TEVA-CYCLOBENZAPRINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CYCLOBENZAPRINE HYDROCHLORIDE

Available from:

TEVA CANADA LIMITED

ATC code:

M03BX08

INN (International Name):

CYCLOBENZAPRINE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Product summary:

Active ingredient group (AIG) number: 0112363001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-06-12

Summary of Product characteristics

_Teva-Cyclobenzaprine _
_ Product Monograph_
Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CYCLOBENZAPRINE
Cyclobenzaprine hydrochloride
Tablets, 10 mg, Oral
USP
Skeletal Muscle Relaxant
Teva Canada Limited.
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
Mar 18, 1994
Date of Revision:
Aug 26, 2021
Submission Control No: 250699
_Teva-Cyclobenzaprine _
_ Product Monograph_
Page 2 of 22
RECENT MAJOR LABEL CHANGES
No recent major changes in the last 24 months.
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not
listed.
RECENT MAJOR LABEL CHANGES
...........................................................................................................2
TABLE OF CONTENTS ....................................................................................................................................2
1.
INDICATIONS
........................................................................................................................................3
1.1 Pediatrics
..........................................................................................................3
_ _
1.2 Geriatrics
..........................................................................................................3
_ _
2.
CONTRAINDICATIONS
.......................................................................................................................3
4.
DOSAGE
AND
ADMINISTRATION
..................................................................................................4
4.1
_ _
Dosing Considerations
..................................................................................4
_ _
4.2
_ _
Recommended Dose and Dosage
Adjustment.................................................4
_ _
5.
OVERDOSAGE
....................................................................................................................................4
6.
DOSAGE
FORMS,
STRENGTHS,
COMPOSITION
AND
PACKAGING
.