Irbesartan/Hydrochloorthiazide STADA 300/12,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

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

ATC-code:

C09DA04

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; 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 ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; 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 ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Irbesartan And Diuretics

Product samenvatting:

Hulpstoffen: COPOVIDON; CROSCARMELLOSE NATRIUM (E 468); 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; SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-07-05

Bijsluiter

PL Irbesartan/HCT NL1919
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN/HYDROCHLOORTHIAZIDE STADA 150/12,5 MG, FILMOMHULDE
TABLETTEN
IRBESARTAN/HYDROCHLOORTHIAZIDE STADA 300/12,5 MG, FILMOMHULDE
TABLETTEN
IRBESARTAN/HYDROCHLOORTHIAZIDE STADA 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 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
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 a lowering of blood
pressure.
The two active ingredients in work together to lower
blood pressure further
than if either was given alone.
IS USED TO TREAT HIGH BLOOD PRESSURE, when treatment
with irbesartan or
hydrochlorothiazide alone d

Productkenmerken

SmPC Irbesartan/HCT NL1919
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Irbesartan/Hydrochloorthiazide STADA 150/12,5 mg, filmomhulde
tabletten
Irbesartan/Hydrochloorthiazide STADA 300/12,5 mg, filmomhulde
tabletten
Irbesartan/Hydrochloorthiazide STADA 300/25 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ 150 mg/12.5 mg film-coated tablets _
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
_ 300 mg/12.5 mg film-coated tablets _
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
_ 300 mg/25 mg film-coated tablets _
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
Excipient(s) with known effect
_ 150 mg/12.5mg film-coated tablets _
Each film-coated tablet contains 34.16 mg lactose (as lactose
monohydrate).
_ 300 mg/12.5 mg and 300 mg/25 mg
film-coated tablets _
Each film-coated tablet contains 68.32 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
_ 150 mg/12.5 mg film-coated tablet _
Pink, oblong, biconvex film-coated tablet and approximately 13 mm in
length.
_ 300 mg/12.5 mg film-coated tablet _
Pink, oblong, biconvex film-coated tablet and approximately 16 mm in
length.
_ 300 mg/25 mg film-coated tablet _
Red, oblong, biconvex film-coated tablet and approximately 16 mm in
length.
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
can be taken once daily, with or without food.
Dose titration with the individual components (i.e. irbesartan and
hydrochlorothiazide) may be
recommended.
SmPC Irbesartan/HCT NL1