Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

irbesartan, hydrochlorothiazide

Available from:

sanofi-aventis groupe 

ATC code:

C09DA04

INN (International Name):

irbesartan, hydrochlorothiazide

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

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.

Product summary:

Revision: 34

Authorization status:

Authorised

Authorization date:

2007-01-18

Patient Information leaflet

110
B. PACKAGE LEAFLET
111
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA 150 MG/12.5 MG 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 Zentiva is and what it is used for
2.
What you need to know before you take Irbesartan Hydrochlorothiazide
Zentiva
3.
How to take Irbesartan Hydrochlorothiazide Zentiva
4.
Possible side effects
5.
How to store Irbesartan Hydrochlorothiazide Zentiva
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA IS AND WHAT IT IS USED FOR
Irbesartan Hydrochlorothiazide Zentiva 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 Zentiva
work together to lower blood
pressure further than if either was given alone.
IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA IS USED TO TREAT HIGH BLOOD
PRESSURE, when treatment w

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect
Each tablet contains 26.65 mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the number 2775 engraved 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 Zentiva 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:
•
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg may be
administered in patients whose
blood pressure is not adequately controlled with hydrochlorothiazide
or irbesartan 150 mg
alone;
•
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg may be
administered in patients
insufficiently controlled by irbesartan 300 mg or by Irbesartan
Hydrochlorothiazide
Zentiva 150 mg/12.5 mg.
•
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg may be
administered in patients
insufficiently controlled by Irbesartan Hydrochlorothiazide Zentiva
300 mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended.
When necessary, Irbesartan Hydrochlorothiazide Zentiva may be
administered with another
antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and
5.1).
3
_Special populations _
_Renal impairment _
Due to the hydrochloroth