DONECEPT Film-coated tablet Ref.[49839] Active ingredients: Donepezil

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland

Product name and form

Donecept 5mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Donecept 5 mg film-coated tablet is white, round and biconvex engraved with ‘DZ 5’ on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg donepezil hydrochloride.

Excipients with known effect: Donecept 5 mg film-coated tablet contains 92.5 mg lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Donepezil

Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain. Donepezil hydrochloride is in vitro over 1000 times more potent an inhibitor of this enzyme than of butyrylcholinesterase, an enzyme that is present mainly outside the central nervous system.
List of Excipients

Tablet core:

Lactose monohydrate
Maize starch
Cellulose, microcrystalline
Magnesium stearate

Tablet coating:

Polyvinyl alcohol
Macrogol 3350
Talc
Titanium dioxide E171

Pack sizes and marketing

Blister PVC/Aluminium

Tablet container (polyethylene) with snap on cap (polyethylene)

Pack sizes:

Blister: 7, 28, 30, 50, 50 × 1, 56, 60, 84, 98, 100 or 120 film-coated tablets.

Tablet container: 28, 30, 100 and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland

Marketing authorization dates and numbers

PA2315/231/001

Date of first authorisation: 21st November 2008
Date of last renewal: 25th January 2013

Drugs

Drug Countries
DONECEPT Hong Kong, Ireland, Malta, Poland, Romania, Tunisia, South Africa
 
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