Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland
Dozept 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White, round (diameter approx 7 mm) film-coated tablet. |
Each film-coated tablet contains 5 mg of donepezil as (donepezil hydrochloride).
Excipient(s) with known effect:
19 mg lactose/film-coated tablet
0.2 mg soya lecithin/film-coated tablet
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: Microcrystalline cellulose Tablet coat: Polyvinyl alcohol |
PVC/Aluminium blister.
Pack sizes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 100x1 or 120 film-coated tablets.
HDPE-bottle with a PP- or a HDPE-screw cap.
Pack size of 100 film-coated tablets.
Not all pack sizes may be marketed.
Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland
PA0711/141/001
Date of first authorisation: 10th October 2008
Date of last renewal: 15th August 2012
| Drug | Countries | |
|---|---|---|
| DOZEPT | Ecuador, Ireland |
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