CoPlavix Film-Coated Tablet 75 mg/100 mg

TABLET, FILM COATED

**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”_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks. The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section _“Pharmacodynamic properties”_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For patients greater than 75 years of age therapy should be initiated without a loading dose of clopidogrel. However, there is limited clinical experience in patients > 75 years of age. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children and adolescents - There is no experience in children. CoPlavix is not indicated for use in children or adolescents. Renal impairment - CoPlavix must not be used in patients with severe renal impairment (see section _“Contraindications”_). Therapeutic experience is limited in patients with mild to moderate renal impairment (see section _“Special warnings and precautions for use”_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Therefore CoPlavix should be used with caution in these patients. Liver impairment - CoPlavix must not be used in patients with severe liver impairment (see section _“Contraindications”_). Therapeutic experience is limited in patients with moderate liver disease who may have bleeding diatheses (see section _“Special warnings and precautions for use”_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Therefore CoPlavix should be used with caution in these patients.