Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 80 mg
Generic Health Pty Ltd
Simvastatin
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; magnesium stearate; citric acid monohydrate; ascorbic acid; microcrystalline cellulose; lactose monohydrate; butylated hydroxyanisole; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red; iron oxide black
Oral
30 tablets
(S4) Prescription Only Medicine
Simvastatin generichealth tablets are 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 generichealth tablets are indicated in patients at high risk of CHD (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitilisation 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. Simvastatin generichealth tablets are indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (HeFH). 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.
Visual Identification: Brick red coloured, capsule shaped, biconvex, film-coated tablets, debossed with '80' on one side and breakline on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-07-17
CONSUMER MEDICINE INFORMATION SIMVASTATIN GENERICHEALTH (SIMVASTATIN) FILM-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Simvastatin generichealth. 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 generichealth 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 GENERICHEALTH IS USED FOR Simvastatin generichealth helps to lower cholesterol and triglyceride levels. Simvastatin generichealth 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 generichealth 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. When you have high levels of cholesterol, it ma Đọc toàn bộ tài liệu
AUSTRALIAN PRODUCT INFORMATION – SIMVASTATIN GENERICHEALTH (SIMVASTATIN) FILM COATED TABLET 1 NAME OF THE MEDICINE Simvastatin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet for oral administration contains either 10 mg, 20 mg, 40 mg or 80 mg of simvastatin. List of excipients with known effect: sugars (as lactose monohydrate). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Simvastatin generichealth 10 mg: Peach coloured, oval shaped, biconvex, film-coated tablets, debossed with ‘10’ on one side and a breakline on the other side. Simvastatin generichealth 20 mg: Tan coloured, oval shaped, biconvex, film-coated tablets, debossed with ‘20’ on one side and a breakline on the other side. Simvastatin generichealth 40 mg: Brick red coloured, oval shaped, biconvex, film-coated tablets, debossed with ‘40’ on one side and a breakline on the other side. Simvastatin generichealth 80 mg: Brick red coloured, capsule shaped, biconvex, film-coated tablets, debossed with ‘80’ on one side and a breakline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Simvastatin generichealth is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. • Simvastatin generichealth 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 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, Đọc toàn bộ tài liệu