Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
ASTRAZENECA SDN. BHD.
ROSUVASTATIN CALCIUM
28Tablet Tablets
IPR PHARMACEUTICALS INC
CRESTOR ® TABLET ROSUVASTATIN 5 MG, 10 MG & 20 MG _CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP)_ 1 WHAT IS IN THIS LEAFLET 1. What Crestor is used for 2. How Crestor works 3. Before you use Crestor 4. How to use Crestor 5. While you are using it 6. Side effects 7. Storage and disposal of Crestor 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial number WHAT CRESTOR IS USED FOR You have been prescribed Crestor because you have a high cholesterol level. This means you are at risk from a heart attack or stroke. HOW CRESTOR WORKS Crestor 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). • Crestor 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 Crestor, 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 CRESTOR - _When you must not use it _ Do not take Crestor: • If you have ever had an allergic reaction to Crestor or similar medicines, or to any of its ingredients. Crestor contains lactose, which may cause a problem in a small number Baca dokumen lengkapnya
CRESTOR ® 5 mg, 10 mg, 20 mg Film-coated Tablets COMPOSITION Each tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin as rosuvastatin calcium. PHARMACEUTICAL FORM Film-coated tablet. Round, yellow coloured (5 mg); Round, pink coloured (10 mg and 20 mg). THERAPEUTIC INDICATIONS Crestor (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, Crestor is indicated to reduce total mortality and the risk of major cardiovascular events (cardiovascular death, stroke, MI, unstable angina, or arterial revascularization) Crestor 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 Crestor is used either alone or as an adjunct to diet and other lipid lowering treatment such as apheresis. Crestor 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 target levels. Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH): Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at l Baca dokumen lengkapnya