IRBESARTAN HCTZ AN 300/25 irbesartan and hydrochlorothiazide 300/25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hydrochlorothiazide,Irbesartan

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Hydrochlorothiazide,Irbesartan

Patient Information leaflet

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_Irbesartan HCTZ AN capsules – Consumer Medicine Information _
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IRBESARTAN HCTZ AN CAPSULES
_Irbesartan plus hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Irbesartan
HCTZ
AN.
It
does
not
contain
all
of
the
available information. It does not
take
the
place
of
talking
to
your
doctor or pharmacist.
All
medicines
have
benefits
and
risks. Your doctor has weighed the
risks of you taking Irbesartan HCTZ
AN against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT IRBESARTAN HCTZ
AN IS USED FOR
Irbesartan
HCTZ
AN
lowers
high
blood pressure, which doctors call
hypertension.
Everyone has blood pressure. This
pressure helps get your blood all
around
your
body.
Your
blood
pressure
may
be
different
at
different
times
of
the
day,
depending on how busy or worried
you are. You have hypertension
(high blood pressure) which means
your
blood
pressure
stays
high,
even
when
you
are
calm
and
relaxed.
There
are
often
no
symptoms
of
high blood pressure. The only way
of
knowing
that
you
have
hypertension is to have your blood
pressure
checked
on
a
regular
basis.
If high blood pressure is not treated
it
can
lead
to
serious
health
problems,
such
as
stroke,
heart
disease and kidney failure.
HOW IRBESARTAN HCTZ AN
WORKS
Irbesartan
HCTZ
AN
contains
irbesartan and hydrochlorothiazide.
Both
medicines
reduce
blood
pressure
in
different
ways.
Irbesartan
belongs
to
a
group
of
medicines known as angiotensin-II
receptor antagonists. Angiotensin-II
is a substance produced in the body
that
causes
blood
vessels
to
narrow.
Irbesartan
blocks
angiotensin-II and therefore widens
your blood vessels, making it easier
for
your
heart
to
pump
blood
throughout your body. This helps to
lower your blood pressure.
Hydrochlorothiazide belongs to the
class
of
medicines
known
as
diure

Summary of Product characteristics

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_Irebesartan HCTZ AN tablets Product Information _
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_Scentia Pharmaceuticals Pty Ltd _
Doc ID: 109.AN.P.1.0
Page 1
IRBESARTAN HCTZ AN 150/12.5, 300/12.5 &
300/25
_IRBESARTAN 150 MG + HYDROCHLOROTHIAZIDE 12.5 MG TABLETS _
_IRBESARTAN 300 MG + HYDROCHLOROTHIAZIDE 12.5 MG TABLETS _
_IRBESARTAN 300 MG + HYDROCHLOROTHIAZIDE 25 MG TABLETS _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is Irbesartan/Hydrochlorothiazide
IRBESARTAN:
CHEMICAL NAME:
2-butyl-3-[(2'-(1_H_-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro
[4,4]
non-1- en-4-one
MOLECULAR FORMULA:
C
25
H
28
N
6
O
MOLECULAR WEIGHT: 428.5
CAS REGISTRY NUMBER: 1384-11-6
HYDROCHLOROTHIAZIDE:
CHEMICAL NAME:
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide
MOLECULAR FORMULA: C
7
H
8
ClN
3
O
4
S
2
MOLECULAR WEIGHT: 297.7
CAS REGISTRY NUMBER: 58-93-5
DESCRIPTION
IRBESARTAN HCTZ AN 150/12.5, IRBESARTAN HCTZ AN 300/12.5 and
IRBESARTAN HCTZ AN 30/25 (irbesartan/hydrochlorothiazide) is an oral
antihypertensive
agent combining a nonpeptide angiotensin II receptor (AT
1
thiazide diuretic,
hydrochlorothiazide.
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_Irebesartan HCTZ AN tablets Product Information _
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_Scentia Pharmaceuticals Pty Ltd _
Doc ID: 109.AN.P.1.0
Page 2
Irbesartan is a white or off-white crystalline powder. It is a
relatively non-polar compound
with a partition coefficient (octanol-water) of 10.1 at a pH of 7.4.
Irbesartan is practically
insoluble in water, sparingly soluble in methanol, slightly soluble in
methylene chloride.
Hydrochlorothiazide is a white crystalline powder. It is Very slightly
soluble in water, soluble
in acetone, sparingly soluble in ethanol (96 percent). It dissolves in
dilute solutions of alkali
hydroxides.
The inactive ingredients in Irbesartan HCTZ tablets include lactose;
croscarmellose sodium;
povidone, pigment blend PB-24899 (ARPING 107861 consisting of iron
oxide red, iron oxide
yellow, lactose); magnesium stearate.
Irbesartan HCTZ AN
300/12.5mg
and
Irbesartan HCTZ AN
150/12.5mg
tablets
contain
opadry II