ANALGESIC AND MUSCLE RELAXANT TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-10-2020
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Active ingredient:
METHOCARBAMOL; IBUPROFEN
Available from:
PHARMASCIENCE INC
ATC code:
M03BA53
INN (International Name):
METHOCARBAMOL, COMBINATIONS EXCL PSYCHOLEPTICS
Dosage:
500MG; 400MG
Pharmaceutical form:
TABLET
Composition:
METHOCARBAMOL 500MG; IBUPROFEN 400MG
Administration route:
ORAL
Units in package:
18/40/50
Prescription type:
OTC
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0248961002; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-01-03
Summary of Product characteristics
_ _
_ANALGESIC AND MUSCLE RELAXANT Product Monograph _
_Page 1 of 51_
PRODUCT MONOGRAPH
ANALGESIC AND MUSCLE RELAXANT
Methocarbamol and Ibuprofen caplets
Caplets, 500 mg/400 mg
Muscle Relaxant/Analgesic
Pharmascience Inc.
6111 Avenue Royalmount,
Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
October 19, 2020
Submission
Control No: 243739
_ _
_ANALGESIC AND MUSCLE RELAXANT 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
............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE
REACTIONS............................................................................................15
DRUG INTERACTIONS
............................................................................................19
DOSAGE AND ADMINISTRATION
.........................................................................22
OVERDOSAGE
.........................................................................................................23
ACTION AND CLINICAL
PHARMACOLOGY.........................................................25
STORAGE AND STABILITY
....................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................28
PART II: SCIENTIFIC INFORMATION
.........................................................................
29
PHARMACEUTICAL INFORMATION
.....................................................................29
CLINICAL TRIALS
...................................................................................................30
DETAILED
PHARMACOLOGY..................
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