CoPlavix

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Clopidogrel hydrogen sulfate; Aspirin

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

COPLAVIX
®

(CO-PLAV-ICKS)
_Clopidogrel (clop-id-o(h)-grel) and Aspirin (as-per-in)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CoPlavix tablets.
It does not contain all the available
information. Some of the information
it contains may not apply to you.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. In deciding to give you
CoPlavix, your doctor has weighed
the risks of you taking CoPlavix
against the expected benefits it will
have for you.
Always follow the instructions that
your doctor and pharmacist give you
about CoPlavix tablets.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Please read this leaflet carefully
before you start taking CoPlavix.
You may wish to keep it to read
again.
WHAT COPLAVIX IS USED
FOR
COPLAVIX CONTAINS THE MEDICINES
CLOPIDOGREL AND ASPIRIN. COPLAVIX
BELONGS TO A GROUP OF MEDICINES
CALLED ANTI-PLATELET MEDICINES.
Platelets are very small blood cells
which clump together during blood
clotting. By preventing this
clumping, anti-platelet medicines
reduce the chances of blood clots
forming (a process called
thrombosis).
CoPlavix is used to prevent blood
clots forming in hardened blood
vessels (a process known as
atherothrombosis) which can lead to
events such as stroke, heart attack or
death.
You may have been prescribed
CoPlavix to help prevent blood clots
forming and to reduce the risk of
heart attack, stroke or death, because
you have suffered a severe type of
chest pain called unstable angina, or
had a heart attack.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
CoPlavix is only available on a
doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
YOU SHOULD NOT TAKE COPLAVIX IF:
•
YOU ARE ALLERGIC TO CLOPIDOGREL,
ASPIRIN, SALICYLATES, ANTI-
INFLAMMATORIES (NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS) OR
ANY OF THE INGREDIENTS LISTED
UNDER 'PRO

Summary of Product characteristics

PRODUCT INFORMATION  
May-2013

CoPlavix - Clopidogrel/Aspirin 

Property of the sanofi-aventis group - strictly confidential 
coplavix-ccdsv4-piv7-31may13 
1 
PRODUCT INFORMATION 
COPLAVIX
®
 75MG/75MG & COPLAVIX
® 
75MG/100MG 
NAME OF MEDICINE 
AUSTRALIAN APPROVED NAME 
CoPlavix 75mg/75mg containing clopidogrel 75 mg (as clopidogrel hydrogen sulfate) and aspirin 
75 mg 
CoPlavix  75mg/100mg  containing  clopidogrel  75  mg  (as  clopidogrel  hydrogen  sulfate)  and 
aspirin 100 mg 
CHEMICAL STRUCTURE 
CLOPIDOGREL 
Clopidogrel hydrogen sulfate has the following chemical structure: 

C O
O
S
N
H
Cl
,H
2
SO
4
CH
3

Molecular Formula: C
16
H
16
ClNO
2
S.H
2
SO
4

Molecular Weight: 419.9 
Chemical  Name:  methyl  (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]  pyridine-5(4H)-
acetate sulfate (1:1). 
CAS number: 120202-66-6 (Clopidogrel hydrogen sulfate), 113 665-84-2
(Clopidogrel base). 
PRODUCT INFORMATION  
May-2013

CoPlavix - Clopidogrel/Aspirin 

Property of the sanofi-aventis group - strictly confidential 
coplavix-ccdsv4-piv7-31may13 
2 
ASPIRIN 
Aspirin has the following chemical structure: 

Molecular Formula: C
9
H
8
O
4

Molecular Weight: 180.2 
Chemical Name: 2-acetoxybenzoic acid. 
CAS number: 50-78-2 
DESCRIPTION 
CLOPIDOGREL 
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°. 
ASPIRIN 
Aspirin is a white crystalline powder or colourless crystals, odourless or almost odourless, slightly 
soluble in  water, freely soluble in  alcohol, soluble in  chloroform  and in  ether.   It  m