Valsartan/Hydrochloorthiazide Viatris 160 mg/25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

HYDROCHLOORTHIAZIDE 25 mg/stuk ; VALSARTAN 160 mg/stuk

Beschikbaar vanaf:

Mylan S.A.S 117 Allée des Parcs 69800 SAINT PRIEST (FRANKRIJK)

ATC-code:

C09DA03

INN (Algemene Internationale Benaming):

HYDROCHLOORTHIAZIDE 25 mg/stuk ; VALSARTAN 160 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Valsartan And Diuretics

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMLAURILSULFAAT (E 487); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

BIJSLUITER
Valsartan/HCTZ Viatris 80/12,5 mg, 160/12,5 mg, 160/25 mg, 320/125 mg
en 320/25 mg, filmomhulde tabletten
Versie: februari 2023
RVG 109818-20, 112837-8
Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN/HYDROCHLOORTHIAZIDE VIATRIS 80 MG/12.5 MG, FILMOMHULDE
TABLETTEN
VALSARTAN/HYDROCHLOORTHIAZIDE VIATRIS 160 MG/12.5 MG, FILMOMHULDE
TABLETTEN
VALSARTAN/HYDROCHLOORTHIAZIDE VIATRIS 160 MG/25 MG, FILMOMHULDE
TABLETTEN
VALSARTAN/HYDROCHLOORTHIAZIDE VIATRIS 320 MG/12.5 MG, FILMOMHULDE
TABLETTEN
VALSARTAN/HYDROCHLOORTHIAZIDE VIATRIS 320 MG/25 MG, FILMOMHULDE
TABLETTEN
valsartan/hydrochloorthiazide
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 Valsartan/Hydrochloorthiazide Viatris is and what it is used for
2.
What you need to know before you take Valsartan/Hydrochloorthiazide
Viatris
3.
How to take Valsartan/Hydrochloorthiazide Viatris
4.
Possible side effects
5.
How to store Valsartan/Hydrochloorthiazide Viatris
6.
Contents of the pack and other information
1.
WHAT VALSARTAN/HYDROCHLOORTHIAZIDE VIATRIS IS AND WHAT IT IS USED FOR
Valsartan/Hydrochloorthiazide Viatris film-coated tablets contain two
medicines called valsartan and
hydrochlorothiazide. Both of these medicines help to control high
blood pressure (hypertension).
•
VALSARTAN belongs to a class of medicines known as “angiotensin II
receptor antagonists”,
which help to control high blood pressure. Angiotensin II is a
substance in the body that causes
vessels to tighten, thus causing your blood pressure

Productkenmerken

SAMENVATTING VAN PRODUCTKENMERKEN
Valsartan/HCTZ Viatris 80/12,5 mg, 160/12,5 mg, 160/25 mg, 320/125 mg
en 320/25 mg, filmomhulde tabletten
Versie: februari 2023
RVG 109818-20
Page 1 of 26
1.
NAME OF THE MEDICINAL PRODUCT
Valsartan/Hydrochloorthiazide Viatris 80 mg/12.5 mg, filmomhulde
tabletten
Valsartan/Hydrochloorthiazide Viatris 160 mg/12.5 mg, filmomhulde
tabletten
Valsartan/Hydrochloorthiazide Viatris 160 mg/25 mg, filmomhulde
tabletten
Valsartan/Hydrochloorthiazide Viatris 320 mg/12.5 mg filmomhulde
tabletten
Valsartan/Hydrochloorthiazide Viatris 320 mg/25 mg filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valsartan/Hydrochloorthiazide Viatris 80 mg/12.5 mg, filmomhulde
tabletten
Each tablet contains 80 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: 51.950 mg of lactose monohydrate.
Valsartan/Hydrochloorthiazide Viatris 160 mg/12.5 mg, filmomhulde
tabletten
Each tablet contains 160 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: 103.900 mg of lactose monohydrate.
Valsartan/Hydrochloorthiazide Viatris 160 mg/25 mg, filmomhulde
tabletten
Each tablet contains 160 mg of valsartan and 25 mg of
hydrochlorothiazide.
Excipient with known effect: 103.900 mg of lactose monohydrate.
Valsartan/Hydrochloorthiazide Viatris 320 mg/12.5 mg filmomhulde
tabletten
Each tablet contains 320 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: 207.800 mg of lactose monohydrate
Valsartan/Hydrochloorthiazide Viatris 320 mg/25 mg filmomhulde
tabletten
Each tablet contains 320 mg of valsartan and 25 mg of
hydrochlorothiazide.
Excipient with known effect: 207.800 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Valsartan/Hydrochloorthiazide Viatris 80 mg/12.5 mg, filmomhulde
tabletten
Peach, oval, biconvex film-coated tablet (12.5 x 6.4 mm) debossed with
“VH1” on one side of the tablet and
“M” on other side.
Valsartan/Hydrochloorthiazide Viatris 1