ISCOVER Film-coated tablet Ref.[115114] Active ingredients: Clopidogrel

Posology

Adults and elderly

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

Iscover 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 or 600 mg loading dose. A 600 mg loading dose may be considered in patients <75 years of age when percutaneous coronary intervention is intended (see section 4.4). Clopidogrel treatment should be 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:
  • For medically treated patients eligible for thrombolytic/fibrinolytic therapy, 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 medically treated 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).
  • When percutaneous coronary intervention (PCI) is intended:
    • Clopidogrel should be initiated at a loading dose of 600 mg in patients undergoing primary PCI and in patients undergoing PCI more than 24 hours of receiving fibrinolytic therapy. In patients ≥75 years old the 600 mg LD should be administered with caution (see section 4.4).
    • Clopidogrel 300 mg loading dose should be given in patients undergoing PCI within 24 hours of receiving fibrinolytic therapy.

Clopidogrel treatment should be continued at 75 mg once a day with ASA 75 mg – 100 mg daily. Combined therapy should be started as early as possible after symptoms start and continued up to 12 months (see section 5.1).

Adult patients with moderate to high-risk TIA or minor IS:

Adult patients with moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) should be given a loading dose of clopidogrel 300 mg followed by clopidogrel 75 mg once daily and ASA (75 mg-100 mg once daily). Treatment with clopidogrel and ASA should be started within 24 hours of the event and be continued for 21 days followed by single antiplatelet therapy.

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.

Special populations

Elderly patients

Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction):

• A 600 mg loading dose may be considered in patients <75 years of age when percutaneous coronary intervention is intended (see section 4.4).

ST segment elevation acute myocardial infarction:

• For medically treated patients eligible for thrombolytic/fibrinolytic therapy: in patients over 75 years of age clopidogrel should be initiated without a loading dose.

For patients undergoing primary PCI and in patients undergoing PCI more than 24 hours of receiving fibrinolytic therapy:

• In patients ≥75 years old the 600 mg LD should be administered with caution (see section 4.4).

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.

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.

Iscover 75 mg film-coated tablets: PVC/PVDC/Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 film-coated tablets. PVC/PVDC/Aluminium or all aluminium unit-dose blister packs in cardboard cartons containing 50x1 film-coated tablets.

Iscover 300 mg film-coated tablets: Aluminium 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.