Irbesartan/Hydrochlorothiazide Teva
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
16-06-2023
Fachinformation
(SPC)
16-06-2023
Öffentlichen Beurteilungsberichts
(PAR)
10-11-2015
Wirkstoff:
irbesartan, hydrochlorothiazide
Verfügbar ab:
Teva B.V.
ATC-Code:
C09DA04
INN (Internationale Bezeichnung):
irbesartan, hydrochlorothiazide
Therapiegruppe:
Agents acting on the renin-angiotensin system
Therapiebereich:
Hypertension
Anwendungsgebiete:
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.
Produktbesonderheiten:
Revision: 22
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2009-11-26
Gebrauchsinformation
40
B. PACKAGE LEAFLET
41 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRBESARTAN/HYDROCHLOROTHIAZIDE TEVA 150 MG/12.5 MG FILM-COATED TABLETS
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/Hydrochlorothiazide Teva is and what it is used for
2.
What you need to know before you take Irbesartan/Hydrochlorothiazide
Teva
3.
How to take Irbesartan/Hydrochlorothiazide Teva
4.
Possible side effects
5.
How to store Irbesartan/Hydrochlorothiazide Teva
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN/HYDROCHLOROTHIAZIDE TEVA IS AND WHAT IT IS USED FOR
Irbesartan/Hydrochlorothiazide Teva 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 Irbesartan/Hydrochlorothiazide Teva work
together to lower blood pressure
further than if either was given alone.
IRBESARTAN/HYDROCHLOROTHIAZIDE TEVA IS USED TO TREAT HIGH BLOOD
PRESSURE,
when treatment with
ir
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Fachinformation
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets
Light pink to pink, film-coated capsule shaped tablet. One side of the
tablet debossed with the number "93".
The other side of the tablet debossed with the number "7238".
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets
Light pink to pink, round film-coated tablet. One side of the tablet
debossed with the number "2" and plain
on the other side.
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets
Pink to dark pink, round film-coated tablet. One side of the tablet
debossed with the number "3" and plain on
the 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
Irbesartan/Hydrochlorothiazide Teva can be taken once daily, with or
without food.
Dose titration with the individual components (i.e. irbesartan and
hydrochlorothiazide) may be
recommend
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