CLONAPAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-09-2021
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Active ingredient:
CLONAZEPAM
Available from:
BAUSCH HEALTH, CANADA INC.
ATC code:
N03AE01
INN (International Name):
CLONAZEPAM
Dosage:
0.5MG
Pharmaceutical form:
TABLET
Composition:
CLONAZEPAM 0.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0111558001; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-03-10
Summary of Product characteristics
PRODUCT MONOGRAPH
CLONAPAM
®
Clonazepam Tablets, USP
0.5 mg. 1 mg, and 2 mg
ANTICONVULSANT
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
September 1, 2021
Laval, Quebec
H7L 4A8
Control #: 253836
_T/C_
_CLONAPAM_
_®_
_ Product Monograph Page 2 of 34_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................................
4
ADVERSE
REACTIONS.....................................................................................................12
DRUG INTERACTIONS
.....................................................................................................14
DOSAGE AND ADMINISTRATION
..................................................................................16
OVERDOSAGE
..................................................................................................................17
ACTION AND CLINICAL
PHARMACOLOGY..................................................................19
STORAGE AND STABILITY
.............................................................................................20
SPECIAL HANDLING INSTRUCTIONS
............................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................21
PART II: SCIENTIFIC
INFORMATION...............................................................................
22
PHARMACEUTICAL INFORMATION
..............................................................................22
CLINICAL TRIALS
...................................................
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