ACT DONEPEZIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-02-2015
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Active ingredient:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
N06DA02
INN (International Name):
DONEPEZIL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0131548001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-12
Summary of Product characteristics
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ACT
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DONEPEZIL
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_Page 1 of 49_
PRODUCT MONOGRAPH
Pr
ACT_ _DONEPEZIL
(donepezil hydrochloride as donepezil hydrochloride monohydrate)
Donepezil Hydrochloride Tablets USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Submission Control No: 181946
Date of Revision:
February 26, 2015
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ACT
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DONEPEZIL
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
..........................................................................
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