M-BETAHISTINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-08-2021
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Active ingredient:
BETAHISTINE HYDROCHLORIDE
Available from:
MANTRA PHARMA INC
ATC code:
N07CA01
INN (International Name):
BETAHISTINE
Dosage:
8MG
Pharmaceutical form:
TABLET
Composition:
BETAHISTINE HYDROCHLORIDE 8MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS THERAPEUTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0103555002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-08-30
Summary of Product characteristics
_M-Betahistine Product Monograph_
Page 1 of 20
PRODUCT MONOGRAPH
PR
M-BETAHISTINE
BETAHISTINE DIHYDROCHLORIDE TABLETS BP
8 MG, 16 MG AND 24 MG
ANTI-VERTIGO AGENT
MANTRA PHARMA INC.
9150 Boulevard Leduc, Suite 201
Brossard, QC, Canada
J4Y 0E3
DATE OF PREPARATION:
August 25, 2021
SUBMISSION CONTROL NO: 254780
_M-Betahistine Product Monograph_
Page 2 of 20
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
.......................................................................................
5
DRUG INTERACTIONS
.......................................................................................
6
DOSAGE AND ADMINISTRATION
................................................................... 7
OVERDOSAGE
.....................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
................................................. 8
STORAGE AND STABILITY
.............................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 11
PART II: SCIENTIFIC INFORMATION
................................................................. 12
PHARMACEUTICAL INFORMATION
............................................................. 12
CLINICAL TRIALS
.............................................................................................
13
DETAILED PHARMACOLOGY
........................................................................
13
TOXICOLOGY
............................................................................................
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