Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
simvastatin
Novotech Australia Pty Ltd
Simvastatin
Medicine Registered
Registered
1/10 CMI v3 02/05/2013 CONSUMER MEDICINE INFORMATON Simvastatin Tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Simvastatin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Simvastatin against the benefits they expect it will have for you. _If you have any concerns about taking this medicine, ask your doctor or pharmacist. _ _Keep this leaflet with the medicine. _ You may need to read it again. WHAT SIMVASTATIN IS USED FOR Simvastatin helps to lower cholesterol and triglyceride levels. Simvastatin is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease). Simvastatin may be used in these people, regardless of their cholesterol level to: help prolong life by reducing the risk of a heart attack reduce the risk of stroke reduce the need for surgery to increase blood flow to the heart reduce the need for hospitalisation due to angina. _CHOLESTEROL_ Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem. Your body makes cholesterol, but it also comes from food. Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in fat, your body may not keep this balance and your cholesterol levels rise. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. 2/10 CMI v3 02/05/2013 When you have high levels of cholesterol, it may 'stick' to the inside of your blood vessels instead of being carried to th Aqra d-dokument sħiħ
1/26 PI v7 SRN 19/04/13 PRODUCT INFORMATION NAME OF THE MEDICINE SIMVASTATIN TABLETS Simvastatin is a lipid-lowering agent derived synthetically from a fermentation product of _Aspergillus terreus._ Simvastatin is a white crystalline powder, practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Simvastatin is described chemically as [1S-[1 , 3 , 7 , 8 (2S*,4S*),8a ]]- 1,2,3,7,8,8a- hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 _H_ -pyran-2- yl) ethyl]-1-naphthalenyl 2,2-dimethylbutanoate. Structure: Empirical formula: C 25 H 38 O 5 Molecular weight: 418.57. CAS: 79902-63-9 DESCRIPTION Each tablet for oral administration contains either 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following excipients: lactose monohydrate, starch pregelatinised, cellulose microcrystalline, butylated hydroxyanisole, magnesium stearate, ascorbic acid, citric acid monohydrate, hydroxypropylcellulose, talc purified, titanium dioxide and Opadry white. Each tablet may also contain one or both of the following: yellow iron oxide CI77492 and red iron oxide CI77491. PHARMACOLOGY The involvement of low-density lipoprotein-cholesterol (LDL-C) in atherogenesis has been well documented in clinical and pathological studies, as well as in many animal experiments. Epidemiological studies have established that high LDL-C and low high- density lipoprotein-cholesterol (HDL-C) are both risk factors for coronary heart disease (CHD). 2/26 PI v7 SRN 19/04/13 After oral ingestion, simvastatin, which is an inactive lactone, is hydrolysed to the corresponding -hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3- methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which catalyses an early and rate-limiting step in the biosynthesis of cholesterol. As a result, in clinical studies simvastatin reduced total plasma cholesterol (total-C), LDL-C and very low-density lipoprotein -cholesterol (VLDL-C) concentrations. In addition, simvastatin increases HDL-C Aqra d-dokument sħiħ