מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATORVASTATINE CALCIUM 3-WATER SAMENSTELLING overeenkomend met ; ATORVASTATINE ; EZETIMIB
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
C10BA05
ATORVASTATIN CALCIUM 3-WATER COMPOSITION equivalent to ; ATORVASTATIN ; EZETIMIB
Tablet
CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201)
Oraal gebruik
Atorvastatin and ezetimibe
2019-10-22
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/10 MG, TABLETTEN EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/20 MG, TABLETTEN EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/40 MG, TABLETTEN EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/80 MG, TABLETTEN EZETIMIBE AND ATORVASTATIN 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 Ezetimibe/Atorvastatine Zentiva is and what it is used for 2. What you need to know before you take Ezetimibe/Atorvastatine Zentiva 3. How to take Ezetimibe/Atorvastatine Zentiva 4. Possible side effects 5. How to store Ezetimibe/Atorvastatine Zentiva 6. Contents of the pack and other information 1. WHAT EZETIMIBE/ATORVASTATINE ZENTIVA IS AND WHAT IT IS USED FOR Ezetimibe/Atorvastatine Zentiva is a medicine to lower increased levels of cholesterol. Ezetimibe/Atorvastatine Zentiva contains ezetimibe and atorvastatin. Ezetimibe/Atorvastatine Zentiva is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetimibe/Atorvastatine Zentiva raises levels of “good” cholesterol (HDL cholesterol). Ezetimibe/Atorvastatine Zentiva 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. LDL cholesterol is often called “ קרא את המסמך השלם
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ezetimibe/Atorvastatine Zentiva 10 mg/10 mg, tabletten Ezetimibe/Atorvastatine Zentiva 10 mg/20 mg, tabletten Ezetimibe/Atorvastatine Zentiva 10 mg/40 mg, tabletten Ezetimibe/Atorvastatine Zentiva 10 mg/80 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipients with known effect Each 10 mg/ 10 mg tablet contains 145 mg lactose. Each 10 mg/ 20 mg tablet contains 170 mg lactose. Each 10 mg/ 40 mg tablet contains 219 mg lactose. Each 10 mg/ 80 mg tablet contains 317 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 10 mg/ 10 mg tablet: White to off white, capsule shaped tablets (12.7mm x 5.1mm) on one side debossed with“1” 10 mg/ 20 mg tablet: White to off white, capsule shaped tablets (14.5mm x 6.8 mm) on one side debossed with“2” 10 mg/ 40 mg tablet: White to off white, capsule shaped tablets (16.4mm x 6.3 mm) on one side debossed with“3” 10 mg/ 80 mg tablet: White to off white, capsule shaped tablets (17.0mm x 8.0mm) on one side debossed with“4” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ezetimibe/Atorvastatine Zentiva as an adjunct to diet is indicated as substitution therapy for treatment of adults with primary (heterozygous and homozygous familial and non-familal) hypercholesterolaemia or mixed hyperlipidaemia already controlled with atorvastatin and ezetimibe given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Ezetimibe/Atorvastatine Zentiva is 1 tablet per day. The maximum recommended dose of Ezetimibe/Atorvastatine Zentiva is 10 mg/80 mg per day. The patient should be on an appropriate lipid lowering diet and should continue on this diet during treatment with Ezetimibe/Atorvastatine Zentiva. Ezetimibe/Atorvastatine Zentiva is not suitable for initial therapy. Treatment initiation o קרא את המסמך השלם