CoPlavix Film-Coated Tablet 75 mg100 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

(Acetylsalicylic acid layer) Acetylsalicylic acid (as Acetylsalicylic acid granulated with starch); (Clopidogrel layer) Clopidogrel (as Clopidogrel hydrogen sulfate form II)

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

B01AC30

Dosage:

100 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

(Acetylsalicylic acid layer) Acetylsalicylic acid (as Acetylsalicylic acid granulated with starch) 100 mg; (Clopidogrel layer) Clopidogrel (as Clopidogrel hydrogen sulfate form II) 75 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

2008-08-08

Patient Information leaflet

Page 1 of 19 
COPLAVIX FILM-COATED TABLET 75MG/100 MG  

QUALITATIVE AND QUANTITATIVE COMPOSITION 

Clopidogrel hydrogen sulphate 97.875 mg (molar equivalent of 75 mg of
clopidogrel 
base) and 111.11 mg of acetylsalicylic acid granulated
with maize-starch corresponding 
to 100 mg of acetylsalicylic acid (ASA).  
Excipients: lactose 8 mg, hydrogenated castor oil 3.3 mg.  
For a full list of excipients, see section “_List of
excipients_”.  

PHARMACEUTICAL FORM 

Film-coated tablet.  
CoPlavix tablets are light pink, oval, slightly biconvex,
film-coated, engraved with «C75» 
on one side and «A100» on the other side.  

CLINICAL PARTICULARS 

THERAPEUTIC INDICATIONS 

CoPlavix is indicated for the prevention of atherothrombotic events
in patients suffering 
from acute coronary syndrome:  

- Non-ST segment elevation acute coronary syndrome (unstable angina
or non-Q-
wave myocardial infarction).  

- ST segment elevation acute myocardial infarction in medically
treated patients 
eligible for thrombolytic therapy  

For further information please refer to section “_Pharmacodynamic
properties_”.  

POSOLOGY AND METHOD OF ADMINISTRATION 

Adults and elderly  
CoPlavix should be given as a single daily 75 mg/100 mg dose. CoPlavix
is used in adult 
patients already taking both clopidogrel and ASA. It may be given with
or without food.  

- In patients with non-ST segment elevation acute coronary syndrome
(unstable 
angina or non-Q-wave myocardial infarction), treatment should be
initiated with a 
single 300 mg loading dose of clopidogrel and an appropriate
dose of ASA and 
then continued with CoPlavix 75 mg/100 mg once a day. The optimal
duration of 
treatment has not been formally established. Clinical trial data
support use up to 12 
months, and the maximum benefit was seen at 3 months (see section 
“_Pharmacodynamic properties_”).  

- In patients with ST segment elevation acute myocardial infarction:
Therapy sho

Summary of Product characteristics

SG/COP/0822/CCDSv21
Page 1 of 23
COPLAVIX FILM-COATED TABLET 75MG/100 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clopidogrel hydrogen sulphate 97.875 mg (molar equivalent of 75 mg of
clopidogrel base)
and 111.11 mg of acetylsalicylic acid granulated with maize-starch
corresponding to 100
mg of acetylsalicylic acid (ASA).
Excipients: lactose 8 mg, hydrogenated castor oil 3.3 mg.
For a full list of excipients, see section “_List of excipients_”.
PHARMACEUTICAL FORM
Film-coated tablet.
CoPlavix tablets are light pink, oval, slightly biconvex, film-coated,
engraved with «C75»
on one side and «A100» on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
CoPlavix is indicated for the secondary prevention of atherothrombotic
events in patients
suffering from acute coronary syndrome:
- NON-ST SEGMENT elevation acute coronary syndrome (unstable angina or
non-Q-
wave myocardial infarction).
- ST segment elevation acute myocardial infarction in medically
treated patients
eligible for thrombolytic therapy
For further information please refer to section “_Pharmacodynamic
properties_”.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly
CoPlavix fixed dose combination (FDC) should be given as a single
daily 75 mg/100 mg
dose. CoPlavix FDC is used in adult patients already taking both
clopidogrel and ASA
given separately at the appropriate dose, and replaces the individual
clopidogrel and ASA
product. It may be given with or without food.
- In patients with non-ST segment elevation acute coronary syndrome
(unstable
angina or non-Q-wave myocardial infarction), treatment should be
initiated with a
single 300 mg loading dose of clopidogrel and an appropriate dose of
ASA and then
continued with CoPlavix 75 mg/100 mg once a day. The optimal duration
of
treatment has not been formally established. Clinical trial data
support use up to 12
months,
and
the
maximum
benefit
was
seen
at
3
months
(see
section
“_Pharmacodynamic properties_”).
- In patients with ST segment elevation acute myocardial infarction: