CLOPIDOGREL Film Coated Tablet 75 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
CLOPIDOGREL
Available from:
Pfizer Healthcare Ireland
Dosage:
75 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-05-20
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel 75 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel base).
Excipient: each film-coated tablet contains 175 mg lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, film-coated, round, biconvex tablets debossed with «C» on one side and «75» on the other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7
days until less than 6 months) or established peripheral arterial disease.
For further information please refer to section 5.1.
4.2 Posology and method of administration
Adults and elderly
Clopidogrel should be given as a single daily dose of 75 mg with or without food.
Pharmacogenetics
CYP2C19 poor metaboliser status is associated with diminished response to clopidogrel.
The optimal dose regimen for poor metabolisers has yet to be determined
(see section 5.2).
Paediatric patients
The safety and efficacy of&#
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