Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 5 mg
Sandoz Pty Ltd
Simvastatin
Tablet, film coated
Excipient Ingredients: magnesium stearate; ascorbic acid; lactose monohydrate; pregelatinised maize starch; titanium dioxide; microcrystalline cellulose; purified talc; butylated hydroxyanisole; citric acid monohydrate; hypromellose; iron oxide yellow
Oral
30 tablets
(S4) Prescription Only Medicine
Adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with Simvastatin Sandoz, 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 Sandoz is indicated in patients at high risk of coronary heart disease (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, 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.,Simvastatin Sandoz is 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 Sandoz, 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: Yellow, coated, oval, scored, convex tablets, coded "SIM 5" on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2005-02-14
SIMVASTATIN SANDOZ ® 1 SIMVASTATIN SANDOZ ® _simvastatin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Simvastatin Sandoz. 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 risk of you taking this medicine against the benefits it is expected to 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 SANDOZ IS USED FOR Simvastatin Sandoz helps to lower cholesterol and triglyceride levels. Simvastatin Sandoz 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 Sandoz 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, such as 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 may 'stick' to the inside of your blood vessels instead of bei Les hele dokumentet
210423-simvastatin-sandoz-pi Page 1 of 32 AUSTRALIAN PRODUCT INFORMATION SIMVASTATIN SANDOZ ® (SIMVASTATIN) 1 NAME OF THE MEDICINE Simvastatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Simvastatin Sandoz ® 5 mg film coated tablet contains 5 mg simvastatin. Each Simvastatin Sandoz ® 10 mg film coated tablet contains 10 mg simvastatin. Each Simvastatin Sandoz ® 20 mg film coated tablet contains 20 mg simvastatin. Each Simvastatin Sandoz ® 40 mg film coated tablet contains 40 mg simvastatin. Each Simvastatin Sandoz ® 80 mg film coated tablet contains 80 mg simvastatin. _Excipient with known effect:_ Sugars as lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Simvastatin Sandoz 5 mg film-coated tablets are yellow coated, oval, scored, convex tablets, coded ‘SIM 5’ on one side. Simvastatin Sandoz 10 mg film-coated tablets are pale pink coated, oval, scored, convex tablets, coded ‘SIM 10’ on one side. Simvastatin Sandoz 20 mg film-coated tablets are orange coated, oval, scored, convex tablets, coded ‘SIM 20’ on one side. Simvastatin Sandoz 40 mg film-coated tablets are pink coated, oval, scored, convex tablets, coded ‘SIM 40’ on one side. Simvastatin Sandoz 80 mg film-coated tablets are light green coated, oval, scored, convex tablets, coded ‘SIM 80’ on one side. _Not all strengths may be available in Australia. _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • Adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with Simvastatin Sandoz, 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 Sandoz is indicated in patients at high risk of coronary heart disease (CHD) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, periphera Les hele dokumentet