PHL-TERBINAFINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-10-2016
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Active ingredient:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Available from:
PHARMEL INC
ATC code:
D01BA02
INN (International Name):
TERBINAFINE
Dosage:
250MG
Pharmaceutical form:
TABLET
Composition:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ALLYLAMINES
Product summary:
Active ingredient group (AIG) number: 0132855002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-10-25
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PHL-TERBINAFINE
Terbinafine Tablets, USP
250 mg Terbinafine, as Terbinafine Hydrochloride
ANTIFUNGAL AGENT
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
October 03, 2016
SUBMISSION CONTROL NO.: 197968
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_phl-TERBINAFINE Product Monograph _
_Page 2 of 42_
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
OVERDOSAGE
.....................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 14
STORAGE AND STABILITY
................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 15
PART II: SCIENTIFIC INFORMATION
...........................................................................
16
PHARMACEUTICAL INFORMATION
................................................................................
16
CLINICAL TRIALS
..........................................................................................
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