COPLAVIX 75 mg/75 mg clopidogrel (as hydrogen sulfate)/aspirin tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aspirin,clopidogrel hydrogen sulfate

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Aspirin,clopidogrel hydrogen sulfate

Authorization status:

Registered

Summary of Product characteristics

coplavix-ccdsv27-ccds20-piv17-4aug20
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AUSTRALIAN PRODUCT INFORMATION – COPLAVIX
®
(CLOPIDOGREL (AS HYDROGEN SULFATE)/ ASPIRIN) FILM
COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel (as hydrogen sulfate) and aspirin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Excipient with known effect: The coating contains lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CoPlavix 75mg/75mg tablets are yellow, oval, slightly biconvex,
film-coated, engraved with
“C75” on one side and “A75” on the other side.
CoPlavix 75mg/100mg tablets are light pink, oval, slightly biconvex,
film-coated, engraved
with “C75” on one side and “A100” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CoPlavix is a fixed-dose combination product.
CoPlavix is intended as continuation of therapy in patients with acute
coronary syndrome
already initiated with separate clopidogrel and aspirin products:
•
Unstable angina or non-ST elevation myocardial infarction in order to
prevent early
and long-term atherothrombotic events (myocardial infarction, stroke,
vascular death
or refractory ischaemia). CoPlavix is indicated for the treatment of
acute coronary
syndrome whether or not patients undergo cardiac revascularisation
(surgical or PCI,
with or without stent).
•
ST-segment elevation acute myocardial infarction in order to prevent
atherothrombotic events. In this population, CoPlavix has been shown
to reduce the
rate of death from any cause and the rate of a combined endpoint of
death, re-
infarction or stroke in medically treated patients eligible for
thrombolytic therapy.
coplavix-ccdsv27-ccds20-piv17-4aug20
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4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
CoPlavix is given as a single tablet (75mg/75mg or 75mg/100mg) once a
day taken with
adequate water.