Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
Abio Marketing Sdn Bhd
ROSUVASTATIN CALCIUM
28tablet Tablets
CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ROVASTIN FILM COATED TABLET ROSUVASTATIN 5MG AND 10MG 1 WHAT IS IN THIS LEAFLET 1. What Rovastin is used for 2. How it works 3. Before you use Rovastin 4. How to use Rovastin 5. While you are using Rovastin 6. Side effects 7. Storage and Disposal of Rovastin 8. Product Description 9. Manufacturer 10.Product Registration Holder 11.Date of Revision WHAT ROVASTIN IS USED FOR Rovastin belongs to a group of medicines called statins. You have been prescribed Rovastin 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 Rovastin. Or - 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 IT WORKS Most of the cholesterol in your blood is made in the liver. Rovastin works by reducing cholesterol in 2 ways: - Rovastin blocks an enzyme in the liver causing the liver to make less cholesterol - Rovastin increases the uptake and breakdown by the liver of cholesterol already in the blood Along with diet, Rovastin lowers bad (LDL) cholesterol and slows plaque buildup in arteries as part of a treatment plan to lower cholesterol to goal. You may see results for lowering your bad cholesterol as soon as 2-4 weeks after starting Rovastin. People can have different responses to the same medicine, so your results may vary. BEFORE YOU USE ROVASTIN When you must not use it Do not take Rovastin: - If you have ever had an allergic reaction to Rovastin or similar medicines,, or to any of its ingredients. Rovastin contains lactose, which may cause a problem in a small number of patients who are a Izlasiet visu dokumentu
COMPOSITION Rovastin 5mg Film Coated Tablet: Each tablet contains Rosuvastatin calcium equivalent to Rosuvastatin 5 mg Rovastin 10mg Film Coated Tablet: Each tablet contains Rosuvastatin calcium equivalent to Rosuvastatin 10 mg PRODUCT DESCRIPTION Rovastin 5mg Film Coated Tablet: Round, yellow film coated tablets, engraved with CCP 231 on one side and plain on the reverse. Rovastin 10mg Film Coated Tablet: Round, pink film-coated tablets, engraved with CCP 173 on one side and plain on the reverse. PHARMACOLOGY Mechanism of Action: Rosuvastatin is a selective, potent and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated with apolipoprotein B (ApoB), into very low density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues. VLDL particles are TG-rich. Cholesterol-rich low density lipoprotein (LDL) is formed from VLDL and is cleared primarily through the high affinity LDL receptor in the liver. Rosuvastatin produces its lipid-modifying effects in 2 ways; it 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. High density lipoprotein (HDL), which contains ApoA-I is involved, amongst other things, in transport of cholesterol from tissues back to the liver (reverse cholesterol transport). The involvement of LDL-Cholesterol (LDL-C) in atherogenesis has been well documented. Epidemiological studies have established that high LDL-C, TG, low HDL-C and ApoA-I have been linked to a higher risk of cardiovascular (CV) disease. Intervention studies have shown the benefits on mortality and CV event rates of lowering LDL-C and TG or raising HDL-C. More recent data has linked the beneficial effects of HMG-CoA reductase inhibitors to lowering of non-HDL (ie, all circ Izlasiet visu dokumentu