COAPROVEL 300MG/12.5MG TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

HYDROCHLOROTHIAZIDE; IRBESARTAN

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

HYDROCHLOROTHIAZIDE; IRBESARTAN

Units in package:

28 Tablets; 14 Tablets

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
COAPROVEL
® FILM-COATED TABLET
_ _
Irbesartan/ Hydrochlorothiazide (150 mg/12.5 mg)
Irbesartan/ Hydrochlorothiazide (300 mg/12.5 mg)
Irbesartan/ Hydrochlorothiazide (300 mg/25 mg)
1
WHAT IS IN THIS LEAFLET
1. What CoAprovel is used for
2. How CoAprovel works
3. Before you use CoAprovel
4. How to use CoAprovel
5. While you are using it
6. Side effects
7. Storage and Disposal of CoAprovel
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT COAPROVEL IS USED FOR
COAPROVEL
IS
USED
TO
TREAT
HIGH
BLOOD PRESSURE
, when treatment with
irbesartan or hydrochlorothiazide alone
did
not
provide
adequate
control
of
your blood pressure.
HOW COAPROVEL WORKS
CoAprovel
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
CoAprovel
work
together
to
lower
blood pressure further than if either
was given alone.
BEFORE YOU USE COAPROVEL
_-When you must not use it _
DO NOT TAKE COAPROVEL
•
if you are
ALLERGIC
(hypersensitive)
to
irbesartan
or
any
of
the
other
ingredients of CoAprovel
•
if you are
ALLERGIC
(hypersensitive)
to hydrochlorothiazide or any other
sulfonamide-derived medicines
•
if
you
are
MORE
THAN
3
MONTHS
PREGNANT
. (It is also better to avoid
CoAprovel in early pregnancy – see
pregnancy section)
•
if you have
SEVERE LIVER
or
KIDNEY
PROBLEMS
•
if you have
DIFFICULTY IN PRODUCING
URINE
•
if your doctor determines that you

Summary of Product characteristics

MY/COA/1220/SmPC1020
1
NAME OF THE MEDICINAL PRODUCT
CoAprovel 150 mg/12.5 mg film-coated tablets
CoAprovel 300 mg/12.5 mg film-coated tablets
CoAprovel 300 mg/25 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
COAPROVEL 150 MG/12.5 MG FILM-COATED TABLETS
Each tablet contains 150 mg irbesartan and 12.5 mg of
hydrochlorothiazide.
COAPROVEL 300 MG/12.5 MG FILM-COATED TABLETS
Each tablet contains 300 mg irbesartan and 12.5 mg of
hydrochlorothiazide.
COAPROVEL 300 MG/25 MG FILM-COATED TABLETS
Each tablet contains 300 mg irbesartan and 25 mg of
hydrochlorothiazide.
PHARMACEUTICAL FORM
COAPROVEL 150 MG/12.5 MG
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the number 2875 engraved on
the other side.
COAPROVEL 300/12.5 MG
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the number 2876 engraved on
the other side.
COAPROVEL 300/25 MG
Pink, biconvex, oval-shaped, with a heart debossed on one side and the
number 2788 engraved on the
other side.
CLINICAL PARTICULARS
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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CoAprovel 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:
•
CoAprovel 150 mg/12.5 mg may be administered in patients whose blood
pressure is not
adequately controlled with hydrochlorothiazide or irbesartan 150 mg
alone;
•
CoAprovel 300 mg/12.5 mg may be administered in patients
insufficiently controlled by irbesartan
300 mg or by CoAprovel 150 mg/12.5 mg.
•
CoAprovel 300 mg/25 mg may be administered in patients insufficiently
controlled by CoAprovel
300 mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily a