Irbesartan comp HEXAL 300/12,5 mg, filmomhulde tabletten

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; IRBESARTAN 300 mg/stuk

Boleh didapati daripada:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

Kod ATC:

C09DA04

INN (Nama Antarabangsa):

HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; IRBESARTAN 300 mg/stuk

Borang farmaseutikal:

Filmomhulde tablet

Komposisi:

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

Laluan pentadbiran:

Oraal gebruik

Kawasan terapeutik:

Irbesartan And Diuretics

Ringkasan produk:

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

Tarikh kebenaran:

1900-01-01

Risalah maklumat

Hexal AG
Page 1
Irbesartan comp HEXAL 300/12,5 mg, filmomhulde
tabletten
RVG 107107
1313-V14
Februari 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRBESARTAN COMP HEXAL
® 300/12,5 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, HYDROCHLOROTHIA

Ciri produk

Hexal AG
Page 1
Irbesartancomp HEXAL 300/12,5mg, filmomhulde
tabletten
RVG 107107
1311-V15
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1 .
NAME OF THE MEDICINAL PRODUCT
Irbesartan comp HEXAL 300/12,5 mg, filmomhulde tabletten.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect
Each film-coated tablet contains 19.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Apricot, oval biconvex film-coated tablet, debossed with 300H on one
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:
•
[Nationally 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
Irbesartancomp HEXAL 300/12,5mg, filmomhulde
tabletten
RVG 107107
1311-V15
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2024
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended.
When necessary, [Nati