Amlodipine/Valsartan/HCT STADA 5 mg/160 mg/25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 25 mg/stuk ; VALSARTAN 160 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

C09DX01

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 25 mg/stuk ; VALSARTAN 160 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Valsartan, amlodipine and hydrochlorothiazide

Autorisatie datum:

1900-01-01

Bijsluiter

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. What is and what it is used for
2. What you need to know before you take
3. 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

Productkenmerken

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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