Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Rosuvastatin; Ezetimibe
Sanofi-Aventis Ireland Limited T/A SANOFI
C10BA06
Rosuvastatin; Ezetimibe
20/10 mg/mg
Film-coated tablet
rosuvastatin and ezetimibe
Marketed
2019-06-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SUVEZEN 10 MG/10 MG FILM-COATED TABLETS SUVEZEN 20 MG/10 MG FILM-COATED TABLETS SUVEZEN 40 MG/10 MG FILM-COATED TABLETS rosuvastatin/ezetimibe SANOFI 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. What Suvezen is and what it is used for 2. What you need to know before you take Suvezen 3. How to take Suvezen 4. Possible side effects 5. How to store Suvezen 6. Contents of the pack and other information 1. WHAT SUVEZEN IS AND WHAT IT IS USED FOR Suvezen contains two different active substances in one tablet. One of the active substances is rosuvastatin, belonging to the group of so called statins, the other active substance is ezetimibe. Suvezen is a medicine used to lower levels of total cholesterol, “bad“ cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Suvezen raises levels of “good” cholesterol (HDL cholesterol). Suvezen works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as 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. It is used for patients who cannot control their cholesterol levels by diet alone. You should always stay on a cholesterol-lowering diet while taking this medicine. Suvezen is used in addition to your cholesterol lowering diet if you have a raised cholesterol level in your b Leggi il documento completo
Health Products Regulatory Authority 10 November 2023 CRN00DV9R Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Suvezen 20 mg/10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Suvezen 20 mg/10 mg: Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe. Excipients with known effect: Suvezen 20 mg/10 mg: Each film-coated tablet contains 268.9 mg of lactose (as lactose monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Suvezen 20 mg/10 mg: yellow to light yellow, round, biconvex, film-coated tablets with a diameter about 9.9 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH) Suvezen is indicated as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia in adult patients who are not appropriately controlled with statin alone, who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products Prevention of Cardiovascular Events Suvezen is indicated as substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently, at the same dose level as in the fixed dose combination, but as separate products to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS). 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 Suvezen. Suvezen is not suitable for initial therapy. When Suvezen is indicated for patients not controlled by statin alone, the dose of Suvezen should be individualized according to the target lipid levels and the patient's response. When Suvezen Leggi il documento completo