Држава: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EZETIMIBE; SIMVASTATIN
RANBAXY (MALAYSIA) SDN. BHD.
EZETIMIBE; SIMVASTATIN
30 Tablets
Sun Pharmaceutical Industries Limited
ZETEZE-SM Page 1 ZETEZE-SM (Ezetimibe/Simvastatin Tablets _Consumer Medication Information Leaflet (RiMUP) _ 10+10 mg, 10+20 mg,10+40 mg, 10+80 mg) _ _ WHAT IS IN THIS LEAFLET 1. What ZETEZE-SM is used for 2. How ZETEZE-SM works 3. Before you use ZETEZE-SM 4. How to use ZETEZE-SM 5. While you are using it 6. Side effects 7. Storage and Disposal of ZETEZE- SM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision This leaflet answers some common questions about ZETEZE-SM . It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ZETEZE-SM against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZETEZE-SM IS USED FOR ZETEZE-SM contains the active ingredients ezetimibe and simvastatin. ZETEZE-SM is used to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty substances called triglycerides in the blood. In addition, it raises levels of HDL (good) cholesterol. ZETEZE-SM is for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. HOW ZETEZE-SM WORKS ZETEZE-SM works to reduce your cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in your digestive tract. The active ingredient simvastatin belonging to the class of "statins" inhibits the production of the cholesterol your body makes by itself. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing ca Прочитајте комплетан документ
_For the use of a Registered Medical Practitioner only _ PRESCRIBING INFORMATION ZETEZE-SM 10+10, 10+20, 10+40, 10+80 MG (Ezetimibe and Simvastatin Tablets) COMPOSITION ZETEZE-SM 10+10 MG TABLETS Each uncoated tablet contains Ezetimibe USP ……………….10 mg Simvastatin Ph. Eur…………..10 mg ZETEZE-SM 10+20 MG TABLETS Each uncoated tablet contains Ezetimibe USP ……………….10 mg Simvastatin Ph. Eur.……….....20 mg ZETEZE-SM 10+40 MG TABLETS Each uncoated tablet contains Ezetimibe USP ……………….10 mg Simvastatin Ph. Eur.……….....40 mg ZETEZE-SM 10+80 MG TABLETS Each uncoated tablet contains Ezetimibe USP ……………….10 mg Simvastatin Ph. Eur.……….....80 mg Excipients: Lactose Monohydrate, Croscarmellose Sodium, Hypromellose, Cellulose Microcrystalline, Citric Acid Monohydrate, Propyl Gallate, Butylated Hydroxy Anisole, Magnesium Stearate, Purified Water and Isopropyl Alcohol. PRODUCT DESCRIPTION ZETEZE-SM 10+10 MG are white to off white, capsule shaped uncoated tablets, debossed with ‘L’ on one side and plain on other side. ZETEZE-SM 10+20 MG are white to off white, capsule shaped uncoated tablets, debossed with ‘I’ on one side and plain on other side. ZETEZE-SM 10+40 MG are white to off white, capsule shaped uncoated tablets, debossed with ‘F’ on one side and plain on other side. ZETEZE-SM 10+80 MG are white to off white, capsule shaped uncoated tablets, debossed with ‘T’ on one side and plain on other side. DESCRIPTION ZETEZE-SM (ezetimibe/simvastatin) is a lipid lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous synthesis of cholesterol. PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES PHARMACODYNAMICS Mechanism of action: _Ezetimibe and Simvastatin _ Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. Ezetimibe and simvastatin are two lipid-lowering compounds with complementary mechanisms of action. Ezetimibe and simvastatin redu Прочитајте комплетан документ