COPLAVIX FILM-COATED TABLET 75 MG/100 MG [SIN13514P]

Product Info

COPLAVIX FILM-COATED TABLET 75 MG/100 MG

[SIN13514P]

Therapeutic indications
CoPlavix is indicated for the secondary prevention of atherothrombotic events in patients suffering from acute coronary syndrome:

• Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention (PCI).

• ST segment elevation acute myocardial infarction (STEMI) in patients undergoing PCI (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/ fibrinolytic therapy

For further information please refer to section “Pharmacodynamic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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), 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:

  • For medically treated patients, CoPlavix 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.

  • When PCI is intended, CoPlavix treatment should be started as early as possible after symptoms start and continued up to 12 months (see section “Pharmacodynamic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Contraindications
Due to the presence of both components of the product, CoPlavix is contraindicated in case of:

• Hypersensitivity to either of the active substances or the excipients of the medicinal product.

• severe liver impairment.

• active pathological bleeding such as peptic ulcer or intracranial haemorrhage.

In addition, due to the presence of ASA, its use is also contraindicated:

• In patients with known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) products and in patients with the syndrome of asthma, rhinitis, and nasal polyps.
  Patients with pre-existing mastocytosis, in whom the use of ASA may induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting).

• In patients with severe renal impairment (CrCL < 30 ml/min).

• In patients with active or history of peptic ulceration, haemophilia and other bleeding disorders

• Third trimester of pregnancy (see section “Pregnancy and lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).