TARO-DONEPEZIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-03-2020
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
SUN PHARMA CANADA 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:
2020-03-10
Summary of Product characteristics
Page 1 of 52
PRODUCT MONOGRAPH
PR
TARO-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std
5 and 10 mg
CHOLINESTERASE INHIBITOR
Sun Pharma Canada Inc.
Date of Revision: March 6, 2020
126 East Drive
Brampton, Ontario
L6T 1C1
Submission Control No.: 236591
Page 2 of 52
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
.......................................................................................................
17
DOSAGE AND ADMINISTRATION
...................................................................................
18
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 20
STORAGE AND STABILITY
...............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.............................................................................
24
CLINICAL TRIALS
...............................................................................................................
25
DETAILED PHARMACOLOGY
..............
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