Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SIMVASTATIN
DUOPHARMA (M) SDN. BHD.
SIMVASTATIN
3 x 10 Tablets; 10 x 10 Tablets; 12 x 10 Tablets
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ VASCOR TABLET 20MG FILM COATED Simvastatin (20mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What VASCOR TABLET is used for 2. How VASCOR TABLET works 3. Before you use VASCOR TABLET 4. How to use VASCOR TABLET 5. While you are using VASCOR TABLET 6. Side effects 7. Storage and disposal of VASCOR TABLET 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VASCOR TABLET IS USED FOR VASCOR TABLET helps to lower cholesterol. VASCOR TABLET is used in people who have coronary heart disease (CHD) [plaque builds up in the coronary arteries] or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease). VASCOR TABLET may be used in these people, regardless of their cholesterol level to: help prolong life by reducing the risk of a heart attack the reduce risk of stroke reduce the need for surgery to increase blood flow to the heart HOW VASCOR TABLET WORKS VASCOR TABLET belongs to a group of medicines known as HMG-CoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. VASCOR TABLET reduces the bad cholesterol (LDL-C) and raises the good cholesterol (HDL-C). BEFORE YOU USE VASCOR TABLET _-_ _ _ _When you must not use it _ Do not use VASCOR TABLET if you are allergic to simvastatin or any of the other ingredients listed at the end of the leaflet. Symptoms of an allergic reaction may include skin rash, itchiness, short of breath, swelling of the tongue or face, or painful joints. Do not used VASCOR TABLET if you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides _-_ _ _ _Before you start to use it _ Before taking VASCOR TABLET, you must tell your doctor or pharmacist if you have, or have had, any of the following conditions: Active liver disease Kidney disease Drink alcohol regularly Allergic to any other medicines or any other substances, such as foods, p Διαβάστε το πλήρες έγγραφο
[DUOPHARMA (M) SDN BHD] Page 1 of 3 [REVISION DATE: 29.07.2020] VASCOR TABLET 20MG F/C DESCRIPTION: VASCOR TABLET 20MG F/C: 11mm, oval, scored and marked ‘20’ on one side, and marked ‘VAS’ on the other side, orange film-coated tablet. COMPOSITION: Each tablet contains 20mg of Simvastatin. PHARMACODYNAMICS: The active form of Simvastatin is a specific inhibitor of HMG-CoA Reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate. However, at therapeutic doses, the enzyme is not completely blocked, thereby allowing biologically necessary amount of mevalonate to be available. Because the conversion of HMG- CoA to mevalonate is an early step in the biosynthetic pathway of cholesterol, therapy with simvastatin would not be expected to cause an accumulation of potentially toxic sterols. In addition, HMG-CoA is metabolized readily back to acetyl-CoA, that participates in many biosynthetic processes in the body. Although cholesterol is the precursor of all steroid hormones, simvastatin has not been shown to have any clinical effect on steroidogenesis. Simvastatin caused no increase in billiary lithogenicity and, therefore, would not be expected to increase the incidence of gallstones. PHARMACOKINETICS: Simvastatin is an inactive lactone which is readily hydrolyzed in vivo to the corresponding ß-hydroxyacid, L-654,969, a potent inhibitor of HMG-CoA reductase. Inhibition of HMG-CoA reductase is the basis for an assay in pharmacokinetic studies of the ß-hydroxyacid metabolites (active inhibitors) and, following base hydrolysis, active plus latent inhibitors (total inhibitors). Both are measured in plasma following administration of simvastatin. In a disposition study with 14 C-labeled simvastatin, 100 mg (20 µCi) of drug was administered as capsules (5 X 20 mg), and blood, urine, and feces collected. Thirteen percent of the radioactivity was recovered in the urine and 60% in feces. The latter represents absorbed drug equivalents excreted in bile as well as unabsorbed drug. Less than 0.5% of th Διαβάστε το πλήρες έγγραφο