Таблетки Ezetrol

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS! -1986

The dispensing of this medicine requires a doctor's prescription. Read the package insert carefully in its entirety before using this medicine. You should also read any information provided with other medicines you are currently taking.

Ezetrol 10 mg

Tablets

COMPOSITION: Each tablet contains: Ezetimibe 10 mg

THERAPEUTIC ACTIVITY:

Ezetrol 10 mg tablets are used for lowering high blood lipid levels. Ezetrol is sometimes given together with medicines of the statin family (e.g. simvastatin, atorvastatin, etc.); if that is the case, a thorough review of the patient package insert of the statin should be done before starting treatment and you should consult your physician.

Ezetrol 10 мг таблетки используются для снижения высокого уровня липидов в крови. Ezetrol иногда дается вместе с лекарствами из группы статинов семьи (например, симвастатин, аторвастатин, и т.д.), а если это так, тщательный обзор вставить пациента пакет статинами должно быть сделано до начала лечения, и вы должны проконсультироваться с врачом.

WHEN SHOULD THE PREPARATION NOT BE USED?

Do not use this medicine if you are sensitive to any of its ingredients. Do not use this medicine together with a statin, if you have active liver disease. Do not use this medicine together with a statin if you are breastfeeding. lliitot use this medicine without consulting your physician before starting treatment:

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If you are pregnant or plan to become pregnant (see WARNINGS).

If you suffer, or have suffered in the past, from liver impairment (see WARNINGS).

WARNINGS:

If you are sensitive to any type of food or medicine, inform your doctor before commencing treatment with this medicine.

If you have moderate or severe liver impairment, the use of Ezetrol is not recommended. If Ezetrol is administered together with a statin, liver function tests (transaminases) should be reviewed when starting treatment and as stated in the instructions for the relevant statin. If you are pregnant or plan to become pregnant, Ezetrol may not be right for you. No evidence of harmful effects of Ezetrol on offspring had been found in animal experiments. Since statins must not be used during pregnancy, combination treatment with Ezetrol and a statin must not be carried out during pregnancy.

Ezetrol should not be used during breastfeeding since it is not known if ezetimibe is secreted into breast milk.

Ezetrol must not be used in combination with a statin during breastfeeding. DRUG INTERACTIONS:

If you are taking another drug at the same time, including other lipid-lowering medicines, cyclosporine ana non-prescription medicines (OTC), or if you have just finished treatment with another medicine, inform the attending doctor in order to prevent hazards or lack of efficacy arising from drug interactions.

The safety and efficacy of Ezetrol have not been tested together with fibrates. Therefore,

the combined use of Ezetrol and fibrates is not recommended.

Combined use of cholestyramine with ezetimibe significantly lowers the amount of ezetimibe

absorbed by your body, which might lower the effectiveness of ezetimibe.

SIDE EFFECTS:

In addition to the desired effect of the drug, adverse reactions may occur during the course of taking this medicine.

In clinical studies, Ezetrol was generally well tolerated. The side effects were usually mild, transient and similar in type and frequency to side effects in patients who were given a placebo. Side effects generally did not cause patients to stop treatment with Ezetrol. When used alone, the following common side effects were reported: headache, abdominal pain and diarrhea.

When used together with a statin, the following common side effects were reported: headache, fatigue, abdominal pain, constipation, diarrhea, flatulence, nausea, muscle aches, and elevations in some laboratory blood tests of liver function. Additionally, the following side effects have been reported in general use: allergic reactions (which may require immediate treatment) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, and rash— If you are prescribed Ezetrol together with a statin, your healthcare professional may want to conduct routine blood tests to check your liver function before and after starting treatment. In the event that you experience side effects not mentioned in this leaflet, or if there is a change in your general health, consult your doctor immediately.

ADMINISTRATION AND DOSAGE: Dosage is according to doctor's instructions only. Do not exceed the recommended dosage.

Before starting Ezetrol, you should be placed on a standard lipid-lowering diet and should continue on this diet during treatment.

Continue taking your other lipid-lowering medicines unless your doctor tells you to stop. If not otherwise prescribed, the usual dose is 1 tablet of Ezetrol 10 mg, once a day at any time of day, according to your doctor's instructions.

If your doctor has prescribed Ezetrol along with a statin, both medicines can be taken at the same time. In this case, please consult also the dosage instructions described in the patient package insert of that particular statin.

If your doctor has prescribed Ezetrol along with a cholestyramine (a bile acid sequestrant) or any other bile acid sequestrant, Ezetrol should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

This medicine is not intended for administration to infants and children under the age of 10 years.

This medicine is to be taken at specific time intervals as determined by the attending doctor. If you forget to take this medicine at the specified time, never take an extra dose, just resume the usual schedule of the prescribed dose.

DIRECTIONS FOR USE: Swallow the medicine with a small amount of water. Do not chew or crush the tablet. Ezetrol tablets can be taken with or without food.

Complete the full course of treatment as instructed by the doctor.

Even if there is an improvement in your health, do not discontinue use of this medicine

before consulting your doctor.

AVOID POISONING! This medicine, as all other medicines, must be stored in a safe place out of the reach of children and/or infants, in order to avoid poisoning. If you have taken an overdose, or if a child has accidentally swallowed the medicine, proceed immediately to a hospital emergency room and bring the package of the medicine with you. Do not induce vomiting unless explicitly instructed to do so by a doctor! This medicine has been prescribed for the treatment of your ailment; in another patient it may cause harm. Do not give this medicine to your relatives, neighbors or acquaintances.

Do not take medicines in the dark! Check the label and the dose each time you take your medicine. Wear glasses if you need them. STORAGE: Store this medicine in a cool place.

Even if kept in their original container and stored as recommended, medicines may be kept for a limited period only. Please note the expiry date of the medicine! In case of doubt, consult the pharmacist who dispensed the medicine to you. Do not store different medications in the same package.

Drug Reg. No.: 12841 30721 05

Manufactured by Merck Sharp & Dohme UK Ltd., Cramlington, England for Merck Sharp & Dohme (Israel -1996) Company Ltd. P.O.Box 7121, Petah-Tikva 49170, Israel