מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
ROSUVASTATIN, EZETIMIBE
Adamed Sp. Z.o.o. Pieńków 149, 05-152 Czosnów, Poland
C10BA06
EZETIMIBE 10 mg ROSUVASTATIN 20 mg
TABLET
EZETIMIBE 10 mg ROSUVASTATIN 20 mg
POM
LIPID MODIFYING AGENTS
Authorised
2018-02-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EZEHRON DUO 20 MG/10 MG, TABLET EZEHRON DUO 10 MG/10 MG, TABLET EZEHRON DUO 5 MG/10 MG, TABLET rosuvastatin and 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. What Ezehron Duo tablets is and what it is used for 2. What you need to know before you take Ezehron Duo tablets 3. How to take Ezehron Duo tablets 4. Possible side effects 5. How to store Ezehron Duo tablets 6. Contents of the pack and other information 1. WHAT EZEHRON DUO TABLETS IS AND WHAT IT IS USED FOR Ezehron Duo tablets 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. Ezehron Duo tablets is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in your blood. In addition, it also raises levels of “good” cholesterol (HDL cholesterol). This medicine 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. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to קרא את המסמך השלם
Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ezehron Duo 20 mg/10 mg, tablet Ezehron Duo 10 mg/10 mg, tablet Ezehron Duo 5 mg/10 mg, tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ezehron Duo 20 mg/10 mg tablet Each tablet contains 20 mg rosuvastatin (as calcium salt) and 10 mg of ezetimibe. Excipients of known activity: lactose monohydrate (each tablet contains 228.29 mg lactose monohydrate) Ezehron Duo 10 mg/10 mg tablet Each tablet contains 10 mg rosuvastatin (as calcium salt) and 10 mg of ezetimibe. Excipients of known activity: lactose monohydrate (each tablet contains 238.39 mg lactose monohydrate) Ezehron Duo 5 mg/10 mg tablet Each tablet contains 5 mg rosuvastatin (as calcium salt) and 10 mg of ezetimibe. Excipients of known activity: lactose monohydrate (each tablet contains 243.89 mg lactose monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Ezehron Duo 20 mg/10 mg tablet: white to off-white, round, biconvex, uncoated tablet. The diameter of the tablet is 11 mm. Ezehron Duo 10 mg/10 mg tablet: white to off-white, oval, biconvex, uncoated tablet, engraved E1 on one side and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm Ezehron Duo 5 mg/10 mg tablet: white to off-white, round, flat, uncoated tablet, engraved E2 on one side and 2 on the other side. The diameter of the tablet is 10 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary Hypercholesterolaemia Page 2 of 22 Ezehron Duo is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. _ _ Prevention of Cardiovascular Events Ezehron Duo is indicated to reduce the risk of cardiovascular events (see section 5.1) as substitution therapy in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), who קרא את המסמך השלם