Страна: Великобритания
Език: английски
Източник: myHealthbox
simvastatin
Caduceus Pharma Ltd
C10AA01
simvastatin
10mg
Film-coated tablets
Oral use
Pack sizes: 10, 20, 28, 30, 50, 60, 98 and 100 tablets
POM - Prescription Only Medicine
Actavis UK Ltd
HMG-CoA reductase inhibitors
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. 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
Authorised
2015-05-05
296x210 reel fed bi-fold leaflet profile UK BST (DR/RW/MC 10.02.11) Simvastatin 10mg, 20mg & 40mg Tablets PIL - UK item no: AAAF7934 print proof no: 2 origination date: 16.08.13 originated by: SA revision date: 11.09.13 revised by: SA dimensions: 296 x 210 Reel Fed pharmacode: colours/plates: approved for print/date Non Printing Colours 1. 2. 3. 4. 5. 6. 1. 2. 3. date sent: N/A supplier: Actavis UK technically app. date: min pt size: TECHNICAL APPROVAL black page 1 page 4 AAAF7934 AAAF7934 SIMVASTATIN 10MG, 20MG AND 40MG FILM-COATED TABLETS 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. Do not pass it on to others. It may harm them, even if their symptoms 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. _ _ IN THIS LEAFLET: 1 WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN 3 HOW TO TAKE SIMVASTATIN 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE SIMVASTATIN 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR Simvastatin 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, simvastatin raises levels of ‘good’ cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. SIMVASTATIN IS USED: • to lower cholesterol and triglycerides in the blood when a low fat diet and other measures (such as exercise, weight loss) have failed (primary hypercholesterolaemi Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated Simvastatin 10mg tablet contains 10 mg of simvastatin; Each tablet contains 65.73 mg of lactose monohydrate For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Simvastatin 10mg Tablet is a peach-coloured, oval, biconvex, film-coated tablet, scored on one side; The tablet can be divided into equal halves. 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. 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, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The 80- mg dose is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks (see sections 4.4 Прочетете целия документ