Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SIMVASTATIN
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
SIMVASTATIN
3 x 10 Tablets; 100 Tablets
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What is Covastin used for 2. How Covastin works 3. Before you use Covastin 4. How to use Covastin 5. While you are using it 6. Side effects 7. Storage and Disposal of Covastin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision _ _ 11. Serial Number _ _ WHAT IS COVASTIN USED FOR It is used to treat high cholesterol levels and helps to reduce risk of heart disease problems (coronary heart disease (CHD)). If you have CHD, diabetes, history of stroke, or other vessel disease (regardless of the amount of cholesterol in your blood), COVASTIN: a. can prolong your life by reducing the risk of heart attack or stroke b. reduces the need for surgery to increase blood flow to the legs and major organs such as the heart c. reduces the need for hospitalization for chest pain (called angina) HOW COVASTIN WORKS Simvastatin is the drug classified as statins. It works by blocking HMG-CoA enzyme that involves in cholesterol production. Therefore, less cholesterol is made and reduces cholesterol levels in the blood. Simvastatin lowers the level of total cholesterol, ‘bad’ cholesterol (LDL, low density lipoprotein) and fatty substances called triglycerides. It raises ‘good’ cholesterol (HDL, high density lipoprotein). BEFORE YOU TAKE COVASTIN _When you must not use it _ Do not take Covastin if you: • have acute liver disease. • are pregnant or plan to become pregnant. • are breast-feeding or plan to start breast-feeding. • taking potent CYP3A4 inhibitors, gemfibrozil, ciclosporin or danazol • have homozygous familial hypercholesterolaemia and taking lomitapide with more than 40mg simvastatin dose • are allergic (hypersensitive) to Simvastatin or any ingredients in this medicine. _Before start to take it _ Tell your doctor or pharmacist: - If you are allergic (hypersensitivity) to simvastatin or any other ingredients in this medicine. - If you are pregnant or plan to become pregnant. - Læs hele dokumentet
COVASTIN TABLET (10MG, 20MG & 40MG) COMPOSITION Covastin Tablet 10mg: Each film coated tablet contains Simvastatin 10mg Covastin Tablet 20mg: Each film coated tablet contains Simvastatin 20mg Covastin Tablet 40mg: Each film coated tablet contains Simvastatin 40mg PHARMACODYNAMICS Mechanism of action After oral ingestion, simvastatin which is an inactive lactone, is hydrolysed in the liver to the corresponding active beta-hydroxyacid form which has a potent activity in inhibiting HMG-CoA reductase (3 hydroxy – 3 methylglutaryl CoA reductase). This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations. LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor. The mechanism of the LDL-lowering effect of simvastatin may involve both reduction of VLDL-cholesterol (VLDL-C) concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with simvastatin. In addition, simvastatin moderately increases HDL-C and reduces plasma TG. As a result of these changes the ratios of total- to HDL-C and LDL- to HDL-C are reduced. PHARMACOKINETICS Simvastatin is absorbed from the gastrointestinal tract and must be hydrolysed to its active β-hydroxyacid form. Other active metabolites have been detected and several inactive metabolites are also formed. Simvastatin is a substrate for the cytochrome P450 isoenzyme CYP3A4 and undergoes extensive first-pass metabolism in the liver, its primary site of action. Less than 5 % of the oral dose has been reported to reach the circulation as active metabolites. Both simvastatin and its β-hydroxyacid metabolite are about 95 % bound to plasma proteins. Simvastatin is mainly excreted in the faeces via the bile as metabolites. About 10 to 15 % is recovered in the urine, mainly i Læs hele dokumentet