Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
ROSUVASTATIN CALCIUM
28 Tablets; 30 Tablets
LEK PHARMACEUTICALS D.D.
ROSUVASTATIN SANDOZ FILM-COATED TABLETS Rosuvastatin calcium (10 mg and 20 mg) 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What is Rosuvastatin Sandoz used for 2. How Rosuvastatin Sandoz works 3. Before you use Rosuvastatin Sandoz 4. How to use Rosuvastatin Sandoz 5. While you are using it 6. Side effects 7. Storage and disposal of Rosuvastatin Sandoz 8. Product description 9. Manufacturer & Product Registration Holder 10. Date of revision WHAT IS ROSUVASTATIN SANDOZ USED FOR You have been prescribed Rosuvastatin Sandoz because either: (a) You have a high cholesterol level. This means you are at risk of getting a heart attack or stroke. You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin Sandoz. Or (b) You have other factors that increase your risk of getting a heart attack, stroke or related health problems. Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to build-up of fatty deposits in your arteries. HOW ROSUVASTATIN SANDOZ WORKS Rosuvastatin Sandoz belongs to a group of medicines called statins. There are different types of cholesterol found in the blood, including – ‘bad’ cholesterol (LDL- C) and ‘good’ cholesterol (HDL-C). • Rosuvastatin Sandoz can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol. • It works by helping to block your body’s production of ‘bad’ cholesterol in the liver. It also improves your body’s ability to remove it from your blood. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to t Les hele dokumentet
PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatin Sandoz 10 mg film-coated tablets Rosuvastatin Sandoz 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rosuvastatin Sandoz 10 mg film-coated tablets Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Each film-coated tablet contains 52.92 mg lactose anhydrous. Rosuvastatin Sandoz 20 mg film-coated tablets Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Each film-coated tablet contains 105.84 mg lactose anhydrous. 3. PHARMACEUTICAL FORM Film-coated tablet. Rosuvastatin Sandoz 10 mg film-coated tablets Brown, round, film-coated tablets with “RSV 10” debossed on one side. Rosuvastatin Sandoz 20 mg film-coated tablets Brown, round, film-coated tablets with “RSV 20” debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol, LDL-cholesterol, ApoB, the total cholesterol: HDL-cholesterol ratio and triglycerides and for increasing HDL-C, in hyperlipidemic and dyslipidemic conditions, when response to diet and exercise alone has been inadequate including: Prevention of Cardiovascular Events: In adult patients with an increased risk of atherosclerotic cardiovascular disease based on the presence of cardiovascular disease risk markers e.g., an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease. Rosuvastatin Sandoz is indicated to reduce total mortality and the risk of major cardiovascular events (cardiovascular death, stroke, myocardial infarction (MI), unstable angina, or arterial revascularization). As an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (type III hyperlipoproteinemia). Primary hypercholesterolaemia. Combined (mixed) dyslipidemia (type IIb). Homozygous familial hypercholesterolaemia where Rosuvastatin Sandoz Les hele dokumentet