Country: Canada
Language: English
Source: Health Canada
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
TEVA CANADA LIMITED
D01BA02
TERBINAFINE
125MG
TABLET
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG
ORAL
100
Prescription
ALLYLAMINES
Active ingredient group (AIG) number: 0132855001; AHFS:
CANCELLED PRE MARKET
2015-10-16
_TEVA-TERBINAFINE _ _ Page 1 of 44_ PRODUCT MONOGRAPH PR TEVA-TERBINAFINE (terbinafine hydrochloride) 125 mg and 250 mg tablet (expressed as base) Teva Standard ANTIFUNGAL AGENT Teva Canada Limited Date of Revision: 30 Novopharm Court October 7, 2014 Toronto, Canada M1B 2K9 www.tevacanada.com Control No.: 177227 _TEVA-TERBINAFINE _ _ Page 2 of 44_ 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 ......................................................................................................................................8 DRUG INTERACTIONS .....................................................................................................................................11 DOSING CONSIDERATIONS ...........................................................................................................................15 OVERDOSAGE ...................................................................................................................................................15 ACTION AND CLINICAL PHARMACOLOGY ...............................................................................................16 STORAGE AND STABILITY ............................................................................................................................17 SPECIAL HANDLING INSTRUCTION ................................................................. Read the complete document