SureLac
Pronunciation: LAK-taseGeneric Name: LactaseBrand Name: Examples include Lactaid and SureLac

Chlorpheniramine/Pseudoephedrine/Ibuprofen
Pronunciation: KLOR-fen-IR-a-meen/SOO-do-e-FED-rin/EYE-bue-PROE-fenGeneric Name: Chlorpheniramine/Pseudoephedrine/IbuprofenBrand Name: Advil Allergy Sinus Caplets

Entocort Enema

Entocort Enema

budesonide 0.02 mg/ml

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 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 Entocort Enema is and what it is used for 2. Before you use Entocort Enema 3. How to use Entocort Enema 4. Possible side effects 5. How to store Entocort Enema 6. Further information What Entocort Enema is and what it is used for

Entocort Enema contains a medicine called budesonide. This belongs to a group of medicines called ‘corticosteroids’. These are used to reduce inflammation.

An enema is a liquid that is inserted into the back passage (rectum). Entocort Enema is used to treat inflammation and ulcers in the large intestine (colon) and rectum. This is known as ulcerative colitis. Before you use Entocort Enema Do not use Entocort Enema if:

You are allergic (hypersensitive) to budesonide or any of the other ingredients of Entocort Enema (listed in Section 6: Further information).

Take special care with Entocort Enema

Check with your doctor or pharmacist before using Entocort Enema if:

You have recently had a bowel infection. You or a member of your family has ever had mental health problems. Taking other medicines

Please tell your doctor or pharmacist before using Entocort Enema 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 Entocort Enema can affect the way some medicines work and some medicines can have an effect on Entocort Enema.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

Steroid medicines, such as prednisolone or dexamethasone. Ketoconazole or itraconazole, used to treat infections caused by a fungus. Medicines that contain oestrogen, such as hormone replacement therapy (HRT) and some oral contraceptives. Pregnancy and breast-feeding

Talk to your doctor before using Entocort Enema if you are pregnant, may become pregnant or are breast-feeding.

Driving and using tools and machines

Entocort Enema is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients

Entocort Enema contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), these may cause allergic reactions (possibly delayed).

How to use Entocort Enema

Always use Entocort Enema exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Entocort Enema should only be used in your back passage (rectum), as directed by your doctor.

Entocort Enema is not recommended for use by children.

When to use Entocort Enema and how long to use it for It is important to use each enema at the right time. Usually this will be once a day, just before bedtime. Normally, your treatment will last for 4 weeks. However, your doctor may decide that you need to use Entocort Enema for longer. Preparing Entocort Enema for use

To prepare one enema, dissolve one tablet in one bottle of liquid. To do this, follow the instructions below:

1. Take one of the plastic bottles containing a liquid. Unscrew the complete nozzle section and protective cap in one piece. 2. Take one of the tablets from its foil strip. Then drop it into the bottle. 3. Put the nozzle and protective cap back onto the bottle. Then screw them up until they are tight. 4. Shake the bottle well for at least 15 seconds, or until you cannot see the tablet in the liquid any more. 5. The enema is now ready. Use it straight away. You will find it more comfortable to use Entocort Enema if you empty your bowels and bladder before using it. Entocort Enema can stain your bedclothes. It is best to protect your bedclothes with a plastic sheet in case any liquid is spilled. Inserting the enema into your back passage

To insert the enema into your back passage, follow the instructions below:

1. Shake the bottle again. Then only take off the protective cap. This will reveal the nozzle. 2. Undress from the waist down, then lie down on your side.

AccessPak for HIV PEP Basic

Generic Name: emtricitabine and tenofovir (em trye SYE ta been and ten OF oh vir) Brand Names: AccessPak for HIV PEP Basic, Truvada

What is AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

The combination of emtricitabine and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Emtricitabine and tenofovir is not a cure for HIV or AIDS.

Emtricitabine and tenofovir may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread).

Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

Some people develop lactic acidosis while taking emtricitabine and tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Emtricitabine and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). What should I discuss with my healthcare provider before taking AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

If you have any of these other conditions, you may need an emtricitabine and tenofovir dose adjustment or special tests:

liver or kidney disease;

osteopenia (low bone mineral density); or

if you also have hepatitis B infection.

Some people develop a life-threatening condition called lactic acidosis while taking emtricitabine and tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. FDA pregnancy category B. Emtricitabine and tenofovir is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of emtricitabine and tenofovir on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to anyone under 18 without the advice of a doctor. How should I take AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Use emtricitabine and tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your kidney and liver function or bone density may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop taking emtricitabine and tenofovir, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using the medicine. Do not miss any follow-up visits to your doctor.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet of moisture-absorbing preservative that comes with emtricitabine and tenofovir. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. AccessPak for HIV PEP Basic (emtricitabine and tenofovir) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

muscle pain or weakness;

numb or cold feeling in your arms and legs;

trouble breathing;

feeling dizzy, light-headed, tired, or very weak;

stomach pain, nausea with vomiting; or

fast or uneven heart rate.

Call your doctor at once if you have any of these other serious side effects:

signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

increased thirst, urinating more or less than usual or not at all;

swelling, rapid weight gain, feeling short of breath; or

signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

diarrhea, mild nausea;

headache, tired feeling;

dizziness, depressed mood;

sleep problems (insomnia), strange dreams;

mild itching or skin rash;

runny or stuffy nose, cough; or

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Emtricitabine and tenofovir can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

lithium (Lithobid);

methotrexate (Rheumatrex, Trexall);

pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

an IV antibiotic such as gentamicin (Garamycin), vancomycin (Vancocin, Vancoled), and others;

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

You may need dose adjustments or special tests when taking any of these medications together with emtricitabine and tenofovir.

Other medications that can affect emtricitabine and tenofovir include:

the herpes medications acyclovir (Zovirax) or valacyclovir (Valtrex);

medications to treat cytomegalovirus (CMV) such as cidofovir (Vistide), ganciclovir (Cytovene) or valganciclovir (Valcyte); or

certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), or ritonavir (Norvir).

This list is not complete and other drugs may interact with emtricitabine and tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More AccessPak for HIV PEP Basic resources AccessPak for HIV PEP Basic Side Effects (in more detail)AccessPak for HIV PEP Basic Use in Pregnancy & BreastfeedingAccessPak for HIV PEP Basic Drug Interactions0 Reviews for AccessPak for HIV PEP Basic - Add your own review/rating Truvada Prescribing Information (FDA) Truvada Advanced Consumer (Micromedex) - Includes Dosage Information Truvada MedFacts Consumer Leaflet (Wolters Kluwer) Truvada Consumer Overview Compare AccessPak for HIV PEP Basic with other medications HIV InfectionNonoccupational Exposure Where can I get more information? Your pharmacist can provide more information about emtricitabine and tenofovir.

See also: AccessPak for HIV PEP Basic side effects (in more detail)

Imdur
Generic Name: isosorbide mononitrate Dosage Form: tablet, extended releaseImdur®

Charcoal Activated
Pronunciation: CHAR-koleGeneric Name: Charcoal ActivatedBrand Name: Generic only. No brands available.

Calmol-4 Suppository

Generic Name: zinc oxide topical (ZINK OX ide) Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Calmol-4 Suppository (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Calmol-4 Suppository (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Calmol-4 Suppository (zinc oxide topical)? You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Calmol-4 Suppository (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting. What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Calmol-4 Suppository (zinc oxide topical)? Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury. Calmol-4 Suppository (zinc oxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Calmol-4 Suppository (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Calmol-4 Suppository resources Calmol-4 Suppository Side Effects (in more detail)Calmol-4 Suppository Use in Pregnancy & BreastfeedingCalmol-4 Suppository Support Group0 Reviews for Calmol-4 - Add your own review/rating Arcalyst Monograph (AHFS DI) Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Calmol-4 Suppository with other medications Anal ItchingDermatologic Lesion Where can I get more information? Your pharmacist can provide more information about zinc oxide topical.

See also: Calmol-4 side effects (in more detail)

Otitis Media Medications

Definition of Otitis Media:

Infection and inflammation of the middle ear space and ear drum.

Symptoms include earache, fever and in some cases, diminished hearing.

Drugs associated with Otitis Media

The following drugs and medications are in some way related to, or used in the treatment of Otitis Media. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Otitis MediaChronic Otitis Media (2 drugs in 2 topics) Otitis Media with Perforation of Ear Drum (0 drugs) Perforated Tympanic Membrane (0 drugs) Drug List:Ak-Spore-Hc-Otic-SuspensionAmoxilAugmentin-Es-600-SuspensionAurodexAzithromycin-3-Day-Dose-PackBactrim-DsBiaxinBicillin-C-RBicillin-L-A-SuspensionCedaxCefzilChlorphenylcaine-Ear-DropsCo-TrimoxazoleCort-BioticCortatrigen-ModifiedCortisporin-Tc-DropsCotrimDoloticDynabacE-E-S-Granules-SuspensionE-E-S-400Ery-TabEryped-DropsErythromycin-Lactobionate-I-VEryzoleFortazGantrisin-PediatricPermapen-IsojectLevaquinLorabidMasporin-OticOmnicef-Omni-PacOtimarOtocort-Sterile-SuspensionPanixinePcePedioticPenicillin-G-Procaine-Injectable-SuspensionPfizerpenPrincipenRaniclorRx-OticSeptra-DsSpectrobidSulfatrim-PediatricSupraxTequinTrimoxTruxazoleUad-OticVeetidsZinacefZmax-Extended-Release-Oral-Suspension

Improvil

Improvil may be available in the countries listed below.

Ingredient matches for Improvil Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Improvil in the following countries:

Australia Norethisterone

Norethisterone is reported as an ingredient of Improvil in the following countries:

Australia

International Drug Name Search

Anzemet Tablets
Pronunciation: doe-LAS-e-tronGeneric Name: DolasetronBrand Name: Anzemet

Campral

Generic Name: acamprosate (a KAM proe sate) Brand Names: Campral

What is acamprosate?

Acamprosate affects chemicals in the brain that may become unbalanced in a person who is addicted to alcohol. Acamprosate works by restoring this chemical balance in the brain in an alcohol-dependent person who has recently quit drinking.

Acamprosate is used to help a person who has recently quit drinking alcohol continue to choose not to drink (remain abstinent from alcohol). It is used together with behavior modification and counseling support to help you stop drinking.

Acamprosate is not likely to be helpful to a person who has not already quit drinking or undergone detoxification. It may not be helpful to a person who is also addicted to other substances besides alcohol.

Acamprosate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about acamprosate? You should not use this medication if you are allergic to acamprosate, or if you have severe kidney disease.

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

Before you take acamprosate, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.

You may have thoughts about suicide while you are taking acamprosate. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.

Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.

Acamprosate can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking acamprosate, tell your doctor about any alcoholic drinks you consume, no matter how many. What should I discuss with my healthcare provider before taking acamprosate? You should not use this medication if you are allergic to acamprosate, or if you have severe kidney disease.

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

Before you take acamprosate, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. It is not known whether acamprosate is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether acamprosate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. You may have thoughts about suicide while you are taking acamprosate. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.

Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.

How should I take acamprosate?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Acamprosate treatment should be started as soon as possible after you have quit drinking.

Take this medicine with water.

Acamprosate is usually taken 3 times daily, and may be taken with or without food. If you regularly eat 3 meals per day, it may help you remember to take your acamprosate if you take a dose with each meal. Follow your doctor's instructions.

Acamprosate is only part of a complete program of treatment that also includes counseling support and continued abstinence from alcohol.

Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking acamprosate, tell your doctor about any alcoholic drinks you consume, no matter how many.

It is important to use acamprosate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store acamprosate at room temperature away from moisture and heat.

See also: Campral dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause diarrhea but is not expected to produce serious side effects.

What should I avoid while taking acamprosate? Acamprosate can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Acamprosate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effects such as:

mood or behavior changes;

thoughts about hurting yourself;

severe anxiety or depression;

feeling like you might pass out;

fast or pounding heartbeats;

swelling, weight gain, feeling short of breath;

confusion, increased thirst; or

urinating less than usual or not at all.

Less serious side effects may include:

nausea, vomiting, stomach pain, loss of appetite;

constipation, diarrhea;

headache, dizziness, drowsiness;

vision problems;

problems with memory or thinking;

weakness, cold or flu-like symptoms;

back pain, joint or muscle pain;

dry mouth, decreased or distorted sense of taste;

sleep problems (insomnia);

impotence, loss of interest in sex;

sweating, mild skin rash; or

numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acamprosate?

There may be other drugs that can interact with acamprosate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Campral resources Campral Side Effects (in more detail)Campral DosageCampral Use in Pregnancy & BreastfeedingDrug ImagesCampral Support Group51 Reviews for Campral - Add your own review/rating Campral Prescribing Information (FDA) Campral Monograph (AHFS DI) Campral Advanced Consumer (Micromedex) - Includes Dosage Information Campral MedFacts Consumer Leaflet (Wolters Kluwer) Campral Consumer Overview Compare Campral with other medications Alcohol Dependence Where can I get more information? Your pharmacist can provide more information about acamprosate.

See also: Campral side effects (in more detail)

Sterile Dopamine Concentrate BP 800mg / 5ml
1. Name Of The Medicinal Product

Sterile Dopamine Concentrate B.P. 800mg/5ml.

2. Qualitative And Quantitative Composition

Dopamine Hydrochloride U.S.P., 800mg in 5ml.

3. Pharmaceutical Form

Clear, colourless or pale yellow sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For the correction of haemodynamic imbalances in low-perfusion circulatory insufficiency associated with myocardial infarction, trauma, septicaemia, cardiac failure and open heart surgery.

4.2 Posology And Method Of Administration

The solution must be diluted before administration. Alkaline solutions such as 5% sodium bicarbonate should NOT be added to dopamine hydrochloride because the drug will be inactivated. The usual dilution is 1,600 micrograms per ml and this may be achieved by transfer, aseptically of 800mg of dopamine hydrochloride to one of the following sterile I.V. solutions: -

Sodium Chloride Injection

5% Dextrose Injection

5% Dextrose and 0.9% Sodium Chloride Injection

5% Dextrose and 0.45% Sodium Chloride Solution

5% Dextrose in Ringer Lactate Solution

Sodium Lactate 1/6 Molar Injection

Lactated Ringer's Injection

A suitable metering device is required in the infusion system to control the rate of flow, and this should be adjusted to the optimum patient response and monitored constantly in the light of the individual patient's response.

Adults: Use as large a vein as possible for infusion. The initial rate of infusion is 2 to 5 micrograms per kilogram bodyweight per minute and this may be increased gradually by increments of 5 to 10 micrograms/kg/minute until the optimum dose for the individual is achieved. Up to 50 micrograms/kg/minute may be required, and even higher doses have been used.

Children: The safety and efficacy of dopamine hydrochloride therapy in children have not been established.

4.3 Contraindications

Dopamine should not be used in patients with –

• Hypersensitivity to dopamine or any of the excipients.

• Phaeochromocytoma or hyperthyroidism

Dopamine should not be used in the presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation.

Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.

4.4 Special Warnings And Precautions For Use

The solution contains an antioxidant, sodium metabisulphite, a sulphite that may cause hypersensitivity reactions including bronchospasm, anaphylaxis and life-threatening episodes in certain susceptible individuals. The prevalence of sulphite-sensitivity in the general population is unknown and is probably low. Sulphite-sensitivity is seen more frequently in persons with a history of asthma or atopic allergy.

Each ampoule of this injection contains 2.42 mg sodium per ml.

Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses; the starting dose should be one tenth (1/10th) of the usual dose.

Excess administration of potassium-free solutions may result in significant hypokalaemia.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema.

Precautions:

Hypovolaemia should be corrected where necessary prior to dopamine infusion. Low doses should be used in shock due to acute myocardial infarction.

If a disproportionate rise in diastolic pressure (i.e. a marked decrease in pulse pressure) is observed, the infusion rate should be decreased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such an effect is desired.

Patients with a history of peripheral vascular disease should be closely monitored for any changes in colour or temperature of the skin of the extremities. If change of skin colour or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued dopamine infusion should be weighed against the risk of possible necrosis. These changes may be reversed by decreasing the rate or discontinuing the infusion. IV administration of phentolamine mesylate 5-10 mg may reverse the ischaemia.

Dopamine hydrochloride in 5% dextrose injection should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. Extravasation of dopamine hydrochloride during infusion may cause ischaemic necrosis and sloughing of surrounding tissue. Ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.

Administration of dopamine hydrochloride should always be under the direct supervision of a physician to whom facilities are available for monitoring cardiovascular and renal indices, including blood volume, cardiac output, blood pressure, electrocardiography and urine flow.

Dextrose solutions should be used with caution in patients with known subclinical or overt diabetes mellitus.

When dopamine is used in patients with a history of occlusive vascular disease, particular attention should be paid to the status of blood circulation in the extremities.

The occurrence of undesirable increases in blood pressure or vasoconstriction or decrease in urinary output requires a reduction in dosage of dopamine hydrochloride.

The routine use of low-dose dopamine hydrochloride in critically ill patients to prevent or treat acute renal failure is not recommended because this may cause adverse effects which could further compromise such patients.

As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised.

Dopamine infusion should be withdrawn gradually, to avoid unnecessary hypotension.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

i) Anaesthetics:

The myocardium is sensitised by the effect of dopamine, cyclopropane or halogenated hydrocarbon anaesthetics, and these should be avoided. This interaction applies both to pressor activity and cardiac beta adrenergic stimulation.

ii) Alpha and Beta Blockers:

The cardiac effects of dopamine are antagonised by ? -adrenergic blocking agents such as propanolol and metoprolol, and the peripheral vasoconstriction caused by high doses of dopamine is antagonised by ? adrenergic blocking agents. Dopamine induced renal and mesenteric vasodilation is not antagonised by either ? or ?- adrenergic blocking agents, but, in animals, is antagonised by haloperidol or other butrophenones, phenothiazines and opiates.

iii) Monoamine Oxidase (MAO) Inhibitors :

MAO inhibitors potentiate the effect of dopamine and its duration of action. Patients who have been treated with MAO inhibitors prior to administration of dopamine will therefore require a substantially reduced dosage. (The starting dose should be reduced to at least 1/10th of the usual dose).

iv) Phenytoin:

Administration of IV phenytoin to patients receiving dopamine has resulted in hypotension and bradycardia; some clinicians recommend that phenytoin be used with extreme caution, if at all, in patients receiving dopamine.

Dopamine may increase the effect of diuretic agents.

The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine.

4.6 Pregnancy And Lactation

Use in Pregnancy:

Animal studies have shown no evidence of teratogenic effects with dopamine.

However, the effect of dopamine on the human foetus is unknown. Therefore the drug should be used in pregnant women only when the expected benefits outweigh the potential risk to the foetus.

Use in Lactation:

It is not known if dopamine is excreted in breast milk, nor is the effect on the infant known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable in view of the indications for use and the short half-life of the drug.

4.8 Undesirable Effects

Adverse reactions to dopamine are related to its pharmacological action.

More common reactions include-

Cardiovascular: Ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction.

Gastrointestinal: Nausea, vomiting

Nervous System: Headache

Respiratory: Dyspnoea

Less common reactions include-

Biochemical Abnormalities- Azotaemia

Cardiovascular: Aberrant conduction, bradycardia, widened QRS complex, hypertension, gangrene, fatal ventricular arrhythmias have been reported on rare occasions.

Eye Disorders: Mydriasis

Nervous system- Piloerection

Serious or Life-threatening Reactions:

Gangrene of the feet has occurred following doses of 10-14 microgram/kg/min and higher in a few patients with pre-existing vascular disease.

4.9 Overdose

Excessive elevation of blood pressure and vasoconstriction can occur due to the alpha adrenergic actions of dopamine, especially in patients with a history of occlusive vascular disease. If desired, this condition can be rapidly reversed by dose reduction or discontinuing the infusion, since dopamine has a half-life of less than 2 minutes in the body.

Should these measures fail, an infusion of an alpha adrenergic blocking agent, e.g., phentolamine mesylate, should be considered.

Dopamine at the infusion site can cause local vasoconstriction hence the desirability of infusing into a large vein. The resulting ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 mg to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.

Accidental Overdosage:

Accidental overdosage as evidenced by excessive blood pressure elevation can be controlled by dose reduction or discontinuing the dopamine infusion for a short period, since the duration of action of dopamine is short.

Should these measures fail, an infusion of phentolamine mesylate should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Dopamine (3,4-dihydroxyphenylethylamine) is the third naturally-occurring catecholamine and is a metabolic precursor of noradrenaline and adrenaline. Dopamine is used therapeutically as the hydrochloride and its main effects are seen in the cardiovascular system and the kidneys.

Heart

Dopamine exerts positive inotropic and chronotropic effects on the myocardium, acting as an agonist at beta-adrenergic receptors. In addition to its direct action on beta-adrenergic receptors, dopamine acts indirectly by releasing noradrenaline from sympathetic storage sites.

Blood Vessesls

Depending on the vascular bed being studied and the dose administered, Dopamine can cause relaxation or contraction of vascular smooth muscle.

Dopamine Receptors

Unlike other endogenous catecholamines or sympathomimetic amines, Dopamine caused vasodilatation in renal, coronary, mesenteric and intracerebral arterial vascular beds in anaesthetised dogs. This vasodilator effect is not antagonised by beta-adrenergic blockers, atropine or antihistamines. However, butyrophenones, phenothiazines, apomorphine and bulbocapnine selectively attenuate dopamine-induced vasodilatation, thus suggesting the existence of specific dopamine vascular receptors similar to those in the basal ganglia and other areas in the central nervous system.

Alpha-adrenergic Receptors

Dose response studies indicate that with a sufficiently large dose, the vasoconstrictor effect of dopamine predominates over its vasodilator effect. This dopamine-induced vasoconstrictor effect is antagonised by alpha-adrenoreceptor blocking agents such as phentolamine and phenoxybenzamine, indicating that vasoconstriction results from the action of dopamine on alpha-adrenergic receptors.

Kidney

Intravenous infusions of dopamine (2.6 to 7.1µg/kg/min.) to seven normal subjects increased estimated average renal plasma flow from 507 to 798ml/min., insulin clearance from 109 to 136ml/min. and average sodium excretion from 171 to 571µEq./min. Although the diuretic and natriuretic effects of dopamine may result from vasodilatation in renal vascular bed (vide supra), disassociation between natriuresis and increments in renal blood flow has been observed, suggesting that other mechanisms such as redistribution of intrarenal blood flow may be involved.

5.2 Pharmacokinetic properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration by subcutaneous or intramuscular injection. Dopamine hydrochloride is administered by intravenous infusion.

Dopamine is a metabolic precursor of nor-adrenaline and, whereas a proportion is excreted as the metabolic products of nor-adrenaline, the majority is mainly metabolised into 3,4,-Dihydroxyphenylacetic Acid (DOPAC) and 3-methoxy-4-hydroxyphenylacetic (HVA) which are rapidly excreted in the urine.

The plasma half-life of dopamine is approximately two minutes.

5.2 Pharmacokinetic Properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration by subcutaneous or intramuscular injection. Dopamine hydrochloride is administered by intravenous infusion.

Dopamine is a metabolic precursor of nor-adrenaline and, whereas a proportion is excreted as the metabolic products of nor-adrenaline, the majority is mainly metabolised into 3,4,-Dihydroxyphenylacetic Acid (DOPAC) and 3-methoxy-4-hydroxyphenylacetic (HVA) which are rapidly excreted in the urine.

The plasma half-life of dopamine is approximately two minutes.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Metabisulphite B.P.

Water for Injections B.P.

6.2 Incompatibilities

Iron salts, alkalis or oxidising agents.

6.3 Shelf Life

3 years (36 months)

6.4 Special Precautions For Storage

Do not store above 25°C.

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

6.5 Nature And Contents Of Container

5ml Clear glass one point-cut (OPC) ampoules, glass type I Ph Eur. with white ring packed in cardboard cartons to contain 10 x 5ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

This solution must be diluted before use.

Do not dilute with alkaline solution.

Do not use the injection if it is darker than slightly yellow or discoloured in any other way.

For the preparation of Dopamine Hydrochloride Intravenous Infusion.

Use as directed by the physician.

Keep out of reach of children.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 02848/0131.

9. Date Of First Authorisation/Renewal Of The Authorisation

14 September 1989 / 25 July 1997

10. Date Of Revision Of The Text

18/03/2010

Verapamil Sustained-Release Tablets (Controlled Onset)
Pronunciation: ver-AP-a-milGeneric Name: VerapamilBrand Name: Covera-HS

Normacol
1. Name Of The Medicinal Product

NORMACOL.

2. Qualitative And Quantitative Composition

The active ingredient is Sterculia 62% w/w.

3. Pharmaceutical Form

Oral granules.

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of constipation, particularly simple or idiopathic constipation and constipation during pregnancy.

Management of colostomies and ileostomies.

The 'High Residue Diet' management of diverticular disease of the colon and other conditions requiring a high fibre regimen.

The initiation and maintenance of bowel action after rectal and anal surgery.

Administration after ingestion of sharp foreign bodies to provide a coating and reduce the possibility of intestinal damage during transit.

4.2 Posology And Method Of Administration

Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.

Elderly: As adult dose.

Children: (6-12 years): one half the above amount.

The granules should be placed dry on the tongue and without chewing or crushing, swallowed immediately with plenty of water or a cool drink. Prior to drinking they may also be sprinkled onto and taken with soft food such as yoghurt.

4.3 Contraindications

Intestinal obstruction, faecal impaction, and total atony of the colon.

Known hypersensitivity to any of the ingredients

4.4 Special Warnings And Precautions For Use

Caution should be exercised in cases of ulcerative colitis.

Patients with rare hereditary problems of fructose intolerance, glucose –galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Not to be taken immediately before going to bed or in a recumbent position especially in the elderly. Adequate fluid should be maintained.

Not to be taken for more than 4 days if there has been no movement of the bowels.

It is not unusual for stool to appear paler in colour than normal as a result of local contact with sterculia. This does not indicate anything untoward.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

NORMACOL may be recommended during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Immune system disorders:

Allergic reactions

Gastrointestinal disorders:

Intestinal/colonic obstruction or impaction, flatulence

Occasionally mild abdominal distension may occur.

Oesophageal obstruction is possible if the product is taken in overdosage or if it is not adequately washed down with fluid.

4.9 Overdose

Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect.

5.2 Pharmacokinetic Properties

Sterculia is not absorbed or digested in the gastrointestinal tract and its laxative action is normally effective within 12 hours of oral administration.

5.3 Preclinical Safety Data

There is no evidence that Sterculia has a significant systemic toxicity potential.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium bicarbonate

Sucrose

Talc

Paraffin wax

Titanium dioxide

Vanillin

6.2 Incompatibilities

None known.

6.3 Shelf Life

Sachet and lined carton: 2 years

6.4 Special Precautions For Storage

Store in a dry place below 25°C.

6.5 Nature And Contents Of Container

Sachet containing 7 g of white granules in boxes of 2, 7, 30 or 60 sachets.

Lined box of 100 g or 500 g of white granules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Norgine Limited

Norgine House

Widewater Place

Moorhall Road

Harefield

UXBRIDGE

Middlesex UB9 6NS

United Kingdom

8. Marketing Authorisation Number(S)

PL 0322/5010R

9. Date Of First Authorisation/Renewal Of The Authorisation

January 1991

10. Date Of Revision Of The Text

July 2010

Elixophyllin Elixir
Pronunciation: thee-OF-i-linGeneric Name: TheophyllineBrand Name: Elixophyllin

Vetprofen
Dosage Form: FOR ANIMAL USE ONLYVetprofen™

Trimethobenzamide/Benzocaine Suppositories
Pronunciation: trye-METH-oh-BENZ-a-mide/BEN-zoe-kaneGeneric Name: Trimethobenzamide/BenzocaineBrand Name: Examples include Tebamide and Tigan

NiQuitin 4 mg Mint Lozenges / NiQuitin Pre-Quit 4 mg Mint Lozenges
1. Name Of The Medicinal Product

NiQuitin 4 mg Mint Lozenges.

NiQuitin Pre-Quit 4 mg Mint Lozenges.

2. Qualitative And Quantitative Composition

Each lozenge contains 4 mg nicotine (as nicotine resinate). For excipients see Section 6.1.

3. Pharmaceutical Form

Lozenge.

White, round lozenge with convex surfaces, debossed NL4S on one side.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin Mint Lozenges relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Mint Lozenges are indicated in pregnant and lactating women making a quit attempt.

NiQuitin Mint Lozenges should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Directions for use:

NiQuitin 4 mg Mint Lozenges are suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.

One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 20 – 30 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth.

Behavioural therapy, advice & support will normally improve the success rate.

Adults (18 years and over):

Abrupt cessation of smoking:

Users should make every effort to stop smoking completely during treatment with NiQuitin Mint Lozenges.

Recommended treatment schedule:

Step 1

Weeks 1 to 6

Step 2

Weeks 7 to 9

Step 3

Weeks 10 to 12

Initial treatment period

Step down treatment period

Step down treatment period

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

During weeks 1 to 6 it is recommended that users take a minimum of 9 lozenges per day. Users should not exceed 15 lozenges per day.

To help stay smoke free beyond 12 weeks, users may take 1-2 lozenges per day only on occasions when they are strongly tempted to smoke.

Those who have quit smoking but are having difficulty discontinuing using the lozenges are recommended to seek additional help and advice from a healthcare professional.

Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If users are still feeling the need to use the lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary abstinence:

Use a lozenge every 1-2 hours to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 lozenges per day.

Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children:

Adolescents (12-17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Mint Lozenges are not recommended for use in children under 12 years of age.

4.3 Contraindications

NiQuitin Mint Lozenges are contraindicated in:

• those with hypersensitivity to nicotine or any of the excipients;

• children under the age of 12 years and non-smokers.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Mint Lozenges may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: Susceptibility to angioedema and urticaria

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

• GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Phenylketonuria: NiQuitin Mint Lozenges contain a source of phenylalanine equivalent to 3mg/dose. May be harmful for people with phenylketonuria.

Sodium content: Each NiQuitin Mint Lozenge contains 15 mg of sodium. People on a low sodium diet should take this into account.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

NRT can cause adverse reactions similar to those associated with nicotine administered in other ways, including smoking. These may be attributed to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses NiQuitin Mint Lozenges have not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Mint Lozenges by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Certain symptoms which have been reported such as depression, irritability, anxiety and insomnia may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.

Related adverse events with excess in active compared to placebo group in a controlled study.

Immune system disorder

   

Very rare <1/10000: anaphylactic reactions

   

Platelet, bleeding and clotting disorders

   

Uncommon >1/1000; <1/100: gingival bleeding

   

Metabolic and nutritional disorders

   

Uncommon >1/1000; <1/100: thirst; excessive thirst

   

Psychiatric disorders

   

Common >1/100; >1/10: insomnia

 

Uncommon >1/1000; <1/100: anxiety; anxiety attack; anxiety reaction; nightmares; marked restlessness; decreased appetite; lost appetite; lethargy

   

Central and peripheral nervous system disorders

   

Common >1/100; <1/10: dizziness; headache

 

Uncommon >1/1000; <1/100; migraine; mucosal burning; burning sensation; paraesthesia mouth; sensory disturbance; hyperalertness

   

Respiratory system disorders

   

Common >1/100; <1/10: coughing; pharyngitis; sore throat

 

Uncommon >1/1000; <1/100: dyspnoea; shortness of breath; aggravated cough; lower respiratory tract infection; respiratory disorder; excessive sneezing

   

Gastrointestinal system disorders

   

Very common >1/10: nausea; hiccup, flatulence

 

Common >1/100; <1/10: vomiting; constipation, diarrheoa; dysphagia; dyspepsia; heartburn; indigestion; belching; mouth irritation, mouth ulceration; tongue ulceration; dry mouth; bloating

 

Uncommon >1/1000; <1/100: gastroesophageal reflux; oesophageal reflux aggravated; retching; eructation; gagging; catarrh; increased saliva; lip ulceration; GI disorder; abdominal griping; sore lips; dry throat

   

Special senses other, disorders:

   

Uncommon >1/1000; <1/100: taste perversion

   

Skin and appendages disorders:

   

Uncommon >1/1000; <1/100: itching; rash

   

Body as a whole: general disorders:

   

Uncommon >1/1000; <1/100: throat swelling; chest pain; tightness of chest; overdose effect; withdrawal syndrome; malaise; hot flushes; halitosis

4.9 Overdose Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: N07B A01

Nicotine is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. When consumed in tobacco products, it has been shown to be addictive and abstinence is linked to craving and withdrawal symptoms. These craving and withdrawal symptoms include urge to smoke, depressed mood, insomnia, irritability, frustration or anger, anxiety, difficulty in concentrating, restlessness and increased appetite or weight gain. The lozenges replace some of the nicotine provided by tobacco and help reduce the severity of these nicotine craving and withdrawal symptoms.

5.2 Pharmacokinetic Properties

NiQuitin Mint Lozenges dissolve completely in the oral cavity, and the entire amount of nicotine contained in the lozenge becomes available for buccal absorption or ingestion (swallowing). The complete dissolution of NiQuitin Mint Lozenges is typically achieved in 20-30 minutes. The peak plasma concentrations of nicotine achieved after single dose are approximately 10.8 ng/ml. When dosed every 1.5 hours, the steady state peak and trough concentrations are 26.0 and 19.7 ng/ml respectively. Ingestion of NiQuitin Mint Lozenges not following dosing instruction (chewed, retained in the mouth, and swallowed; chewed and immediately swallowed) does not result in faster or higher absorption, but a substantial amount of nicotine (80-93%) is still absorbed.

As the plasma protein binding of nicotine is low (4.9% - 20%), the volume of distribution of nicotine is large (2.5 l/kg). The distribution of nicotine to tissue is pH dependent, with the highest concentrations of nicotine found in the brain, stomach, kidney and liver.

Nicotine is extensively metabolized to a number of metabolites, all of which are less active than the parent compound. The metabolism of nicotine primarily occurs in the liver, but also in the lung and kidney. Nicotine is metabolized primarily to cotinine but is also metabolized to nicotine N?-oxide. Cotinine has a half-life of 15-20 hours and its blood levels are 10 times higher than nicotine. Cotinine is further oxidized to trans-3?-hydroxycotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.

The elimination half-life of nicotine is approximately 2 hours (range 1 - 4 hours). Total clearance for nicotine ranges from approximately 62 to 89 l/hr. Non-renal clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and its metabolites are excreted almost exclusively in the urine. The renal excretion of unchanged nicotine is highly dependent on urinary pH, with greater excretion occurring at acidic pH.

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.

Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin Mint Lozenges. Effects on fertility have not been established.

Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin Mint Lozenges indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin Mint Lozenges should only be used by pregnant women on medical advice if other forms of treatment have failed.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Mannitol

Sodium alginate

Xanthan gum

Potassium bicarbonate

Calcium polycarbophil

Sodium carbonate anhydrous

Aspartame

Magnesium stearate

Mint flavour powder 57581

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

Clear or opaque Polyvinyl Chloride/Polyethylene/Polyvinylidene Chloride blisters in packs of 12, 24, 36, 48, 72, 96, 108 and 144, or a polypropylene tablet container with cap containing 24 lozenges in packs of 24, 48 and 72.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

T/A GlaxoSmithKline Consumer Healthcare

Brentford, TW8 9GS, UK

8. Marketing Authorisation Number(S)

PL 00079/0370

9. Date Of First Authorisation/Renewal Of The Authorisation

24 September 2001

10. Date Of Revision Of The Text

23/03/2011

Strong Pholcodine Linctus BP
1. Name Of The Medicinal Product

Strong Pholcodine Linctus BP

2. Qualitative And Quantitative Composition

Each 5ml contains Pholcodine BP 10mg

3. Pharmaceutical Form

Oral solution: Clear, colourless, raspberry and cola flavoured syrup.

4. Clinical Particulars 4.1 Therapeutic Indications

Suppression of non-productive cough.

4.2 Posology And Method Of Administration

Adults:

5ml spoonful 3-4 times daily

Children:

Not recommended.

4.3 Contraindications

Liver disease, ventilatory failure, asthma, bronchitis, bronchiectasis. Use in patients with hypersensitivity or idiosyncratic response to the active ingredient, use in children.

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Depressant effects may occur with concurrent alcohol ingestion; concurrent (or within 2 weeks) use of MAOIs may lead to excitation; the depressant effects might be increased by phenothiazines, MAOIs and tricyclic anti-depressants.

4.6 Pregnancy And Lactation

This product should not be used during pregnancy or lactation unless it is considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Pholcodine may induce drowsiness. Patients receiving this medication should not drive or operate machinery unless it has been shown not to affect mental or physical ability.

4.8 Undesirable Effects

Constipation, nausea and drowsiness occasionally occur.

Immune system disorders: hypersensitivity reactions, anaphylaxis.

4.9 Overdose

Restlessness, excitement and ataxia may occur after large doses. A toxic dose in children is reported to be about 200mg.

Treatment: Gastric lavage with supportive and symptomatic measures. In severe cases, and where respiratory depression occurs an opioid antagonist such as Naloxone – should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Morphine or codeine derivatives. By tradition used mainly as an antitussive. It suppresses the cough reflex by a direct central action, probably in the medulla or pons. It has little or no analgesic or euphorigenic activity.

5.2 Pharmacokinetic Properties

Metabolised in the liver.

5.3 Preclinical Safety Data

Not stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric Acid BP

Sodium Carboxymethylcellulose 7HOF BP

Glycerol BP

Sodium Benzoate BP

Saccharin Sodium BP

Lycasin 80/55 HSE

Ethanol 96% BP

Raspberry/Cola flavour

Purified Water BP to volume

6.2 Incompatibilities

None known

6.3 Shelf Life

Amber glass bottles – 2 years

High density polyethylene bottles – 2 years

6.4 Special Precautions For Storage

Store below 20°C. Protect from light.

6.5 Nature And Contents Of Container

Amber Grade III glass bottle with pilfer proof screw cap, 100ml, 125ml, 200ml and 500ml.

Virgin HDPE bottle with tamper evident screw cap, 500ml, 1 Litre, 2 Litres.

6.6 Special Precautions For Disposal And Other Handling

As for all medicines – no special requirements.

Administrative Data 7. Marketing Authorisation Holder

Pinewood Laboratories Ltd.,

Ballymacarbry, Clonmel,

Co. Tipperary, Ireland

8. Marketing Authorisation Number(S)

PL 04917/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

15 August 1991

10. Date Of Revision Of The Text

February 2008

X-Viate Gel
urea Dosage Form: gelX-VIATE™ 40% CREAM

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