Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; VALSARTAN 80 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
C09DB01
AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; VALSARTAN 80 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (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); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-10-05
Sandoz B.V. Page 1/9 Dipperam 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg RVG 119500-5-6 1313-v7 1.3.1.3 Bijsluiter Juni 2022 BIJSLUITER: INFORMATIE VOOR DE PATIËNT DIPPERAM 5 MG/80 MG, FILMOMHULDE TABLETTEN DIPPERAM 5 MG/160 MG, FILMOMHULDE TABLETTEN DIPPERAM 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, the blood vessels relax and blood pressure is lowered. [Nationally compl Lees het volledige document
Sandoz B.V. Page 1/21 Dipperam 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg filmomhulde tabletten RVG 119500-5-6 1311-V5 1.3.1.1 Summary of Product Characteristics Juni 2022 1. NAAM VAN HET GENEESMIDDEL Dipperam 5 mg/80 mg, filmomhulde tabletten Dipperam 5 mg/160 mg, filmomhulde tabletten Dipperam 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. _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. Approximate size: diameter 8.20 mm. _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. Approximate size: 14.2 mm (length) x 5.7 mm (width). _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. Approximate size: 14.2 mm (length) x 5.7 mm (width). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. [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. Sandoz B.V. Page 2/21 Dipperam 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg filmomhulde tabletten RVG 119500-5-6 1311-V5 1.3.1.1 Summary of Product Characteristics Juni 2022 [Nationally completed name] 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlle Lees het volledige document