Država: Malta
Jezik: engleski
Izvor: Medicines Authority
SIMVASTATIN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C10AA01
SIMVASTATIN 20 mg
FILM-COATED TABLET
SIMVASTATIN 20 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2008-02-26
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER Sivacor 10mg film-coated tablets Sivacor 20 mg, film-coated tablets Sivacor 40 mg, film-coated tablets simvastatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1_. _ What Sivacor is and what it is used for. 2. What you need to know before you take Sivacor. 3. How to take Sivacor. 4. Possible side effects. 5. How to store Sivacor. 6. Contents of the pack and other information._ _ 1. WHAT SIVACOR IS AND WHAT IT IS USED FOR Sivacor contains the active substance simvastatin and belongs to a group of medicines known as statins. These work by reducing the amount of total cholesterol, “bad” cholesterol (LDL cholesterol), and certain fatty substances called triglycerides in your blood. In addition, Sivacor raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called ‘bad’ cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called ‘good’ cholesterol because it helps keep the bad cholesterol from building up in the art Pročitajte cijeli dokument
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sivacor 10 mg, film-coated tablets. Sivacor 20 mg, film-coated tablets. Sivacor 40 mg, film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet Sivacor 10 mg contains 10 mg of simvastatin; Excipient with known effect: Each tablet contains 65.73 mg of lactose monohydrate One film-coated tablet Sivacor 20 mg contains 20 mg of simvastatin; Excipient with known effect: Each tablet contains 131.46 mg of lactose monohydrate One film-coated tablet Sivacor 40 mg contains 40 mg of simvastatin._ _ Excipient with known effect: Each tablet contains 262.92 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Sivacor 10 mg is a peach-coloured, oval, biconvex, film-coated tablet, scored on one side; Sivacor 20 mg is a tan-coloured, oval, biconvex, film-coated tablet, scored on one side; Sivacor 40 mg is a brick red-coloured, oval, biconvex, film-coated tablet, scored on one side; The tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. Page 2 of 18 Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage range is 5-80 mg/day given orally as a single dose in the evening. Adjustments of dosage, if required, shou Pročitajte cijeli dokument