SERC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BETAHISTINE HYDROCHLORIDE

Available from:

BGP PHARMA ULC

ATC code:

N07CA01

INN (International Name):

BETAHISTINE

Dosage:

24MG

Pharmaceutical form:

TABLET

Composition:

BETAHISTINE HYDROCHLORIDE 24MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Product summary:

Active ingredient group (AIG) number: 0103555004; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-01-04

Summary of Product characteristics

_SERC_
_® _
_Product Monograph _
_Page 1 of 19 _
_Date of Revision: August 1, 2017 and Control No. 203694 _
PRODUCT MONOGRAPH
PR
SERC
®

betahistine dihydrochloride
tablets (16 mg and 24 mg)
Anti-vertigo Agent
®
Registered Trade-mark Abbott Products Operations AG, Licensed use by
BGP Pharma ULC,
Etobicoke, Ontario, M8Z 2S6
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
August 1, 2017
Submission Control No: 203694
_SERC_
_® _
_Product Monograph _
_Page 2 of 19 _
_Date of Revision: August 1, 2017 and Control No. 203694 _
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
....................................................................................................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
..............