Basic Information
CoPlavix Film-Coated Tablet 75 mg/100 mg
TABLET, FILM COATED
Regulatory Information
SIN13514P
August 8, 2008
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XB01AC30
Company Information
Active Ingredients
Detailed Information
Contraindications
**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_).
Indication Information
**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). - ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic 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_.