Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATORVASTATINE CALCIUM 3-WATER 10,85 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk
ATORVASTATINE CALCIUM 3-WATER 10,85 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 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 HIMAVAT 10 MG/10 MG, TABLETTEN HIMAVAT 10 MG/20 MG, TABLETTEN HIMAVAT 10 MG/40 MG, TABLETTEN HIMAVAT 10 MG/80 MG, TABLETTEN EZETIMIBE EN ATORVASTATINE 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 HIMAVAT is and what it is used for 2. What you need to know before you take HIMAVAT 3. How to take HIMAVAT 4. Possible side effects 5. How to store HIMAVAT 6. Contents of the pack and other information 1. WHAT HIMAVAT IS AND WHAT IT IS USED FOR HIMAVAT is a medicine to lower increased levels of cholesterol. HIMAVAT contains ezetimibe and atorvastatin. HIMAVAT is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, HIMAVAT raises levels of “good” cholesterol (HDL cholesterol). HIMAVAT 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 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 i Olvassa el a teljes dokumentumot
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Himavat 10 mg/10 mg, tabletten Himavat 10 mg/20 mg, tabletten Himavat 10 mg/40 mg, tabletten Himavat 10 mg/80 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of 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 HIMAVAT 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 HIMAVAT is 1 tablet per day. The maximum recommended dose of HIMAVAT 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 HIMAVAT. HIMAVAT is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. 2 _ _ _Elderly peopl Olvassa el a teljes dokumentumot