DONEPEZIL HYDROCHLORIDE TABLETS USP
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-10-2022
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Active ingredient:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)
Available from:
DR REDDY'S LABORATORIES LTD
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:
7/14/30/90/500/1000/9000
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0131548001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-12-27
Summary of Product characteristics
1
PRODUCT MONOGRAPH
Pr
DONEPEZIL HYDROCHLORIDE TABLETS USP
5 mg and 10 mg
donepezil hydrochloride (as donepezil hydrochloride monohydrate)
CHOLINESTERASE INHIBITOR
Manufactured by:
DR. REDDY’S LABORATORIES LTD.,
Bachupally – 500 090
India
Imported and Distributed by:
Date of Revision:
DR. REDDY’S LABORATORIES CANADA INC.,
October 31, 2022
Mississauga, ON L4W 4Y1
Canada
Submission
Control Number: 264379
2
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
....................................................................................17
OVERDOSAGE.....................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
...............................................................................................20
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................21
PART II: SCIENTIFIC INFORMATION
...........................................................................22
PHARMACEUTICAL INFORMATION
................................................................................22
CLINICAL
TRIALS..........
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