Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATORVASTATINE CALCIUM 3-WATER 21,7 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 20 mg/stuk ; EZETIMIB 10 mg/stuk
G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)
ATORVASTATINE CALCIUM 3-WATER 21,7 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 20 mg/stuk ; EZETIMIB 10 mg/stuk
Tablet
CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201), 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
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EZETIMIBE/ATORVASTATINE GL 10 MG/ 10 MG, TABLETTEN EZETIMIBE/ATORVASTATINE GL 10 MG/ 20 MG, TABLETTEN EZETIMIBE/ATORVASTATINE GL 10 MG/ 40 MG, TABLETTEN EZETIMIBE/ATORVASTATINE GL 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 GL is and what it is used for 2. What you need to know before you take Ezetimibe/Atorvastatine GL 3. How to take Ezetimibe/Atorvastatine GL 4. Possible side effects 5. How to store Ezetimibe/Atorvastatine GL 6. Contents of the pack and other information 1. WHAT EZETIMIBE/ATORVASTATINE GL IS AND WHAT IT IS USED FOR Ezetimibe/Atorvastatine GL is a medicine to lower increased levels of cholesterol. Ezetimibe/Atorvastatine GL contains ezetimibe and atorvastatin. Ezetimibe/Atorvastatine GL 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 GL raises levels of “good” cholesterol (HDL cholesterol). Ezetimibe/Atorvastatine GL 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 “bad” cholesterol because it can build up in the walls of your ar Lees het volledige document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Ezetimibe/Atorvastatine GL 10 mg/ 10 mg, tabletten Ezetimibe/Atorvastatine GL 10 mg/ 20 mg, tabletten Ezetimibe/Atorvastatine GL 10 mg/ 40 mg, tabletten Ezetimibe/Atorvastatine GL 10 mg/ 80 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg 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 (12.7 mm x 5.1 mm) on one side debossed with “1” 10 mg/20 mg tablet: White to off white, capsule shaped tablets (14.5 mm x 6.8 mm) on one side debossed with “2” 10 mg/40 mg tablet: White to off white, capsule shaped tablets (16.4 mm x 6.3 mm) on one side debossed with “3” 10 mg/80 mg tablet: White to off white, capsule shaped tablets (17.0 mm x 8.0 mm) on one side debossed with “4” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ezetimibe/Atorvastatine GL 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 GL is 1 tablet per day. 2 The maximum recommended dose of Ezetimibe/Atorvastatine GL 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 GL. Ezetimibe/Atorvastatine GL is not suitable for initial therapy. Treatment initiation or dose adjustment if necessar Lees het volledige document