JAMP-DONEPEZIL TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-03-2015
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
JAMP PHARMA CORPORATION
ATC code:
N06DA02
INN (International Name):
DONEPEZIL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
DONEPEZIL HYDROCHLORIDE 5MG
Administration route:
ORAL
Units in package:
28/30/250
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
JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride) Product Monograph
Page 1 of 51
PRODUCT MONOGRAPH
PR
JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride)
Tablets 5 and 10 mg
CHOLINESTERASE INHIBITOR
JAMP PHARMA CORPORATION
1380-203 NEWTON STREET
BOUCHERVILLE, QUEBEC
J4B 5H2
DATE OF REVISION:
MARCH 12, 2015
Submission Control No: 182041
JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride) Product Monograph
Page 2 of 51
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
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
.........................................................................
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