ARICEPT Film-coated tablet Ref.[7231] Active ingredients: Donepezil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

Product name and form

ARICEPT 5 mg film coated tablets.

ARICEPT 10 mg film coated tablets.

Pharmaceutical Form

Film-coated tablet.

ARICEPT 5 mg film coated tablets are white, round, biconvex tablets debossed ‘ARICEPT’ on one side and ‘5’ on the other side.

ARICEPT 10 mg film coated tablets are yellow, round, biconvex tablets debossed ‘ARICEPT’ on one side and ‘10’ on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil free base.

Excipients with known effect: Each 5 mg tablet contains 87.17 mg of lactose.

Each film-coated tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil free base.

Excipients with known effect: Each 10 mg tablet contains 174.33 mg of lactose.

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
Hyprolose
Magnesium Stearate

Film coating:

Talc
Macrogol
Hypromellose
Titanium dioxide "E171"
Yellow iron oxide “E172” (10mg)

Pack sizes and marketing

Bottles (HDPE): Packs of 28, 30 and 100.

Blisters (PVC/Aluminium): Packs of 7, 14, 28, 30, 50, 56, 60, 84, 98,112 and 120.

Not all pack sizes may be marketed.

Marketing authorization holder

Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

Marketing authorization dates and numbers

PL 10555/0006 (5mg)
PL 10555/0007 (10mg)

Date of first authorisation: 14th February 1997
Date of last renewal: 10th January 2007

Drugs

Drug Countries
ARICEPT Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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