Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C10AX09
EZETIMIB
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON (E 1201),
Oraal gebruik
Ezetimibe
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POVIDON (E 1201);
2016-10-10
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EZETIMIBE STADA 10MG, TABLETTEN Ezetimibe READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. Whatis and what it is used for 2. What you need to know before you take Perskaitykite visą dokumentą3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is a medicine to lower increased levels of cholesterol in your blood. 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 can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, raises levels of "good" cholesterol (HDL cholesterol). Ezetimibe, the ac
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ezetimibe STADA 10 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipients with known effect: Each tablet contains 58 mg of lactose monohydrate and 0.80 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, oval, capsule-shaped tablets with a length of approximately 8 mm and a width of approximately 4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary hypercholesterolaemia, co-administered 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 who are not appropriately controlled with a statin alone. Perskaitykite visą dokumentąmonotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated. Prevention of cardiovascular events is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin. Homozygous familial hypercholesterolaemia (HoFH) co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis). Homozygous sitosterolaemia (phytosterolaemia) is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolaemia. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe. The recommended dose is one ezetimibe 10 mg tablet daily. Ezetimibe can be admini