IRBESARTAN HCT SANOFI 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hydrochlorothiazide,Irbesartan

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Hydrochlorothiazide,Irbesartan

Patient Information leaflet

IRBESARTAN HCT SANOFI
®
_irbesartan & hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Irbesartan HCT
Sanofi. It does not contain all 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
benefits of you taking this medicine
against the risks it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IRBESARTAN HCT
SANOFI IS USED FOR
Irbesartan HCT Sanofi is used to
lower 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)
when your blood pressure stays
higher than is needed, even when you
are calm and relaxed.
There are often no symptoms of high
blood pressure. The only way of
knowing that you have high blood
pressure 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 HCT SANOFI _
_WORKS _
Irbesartan HCT Sanofi 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
diuretics. Diuretics cause an increase
in the volume of urine. They also
help with lowering bloo

Summary of Product characteristics

PRODUCT INFORMATION
June 2017
Irbesartan HCT Sanofi - irbesartan hydrochlorothiazide
irbesartan-hct-sanofi-ccdsv13-piv7-29jun17
1
PRODUCT INFORMATION
IRBESARTAN HCT SANOFI
®
NAME OF MEDICINE
AUSTRALIAN APPROVED NAME
Irbesartan/Hydrochlorothiazide
Irbesartan:
2-butyl-3-[(2'-(1
_H_
-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro[4,4]non-1-en-4-
one
Hydrochlorothiazide: 6-chloro-3,4-dihydro-2
_H_
-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide
CHEMICAL STRUCTURE
The chemical structure of irbesartan is:
The empiric formula is C
25
H
28
N
6
O and the molecular weight, 428.5.
The CAS registry number for irbesartan is: CAS-138402-11-6.
The chemical structure of hydrochlorothiazide is:
The empiric formula is C
7
H
8
ClN
3
O
4
S
2
and the molecular weight, 297.7.
N
N
O
(CH
2
)
3
CH
3
N
N
N
N
H
N
N
S
CL
H
H
O
O
S
H
2
N
O
O
PRODUCT INFORMATION
June 2017
Irbesartan HCT Sanofi - irbesartan hydrochlorothiazide
irbesartan-hct-sanofi-ccdsv13-piv7-29jun17
2
The CAS registry number for hydrochlorothiazide is: CAS-58-93-5
DESCRIPTION
Irbesartan
HCT
Sanofi
(irbesartan/hydrochlorothiazide)
is
an
oral
antihypertensive
agent
combining a nonpeptide angiotensin II receptor (AT
1
subtype) antagonist, irbesartan, and a
thiazide diuretic, hydrochlorothiazide.
Irbesartan is a white to 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 slightly soluble in alcohol
and methylene chloride, and practically insoluble in water.
Hydrochlorothiazide is a white crystalline powder. It is slightly
soluble in water but freely soluble
in sodium hydroxide solution.
Irbesartan
HCT
Sanofi
150/12.5
tablets
contain
150
mg
of
irbesartan
and
12.5
mg
of
hydrochlorothiazide and are peach to mottled peach coloured biconvex,
oval-shaped, film-coated
tablets debossed with a heart on one side and the number “2875”
engraved on the other side.
Irbesartan
HCT
Sanofi
300/12.5
tablets
contain
300
mg
of
irbesartan
and
12.5
mg
of
hydrochlorothiazide and are peach to