देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; VALSARTAN 160 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C09DX01
AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 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) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD
Oraal gebruik
Valsartan, amlodipine and hydrochlorothiazide
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AMLODIPINE/VALSARTAN/HCT STADA 5 MG/160 MG/12.5 MG FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT STADA 10 MG/160 MG/12.5 MG FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT STADA 5 MG/160 MG/25 MG FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT STADA 10 MG/160 MG/25 MG FILMOMHULDE TABLETTEN AMLODIPINE/VALSARTAN/HCT STADA 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. Whatis and what it is used for 2. What you need to know before you take पूरा दस्तावेज़ पढ़ें3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR 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 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. • Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”. Hydrochlorothiazid
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan/HCT STADA 5 mg/160 mg/12,5 mg, filmomhulde
tabletten
Amlodipine/Valsartan/HCT STADA 10 mg/160 mg/12,5 mg, filmomhulde
tabletten
Amlodipine/Valsartan/HCT STADA 5 mg/160 mg/25 mg, filmomhulde
tabletten
Amlodipine/Valsartan/HCT STADA 10 mg/160 mg/25 mg, filmomhulde
tabletten
Amlodipine/Valsartan/HCT STADA 10 mg/320 mg/25 mg, filmomhulde
tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg/160 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besilate), 160 mg of
valsartan, and 12.5 mg of hydrochlorothiazide.
10 mg/160 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate), 160 mg of
valsartan, and 12.5 mg of hydrochlorothiazide.
5 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besilate), 160 mg of
valsartan, and 25 mg of hydrochlorothiazide.
10 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate), 160 mg of
valsartan, and 25 mg of hydrochlorothiazide.
Excipients with known effect: Each tablet contains 0.280 mg sunset
yellow (E110).
10 mg/320 mg/25 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate), 320 mg of
valsartan and 25 mg of hydrochlorothiazide.
Excipients with known effect: Each tablet contains 0.560 mg sunset
yellow (E110).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet)
5/160/12.5 mg film-coated tablets are white, oval,
biconvex film-coated
tablets, with a length of approximately 15.6 mm and a width of
approximately 6.2 mm.
10/160/12.5 mg film-coated tablets are pale yellow,
oval, biconvex film-
coated tablets, with a length of approximately 15.6 mm and a width of
approximately 6.2 mm.
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