PLATEL FILM COATED TABLETS 75MG [SIN15871P]

Product Info

PLATEL FILM COATED TABLETS 75MG

[SIN15871P]

4.1 Therapeutic indications

Secondary prevention of atherothrombotic events

Clopidogrel is indicated in:

• Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

• Adult 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, in combination with acetylsalicylic acid (ASA).

  • ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

In patients with AF at increased risk of vascular events who can take VKA therapy, VKA has been shown to result in better clinical benefit than ASA alone or the combination of clopidogrel and ASA for reductions of stroke.
For further information please refer to section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration

Posology

• Adults and elderly
  Clopidogrel should be given as a single daily dose of 75 mg.
  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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  • 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  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.

• Pharmacogenetics
  CYP2C19 poor metaboliser status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolisers increases antiplatelet response (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), an appropriate dose regimen for this patient population has not been established.

• Paediatric population
  Clopidogrel should not be used in children because of efficacy concerns (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Renal impairment
  Therapeutic experience is limited in patients with renal impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Hepatic impairment
  Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
For oral use.
It may be given with or without food.

4.3 Contraindications

• Hypersensitivity to the active substance, soya oil, peanut oil or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Severe hepatic impairment.

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