alcohol.

Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. If surgery is necessary, the anaesthetist should be informed that a patient is being so treated.

It may be advisable to monitor liver function in patients on long term treatment with Surmontil.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Trimipramine should not be given concurrently with, or within 2 weeks of cessation of, therapy with monoamine oxidase inhibitors. Trimipramine may decrease the antihypertensive effect of guanethidine, debrisoquine, betanidine and possibly clonidine. It would be advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants.

Trimipramine should not be given with sympathomimetic agents such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine.

Barbiturates may increase the rate of metabolism.

Surmontil should be administered with care in patients receiving therapy for hyperthyrodism.

4.6 Pregnancy And Lactation

Do not use in pregnancy especially during the first and last trimesters unless there are compelling reasons. There is no evidence from animal work that it is free from hazard.

Trimipramine is contraindicated during lactation.

4.7 Effects On Ability To Drive And Use Machines

Trimipramine may initially impair alertness. Patients should be warned of the possible hazard when driving or operating machinery.

4.8 Undesirable Effects

Cases of suicidal ideation and suicidal behaviours have been reported during trimipramine therapy or early after treatment discontinuation (see section 4.4).

Cardiac arrhythmias and severe hypotension are likely to occur with high dosage or in deliberate overdosage. They may also occur in patients with pre-existing heart disease taking normal dosage.

The following adverse effects, although not necessarily all reported with trimipramine, have occurred with other tricyclic antidepressants.

Atropine-like side effects including dry mouth, disturbance of accommodation, tachycardia, constipation and hesitancy of micturation are common early in treatment but usually lessen.

Other common adverse effects include drowsiness, sweating, postural hypotension, tremor and skin rashes. Interference with sexual function may occur.

Serious adverse effects are rare; the following have been reported: depression of bone marrow, including agranulocytosis, cholestatic jaundice, hypomania, convulsions and peripheral neuropathy. Psychotic manifestations including mania and paranoid delusions, may be excacerbated during treatment with tricyclic antidepressants.

Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

Withdrawal symptoms may occur on abrupt cessation of therapy and include insomnia, irritability and excessive perspiration.

Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken trimipramine during the last trimester of pregnancy.

4.9 Overdose

Acute overdosage may be accompanied by hypotensive collapse, convulsions and coma. Provided coma is not present, gastric lavage should be carried out without delay even though some time may have passed since the drug was ingested. Patients in a coma should have an endotracheal tube passed before gastric lavage is started. Absorption of trimipramine is slow but, as cardiac effects may appear soon after the drug is absorbed, a saline purge should be given. Electrocardiography monitoring is essential.

It is important to treat acidosis as soon as it appears with, for example, 20 ml per kg of M/6 sodium lactate injection by slow intravenous injection. Intubation is necessary and the patient should be ventilated before convulsions develop. Convulsions should be treated with diazepam administered intravenously.

Ventricular tachycardia or fibrillation should be treated by electrical defibrillation. If supraventricular tachycardia develops, pyridostigmine bromide 1 mg (adults) intravenously or propranolol 1mg (adults) should be administered at intervals as required.

Treatment should be continued for at least three days even if the patient appears to have recovered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Psychoanaleptics; Non-selective monoamine reuptake inhibitors, ATC Code: N06AA06

Trimiparamine is a tricyclic antidepressant. It has marked sedative properties.

5.2 Pharmacokinetic Properties

Trimipramine undergoes high first-pass hepatic clearance, with a mean value for bioavailability of about 41% after oral administration.

The absolute volume of distribution is 31 litres/kg and total metabolic clearance is 16 ml/min/kg.

Plasma protein binding of trimipramine is about 95%. The plasma elimination half-life is around 23 hours. Trimipramine is largely metabolised by demethylation prior to conjugation yielding a glucuronide.

5.3 Preclinical Safety Data

No additional pre-clinical data of relevance to the prescriber.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet Core:

Calcium Hydrogen Phosphate

Starch Potato

Magnesium Stearate

Talc

Tablet Coat (Opadry OY-L-28900):

Lactose Monohydrate

Hypromellose

Titanium Dioxide

Macrogol 4000

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Keep the blister in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

10mg: Cartons containing PVDC/coated UPVC/aluminium foil blister packs of 84 or 28 tablets.

25mg: Cardboard cartons containing PVDC/coated UPVC/aluminium foil blister packs of 84 or 28 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

Surmontil 10mg tablets: PL 04425/0266

Surmontil 25mg tablets: PL 04425/0267

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first Authorisation: 6 April 1973

Date of latest Renewal: 3 May 2002

10. Date Of Revision Of The Text

7 June 2011

LEGAL CATEGORY

POM

Read More:

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 Pharmaceuticals
Isis 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 juice

Drinking 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 machines

Zanidip 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.

Read More:

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 For

Famciclovir 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 medicines

Please 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 drink

Famciclovir can be taken with or without food. Swallow the tablets with water.

Pregnancy and breast-feeding

Pregnancy

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 machines

In 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 Famciclovir

Always 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 treatment

Treatment 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 should

Contact 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 famciclovir

If 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 famciclovir

Do 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 Effects

Like 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 Itching

Rare 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 rash

Not known (cannot be estimated from the available data)

Fever

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 Famciclovir

Keep 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 contain

The 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 pack

125mg 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 Greece

This leaflet was last revised in June 2009

5664 (Specifar’s Item No.)

PC 3261

Read More:

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 medicine

Keep 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 tablets

The 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 for

Myfortic 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 Myfortic

Myfortic 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 people

Myfortic can be given to older people.

Myfortic in children and adolescents

There is not enough experience to recommend the use of Myfortic in children and adolescents.

Pregnancy and Breast-feeding

If 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 Myfortic

Follow 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 take

If 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 Myfortic

Swallow 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 Myfortic

Usually 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 effects

Like 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 Information

Leaflet approved: November 2007

Myfortic 180mg film-coated gastro-resistant tablets: PL 00101/0664

Myfortic 360mg film-coated gastro-resistant tablets: PL 00101/0665

Read More:

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 For

Januvia 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 Januvia

Tell 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 medicines

Januvia 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 drink

You can take Januvia with or without food and drink.

Pregnancy and breast-feeding

Women 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 machines

Januvia 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 Januvia

Always 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 mouth

Your 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 should

If you take more than the prescribed dosage of Januvia, contact your doctor immediately.

If you forget to take Januvia

If 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 Effects

Like 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 Januvia

Keep 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 pack

Round, 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 Manufacturer

The Marketing Authorisation Holder is:

Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom

The Manufacturer is:

Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21 27100 - Pavia Italy

For 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.com

This 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 UK

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Myotonine 25 mg (Bethanechol Chloride)

1. Name Of The Medicinal Product

Myotonine ®( bethanechol chloride).

2. Qualitative And Quantitative Composition

Each 25mg tablet weighs 440mg; total active ingredient 25mg bethanechol chloride USPXXIV

3. Pharmaceutical Form

Each 25mg tablet is white, flat with bevelled edge and with a cross score and embossed “MY25”.

4. Clinical Particulars 4.1 Therapeutic Indications

Urinary retention -indicated for the treatment of acute postoperative and postpartum non-obstructive (functional) urinary retention and neurogenic atony of the urinary bladder with retention.

Reflux oesophagitis; treatment of reflux associated with decreased pressure of the lower oesophageal sphincter or delayed gastric emptying.

4.2 Posology And Method Of Administration

Administration orally by tablets.

Adults: 10mg –25mg three or four times daily, taken half an hour before food. Occasionally it may be necessary to initiate therapy with a 50mg dose.

Children: The experience with children is limited therefore no recommended dose is given.

4.3 Contraindications

Intestinal or urinary obstruction, recent myocardial infarction, recent intestinal anastomosis.

4.4 Special Warnings And Precautions For Use

A severe cholinergic reaction is likely if bethanechol chloride is administered IV or IM. This reaction has also rarely occurred in cases of hypersensitivity or overdose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cholinergics, other, especially cholinesterase inhibitors.

Ganglionic blocking agents such as mecamylamine, pentolinium and trimethaphan.

Procainamide or quinidine.

4.6 Pregnancy And Lactation

Should not be used during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

In some cases the ability to drive and operate machinery may be impaired.

4.8 Undesirable Effects

Nausea, vomiting, sweating and intestinal colic.

4.9 Overdose

The symptoms of overdose include nausea, salivation, lachrymation, eructation, involuntary defecation and urination, transient dyspnoea, palpitation, bradycardia and peripheral vasodilation leading to hypertension, transient heart block and a feeling of constriction under the sternum.

Procedure: The stomach should be emptied by aspiration or lavage. Give atropine sulphate 1-2mg intravenously, intramuscularly or subcutaneously to control muscarinic effects. The dose may be repeated every 2-4 hours as necessary.

Supportive treatment includes intravenous administration of diazepam 5-10mg: muscle twitching may be controlled by small doses of tubocararine (together with assisted respiration): oxygen may be required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Bethanechol is a synthetic choline ester of carbamic acid which possesses a significant acetylcholine-like activity. It is active after oral administration.As a consequence of the very slow hydrolysation by acetylcholinesterase bethanechol has a prolonged action as has been demonstrated in the urinary tract. The onset of action occurs after oral administration within an hour.

The major pharmacological effects of bethanechol result from interaction of the drug with muscarinic receptor sites of smooth muscles, especially those of the urinary bladder and gastrointestinal tract.

In addition, minor but important nicotinic effects have been noted. In usual therapeutic doses, bethanechol does not cross the blood brain barrier.

5.2 Pharmacokinetic Properties

Studies not available.

5.3 Preclinical Safety Data

N/A

6. Pharmaceutical Particulars 6.1 List Of Excipients

Calcium sulphate dihydrate BP.

Maize starch BP.

Talc BP(iron free)

6.2 Incompatibilities

Major –none known.

6.3 Shelf Life

The shelf life of Myotonine tablets is currently two years from date of manufacture.

6.4 Special Precautions For Storage

Keep out of reach of children and away from direct heat or light sources.

Store below 25?C.

6.5 Nature And Contents Of Container

The container is of polypropylene with a tamper-evident polyethylene cap and closure. A filla may be inserted to reduce the risk of tablet breakage due to ullage.

Each container is filled with 100 tablets.

6.6 Special Precautions For Disposal And Other Handling 7. Marketing Authorisation Holder

Glenwood Laboratories UK Ltd.

Jenkins Dale

Chatham

Kent

ME4 5RD

8. Marketing Authorisation Number(S)

Myotonine 25mg 00245/5010R.

9. Date Of First Authorisation/Renewal Of The Authorisation

February 2003

10. Date Of Revision Of The Text

November 2003,February 2000, April 1996,July 1995.

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Ethmozine

Generic Name: moricizine (more IH sih zeen)
Brand Names: Ethmozine

What is Ethmozine (moricizine)?

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)

Read More:

Zirtek Allergy Relief Tablets

Zirtek ALLERGY RELIEF

cetirizine hydrochloride

ONE A DAY

What You Should Know About Your Tablets

Please 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 Relief

Each 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 Used

This 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 Relief

If 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 Tablets

Adults 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 Tablets

These 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 rash

Stop 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

Read More:

Zirtek Allergy

Zirtek ALLERGY

Cetirizine hydrochloride

ONE-A-DAY

What You Should Know About Your Tablets

Please read this leaflet carefully before you start taking this medicine. It provides a summary of the information currently available on Zirtek Allergy. For further information or advice ask your doctor or pharmacist.

What Is In Zirtek Allergy

Each tablet contains 10 mg of cetirizine hydrochloride together with microcrystalline cellulose (E460), lactose, colloidal anhydrous silica and magnesium stearate (E572). The film coating contains 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 21 and 30 tablets.

Your medicine belongs to the antihistamine group of drugs.

Product licence number:

PL 00039/0542

This medicine is manufactured and licenced by: UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE When Is Zirtek Allergy Used

This 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 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 Zirtek Allergy

If 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?).

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 Tablets

Adults and children 6 years and over should take one tablet daily. Children aged 6 – 12 years may either take half a tablet twice daily or 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 tablets are not for use in children under 6 years of age.

If symptoms persist consult your doctor.

After Taking Zirtek Allergy Tablets

These 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 rash

Stop 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: P.

Date of preparation of this leaflet: October 2005

UCB 2004 – UCB logo

Read More:

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 for

Arimidex 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 Arimidex

Check 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 medicines

Please 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-feeding

Do 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 Arimidex

Arimidex 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 Arimidex

Always 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 should

If 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 Arimidex

Do not stop taking your tablets unless your doctor tells you to.

Possible side effects

Like 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 contains

The 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 pack

Arimidex comes as film-coated tablets. The tablets are white and round.

Arimidex comes in blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Arimidex 1 mg Film-coated Tablets is held by

AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU UK

Arimidex is manufactured by

AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA UK

To 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

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Hydralazine Tablets BP 25mg

1. Name Of The Medicinal Product

HYDRALAZINE TABLETS BP 25mg

2. Qualitative And Quantitative Composition

Each tablet contains 25mg Hydralazine Hydrochloride.

For excipients, see 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Ivory, circular, biconvex film-coated tablets impressed “C” on one face and the identifying letters “HY” on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

Hydralazine is indicated for:

1) Moderate to severe hypertension (in conjunction with a beta-adrenoceptor blocking agent or diuretic) and hypertensive crisis.

2) The management of moderate to severe congestive cardiac failure (reduces afterload), where optimal doses of diuretics and cardiac glycosides prove insufficient. In patients with high left ventricular filling pressure, it is recommended to combine hydralazine with a nitrate.

4.2 Posology And Method Of Administration

For oral administration.

Adults: Dosage should not be increased beyond 100mg daily without first checking the patient's acetylator status.

Hypertension: The dose should be adjusted to the individual requirements of the patient. Treatment should begin with low doses of hydralazine which, depending on the patient's response, should be increased stepwise to achieve optimal therapeutic effect whilst keeping unwanted effects to a minimum. Initially 25mg twice daily. This can be increased gradually to a dose not exceeding 200mg daily.

Chronic congestive heart failure: Treatment with hydralazine should always be initiated in hospital, where the patient's individual haemodynamic values can be reliably determined with the help of invasive monitoring. It should then be continued in hospital until the patient has become stabilised on the requisite maintenance dose. Doses vary greatly between individual patients and are generally higher than those used for treating hypertension. After progressive titration (initially 25mg 3-4 times daily) the maintenance dosage averages 75mg four times daily.

Children: Not recommended for this age group.

Elderly: Clinical evidence indicates that no special dosage regime is necessary. Advancing age does not affect either blood concentration or systemic clearance. Renal elimination may however be affected in so far as kidney function diminishes with age.

4.3 Contraindications

Hydralazine should not be given to patients with tachycardia and also in cases of left ventricular failure due to severe aortic or mitral stenosis or in constrictive pericarditis; in heart failure associated with high output (ie in thyrotoxicosis); isolated right ventricular failure due to pulmonary hypertension (ie cor pulmonale); hypersensitivity to hydralazine and dihydralazine or to any of the excipients. Idiopathic system lupus erythematosus (SLE) and related diseases. Dissecting aortic aneurism. Porphyria.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with coronary disease (may provoke angina), in those undergoing anaesthesia (which may precipitate severe hypotension) or in patients with cerebrovascular disease.

Avoid after myocardial infarction until stabilised.

During long-term therapy with hydralazine, it is advisable to determine the antinuclear factors and conduct urinalysis (for microhaematuria and proteinuria) at intervals of approximately 6 months. In the event of positive findings for antinucuclear factors, the titres should be monitored more frequently. At the first signs or symptoms suggestive of SLE or renal disease, hydralazine should be withdrawn, (see also under “other undesirable effects”).

In severe renal failure the interval between doses should be prolonged to avoid accumulation; also in hepatic dysfunction a reduction in dosage or prolonged dosage interval may be indicated.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potentiation of effects: Concurrent treatment with other antihypertensives, muscle relaxants (baclofen and tizonidine), nitrates, anaesthetics, minor tranquillisers, antidepressants, levodopa or drugs exerting a central depressant action (including alcohol).

Reduction in effects: Concomitant treatment with sympathomimetics, tricyclic antidepressants or MAOI's, NSAIDs, corticosteroids.

4.6 Pregnancy And Lactation

Due to the discovery that hydralazine has a teratogenic effect in mice, causing a small incidence of cleft palate and certain other minor bone malformations in doses ranging from 20-120mg/kg; its use should be avoided in pregnancy during the period of organogenesis, that is the first half of pregnancy. Hydralazine crosses the placental barrier and is excreted in breast milk. Mothers who are receiving hydralazine should not therefore breast feed their infants.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Tachycardia, palpitations, headache, flushing, dizziness, anorexia, angina, nasal congestion, nausea and vomiting can occur, but may be minimised by the prior administration of a beta blocker. Fluid retention.

Patients may occasionally develop symptoms suggestive of rheumatoid arthritis. Skin reactions and fever may occur producing a syndrome similar to systemic lupus erythematosus. This is more likely to occur with high dosage regimes (more than 200mg daily). If such symptoms develop the drug should be gradually withdrawn, when remission will usually occur.

Rarely: Anaemia, leucopenia, neutropenia, thrombocytopenia with or without purpura, proteinuria, increased plasma creatinine, haematuria, dyspnoea and pleural pain.

Isolated cases: Haemolytic anaemia, leucocytosis, lymphadenopathy, pancytopenia, splenomegaly, agranulocytosis.

Occasionally liver damage may occur resembling an hepatitis-like syndrome which is reversible on withdrawal of the drug. Isolated cases of glomerulonephritis have been reported. Hydralazine should be withdrawn if anxiety, depression, febrile reactions, change in blood count or skin rash occur. Rare cases of peripheral neuritis, causing paraesthesia, may be reversed by the administration of pyridoxine, or by withdrawal of hydralazine.

4.9 Overdose

Symptoms including hypotension, tachycardia, myocardial ischaemia, dysrrhythmias and coma.

Gastric lavage or, in the absence of coma, emetic treatment should be given as soon as possible. If hypotension is present, an attempt should be made to raise blood pressure without increasing tachycardia, hence adrenaline (epinephrine) should be avoided. Supportive measures such as intravenous fluids and elevation of foot of bed are also indicated. Cautious administration of angiotensin or noradrenaline (norepinephrine) intravenously may be of use.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Hydralazine hydrochloride is a vasodilator and antihypertensive agent.

Hydralazine is a direct acting vasodilator which exerts a moderate but significant antihypertensive effect (diastolic more than systolic) principally on the arterioles. It tends to improve the renal, uterine and cerebral blood flow. The effect results in a decrease in arterial blood pressure and peripheral vascular resistance, and an increase in heart rate, reflex tachycardia, stroke volume and cardiac output. The rise in cardiac output accompanies the fall in blood pressure, probably as a reflex response; (hydralazine also serves to improve renal blood flow and renal function). Hydralazine lowers blood pressure seemingly by exerting an arteriolar dilating effect through a direct relaxation of vascular smooth muscle.

In heart failure cardiac output is improved as a result of the afterload reduction which is induced by hydralazine; tachycardia or hypotension are seldom seen in this group.

5.2 Pharmacokinetic Properties

Hydralazine is rapidly absorbed from the gastrointestinal tract and peak plasma concentrations have been reported to occur in the plasma after about one hour. It is metabolised by hydroxylation of the ring system and conjugation with glucuronic acid, and by N-acetylation.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The tablet core contains: polyvidone, disodium edetate, microcrystalline cellulose (E460), magnesium stearate.

The coating contains: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol, glycerol triacetate (E1518), iron oxide (E172).

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Polypropylene and polyethylene containers

Do not store above 25°C. Store in the original container.

Blister packs

Do not store above 25°C. Keep container in the outer carton.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene containers and snap-on polyethylene lids.

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: 250µm white rigid PVC. Surface printed 20µm hard temper aluminium foil with 5-6g/M? PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Polyethylene container with a polypropylene lid.

Pack size: 56s

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Actaivs UK Limited (Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 00142/ 0499

9. Date Of First Authorisation/Renewal Of The Authorisation

6 March 2001

Renewed – 19.03.09

10. Date Of Revision Of The Text

08/07/2009

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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 also

Medical 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-Capsules

Read More:

Urispas

flavoxate hydrochloride
Dosage Form: Tablets
Urispas Description

Urispas® (flavoxate HCl) tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C24H25NO4• HCl. The molecular weight is 427.94. The structural formula appears below.

Urispas® is supplied in tablets for oral administration. Each round, white, film-coated Urispas® tablet is debossed with the product name Urispas® and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, hypromellose, magnesium stearate, polyethylene glycol, starch and talc.

Urispas - Clinical Pharmacology

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate HCl was excreted in the urine within 24 hours.

Indications and Usage for Urispas

Urispas® (flavoxate HCl) is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Urispas® is not indicated for definitive treatment, but is compatible with drugs used for the treatment of urinary tract infections.

Contraindications

Urispas® (flavoxate HCl) is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Warnings

Urispas® (flavoxate HCl) should be given cautiously in patients with suspected glaucoma.

Precautions Information for Patients:

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Urispas® (flavoxate HCl) have not been performed.

Pregnancy:

Teratogenic Effects-Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urispas® is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

Overdosage

The oral LD50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD50 for flavoxate HCl in mice is 1837 mg/kg.

It is not known whether flavoxate HCl is dialyzable.

Urispas Dosage and Administration Adults and children over 12 years of age:

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

How is Urispas Supplied

Urispas® (flavoxate HCl), 100 mg, is supplied as round, white, film-coated tablets, debossed with the product name Urispas® in bottles of 100.

100 mg 100's: NDC 17314-9220-1

Store between 15° and 30°C (59° and 86°F).

Rx only

Revision Date: AUGUST 2004

Manufactured by

Cardinal Health

Winchester, Kentucky 40391

Distributed by
ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869

Printed in U.S.A.

631-10-843-2

Urispas 
flavoxate hydrochloride  tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17314-9220 Route of Administration ORAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength flavoxate hydrochloride (flavoxate) Active 100 MILLIGRAM  In 1 TABLET calcium phosphate Inactive   hypromellose Inactive   magnesium stearate Inactive   polyethylene glycol Inactive   starch Inactive   talc Inactive   Product Characteristics Color WHITE (white ) Score no score Shape ROUND (round) Size 10mm Flavor Imprint Code Urispas Contains          Coating true Symbol false Packaging # NDC Package Description Multilevel Packaging 1 17314-9220-1 100 TABLET In 1 BOTTLE None
Revised: 02/2006ORTHO-McNEIL PHARMACEUTICAL, INC. More Urispas resources Urispas Side Effects (in more detail) Urispas Dosage Urispas Use in Pregnancy & Breastfeeding Drug Images Urispas Drug Interactions Urispas Support Group 0 Reviews for Urispas - Add your own review/rating Urispas Concise Consumer Information (Cerner Multum) Urispas MedFacts Consumer Leaflet (Wolters Kluwer) Urispas Monograph (AHFS DI) Urispas Advanced Consumer (Micromedex) - Includes Dosage Information Flavoxate Professional Patient Advice (Wolters Kluwer) Compare Urispas with other medications Dysuria Overactive Bladder Urinary Incontinence

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Spondylolisthesis 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 Spondylolisthesis

The 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 Spondylolisthesis

Medical Encyclopedia:

Spondylolisthesis
Drug 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

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Spondylolisthesis Medications

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