Irbesartan comp HEXAL 300/25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

HYDROCHLOORTHIAZIDE 25 mg/stuk ; IRBESARTAN 300 mg/stuk

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

C09DA04

INN (Algemene Internationale Benaming):

HYDROCHLOORTHIAZIDE 25 mg/stuk ; IRBESARTAN 300 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Irbesartan And Diuretics

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2010-03-22

Bijsluiter

Hexal AG
Page 1
Irbesartan comp HEXAL 300/25 mg, filmomhulde
tabletten
V12
Augustus 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRBESARTAN COMP HEXAL 300/25 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 [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]
is
a
combination
of
two
active
substances,
irbesartan
and
hydrochlorothiazide.
IRBESARTAN
belongs to a group of medicines called angiotensin-II receptor
antagonists. These work by
widening the blood vessels which in turn lowers the blood pressure.
HYDROCHLOROTHIAZIDE
belongs to a group of medicines called diuretics (water tablets).
The two active substances in [Nationally completed name] work together
to lower blood pressure
further than if either was given alone.
[Nationally completed name] is used in the treatment of high blood
pressure (hypertension), when
treatment with irbesartan or hydrochlorothiazide alone did not provide
adequate control of your blood
pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]_
_
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU:
•
are
ALLERGIC TO IRBESARTAN, HYDROCHLOROTHIAZIDE OR ANY OF THE OTHE

Productkenmerken

Hexal AG
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Irbesartan comp HEXAL 300/25mg, filmomhulde
tabletten.
V13
1.3.1.1 Summary of Product Characteristics
Augustus 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan comp HEXAL 300/25 mg, filmomhulde tabletten.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
Excipient with known effect
Each film-coated tablet contains 15.7 mg of lactose (as monohydrate).
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Dark pink, oval biconvex film-coated tablet, debossed with 300 on one
side and 25H on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
This fixed dose combination is indicated in adult patients whose blood
pressure is not adequately
controlled on irbesartan or hydrochlorothiazide alone (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
[Nationally completed name] can be taken once daily, with or without
food.
Dose titration with the individual components (i.e. irbesartan and
hydrochlorothiazide) may be
recommended.
When clinically appropriate direct change from monotherapy to the
fixed combinations may be
considered:
•
Nnationally completed name 150 mg/12.5 mg] may be administered in
patients whose blood
pressure is not adequately controlled with hydrochlorothiazide or
irbesartan 150 mg alone.
•
[Nationally completed name 300 mg/12.5 mg] may be administered in
patients insufficiently
controlled by irbesartan 300 mg or by [nationally completed name 150
mg/12.5 mg].
•
[Nationally
completed
name
300 mg/25 mg]
may
be
administered
in
patients
insufficiently
controlled by [nationally completed name 300 mg/12.5 mg].
Hexal AG
Page 2
Irbesartan comp HEXAL 300/25mg, filmomhulde
tabletten.
V13
1.3.1.1 Summary of Product Characteristics
Augustus 2021
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended.
When necessary, [Nationally complet