Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
simvastatin
Apotex Pty Ltd
Simvastatin
Registered
CHEMMART SIMVASTATIN TABLETS _Simvastatin_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ 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 using this medicine 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Simvastatin is used: • to help lower high cholesterol and triglyceride levels (together with dietary changes) • in people who have coronary heart disease (CHD) • in people with a high risk of CHD (e.g. diabetes, stroke or other blood vessel disease) Simvastatin can reduce the risk of a heart attack or stroke, and can reduce the need for hospitalisation due to angina. CHOLESTEROL: Everyone has cholesterol and triglycerides in their blood. The body uses them for many things, such as building cell walls and hormones. Your body makes cholesterol, but it also comes from food. 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 high-fat diet, your body may not keep this balance and your cholesterol levels rise. Too much cholesterol or triglycerides can be a problem. When you have high levels of cholesterol, it may 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time this can form hard areas (called plaque) on the walls of blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to heart attacks, angina and stroke. High cholesterol is more likely to occur with certain diseases or if you have a family history of Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION –CHEMMART SIMVASTATIN (SIMVASTATIN) - TABLET 1 NAME OF THE MEDICINE Simvastatin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. Each tablet contains simvastatin 10 mg, 20 mg, 40 mg or 80 mg. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 10 MG TABLET Light pink coloured, oval, biconvex film-coated tablets, marked “SVN 10” on one and ‘NEO’ on the other side. 20 MG TABLET Tan coloured, oval, biconvex film-coated tablets, marked with “SVN 20” on one side and ‘NEO’ on the other side. 40 MG TABLET Pink coloured, oval, biconvex film coated tablets, marked “SVN 40” on one side ‘NEO’ on the other side. 80 MG TABLET Pink coloured, capsule-shaped, biconvex film-coated tablets marked with “SVN 80” on one side and “NEO” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Simvastatin is indicated in patients at high risk of CHD (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral 2 vessel disease, or with existing CHD to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. 4.2 DOSE AND MET Прочитајте комплетан документ