IRBESARTAN SANOFI irbesartan 150 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Irbesartan

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Irbesartan

Patient Information leaflet

IRBESARTAN SANOFI
®
_irbesartan _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Irbesartan 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
SANOFI IS USED FOR
Irbesartan 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. Irbesartan Sanofi is
also used in the treatment of kidney
disease in patients with high blood
pressure and type 2 diabetes.
_HOW IRBESARTAN SANOFI WORKS _
Irbesartan Sanofi 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 Sanofi 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.
Irbesartan Sanofi also slows the
decrease of kidney function in
patients with high blood pressure and
type 2 diabetes.
Your doctor may have prescribed
Irbesartan Sanofi for another reason.

Summary of Product characteristics

PRODUCT INFORMATION
February 2017
Irbesartan Sanofi - irbesartan
PRODUCT INFORMATION
IRBESARTAN SANOFI
®
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Irbesartan:
2-butyl-3-[(2'-(1
_H_
-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro[4.4]non-1-en-4-
one.
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.
DESCRIPTION
Irbesartan is a white, to practically white powder that is less than
0.1mg/mL soluble in water and
slightly soluble in alcohol and methylene chloride.
Irbesartan is a nonpeptide angiotensin II receptor (AT
1
subtype) antagonist. It is available as 75,
150 or 300 mg film-coated tablets for oral administration. The white,
biconvex oval shaped
tablets are debossed with a heart on one side and 2871 (75 mg) or 2872
(150 mg) or 2873 (300
mg) engraved on the other side. The inactive ingredients are: carnauba
wax, croscarmellose
sodium, hypromellose, lactose, macrogol 3000, magnesium stearate,
microcrystalline cellulose,
silicon dioxide, and titanium dioxide.
N
N
O
(CH
2
)
3
CH
3
N
N
N
N
H
irbesartan-sanofi-ccdsv14-piv6-27feb17
1
PRODUCT INFORMATION
February 2017
Irbesartan Sanofi - irbesartan
PHARMACOLOGY
PHARMACODYNAMICS
Irbesartan is a specific antagonist of angiotensin II receptors (AT
1
subtype). Angiotensin II is an
important component of the renin-angiotensin system and is involved in
the pathophysiology of
hypertension and in sodium homeostasis. Irbesartan does not require
metabolic activation for its
activity.
Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting
effects of angiotensin II by
selective antagonism of the angiotensin II (AT
1
subtype) receptors localized on vascular smooth
muscle cells and in the adrenal cortex. It has no agonist activity at
the AT
1
receptor and a much
greater affinity (more than 8500-fold) for the AT
1
receptor than for the AT
2
receptor (a receptor
that has not been shown to be associated with cardiovascular