CLOPIDOGREL ZENTIVA Film-coated tablet

Active ingredients: Clopidogrel

Product name and form

Clopidogrel Zentiva 75 mg film-coated tablets.

Clopidogrel Zentiva 300 mg film-coated tablets.

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: Pink, oblong, engraved with “300” on one side and “1332” on the other side.

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 and 3.3 mg of hydrogenated castor oil.

Clopidogrel Zentiva 300 mg film-coated tablets: Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).

Excipients with known effect: Each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.

List of Excipients

Core:

Mannitol (E421)
Macrogol 6000
Microcrystalline cellulose
Hydrogenated castor oil
Low substituted hydroxypropylcellulose

Coating:

Hypromellose (E464)
Lactose monohydrate
Triacetin (E1518)
Titanium dioxide (E171)
Red iron oxide (E172)

Polishing agent:

Carnauba wax

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

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
EU/1/08/465/003 – Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/08/465/004 – Cartons of 28 film-coated tablets in all aluminium blisters
EU/1/08/465/005 – Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/08/465/006 – Cartons of 30 film-coated tablets in all aluminium blisters
EU/1/08/465/007 – Cartons of 50x1 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/08/465/008 – Cartons of 50x1 film-coated tablets in all aluminium blisters
EU/1/08/465/009 – Cartons of 84 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/08/465/010 – Cartons of 84 film-coated tablets in all aluminium blisters
EU/1/08/465/011 – Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/08/465/012 – Cartons of 90 film-coated tablets in all aluminium blisters
EU/1/08/465/013 – Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/08/465/014 – Cartons of 100 film-coated tablets in all aluminium blisters
EU/1/08/465/018 – Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/08/465/019 – Cartons of 7 film-coated tablets in all aluminium blisters
EU/1/08/465/021 – Cartons of 50 film-coated tablets in PVC/PVDC/Alu blisters

Clopidogrel Zentiva 300 mg film-coated tablets:

EU/1/08/465/015 – Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/1/08/465/016 – Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/1/08/465/017 – Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/1/08/465/020 – Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters

Date of first authorisation: 16 July 2008

Date of latest renewal: 17 December 2012