Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EZETIMIBE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
EZETIMIBE
3 x 10s Tablets
Glenmark Pharmaceuticals Limited
_Consumer Medication Information Leaflet (RiMUP) _ EZZICAD 10MG TABLETS Ezetimibe Tablets 10mg 1 WHAT IS IN THIS LEAFLET 1. What EZZICAD is used for 2. How EZZICAD works 3. Before you use EZZICAD 4. How to use EZZICAD 5. While you are using it 6. Side effects 7. Storage and Disposal of EZZICAD 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT EZZICAD IS USED FOR EZZICAD is a tablet that contains 10mg of ezetimibe as the active ingredient. EZZICAD is a cholesterol- lowering medicine. EZZICAD is for patients whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. EZZICAD reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. EZZICAD may be taken with other cholesterol- lowering medicines known as statins or alone, in addition to diet. EZZICAD may be taken with fenofibrate, another cholesterol-lowering medicine, in addition to diet. HOW EZZICAD WORKS EZZICAD works by decreasing the absorption of cholesterol in the small intestine. Statins and fenofibrate lower cholesterol in a different way, they works in the liver. EZZICAD adds to the cholesterol-lowering effect of statins and fenofibrate. BEFORE YOU USE EZZICAD _- When you must not use it _ Patients who are hypersensitive (allergic) to Ezetimibe or any of its ingredients should not take EZZICAD. _Pregnancy and lactation _ If you are pregnant or plan to become pregnant, EZZICAD may not be right for you. If you are breast-feeding, EZZICAD may be passed in your milk to your baby. Ask your doctor or pharmacist for advice before taking any medicine. _- Before you start to use it _ Ell your doctor about any medical problems (including liver disease or liver problems) or allergies you have now or have had in the past before you start EZZICAD. _- Taking other medicines _ Tell your doctor or pharmacist if you are taking any other medicines, if you have taken any recently, or if you start taki Olvassa el a teljes dokumentumot
_For the use only of a Registered Medical Practitioners _ _or a Hospital or a Laboratory_ SAME SIZE ARTWORK LEAFLET SIZE : 115 mm x 280 mm 50 mm 35 mm SPACE FOR PHARMACODE PE00000 MY PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: LABEL CLAIM Each uncoated tablet contains: Ezetimibe............10 mg. PHARMACEUTICAL FORM Tablets White to off-white, capsule shaped, flat, beveled edged uncoated tablets engraved with glenmark logo 'G' on one side and'44'on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS _PRIMARY HYPERCHOLESTEROLAEMIA_ Ezetimibe, administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia. Ezetimibe, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia. _PREVENTION OF CARDIOVASCULAR EVENTS_ Ezetimibe, administered with a statin, is indicated to reduce the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization), in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS). _HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_ Ezetimibe, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis). _HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA)_ Ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. POSOLOGY AND METHOD OF ADMINISTRATION The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe. _USE IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA _ The recommended dose of ezetimibe is 10 mg once daily, Olvassa el a teljes dokumentumot