Țară: Țările de Jos
Limbă: olandeză
Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; VALSARTAN 160 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
C09DB01
AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; VALSARTAN 160 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Valsartan And Amlodipine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Sandoz B.V. Page 1/9 Amlodipine/Valasartan Sandoz 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg RVG 116955-6-7 V7 1.3.1.3 Bijsluiter Juni 2022 PACKAGE LEAFLET: INFORMATION FOR THE USER AMLODIPINE/VALSARTAN SANDOZ 5 MG/80 MG, FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN SANDOZ 5 MG/160 MG, FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN SANDOZ 10 MG/160 MG, FILMOMHULDE TABLETTEN Amlodipine (as amlodipine besylate) /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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] 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 Citiți documentul complet
Sandoz B.V. Page 1/24 Amlodipine/Valasartan Sandoz 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg RVG 116955-6-7 1311-V5 1.3.1.1 Samenvatting van de Productkenmerken Juni 2022 1. NAME OF THE MEDICINAL PRODUCT Amlodipine/Valsartan Sandoz 5 mg/80 mg, filmomhulde tabletten Amlodipine/Valsartan Sandoz 5 mg/160 mg, filmomhulde tabletten Amlodipine/Valsartan Sandoz 10 mg/160 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan. Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet {[NATIONALLY COMPLETED NAME] 5 MG/80 MG FILM-COATED TABLETS} Dark yellow, round film-coated tablet with beveled edges, debossed with “NVR” on one side and “NV” on the other side. Dimension: approximately 8.20 mm. {[NATIONALLY COMPLETED NAME] 5 MG/160 MG FILM-COATED TABLETS} Dark yellow, ovaloid film-coated tablet with beveled edges, debossed with “NVR” on one side and “ECE” on the other side. Dimension: approximately 14.2 mm x 5.7 mm. {[NATIONALLY COMPLETED NAME] 10 MG/160 MG FILM-COATED TABLETS} Light yellow, ovaloid film-coated tablet with beveled edges, debossed with “NVR” on one side and “UIC” on the other side. Dimension: approximately 14.2 mm x 5.7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Sandoz B.V. Page 2/24 Amlodipine/Valasartan Sandoz 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg RVG 116955-6-7 1311-V5 1.3.1.1 Samenvatting van de Productkenmerken Juni 2022 [Nationally completed name] 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 [Nationally completed name] is one tablet per day. [Na Citiți documentul complet