SANDOZ-TERBINAFINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-07-2016
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Active ingredient:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
D01BA02
INN (International Name):
TERBINAFINE
Dosage:
250MG
Pharmaceutical form:
TABLET
Composition:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Administration route:
ORAL
Units in package:
28/100
Prescription type:
Prescription
Therapeutic area:
ALLYLAMINES
Product summary:
Active ingredient group (AIG) number: 0132855002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-05-19
Summary of Product characteristics
_Sandoz-Terbinafine _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
SANDOZ-TERBINAFINE
TERBINAFINE TABLETS 250 MG (AS TERBINAFINE HYDROCHLORIDE)
ANTIFUNGAL AGENT
Sandoz Canada Inc.
Date of Revision: July 25, 2016
145 Jules Leger St
Boucherville PQ
J4B 7K8
Control No. 196424
_Sandoz-Terbinafine _
_Page 2 of 38_
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
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
12
DOSING CONSIDERATIONS
........................................................................................
12
OVERDOSAGE
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................
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