Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Sigma Pharmaceuticals Plc
C10AA01
Simvastatin
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000
Simvastatin film-coated tablet contains the active substance simvastatin. Simvastatin film-coated tablets is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin film-coated tablets 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 medicine. Simvastatin film-coated tablets is used in addition to your cholesterol lowering diet if you have: • a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia) • a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments. • coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin film-coated tablets may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood. In most people, there are no immediate symptoms of high cholesterol. Your doctor can meas Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin 80mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg of simvastatin. Excipients with known effect Each film-coated tablets contains 533.7 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Light green coated, oval, scored, convex tablet coded “SIM 80” on one side. The tablet 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. _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 dose range is 5-80 mg/day of simvastatin given orally as a single dose in the evening. Adjustments of dose, 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 and 5.1). _Hypercholesterolaemia _ _ _ The patient should be placed on a standard cholesterol-lowering diet, and should continue on this diet during treatment with simvastatin. The u Đọc toàn bộ tài liệu