BACLOFEN-10 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-03-2021
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Active ingredient:
BACLOFEN
Available from:
PRO DOC LIMITEE
ATC code:
M03BX01
INN (International Name):
BACLOFEN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
BACLOFEN 10MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Product summary:
Active ingredient group (AIG) number: 0113246001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-01-15
Summary of Product characteristics
Page 1 of 27
PRODUCT MONOGRAPH
PR
BACLOFEN – 10
PR
BACLOFEN – 20
BACLOFEN TABLETS USP
10 MG AND 20 MG
ANTISPASTIC AGENT
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
March 10, 2021
Laval, Quebec
H7L 3W9
Control Number: 248887
Page 2 of 27
TABLE OF CONTENT
THERAPEUTIC CLASSIFICATION
...........................................................................................................................
3
CLINICAL PHARMACOLOGY
....................................................................................................................................
3
INDICATIONS
...............................................................................................................................................................
5
CONTRAINDICATIONS
...............................................................................................................................................
5
WARNINGS
...................................................................................................................................................................
5
PRECAUTIONS
............................................................................................................................................................
9
ADVERSE REACTIONS
.............................................................................................................................................12
SYMPTOMS AND TREATMENT OF OVERDOSAGE
..........................................................................................14
DOSAGE AND ADMINISTRATION
..........................................................................................................................15
AVAILABILITY
..............................................................................................................................................................17
CHEMISTRY AND PHARMACOLOGY
....................................................................................................................18
PHARMACOLOGY
.........
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