COPLAVIX Film-coated tablet Ref.[50670] Active ingredients: Acetylsalicylic acid Clopidogrel

Source: Marketing Authorisation Holder  Revision Year: 2022  Publisher: SANOFI WINTHROP INDUSTRIE, 1, rue de la Vierge, Ambarès et Lagrave, 33565 Carbon Blanc cedex, France

Product name and form

Coplavix – Film-coated tablet 75mg/100mg.

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.

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”.

Active Ingredient Description
Acetylsalicylic acid

Acetylsalicylic acid combines significant advantages such as strong anti-pyretic, analgesic and anti-inflammatory action, that is the measure of comparison with all the newer NSAIDs.

Clopidogrel

Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.

List of Excipients

Core:

Mannitol (E421)
Macrogol 6000
Microcrystalline cellulose (low water content, 90 mcm)
Low substituted hydroxypropylcellulose
Hydrogenated castor oil
Stearic acid
Anhydrous colloidal silica

Coating:

Lactose
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Red iron oxide (E172)

Polishing agent:

Carnauba wax

Pack sizes and marketing

14, 28, 30, 50, 84 and, 90, and 100 film-coated tablets packed in aluminium blister packs in cardboard cartons.

Not all pack sizes may be marketed.

Marketing authorization holder

SANOFI WINTHROP INDUSTRIE, 1, rue de la Vierge, Ambarès et Lagrave, 33565 Carbon Blanc cedex, France

Drugs

Drug Countries
COPLAVIX Australia, Ecuador, Hong Kong, Mexico, Singapore, South Africa

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