দেশ: নেদারল্যান্ডস
ভাষা: ডাচ
সূত্র: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 25 mg/stuk ; VALSARTAN 160 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
C09DX01
AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 25 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) ; 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) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Valsartan, amlodipine and hydrochlorothiazide
1900-01-01
Sandoz B.V. Page 1/14 Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/12,5 mg, 10 mg/160 mg/12,5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg, 10 mg/320 mg/25 mg RVG 122472-3-4-5-6 1313-7 1.3.1.3 Bijsluiter Juli 2022 PACKAGE LEAFLET: INFORMATION FOR THE USER AMLODIPINE/VALSARTAN/HCT SANDOZ 5 MG/160 MG/12,5 MG, FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT SANDOZ 10 MG/160 MG/12,5 MG, FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT SANDOZ 5 MG/160 MG/25 MG, FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT SANDOZ 10 MG/160 MG/25 MG, FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT SANDOZ 10 MG/320 MG/25 MG, FILMOMHULDE TABLETTEN amlodipine/valsartan/hydrochlorothiazide 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 three substances called amlodipine, valsartan and hydrochlorothiazide. All 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 rec সম্পূর্ণ নথি পড়ুন
Sandoz B.V. Page 1/34 Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/12,5 mg, 10 mg/160 mg/12,5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg, 10 mg/320 mg/25 mg RVG 122472-3-4-5-6 1311-v5 1.3.1.1 Samenvatting van de Productkenmerken September 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/12,5 mg, filmomhulde tabletten Amlodipine/Valsartan/HCT Sandoz 10 mg/160 mg/12,5 mg, filmomhulde tabletten Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/25 mg, filmomhulde tabletten Amlodipine/Valsartan/HCT Sandoz 10 mg/160 mg/25 mg, filmomhulde tabletten Amlodipine/Valsartan/HCT Sandoz 10 mg/320 mg/25 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION {[NATIONALLY COMPLETED NAME] 5 MG/160 MG/12.5 MG FILM-COATED TABLETS} Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. {[NATIONALLY COMPLETED NAME] 10 MG/160 MG/12.5 MG FILM-COATED TABLETS} Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. {[NATIONALLY COMPLETED NAME] 5 MG/160 MG/25 MG FILM-COATED TABLETS} Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan and 25 mg of hydrochlorothiazide. {[NATIONALLY COMPLETED NAME] 10 MG/160 MG/25 MG FILM-COATED TABLETS} Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan and 25 mg of hydrochlorothiazide. {[NATIONALLY COMPLETED NAME] 10 MG/320 MG/25 MG FILM-COATED TABLETS} Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan and 25 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet {[NATIONALLY COMPLETED NAME] 5 MG/160 MG/12.5 MG FILM-COATED TABLETS} White, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VCL” on the other side. Length: approx. 15 mm Width: সম্পূর্ণ নথি পড়ুন