Irbesartan Hydrochloorthiazide Torrent 300 mg/25 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

HYDROCHLOORTHIAZIDE ; IRBESARTAN

Beschikbaar vanaf:

Torrent Pharma GmbH

ATC-code:

C09DA04

INN (Algemene Internationale Benaming):

HYDROCHLOROTHIAZIDE ; IRBESARTAN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Irbesartan And Diuretics

Product samenvatting:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLYETHYLEENGLYCOL (E 1521); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-11-03

Bijsluiter

IRBESARTAN HYDROCHLOORTHIAZIDE TORRENT, 150/12.5-300/12.5-300/25 MG,
FILM-COATED TABLETS – NL/H/2067/001-003/DC
NL PL
NL/P/012/16/3
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN HYDROCHLOORTHIAZIDE TORRENT 150 MG/12,5 MG FILMOMHULDE
TABLETTEN
IRBESARTAN HYDROCHLOORTHIAZIDE TORRENT 300 MG/12,5 MG FILMOMHULDE
TABLETTEN
IRBESARTAN HYDROCHLOORTHIAZIDE TORRENT 300 MG/25 MG FILMOMHULDE
TABLETTEN
irbesartan/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 Irbesartan Hydrochloorthiazide Torrent is and what it is used for
2.
What you need to know before you take Irbesartan Hydrochloorthiazide
Torrent
3.
How to take Irbesartan Hydrochloorthiazide Torrent
4.
Possible side effects
5.
How to store Irbesartan Hydrochloorthiazide Torrent
6.
Contents of the pack and other information
1. WHAT IRBESARTAN HYDROCHLOORTHIAZIDE TORRENT IS AND WHAT IT IS
USED FOR
Irbesartan Hydrochloorthiazide Torrent is a combination of two active
substances, irbesartan and
hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II
receptor antagonists. Angiotensin-
II is a substance produced in the body that binds to receptors in
blood vessels causing them to tighten.
This results in an increase in blood pressure. Irbesartan prevents the
binding of angiotensin-II to these
receptors, causing the blood vessels to relax and the blood pressure
to lower.
Hydrochlorothiazide is one of a group of medicines (called thiazide
diuretics) that causes increased
urine output and so causes

Productkenmerken

IRBESARTAN HYDROCHLOORTHIAZIDE TORRENT, 150/12.5-300/12.5-300/25 MG,
FILM-COATED TABLETS – NL/H/2067/001-003/DC
PAGE 1
NL SMPC
NL/S/009/16/3
1
SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1. NAME OF THE MEDICINAL PRODUCT
Irbesartan Hydrochloorthiazide Torrent 150 mg/12.5 mg filmomhulde
tabletten
Irbesartan Hydrochloorthiazide Torrent 300 mg/12.5 mg filmomhulde
tabletten
Irbesartan Hydrochloorthiazide Torrent 300 mg/25 mg filmomhulde
tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One Irbesartan Hydrochloorthiazide Torrent 150 mg/12.5 mg film-coated
tablet contains 150 mg of
irbesartan and 12.5 mg of hydrochlorothiazide.
Excipient with known effect: Each film-coated tablet contains 114.0 mg
of lactose monohydrate.
One Irbesartan Hydrochloorthiazide Torrent 300 mg/12.5 mg film-coated
tablet contains 300 mg of
irbesartan and 12.5 mg of hydrochlorothiazide.
Excipient with known effect: Each film-coated tablet contains 228.0 mg
of lactose monohydrate.
One Irbesartan Hydrochloorthiazide Torrent 300 mg/25 mg film-coated
tablet contains 300 mg of
irbesartan and 25 mg of hydrochlorothiazide.
Excipient with known effect: Each film-coated tablet contains 228.1 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Irbesartan Hydrochloorthiazide Torrent 150 mg/12.5 mg filmomhulde
tabletten:
Pinkish orange coloured oval shaped, biconvex film-coated tablets,
debossed with “L183” on one side
and plain on other side.
Irbesartan Hydrochloorthiazide Torrent 300 mg/12.5 mg filmomhulde
tabletten:
Pale pink with orange shade coloured, oval shaped, biconvex
film-coated tablets, debossed with
“L184” on one side and plain on other side.
Irbesartan Hydrochloorthiazide Torrent 300 mg/25 mg filmomhulde
tabletten:
Pinkish brown, oval shaped, biconvex film-coated tablets, debossed
with “L185” on one side and
plain on other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension. This fixed dose combination is
indicated in a