TERBINAFINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-04-2017
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Active ingredient:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Available from:
SANIS HEALTH INC
ATC code:
D01BA02
INN (International Name):
TERBINAFINE
Dosage:
250MG
Pharmaceutical form:
TABLET
Composition:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ALLYLAMINES
Product summary:
Active ingredient group (AIG) number: 0132855002; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-06-18
Summary of Product characteristics
_ _
_Product Monograph - _TERBINAFINE_ _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR TERBINAFINE
(Terbinafine Hydrochloride Tablets)
250 mg Terbinafine as Terbinafine hydrochloride
Antifungal Agent
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
April 28, 2017
Control No.: 203937
_ _
_Product Monograph - _TERBINAFINE_ _
_Page 2 of 44_
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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
13
DOSING CONSIDERATIONS
........................................................................................
13
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
..
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