IRBEL HCT TABLETS 300 + 25 mg

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Inapatikana kutoka:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Jina la Kimataifa):

IRBESARTAN; HYDROCHLOROTHIAZIDE

Vitengo katika mfuko:

4x7tablet Tablets

Viwandani na:

Sun Pharmaceutical Industries Limited

Taarifa za kipeperushi

IRBEL HCT
_IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS _
_150 + 12.5 MG / 300 + 12.5 MG / 300 + 25 MG TABLETS _
_ _
_Consumer Medication Information Leaflet (RiMUP _
IRBEL HCT Tablets
Page 1
WHAT IS IN THIS LEAFLET
1.
What
IRBEL HCT
are used for
2.
How
IRBEL HCT
work
3.
Before you use
IRBEL HCT
4.
How to use
IRBEL HCT
5.
While you are using
IRBEL HCT
6.
Side Effects
7.
Storage
and
Disposal
of
IRBEL
HCT
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT IRBEL HCT IS USED FOR
IRBEL
HCT
are
used
to
treat
high
blood
pressure,
when
treatment
with
irbesartan or hydrochlorothiazide alone
did not provide adequate control of your
blood pressure. High blood pressure, if
not treated, can damage blood vessels in
several organs such as heart, kidneys,
brain and eyes. This may lead to heart
attack,
kidney
failure,
stroke,
or
blindness.
HOW IRBEL HCT WORK
IRBEL HCT
is a combination product
which contains two active ingredients,
irbesartan
and
hydrochlorothiazide.
Irbesartan
belongs
to
a
group
of
medicines called angiotensin-II receptor
antagonist
and
hydrochlorothiazide
belongs to a group of medicines called
diuretics
(water
tablets).
These
medicines
are
used
to
lower
blood
pressure.
The
angiotensin
II
receptor
antagonist
(irbesartan)
works
by
causing blood vessels to relax, which in
turn
lowers
blood
pressure.
Diuretic
(hydrochlorothiazide)
works
on
the
kidneys to increase the flow of urine
and decrease the amount of water in the
body, thereby reducing blood pressure.
The
two
active
ingredients
work
together to lower blood pressure further
than
if
either
was
given
alone.
This
medicine
is
available
only
with
a
doctor’s prescription.
BEFORE YOU USE IRBEL HCT
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE IRBEL HCT IF YOU:

have
previously
had
an
allergic
reaction
to
irbesartan
or/and
hydrochlorothiazide
or
to
sulphonamides derived medicines or to
any of the ingredients listed at the end
of this leaflet. Some of the symptoms of
an
allergic
reaction
may
include:
shortness
of
breath,
wheez

Tabia za bidhaa

_“For the use only of a Registered Medical Practitioner” _
IRBEL HCT
(IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS)
COMPOSITION
IRBEL HCT TABLETS 150 + 12.5 MG
Each film-coated tablet contains:
Irbesartan Ph. Eur. …………………… 150 mg
Hydrochlorothiazide Ph.Eur. .…............. 12.5 mg
IRBEL HCT TABLETS 300 + 12.5 MG
Each film-coated tablet contains:
Irbesartan Ph. Eur. .…………………… 300 mg
Hydrochlorothiazide Ph.Eur. .…............. 12.5 mg
IRBEL HCT TABLETS 300 + 25 MG
Each film coated tablet contains:
Irbesartan Ph. Eur. …………………….. 300 mg
Hydrochlorothiazide Ph.Eur. .…................ 25 mg
IN-ACTIVE COMPONENTS:
Lactose monohydrate, Microcrystalline Cellulose (PH 101),
Croscarmellose Sodium, Hypromellose,
Silica, colloidal anhydrous, Microcrystalline Cellulose (PH 102),
Magnesium Stearate, Opadry Pink
03G54386 for Irbel 150+12.5 & 300+25 mg and Opadry yellow 03G52390 for
Irbel 300+12.5 mg,
Water Purified
_Coating composition of_ Opadry Pink 03G54386
Hypromellose, Titanium Dioxide, Macrogol 400, Talc, Macrogol 4000,
Iron Oxide red, Iron oxide black
Coating composition of Opadry yellow 03G52390
Hypromellose, Titanium Dioxide, Macrogol 400, Talc, Macrogol 4000,
Iron oxide yellow
DESCRIPTION
IRBEL HCT tablets are a fixed dose combination of an angiotensin II
receptor antagonist (AT
1
subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide
(HCTZ).
Irbesartan
is
a
non-peptide
compound,
chemically
described
as
2-butyl-3-[_p_-(_o_-1_H_-tetrazol-5-
ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. It has a molecular
weight of 428.5; its empirical
formula is C
25
H
28
N
6
O, and its structural formula is as given below:
IRBESARTAN
Hydrochlorothiazide is 6-chloro-3,
4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It
has a molecular weight of 297.7, its empirical formula is C
7
H
8
ClN
3
O
4
S
2
and its structural formula is as
given below:
HYDROCHLOROTHIAZIDE
PRODUCT DESCRIPTION:
For 150 + 12.5 mg strength: Pink to Red coloured, film coated, ova