Lamisil

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

terbinafine hydrochloride 250 mg

Available from:

Novartis Pharmaceuticals UK Limited

ATC code:

D01BA02

INN (International Name):

terbinafine hydrochloride

Pharmaceutical form:

tablet

Authorization status:

Authorised

Authorization date:

2006-11-08

Patient Information leaflet

148 X 210 L/S
A4
C65
148 X 210 MM LANDSCAPE
REVISION NO.2
21 OCTOBER 2003
FOLD CODE - N/A
TEMPLA
TE
NB MAGENTA KEYLINE, TEXT AND SHADED AREAS DO NOT PRINT. SHADING
INDICATES TEXT-FREE AREA.
DOTTED LINES INDICATE PERFORATIONS
Checking against manuscript
according to BPMSCM003. To be
signed by AwOps.
ARTWORK APPROVAL
Textual approval.
To be signed by DRA (CPO).
TEXT APPROVAL
QA according to SOPSCM0062.
To be signed by QA Function.
QA APPROVAL
Technical approval. To be signed
by Manufacturing Site.
TECHNICAL APPROVAL
Design approval.
To be signed by marketing.
MARKETING APPROVAL
Artwork Design Department, Horsham
T: [phone]     F: [phone]     ISDN: +44 1403
276427
N OT
A P P L I C A B L E
DESCRIPTION:
LAMISIL TABS MT
Size:
148 x 210 mm
Line/Plant:
C65
Proof No.:
a4
Date:
27 Feb 06
Author:
Erik Leudert
COLOURS:
PMS 314
New Pack:
Yes
Change to Price/Addition of Price:
No
Has Document Compare been used
to verify changes in this document?:
Yes
PRIOR TO THIS ARTWORK‘S USE FOR PRINTING IT
MUST BE VALIDATED BY THE PRINTER AGAINST A
FULLY APPROVED NOVARTIS HARD COPY.
MATERIAL ITEM CODE 1401603A
APPROVAL
Final approval.
To be signed by AwOps
READY FOR PRINT
1401603a  27/2/06  14:29  Page 1
Leude
rt Erik
Digitally signed by 
Leudert Erik
DN: CN = Leudert 
Erik, OU = people
Reason: I am 
approving this 
document
Location: Horsham
Date: 2006.02.27 
14:36:21 Z
LAMISIL
®
TABLETS
LAMISIL TABLETS
PLEASE READ THIS PRODUCT INFORMATION CAREFULLY BEFORE YOU
START TAKING LAMISIL. IF YOU HAVE ANY QUESTIONS, ASK YOUR
DOCTOR, NURSE, OR PHARMACIST.
IN THIS LEAFLET:
1. What is Lamisil and what it is used for 
2. Before you take Lamisil 
3. How to take Lamisil 
4. Possible side effects
5. Storing Lamisil 
6. Further information 
1. WHAT IS LAMISIL AND WHAT IT IS USED FOR
Lamisil tablets contain the active substance terbinafine
hydrochloride
and are available in the following strength (mg = milligrams): 250 mg
terbinafine hydrochloride.
Lamisil also contains other

Summary of Product characteristics

Page 1 of 9 
SUMMARY OF PRODUCT CHARACTERISTICS 
1

NAME OF THE MEDICINAL PRODUCT 
LAMISIL
®
 tablets: 250 mg 
2

QUALITATIVE AND QUANTITATIVE COMPOSITION 
The active substance is terbinafine hydrochloride. 
250 mg tablets (scored): 
Each tablet contains 250 mg terbinafine as the hydrochloride. 
For a full list of excipients, see section 6.1 List of excipients. 
3

PHARMACEUTICAL FORM 
Tablets for oral administration. 
4

CLINICAL PARTICULARS 
4.1

THERAPEUTIC INDICATIONS 
•

Onychomycosis (fungal infection of the nail) caused by dermatophyte fungi. 
•

Tinea capitis. 
•

Fungal  infections  of  the  skin  for  the  treatment  of  tinea  corporis,  tinea  cruris,  tinea  pedis  and 
yeast  infections  of  the  skin  caused  by  the  genus  Candida  (e.g.  Candida  albicans)  where  oral 
therapy is generally considered appropriate owing to the site, severity or extent of the infection. 
Note: In contrast to topical Lamisil
®
, oral Lamisil is not effective in pityriasis versicolor. 
4.2

POSOLOGY AND METHOD OF ADMINISTRATION 
The duration of treatment varies according to the indication and the severity of the infection.  
CHILDREN 
No data are available in children under two years of age (usually <12 kg). 
Children weighing 
<20 kg 
62.5 mg 
once daily 
Children weighing 
20 to 40 kg  125 mg 
(half 250 mg tablet) once daily 
Children weighing 
>40 kg 
250 mg 
(one 250 mg tablets) once daily 

ADULTS 
250 mg once daily. 
SKIN INFECTIONS 
Recommended duration of treatment: 
•

Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks. 
•

Tinea corporis, cruris: 2 to 4 weeks. 
•

Cutaneous candidiasis: 2 to 4 weeks. 
Complete resolution of the signs and symptoms of infection may not occur until