Țară: Țările de Jos
Limbă: olandeză
Sursă: 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
Bouchara-Recordati Immeuble Le Wilson 70, avenue du Général de Gaulle 92800 PUTEAUX (FRANKRIJK)
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
2020-09-04
1 NL/H/4866/001-004/IB/004/G BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER LIPENAN 10 MG/ 10 MG, TABLETTEN LIPENAN 10 MG/ 20 MG, TABLETTEN LIPENAN 10 MG/ 40 MG, TABLETTEN LIPENAN 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 [Invented name] is and what it is used for 2. What you need to know before you take [Invented name] 3. How to take [Invented name] 4. Possible side effects 5. How to store [Invented name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [Invented name] is a medicine to lower increased levels of cholesterol. [Invented name] contains ezetimibe and atorvastatin. [Invented name] is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, [Invented name] raises levels of “good” cholesterol (HDL cholesterol). [Invented name] 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 Citiți documentul complet
1 NL/H/4866/001-004/IA/003 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL LIPENAN 10 mg/ 10 mg, tabletten LIPENAN 10 mg/ 20 mg, tabletten LIPENAN 10 mg/ 40 mg, tabletten LIPENAN 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 [Invented name] 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 [Invented name] is 1 tablet per day. The maximum recommended dose of [Invented name] 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 [Invented name]. 2 NL/H/4866/001-004/IA/003 [Invented name] 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 sw Citiți documentul complet