Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLOPIDOGREL BESILATE
Pensa Pharma AB
75 Milligram
Film Coated Tablet
2011-08-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopidogrel Pensa 75 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel besilate). Excipient with known effect: each tablet contains 2.80 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, round, biconvex, film-coated tablets with '75' embossed on one side and a diameter of approximately 8.3 mm. 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 Posology _Adults and elderly_ Clopidogrel should be given as a single daily dose of 75 mg. If a dose is missed: Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time. For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose. _Paediatric population_ The safety and efficacy of clopidogrel in children and adolescents under 18 years old have not yet been established. _Renal impairment_ Therapeutic experience is limited in patients with renal impairment (see section 4.4). _Hepatic impairment_ Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4). Method of administration For oral use It may be given with or without food. IRI Read the complete document