DuoPlavix

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

Clopidogrel hydrogen sulfate; Aspirin; clopidogrel

Patient Information leaflet

                                Consumer Medicine Information  
March 2013 
CoPlavix -  - clopidogrel/aspirin 
 
 
 
Property of the sanofi-aventis group - strictly confidential 
DuoPlavix-ccdsv3-cmiv4-20mar13 
Page 1 
DUOPLAVIX
®
 
(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 
DuoPlavix 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 DuoPlavix, your doctor has 
weighed the risks of you taking 
DuoPlavix against the expected 
benefits it will have for you. 
Always follow the instructions 
that your doctor and pharmacist 
give you about DuoPlavix 
tablets. 
IF YOU HAVE ANY CONCERNS 
ABOUT TAKING THIS MEDICINE, 
ASK YOUR DOCTOR OR 
PHARMACIST. 
Please read this leaflet carefully 
before you start taking 
DuoPlavix. 
You may wish to keep it to read 
again. 
WHAT DUOPLAVIX IS 
USED FOR 
DUOPLAVIX CONTAINS THE 
MEDICINES CLOPIDOGREL AND 
ASPIRIN.  DUOPLAVIX 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). 
DuoPlavix 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 
DuoPlavix 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 unstabl
                                
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Summary of Product characteristics

                                PRODUCT INFORMATION  
May-2013 
DuoPlavix - Clopidogrel/Aspirin 
 
Property of the sanofi-aventis group - strictly confidential 
duoplavix-ccdsv4-piv5-31may13 
1
PRODUCT INFORMATION 
DUOPLAVIX
®
 75MG/75MG & DUOPLAVIX
® 
75MG/100MG 
NAME OF MEDICINE 
AUSTRALIAN APPROVED NAME 
DuoPlavix 75mg/75mg containing clopidogrel 75 mg (as clopidogrel
hydrogen sulfate) and 
aspirin 75 mg 
DuoPlavix
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). 
ASPIRIN 
Aspirin has the following chemical structure: 
 
PRODUCT INFORMATION  
May-2013 
DuoPlavix - Clopidogrel/Aspirin 
 
Property of the sanofi-aventis group - strictly confidential 
duoplavix-ccdsv4-piv5-31may13 
2
 
 
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 melts at about 
135°C. 
DUOPLAVIX 
DuoPlavix tablets are film coated and
for both strengths each tablet
                                
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