SANDOZ DONEPEZIL ODT TABLET (ORALLY DISINTEGRATING)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-03-2015
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
N06DA02
INN (International Name):
DONEPEZIL
Dosage:
5MG
Pharmaceutical form:
TABLET (ORALLY DISINTEGRATING)
Composition:
DONEPEZIL HYDROCHLORIDE 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:
2020-08-10
Summary of Product characteristics
_Sandoz Donepezil & Sandoz Donepezil ODT _
_Page 1 of 47_
PRODUCT MONOGRAPH
PR
SANDOZ
® DONEPEZIL
DONEPEZIL HYDROCHLORIDE TABLETS
5 MG AND 10 MG
PR
SANDOZ
® DONEPEZIL ODT
DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS
5 MG AND 10 MG
CHOLINESTERASE INHIBITOR
Sandoz Canada Inc.
Date of Revision: February 25, 2015
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 181466
_Sandoz Donepezil & Sandoz Donepezil ODT _
_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
..........................................................................................
3
ADVERSE
REACTIONS
............................................................................................................
7
DRUG
INTERACTIONS
...........................................................................................................
14
DOSAGE
AND
ADMINISTRATION
.......................................................................................
15
OVERDOSAGE
.........................................................................................................................
16
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
17
STORAGE
AND
STABILITY...................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 19
PART II: SCIENTIFIC INFORMATION
................................................................................
21
PHARMACEUTICAL
INFORMATION
.........
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