Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
HEALOL PHARMACEUTICALS SDN. BHD.
ROSUVASTATIN CALCIUM
3 x 10 Tablets
GRACURE PHARMACEUTICALS LTD.
_Consumer Medication Information Leaflet (RiMUP) _ VASTICURE-10 (ROSUVASTATIN TABLETS 10MG) Rosuvastatin Calcium (10mg) 1 WHAT IS IN THIS LEAFLET 1. What VASTICURE-10 is used for 2. How VASTICURE-10 works 3. Before you use VASTICURE-10 4. How to use VASTICURE-10 5. While you are using it 6. Side effects 7. Storage and Disposal of VASTICURE-10 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS VASTICURE-10 USED FOR VASTICURE-10 belongs to a group of medicines called statins. You have been prescribed this medicine because: • You have a high cholesterol level. This means you are at risk from 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 VASTICURE-10. • You have other factors that increase your risk of having 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 VASTICURE-10 WORKS VASTICURE-10 works by inhibiting an enzyme in your liver. This enzyme is responsible for cholesterol formation. BEFORE YOU USE VASTICURE-10 -When you must not use it Do not take this medicine: • If you have ever had an allergic reaction to rosuvastatin or similar medicines or to any of its ingredients. • If you are pregnant, trying to become pregnant or are breast-feeding. If you become pregnant while taking VASTICURE-10, stop taking it immediately and tell your doctor. • If you have liver disease. • If you have severe kidney problems. • If you have repeated or unexplained muscle aches or pains. • If you take a drug called ciclosporin (commonly used after organ transplants) • If you are already on a cholesterol lowering medication of the fibrate class (e.g. gemfibrozil) or niacin. If any Přečtěte si celý dokument
_Gracure Pharmaceuticals Ltd _ NAME OF THE PRODUCT VASTICURE-10 PART-I Administrative Data D3. PROPOSED PACKAGE INSERT Enclosed For the use only of a registered Medical Practitioner or a Hospital or a Laboratory VASTICURE-10 (ROSUVASTATIN TABLETS 10 MG) COMPOSITION: Each film coated tablet contains: Rosuvastatin Calcium BP 10.4 mg Eq. to Rosuvastatin 10 mg DESCRIPTION: Light pink coloured, round, biconvex and film coated tablets. PHARMACODYNAMICS / PHARMACOKINETICS: _Mechanism of action_ Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. The primary site of action of rosuvastatin is the liver, the target organ for cholesterol lowering. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles. _PHARMACODYNAMIC EFFECTS_ Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol. It also lowers ApoB, nonHDL-C, VLDL- C, VLDL-TG and increases ApoA-I. Rosuvastatin also lowers the LDL-C/HDL-C, total C/HDL-C and nonHDL-C/HDL-C and the ApoB/ApoA-I ratios. _PHARMACOKINETIC PROPERTIES:_ ABSORPTION: Maximum rosuvastatin plasma concentrations are achieved approximately 5 hours after oral administration. The absolute bioavailability is approximately 20%. DISTRIBUTION : Rosuvastatin is taken up extensively by the liver which is the primary site of cholesterol synthesis and LDL-C clearance. The volume of distribution of rosuvastatin is approximately 134 L. Approximately 90% of rosuvastatin is bound to plasma proteins, mainly to albumin. METABOLISM: Rosuvastatin undergoes limited metabolism (approximately 10%). _In vitro _ metabolism studies using human hepatocytes indicate that rosuvastatin is a poor substrate for cytochrome P450-based metabolism. CYP2C9 was the prin Přečtěte si celý dokument