Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Simvastatin
Synthon Au Pty Ltd
Medicine Registered
SYNTHON SIMVASTATIN ® _Simvastatin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SYNTHON 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 SYNTHON 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 SYNTHON SIMVASTATIN IS USED FOR SYNTHON SIMVASTATIN helps to lower cholesterol and triglyceride levels. SYNTHON 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). SYNTHON 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 bo read_full_document
SYNTHON SIMVASTATIN – PRODUCT INFORMATION MAY 2012 1 of 23 SYNTHON SIMVASTATIN PRODUCT INFORMATION _ _ NAME OF THE MEDICINE Chemical name: [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- 2H-pyran-2-yl) ethyl]- 1- naphthalenyl- 2,2- dimethylbutanoate. H O O O O HO Molecular formula: C 25 H 38 O 5 . MW: 418.57. CAS: 79902-63-9. DESCRIPTION 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. Active ingredient : Simvastatin. Excipients: Butylated hydroxyanisole, cellulose – microcrystalline, starch – pregelatinised maize, magnesium stearate, lactose anhydrous, hypromellose, hydroxypropyl cellulose, titanium dioxide (E 171), talc – purified and yellow iron oxide CI77492 (E 172) (5 mg tablet only). PHARMACOLOGY CLINICAL 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). After oral ingestion, simvastatin, which is an inactive lactone, is hydrolysed to the corresponding beta-hydroxyacid form. This is a read_full_document