Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
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. |
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 Film coating: Talc |
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.
Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
PL 10555/0006 (5mg)
PL 10555/0007 (10mg)
Date of first authorisation: 14th February 1997
Date of last renewal: 10th January 2007
| Drug | Countries | |
|---|---|---|
| ARICEPT | Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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