Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GEMFIBROZIL
DUOPHARMA (M) SDN. BHD.
GEMFIBROZIL
30 Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 LOWIN CAPSULE Gemfibrozil (300mg) WHAT IS IN THIS LEAFLET 1. What LOWIN CAPSULE is used for 2. How LOWIN CAPSULE works 3. Before you use LOWIN CAPSULE 4. How to use LOWIN CAPSULE 5. While you are using LOWIN CAPSULE 6. Side effects 7. Storage and disposal of LOWIN CAPSULE 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LOWIN CAPSULE IS USED FOR LOWIN CAPSULE is used, alongside a low fat diet and other non-medical treatment such as exercise and weight loss, to lower levels of fat in the blood. LOWIN CAPSULE can also be used when other medicines (statins) are unsuitable, to reduce the occurrence of heart problems in men who are at high risk and who have increased ‘bad cholesterol’. LOWIN CAPSULE may also be prescribed to people who cannot be prescribed other lipid-lowering medicines for lowering blood cholesterol levels. HOW LOWIN CAPSULE WORKS LOWIN CAPSULE contains gemfibrozil which is lipid regulating agent and capable to lower the level of fats (lipids) in the blood. BEFORE YOU USE LOWIN CAPSULE _-_ _ _ _When you must not use it _ Do not use LOWIN CAPSULE if you are allergic to gemfibrozil or any of the other ingredients listed at the end of the leaflet. _-_ _ _ _Before you start to use it _ _ _ Before taking LOWIN CAPSULE, you must tell your doctor or pharmacist if you have, or have had, any of the following conditions: • Liver or severe kidney dysfunction • History of /or pre-existing gall bladder or biliary tract disease, including gallstone • Hypersensitivity to gemfibrozil • Previous history of photoallergic (abnormal sensitivity of the skin induced by sunlight) reaction during treatment with fibrates. If you are not sure if you have, or have had, any of these conditions, you should raise those concerns with your doctor or pharmacist. _Pregnancy _ Ask for your doctor’s advice if you are pregnant, or likely to become pregnant during your course of medication. _Breastfeeding _ Ask for your doct Lees het volledige document
[DUOPHARMA (M) SDN BHD] [Page 1/2] _ _ [Revision Date: 03.12.2019] LOWIN CAPSULE 300 MG DESCRIPTION: LOWIN CAPSULE 300MG: White / red capsule with marking _'DUO 861'. _ COMPOSITION: LOWIN CAPSULE 300MG: Each capsule contains Gemfibrozil 300 mg. PHARMACODYNAMICS: Gemfibrozil is a lipid regulating agent which lowers elevated serum lipid primarily by decreasing serum triglyceride with a variable reduction in total serum cholesterol. These decreases occur primarily in the very low density lipoprotein (VLDL) fraction and less frequently in the low density lipoprotein (LDL) fraction. It has been reported that Gemfibrozil may increase levels of high density lipoprotein (HDL) sub fraction, HDL 2 and HDL 3 as well as apolipoproteins A1 and A11. Epidemiological studies have shown that both HDL-cholesterol and high LDL- cholesterol are independent risk factors for coronary heart disease. The mechanism of action has not been definitively established. In man, Gemfibrozil has been shown to inhibit peripheral lipolysis and to decrease the hepatic extraction of free fatty acids, thus reducing hepatic triglyceride production. Gemfibrozil inhibits synthesis and increases clearance of VLDL carrier apolipoprotein B, leading to a decrease in VLDL production. Animal studies suggest that Gemfibrozil may, in addition to elevating HDL cholesterol, reduce incorporation of long- chain fatty acids into newly formed triglycerides, accelerate turnover and removal of cholesterol from the liver and increase excretion of cholesterol in the feces. PHARMACOKINETICS: Gemfibrozil is well absorbed from the gastrointestinal tract after oral administration. Peak plasma levels occur in one to two hours with a plasma half-life of 1.5 hours following single doses and 1.3 hours following multiple doses. Plasma levels appear proportional to dose and do not demonstrate accumulation across time following multiple doses. Gemfibrozil mainly undergoes oxidation of a ring methyl group to successively form a hydroxymethyl and carboxyl metabolite. Approximately sev Lees het volledige document