CLOPIDOGREL ZENTIVA Film-coated tablet Ref.[6741] Active ingredients: Clopidogrel

Posology

Adults and elderly

Clopidogrel Zentiva 75 mg film-coated tablets: Clopidogrel should be given as a single daily dose of 75 mg.

Clopidogrel Zentiva 300 mg film-coated tablets: This 300 mg tablet of clopidogrel is intended for use as a loading dose.

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 (ASA) 75 mg-325 mg daily). Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg. 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 5.1).
• ST segment elevation 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 ASA and with or without thrombolytics. For patients over 75 years of age clopidogrel should be initiated without a loading dose. Combined 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 5.1).

In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).

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

Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).

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.

Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleedings are observed. No antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.

Shelf-life: 3 years.

In PVC/PVDC/aluminium blisters, store below 30°C.

In all aluminium blisters, this medicinal product does not require any special storage conditions.

Clopidogrel Zentiva 75 mg film-coated tablets:

PVC/PVDC/Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 50, 84, 90 and 100 film-coated tablets.

PVC/PVDC/Aluminium or all aluminium perforated unit-dose blister packs in cardboard cartons containing 50x1 film-coated tablets.

Clopidogrel Zentiva 300 mg film-coated tablets:

Aluminium perforated unit-dose blisters in cardboard cartons containing 4x1, 10x1, 30x1 and 100x1 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.