Irbesartan HCTZ Fair-Med 150mg/12.5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCHLOROTHIAZIDE, IRBESARTAN

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

C09DA04

INN (International Name):

HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 150 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 150 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2012-08-22

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
IRBESARTAN HCTZ FAIR-MED 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, pharmacist or
nurse.
-
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, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Irbesartan HCTZ Fair-Med is and what it is used for
2.
What you need to know before you take Irbesartan HCTZ Fair-Med
3.
How to take Irbesartan HCTZ Fair-Med
4.
Possible side effects
5.
How to store Irbesartan HCTZ Fair-Med
6.
Contents of the pack and other information
1. WHAT IRBESARTAN HCTZ FAIR-MED IS AND WHAT IT IS USED FOR
Irbesartan
HCTZ
Fair-Med
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 HCTZ Fair-Med work together
to lower blood pressure
further than if either was given alone.
IRBESARTAN HCTZ FAIR-MED IS USED TO TREAT HIGH BLOOD PRESSURE, when
treatment with irbesartan
or hydrochlorothiazide alone did not provide adequate control of your
blood pressure.
2. WHAT

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan HCTZ Fair-Med 150 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: Each tablet contains 114 mg of lactose
(as lactose monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach coloured, oval shaped, biconvex, film coated tablet, debossed
with “L183” on one side and
plain 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
Irbesartan HCTZ Fair-Med 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 HCTZ Fair-Med 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 HCTZ Fair-Med 300 mg/12.5 mg may be administered in
patients insufficiently
controlled by irbesartan 300 mg or by Irbesartan HCTZ Fair-Med 150
mg/12.5 mg.

Irbesartan HCTZ Fair-Med 300 mg/25 mg may be administered in patients
insufficiently
controlled by Irbesartan HCTZ Fair-Med 300 mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended.
When necessary, Irbesartan HCTZ Fair-Med may be administered with
another antihypertensive
medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Page 2 of 17
Special Populations
_Renal impairment:_ due to the hydrochlorothiazide component,
Irbesartan HCTZ Fair-Med is not
recommende