Irbesartan Sanofi

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Irbesartan

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

irbesartan-winthrop-ccdsv10-cmiv2-10may13 
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 eas

Summary of Product characteristics

PRODUCT INFORMATION  
May-2013 
Irbesartan Sanofi - irbesartan 

Property of the sanofi-aventis group   
irbesartan-sanofi-ccdsv10-piv2-10may13 
1
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
PRODUCT INFORMATION  
May-2013 
Irbesartan Sanofi - irbesartan 

Property of the sanofi-aventis group   
irbesartan-sanofi-ccdsv10-piv2-10may13 
2
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 angiote