MYLAN-CYCLOBENZAPRINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CYCLOBENZAPRINE HYDROCHLORIDE

Available from:

MYLAN PHARMACEUTICALS ULC

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:

CANCELLED POST MARKET

Authorization date:

2018-06-15

Summary of Product characteristics

_MYLAN-CYCLOBENZAPRINE Product Monograph _
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PRODUCT MONOGRAPH
INCLUDING CONSUMER INFORMATION
PR
MYLAN-CYCLOBENZAPRINE
Cyclobenzaprine Hydrochloride Tablets USP
10 MG TABLETS
SKELETAL MUSCLE RELAXANT
Mylan Pharmaceuticals ULC
Date of Revision: July 24, 2017
85 Advance Rd.
Etobicoke ON
M8Z 2S6
Submission Control No.: 205172
_MYLAN-CYCLOBENZAPRINE Product Monograph _
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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
...........................................................................................................
6
DRUG INTERACTIONS
...........................................................................................................
7
DOSAGE AND ADMINISTRATION
.......................................................................................
8
OVERDOSAGE
.........................................................................................................................
8
ACTIONS AND CLINICAL PHARMACOLOGY
................................................................... 9
STORAGE AND STABILITY
.................................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 11
PART II: SCIENTIFIC INFORMATION
....................................................................................
12
PHARMACEUTICAL INFORMATION
...............................................................