MAR-DONEPEZIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-02-2020
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
MARCAN PHARMACEUTICALS INC
ATC code:
N06DA02
INN (International Name):
DONEPEZIL
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
DONEPEZIL HYDROCHLORIDE 10MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0131548002; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-12-27
Summary of Product characteristics
Page 1 of 50
PRODUCT MONOGRAPH
Pr
MAR-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std
5 and 10 mg
CHOLINESTERASE INHIBITOR
Marcan Pharmaceuticals Inc. Date of Revision:
2 Gurdwara Road, Suite 112
February 10, 2020
Ottawa, Ontario
K2E 1A2
Submission Control No.: 235582
Page 2 of 50
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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
...................................................................
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