Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
ZUELLIG PHARMA SDN BHD
ROSUVASTATIN CALCIUM
28tablet Tablets
IPR PHARMACEUTICALS INC
VIVACOR ® TABLET ROSUVASTATIN 10 MG & 20 MG _CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP)_ 1 WHAT IS IN THIS LEAFLET 1. What Vivacor is used for 2. How Vivacor works 3. Before you use Vivacor 4. How to use Vivacor 5. While you are using it 6. Side effects 7. Storage and disposal of Vivacor 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT VIVACOR IS USED FOR You have been prescribed Vivacor because you have a high cholesterol level. This means you are at risk from a heart attack or stroke. HOW VIVACOR WORKS Vivacor is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol. There are different types of cholesterol found in the blood – ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C). • Vivacor can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol. • It works by helping to block your body’s production of ‘bad’ cholesterol. 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 the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems. You need to keep taking Vivacor, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build up of fatty deposits. BEFORE YOU USE VIVACOR _ _ - _When you must not use it _ Do not take Vivacor: • If you have ever had an allergic reaction to Vivacor or similar medicines, or to any of its ingredients. Vivacor contains lactose, which may cause a problem in a small number of patients who are Läs hela dokumentet
VIVACOR ® 10 mg, 20 mg Film-coated Tablet COMPOSITION Each tablet contains 10 mg or 20 mg of rosuvastatin as rosuvastatin calcium. PHARMACEUTICAL FORM Oral tablets. 10mg tablet: Pink, film-coated, round, biconvex, approximately 7mm (diameter) intagliated tablet; obverse side “ZD4522 10”, reverse side none. 20mg tablet: Pink, film-coated, round, biconvex, approximately 9.1mm (diameter) intagliated tablet; obverse side “ZD4522 20”, reverse side none. THERAPEUTIC INDICATIONS Vivacor (rosuvastatin calcium) is indicated 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 such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, Vivacor is indicated to reduce total mortality and the risk of major cardiovascular events (cardiovascular death, stroke, MI, unstable angina, or arterial revascularization). Vivacor is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Primary hypercholesterolaemia (Type IIa including heterozygous familial hypercholesterolaemia and severe non-familial hypercholesterolaemia). Combined (mixed) dyslipidemia (Type IIb). Homozygous familial hypercholesterolaemia where Vivacor is used either alone or as an adjunct to diet and other lipid lowering treatment such as apheresis. Vivacor is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to ta Läs hela dokumentet