Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
SIMVASTATIN
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
C10AA01
SIMVASTATIN 40 mg
FILM-COATED TABLET
SIMVASTATIN 40 mg
POM
LIPID MODIFYING AGENTS
Authorised
2019-09-02
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SIMVASTATIN 10MG, 20MG AND 40MG 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 Simvastatin Tablets are and what they are used for 2. What you need to know before you take Simvastatin Tablets 3. How to take Simvastatin Tablets 4. Possible side effects 5. How to store Simvastatin Tablets 6. Contents of the pack and other information 1. WHAT SIMVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR This medicine contains simvastatin which belongs to a group of drugs known as HMG-CoA reductase inhibitors. These are used to reduce the amount of cholesterol and fatty substances called triglycerides in your blood. Cholesterol is vital to the normal functioning of the body, but if levels of cholesterol in the bloodstream get too high it can be deposited on the walls of the arteries, where it builds up eventually leading to the blocking of the blood vessel. Only a small amount of cholesterol comes from our diet. Nearly all of the cholesterol in our bodies is made by our own livers and is produced mostly at night. If you have had a blood test which shows that you have too much fat (including cholesterol) in your blood, this medicine should lower these levels which will reduce the risk of developing heart disease. If you have coronary heart disease, simvastatin will lessen the risk of heart attack or of needing heart surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN TABLETS DO NOT TAKE SIMVASTATIN TABLETS IF: • y Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin 10mg film-coated tablets Simvastatin 20mg film-coated tablets Simvastatin 40mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10mg simvastatin. Each film-coated tablet contains 20mg simvastatin. Each film-coated tablet contains 40mg simvastatin. Excipients with known effect: Contains lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. The peach-coloured, oval, biconvex film coated tablets with score-line contain 10mg simvastatin. The tan-coloured, oval, biconvex film coated tablets contain 20mg simvastatin. The terracotta-coloured, oval, biconvex film coated tablets contain 40mg simvastatin. 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 (HoFH) 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 Posology The dosage range is 5 to 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 high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when Prečítajte si celý dokument