MOGADON TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-08-2021
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Active ingredient:
NITRAZEPAM
Available from:
AA PHARMA INC
ATC code:
N05CD02
INN (International Name):
NITRAZEPAM
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
NITRAZEPAM 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0114345001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-09-16
Summary of Product characteristics
Page 1 of 27
PRODUCT MONOGRAPH
MOGADON
®
Nitrazepam Tablets BP
5 mg, 10 mg
Hypnotic and Anticonvulsant
AA PHARMA INC.
DATE OF REVISION:
1156 Creditstone Road, Unit#1
August 12, 2021
Vaughan, Ontario
L4K 4N7
Control No: 248565
Page 2 of 27
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
.................................................................................................10
POST-MARKET ADVERSE REACTIONS
......................................................................10
DRUG INTERACTIONS
..................................................................................................11
SERIOUS DRUG INTERACTIONS
.................................................................................11
DOSAGE AND ADMINISTRATION
...............................................................................11
DOSING CONSIDERATIONS
.........................................................................................11
OVERDOSAGE
...............................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
..............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................15
PART II: SCIENTIFIC INFORMATION
.........................................................................
16
PHARMACEUTICAL INFORMATION
.................
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