Clopalvix

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration: 

CLOPALVIX for oral use, once a day, without regard to meals.

Posology

Adults and elderly: Dose 75 mg/time/day

Paediatric population: There is no experience of using this drug in children. It is not recommended using this drug in children

In patients suffering from acute coronary syndrome: 

Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): Clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day with acetylsalicylic acid 75 mg-325 mg daily. Acetylsalicylic acid less than 100 mg is recommended.

Patient with acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300-mg loading dose in combination with acetylsalicylic acid and with or without thrombolytics. For patients over 75 years of age, a daily dose of 75 mg. Treatment is continued for at least four weeks.

In patients with atrial fibrillation: Clopidogrel should be given as a single daily dose of 75 mg, then continue in combination with 75-100 mg acetylsalicylic acid daily.

CONTRAINDICATIONS

Hypersensitivity to clopidogrel or to any ingredient in the drug product

Severe hepatic impairment

Active pathological bleeding such as peptic ulcer or intracranial haemorrhage or any other condition that causes severe bleeding.

Breast-feeding

WARNINGS AND PRECAUTIONS

In patients with acute myocardial infarction, clopidogrel therapy should not be initiated during the first few days after myocardial infarction.

Clopidogrel prolongs bleeding time and therefore should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions (particularly gastrointestinal and intraocular).

Clopidogrel is used with caution in patients with potentially bleeding lesions (such as ulcers).

If the patient is to undergo surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.

Therapeutic experience with clopidogrel is limited in patients with renal impairment and hepatic impairment. Therefore, clopidogrel should be used with caution in these patients.

Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel, the drug should be discontinued when bleeding occurs and that they should report any unusual bleeding to their physician. Patients should inform physicians and dentists hat they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.

Shelf-life

36 months from the manufacturing date. Do not use after the expiry date

Box of 1 blister x 14 film-coated tablets.

Box of 5 blisters x 14 film-coated tablets.