Капсулы SIMVAXON

Patient package insert according to Pharmacists' Regulations (Preparations), 1986. This medicine is to be dispensed upon physician's prescription only. Carefully read the entire package insert before using this medication.

Composition: Each caplet contains:

Simvaxon 10: Simvaxon 20: Simvaxon40:

Simvastatin 10 mg Simvastatin 20 mg Simvastatin 40 mg

Inactive ingredients: Lactose monohydrate, starch pregelatinised, microcrystalline cellulose, ascorbic acid, citric acid monohydrate, magnesium stearate, butylhydroxyanisole, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, iron oxide (red, black, yellow) (E172), carnauba wax.

Each Simvaxon 10 caplet contains 70.48 mg lactose.

Each Simvaxon 20 caplet contains 140.96 mg lactose.

Each Simvaxon 40 caplet contains 281.92 mg lactose.

Therapeutic group: Simvastatin belongs to a group of medicines called "statins". Statins inhibit the action of the enzyme HMG-CoA reductase.

Терапевтическое действие: Simvaxon используется для снижения уровня «плохого» холестерина (LDL) и других липидных компонентов в крови и повышению уровня «хорошего» холестерина (ЛПВП) у пациентов с гиперлипидемией (высокий уровень липидов в крови) . У пациентов с ишемической болезнью сердца и гиперхолестеринемией (чрезмерным содержанием холестерина в крови), Simvaxon снижает риск общей смертности за счет снижения коронарной смерти, снижает риск нефатального инфаркта миокарда, снижает опасность совершения инвазивных процедур (например, ангиопластика или шунтирование операции) и снижает риск инсульта.

Therapeutic action: Simvaxon is used for lowering the levels of "bad" cholesterol (LDL) and other lipid components in the blood and for raising the levels of "good" cholesterol (HDL) in patients with hyperlipidemia (high lipid levels in the blood). In patients with coronary heart disease and hypercholesterolemia (excessive cholesterol in the blood), Simvaxon reduces the risk of total mortality by reducing coronary death, reduces the risk of non-fatal myocardial infarction, reduces the risk of undergoing invasive procedures (e.g. angioplasty or bypass surgery) and reduces the risk of stroke.

When should this medicine not be used?

Do not use Simvaxon: If you are pregnant or breastfeeding.

If you are aware of hypersensitivity to this or to any of the medicine's ingredients.

If you suffer from liver problems, from severe respiratory failure.

If you are taking other medicines such as: medicines for treatment of the AIDS virus called HIV protease inhibitors (e.g. indinavir, nelfinavir, ritonavir and saquinavir), itraconazole and ketoconazole (antifungal agents), erythromycin and clarithromycin (antibiotics of the macrolide group).

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Do not use this medicine without consulting your physician before commencing treatment: if you are suffering from kidney problems. If you suffer from unexplained muscle pain, tenderness or weakness; if you or any of your close family members suffer/s from a hereditary muscular disorder; if you suffered in the past from muscle problems while taking other cholesterol-lowering medicines called statins or fibrates. If you consume a lot of alcoholic beverages or if you suffered in the past from liver disease, if you suffer from impaired thyroid function. If you are above the age of 70. If you are about to undergo surgery. Inform the physician about your medical status including known allergies.

The preparation contains lactose. If you have been told by a physician in the past that you have an intolerance to certain sugars consult the physician before commencing treatment with this medicine. How will this medicine influence your daily schedule?

Simvaxon is not expected to affect ability to dnve or operate dangerous machinery. However, since dizziness has been reported (rare), be careful when driving vehicles or operating dangerous machinery. Warnings: Blood tests for liver function might be required before and during treatment with this medicine. If you are aware of any sensitivities to foods or drugs inform your physicianoefore taking this medicine. Do not take Simvaxon if you are pregnant, planning to become pregnant or suspect that you may be pregnant. Consult your physician regarding appropriate contraception. In case you become pregnant during treatment with Simvaxon, stop taking the medicine and refer to your physician immediately.

Drug interactions: If you are taking other medicines concurrently, or have just completed treatment with another medicine, inform your physician in order to prevent hazards or inefficacy arising from drug interactions. This is especially important in regard to medicines from the following groups: medicines that increase the risk of muscle problems when used concomitantly with simvastatin: ciclosporin (used to suppress the immune system), danazol (hormone), medicines for treatment of the AIDS virus called HIV protease inhibitors (see above), itraconazole and ketoconazole (see above), erythromycin, clarithromycin or fucidic acid (medicines for bacterial infections), other lipid-lowering medicines such as fibrates (bezafibrate), verapamil or diltiazem (used to treat hypertension, chest pain associated with heart disease or other heart problems), amiodarone (for treatment of irregular heart rate). It is also important to tell your physician if you are taking anticoagulants (e.g. warfarin or acenocoumarol) or niacin.

Avoid eating grapefruits or drinking grapefruit juice while under treatment with Simvaxon. Side effects: In addition to the desired effect of the medicine, some side effects may appear during treatment. In rare cases there have been reports of anemia, numbness or weakness of the hands and feet, headaches, tingling sensation, dizziness, gastrointestinal disorders such as: nausea and vomiting, abdominal pain, constipation, diarrhea, flatulence, indigestion; rash, itching, hair loss, weakness, depression, sleep disturbances, loss of memory, sexual function disturbances.

Elevation in liver function and creatine kinase results was observed in blood tests. Side effects requiring special attention: The reported side effects are rare. In all the cases listed, you should discontinue treatment and contact the physician immediately: inflammation of the liver (possibly manifested as yellowing of the skin and whites of the eyes, skin irritation, dark urine, pale stools and in rare cases liver failure), muscle damage (see below) or an allergic reaction (see below), pancreatitis with severe abdominal pain, difficulty breathing, nagging cough, or a general decline in your health (e.g.: fatigue, weight loss and fever). Muscle damage: Discontinue treatment and contact your physician immediately if you experience muscle pain, cramps, tenderness or weakness, since rarely, muscle problems may be serious, including breakdown of muscle tissue that may lead to kidney damage. Allergic reaction: Could be manifested by a number of symptoms, among them: rash with weakness of the limbs and neck muscles, swelling of the face, tongue or throat that may cause breathing difficulties, severe muscle pain mostly in the shoulders and thighs, joint pains, inflammation of the joints and blood vessels, unusual bruising, swelling of the skin, urticaria (a skin disorder), high fever, flushing, skin sensitivity to sunlight, lupus-like illness (including rash, joint disorders and effects on the blood cells). If you experience side effects not mentioned in this insert, or if you feel any change in your general health, contact your physician immediately.

Dosage: Dosage according to physician's instructions only. Do not exceed the recommended dosage. This medicine is not recommended for use in children. This medicine is to be taken at regular intervals as determined by the attending physician. If you have forgotten to take a dose at the specified time, skip the forgotten dose and take the next dose at the specified time. Never take two doses together!

While on treatment with this medicine be sure to adhere to a low-cholesterol diet.

Directions for use: Do not halve the caplet! The caplet may be crushed.

Swallow the medicine with water. It is recommended to take the medicine in the evening.

If you are also taking bile acid binding medicines (medicines for lowering cholesterol), take Simvaxon at least 2 hours before or 4 hours after taking the bile acid binding medicines.

How can you help this treatment succeed?

Complete the entire course of treatment as directed by your physician. Even if there is an improvement in your health, do not discontinue treatment with this medicine without consulting a physician.

Avoid poisoning! This medicine, and any other medicine should be kept in a closed place out of the reach of children and/or infants to avoid poisoning. If you took an overdose, or if a child accidentally swallowed this medicine, proceed immediately to a hospital emergency room and bring the medicine package with you. Do not induce vomiting without explicit instructions from a physician!

This medicine has been prescribed for the treatment of your ailment. In another patient it may cause harm. Do not give this medicine to relatives, neighbors or friends. Medicines should not be taken in the dark! Check the label and the dose every time you take this medicine. Wear glasses if you need them. Storage: Store at a temperature below 30°C. Even if kept in their recommended storage conditions, drugs retain their potency for a limited period only. Please note the expiry date of this medicine. If in doubt, consult with the dispensing pharmacist. Do not store different medicines in the same container.

Registration numbers of the drug: Simvaxon 10 caplets: 132 83 31147 00.

Simvaxon 20 caplets: 132 84 31148 00. Simvaxon 40 caplets: 132 85 31149 00. The format of this leaflet was determined by the Ministry of Health (MOH) and its content was checked and approved by the MOH in November 2009.

License holder: Dexcel Pharma Technologies Ltd., 1 Dexcel street, Or-Akiva 30600.

Manufacturer: Dexcel Ltd.

1 Dexcel street, Or-Akiva 30600, ISRAEL