Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Alliance Healthcare (Distribution) Ltd
C10AA01
Simvastatin
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000
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 Simvastatin Tablets are used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Tablets raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a member of the class of medicines called statins. 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 arteries and protects against heart disease. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. You should stay on a cholesterol-lowering diet while taking this medi Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of the active ingredient simvastatin. Excipient with known effect: Lactose monohydrate (tablet core and tablet coat) 72.03 mg per film-coated tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Simvastatin 10 mg film-coated tablets are presented as “dark peach to pink” coloured, oval shaped, film-coated tablets with “G” on one side and “SM” scoreline “10” on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide 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 (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 5-80 mg/day of simvastatin 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 Preberite celoten dokument