DONEPEZIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-03-2014
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
N06DA02
INN (International Name):
DONEPEZIL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
DONEPEZIL HYDROCHLORIDE 5MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0131548001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2022-08-19
Summary of Product characteristics
_ _
_DONEPEZIL (Donepezil Hydrochloride Tablets, USP) Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
DONEPEZIL
Donepezil Hydrochloride Tablets, USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
DATE OF PREPARATION:
March 7, 2014
Submission Control No: 171793
Trademark owned by Ranbaxy Laboratories Limited
_ _
_DONEPEZIL (Donepezil Hydrochloride Tablets USP) Product Monograph _
_Page 2 of 47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL
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