Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT SAMENSTELLING overeenkomend met ; AMLODIPINE ; VALSARTAN
Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN
C09DB01
AMLODIPINEBESILAAT COMPOSITION corresponding to ; AMLODIPINE ; VALSARTAN
Filmomhulde tablet
ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C ; CALCIUMDIWATERSTOFFOSTAAT 0-WATER ; CELLULOSE, GEPOEDERD (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Valsartan And Amlodipine
Hulpstoffen: ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C; CALCIUMDIWATERSTOFFOSTAAT 0-WATER; CELLULOSE, GEPOEDERD (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2016-03-21
AMLODIPINE/VALSARTAN 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG, FILMOMHULDE TABLETTEN – RVG 116985-6-7 MODULE 1.3 Product Information Version: 2018-08-31 MODULE 1.3.1 Package Leaflet Replaces: 2018-07-05 1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ VALSAMIX, 5 MG/80 MG FILMOMHULDE TABLETTEN VALSAMIX, 5 MG/160 MG FILMOMHULDE TABLETTEN VALSAMIX, 10 MG/160 MG FILMOMHULDE TABLETTEN amlodipine/valsartan 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 Valsamix is and what it is used for 2. What you need to know before you take Valsamix 3. How to take Valsamix 4. Possible side effects 5. How to store Valsamix 6. Contents of the pack and other information 1. WHAT AMLODIPINE/VALSARTAN IS AND WHAT IT IS USED FOR Amlodipine/Valsartan tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure. - Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. - Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered. Amlodipine/Valsartan is used to treat high blo Lees het volledige document
VALSAMIX, 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG, FILMOMHULDE TABLETTEN – RVG 116985-6-7 MODULE 1.3 Product Information Version: 2018-08-31 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2018-07-05 1 1. NAME OF THE MEDICINAL PRODUCT Valsamix, 5 mg/80 mg filmomhulde tabletten Valsamix, 5 mg/160 mg filmomhulde tabletten Valsamix, 10 mg/160 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg amlodipine (as besylate) and 80 mg valsartan. Each tablet contains 5 mg amlodipine (as besylate) and 160 mg valsartan. Each tablet contains 10 mg amlodipine (as besylate) and 160 mg valsartan For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 5 mg/80 mg: Yellow colored, round shaped, bevel edged, film-coated tablets (size: 7.94 mm) with ‘APO’ engraved on one side and ‘5’ over ‘80’ on the other side. 5 mg/160 mg: Yellow colored, modified capsule shaped, film-coated tablets (size: 14.22 mm x 5.555 mm) with ‘APO’ engraved on one side and ‘5/160’ on the other side. 10 mg/160 mg: Light yellow colored, modified capsule shaped, film-coated tablets (size: 14.22 mm x 5.555 mm) with ‘APO’ engraved on one side and ‘10/160’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Amlodipine/Valsartan tablets is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Amlodipine/Valsartan tablets is one tablet per day. Amlodipine/Valsartan tablets 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone. Amlodipine/Valsartan tablets 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone. VALSAMIX, 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG, FILMOMHULDE TABLETTEN – RVG 116985-6-7 MODUL Lees het volledige document