Clopidogrel Sandoz

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Clopidogrel hydrogen sulfate

Disponible depuis:

Sandoz Pty Ltd

classe:

Medicine Registered

Notice patient

Clopidogrel Sandoz
®

1 

CLOPIDOGREL SANDOZ
®
_  _
CLOPIDOGREL HYDROGEN SULFATE FILM-COATED TABLETS_  _

CONSUMER MEDICINE INFORMATION (CMI) 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about Clopidogrel Sandoz.

It does not contain all the available information. It does not take
the place of talking to your doctor or 
pharmacist. 

All medicines have risks and benefits. Your doctor has weighed the
risks of you taking this medicine 
against the benefits they expect it will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT CLOPIDOGREL SANDOZ IS USED FOR 
This medicine is used to prevent blood clots forming and to reduce the
risk of heart attack, stroke or death 
in patients who have previously suffered a heart attack, stroke or
have a condition known as peripheral 
arterial disease (leg pain when walking or at rest)._ _

This medicine contains the active ingredient clopidogrel.  
Clopidogrel belongs to a group of medicines called anti-platelet
medicines._  _

It works by preventing blood clots to form in hardened blood vessels.
This process is called 
atherothrombosis and can lead to events such as stroke, heart attack
or death. 

ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU. 
Your doctor may have prescribed it for another reason. 

This medicine is available only with a doctor’s prescription.  
BEFORE YOU TAKE CLOPIDOGREL SANDOZ 
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: 
•  clopidogrel, the active ingredient, or to any of the other
ingredients listed at the end of this leaflet 
under ‘Product description’. 

Some of the symptoms of an allergic reaction may include: 
•  shortness of breath 
•  wheezing or difficulty breathing 
•  swelling of the face, lips, tongue

Résumé des caractéristiques du produit

_Product Information _
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_Clopidogrel Sandoz 75mg film-coated tablets _
_01/2012 _

_Sandoz Pty Ltd _
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_Version 1  _

PRODUCT INFORMATION 
CLOPIDOGREL SANDOZ 75MG FILM-COATED TABLETS 

NAME OF THE MEDICINE  

Generic name: Clopidogrel hydrogen sulfate  

Chemical name:  Methyl
(+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c] 
pyridine-5(4H)-acetate sulfate (1:1)  

CAS: 120202-66-6 (Clopidogrel hydrogen sulfate) 
113 665-84-2 (Clopidogrel base) 

Empirical formula: 
C
16
H
16
ClNO
2
S.H
2
SO
4

 MW:  419.9  

DESCRIPTION 

Clopidogrel hydrogen sulfate is a white to off-white powder. It is
practically insoluble 
in water at neutral pH but freely soluble at pH 1. It is freely
soluble in methanol, 
sparingly soluble in methylene chloride and is practically insoluble
in ethyl ether. It 
has a specific optical rotation of about + 56°.  

Each tablet contains mannitol, microcrystalline cellulose,
hydroxypropylcellulose, 
hydrogenated vegetable oil, Opadry Pink 03B54942 and Opacode S-1-27794
Black. 

PHARMACOLOGY 

Pharmacodynamics 
Clopidogrel is a specific and potent inhibitor of platelet
aggregation. Platelets have an 
established role in the pathophysiology of atherosclerotic disease
and thrombotic 
events. Long term use of anti-platelet drugs has shown consistent
benefit in the 
prevention of ischaemic stroke, myocardial infarction and vascular
death in patients at 
increased risk of such outcomes, including those with
established atherosclerosis or a 
history of atherothrombosis.  

Clopidogrel selectively inhibits the binding of adenosine diphosphate
(ADP) to its 
platelet receptor, and the subsequent ADP-mediated activation of the
GPIIb/IIIa 
complex, thereby inhibiting platelet aggregation. Biotransformation of
clopidogrel is 
necessary to produce inhibition of platelet aggregation. The active
metabolite, a thiol 
_Product Information _
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_Clopidogrel Sandoz�