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SPC: CLOPIDOGREL / ZENTIVA Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Clopidogrel Zentiva 75 mg film-coated tablets. Clopidogrel Zentiva 300 mg film-coated tablets.

Qualitative and quantitative composition

Clopidogrel Zentiva 75 mg film-coated tablets: Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). Excipients with known effect: Each film-coated tablet contains 3 mg of lactose ...

Pharmaceutical form

Film-coated tablet (tablet). Clopidogrel Zentiva 75 mg film-coated tablets: Pink, round, biconvex, engraved with 75 on one side and 1171 on the other side. Clopidogrel Zentiva 300 mg film-coated tablets: ...

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 ...

Posology and method of administration

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section 6.1. Severe hepatic impairment. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. ...

Special warnings and precautions for use

Bleeding and haematological disorders Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever ...

Interaction with other medicinal products and other forms of interaction

Medicinal products associated with bleeding risk There is an increased risk of bleeding due to the potential additive effect. The concomitant administration of medicinal products associated with bleeding ...

Fertility, pregnancy and lactation

Pregnancy As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure. Animal studies do not indicate ...

Effects on ability to drive and use machines

Clopidogrel has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more. ...

Overdose

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin ATC Code: B01AC04 Mechanism of action Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. ...

Pharmacokinetic properties

Absorption After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed. Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral ...

Preclinical safety data

During non-clinical studies in rat and baboon, the most frequently observed effects were liver changes. These occurred at doses representing at least 25 times the exposure seen in humans receiving the ...

List of excipients

Core: Mannitol (E421) Macrogol 6000 Microcrystalline cellulose Hydrogenated castor oil Low substituted hydroxypropylcellulose Coating: Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium ...

Incompatibilities

Not applicable.

Shelf life

Shelf-life: 3 years.

Special precautions for storage

In PVC/PVDC/aluminium blisters, store below 30°C. In all aluminium blisters, this medicinal product does not require any special storage conditions.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

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

Marketing authorization holder

Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic

Marketing authorization number(s)

Clopidogrel Zentiva 75 mg film-coated tablets: EU/1/08/465/001 Cartons of 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/002 Cartons of 14 film-coated tablets in all aluminium blisters ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 July 2008 Date of latest renewal: 17 December 2012

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