IRBEJUB H (Irbesartan and Hydrochlorothiazide Tablets 300 mg+12.5 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Irbesartan; Hydrochlorothiazide* Ph. Eur

Boleh didapati daripada:

Pharmaniaga Marketing Sdn Bhd

INN (Nama Antarabangsa):

Irbesartan; Hydrochlorothiazide* Ph. Eur

Unit dalam pakej:

4 blisters x 7 Tablets

Dikeluarkan oleh:

Jubilant Generics Limited

Risalah maklumat

IRBEJUB H
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS 150 MG + 12.5 MG, 300 MG +
12.5 MG, 300 MG + 25 MG
1
WHAT IS IN THIS LEAFLET
1.
What Irbejub H is used for
2.
How Irbejub H works
3.
Before you use Irbejub H
4.
How to use Irbejub H
5.
While you are using Irbejub H
6.
Side effects of Irbejub H
7.
Storage and Disposal of Irbejub H
8.
Irbejub H Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS IRBEJUB H USED FOR
Irbejub
H
is
used
to
treat
high
blood
pressure when treatment with irbesartan or
hydrochlorothiazide alone did not provide
adequate control of your blood pressure.
HOW IRBEJUB H WORKS
Irbejub H 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
increases
the
amount
of
water
you
lose
in
your
urine
and
so
causes a lowering of blood pressure. The
two active ingredients in Irbejub H work
together to lower blood pressure further
than if either was given alone.
BEFORE YOU USE IRBEJUB H
_ When you must not use it _
Do not take Irbejub H:
•
if you are allergic (hypersensitive) to
irbesartan,
or
to
any
of
the
other
ingredients of this medicine.
•
if
you
are
allergic
(hypersensitive)
to
hydrochlorothiazide,
or
to
any
other
sulfonamide-derived medicines
•
if you are more than 3 months pregnant.
(It is also better to avoid Irbejub H in
early
pregnancy
–
see
Pregnancy
and
Breast-feeding section).
•
if
you
have
severe
liver
or
kidney
problems
•
if you have difficulty in producing urine
•
if your doctor det

Ciri produk

ITEM CODE: 50000003619
SUPERSEDED ITEM CODE: NA
PHARMA CODE: 6480
Last modified: 3. January 2023, 11:40 AM
FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY
IRBEJUB H
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
150 MG+12.5 MG, 300 MG+12.5 MG AND 300 MG+25 MG
PRODUCT NAME:
Irbesartan and Hydrochlorothiazide tablets 150 mg+12.5 mg
Irbesartan and Hydrochlorothiazide tablets 300 mg+12.5 mg
Irbesartan and Hydrochlorothiazide tablets 300 mg+25 mg
NAME AND STRENGTH OF ACTIVE INGREDIENT:
EACH FILM-COATED TABLET CONTAINS:
Irbesartan Ph. Eur, 150 mg and Hydrochlorothiazide Ph. Eur, 12.5 mg
Irbesartan Ph. Eur, 300 mg and Hydrochlorothiazide Ph. Eur, 12.5 mg
Irbesartan Ph. Eur, 300 mg and Hydrochlorothiazide Ph. Eur, 25 mg
PRODUCT DESCRIPTION:
FOR 150 MG+12.5 MG:
Peach coloured, biconvex, oval shaped film-coated tablets, debossed
with ‘450’ on one side and plain on the other.
FOR 300 MG+12.5 MG:
Peach coloured, biconvex, oval shaped film-coated tablets, debossed
with ‘451’ on one side and plain on the other.
FOR 300 MG+25 MG:
Dark pink coloured, biconvex, oval shaped film-coated tablets,
debossed with ‘452’ on one side and plain on the other.
PHARMACODYNAMICS / PHARMACOKINETICS:
PHARMACODYNAMICS
PHARMACOTHERAPEUTIC GROUP: angiotensin-II antagonists, combinations
ATC CODE: C09DA04
Irbesartan and Hydrochlorothiazide tablet is a combination of an
angiotensin-II receptor antagonist, irbesartan, and a thiazide
diuretic, hydrochlorothiazide. The combination of these ingredients
has an additive antihypertensive effect, reducing blood pressure
to a greater degree than either component alone.
Irbesartan is a potent, orally active, selective angiotensin-II
receptor (AT1 subtype) antagonist. It is expected to block all actions
of angiotensin-II mediated by the AT1 receptor, regardless of the
source or route of synthesis of angiotensin-II. The selective
antagonism of the angiotensin-II (AT1) receptors results in increases
in plasma renin levels and angiotensin-II levels, and a decrease
in pla