LAMISIL SPRAY

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

D01AE15

INN (International Name):

TERBINAFINE

Dosage:

1%

Pharmaceutical form:

SPRAY

Composition:

TERBINAFINE HYDROCHLORIDE 1%

Administration route:

TOPICAL

Units in package:

30ML

Prescription type:

Prescription

Therapeutic area:

ALLYLAMINES

Product summary:

Active ingredient group (AIG) number: 0124452001; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-09-15

Summary of Product characteristics

_LAMISIL_
_®_
_ (Terbinafine Hydrochloride) Product Monograph Page 1 of 58_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LAMISIL
®
Terbinafine Hydrochloride
Tablets, 250 mg, oral
Cream, 1% w/w (10 mg/g), topical
Spray solution, 1% w/w (10 mg/g), topical
Antifungal
ATC code: D01AE15
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
December 31, 1993
Date of Revision:
August 15, 2022
Control No. 261997
LAMISIL is a registered trademark.
_LAMISIL_
_®_
_ (Terbinafine Hydrochloride) Product Monograph _
_Page 2 of 58_
_ _
RECENT MAJOR LABEL CHANGES
None at the time of authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
...................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.............................................................