LAMISIL TABLET 250 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TERBINAFINE HCl EQV TERBINAFINE

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

D01BA02

Dosage:

250 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

TERBINAFINE HCl EQV TERBINAFINE 250 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Produktions GmbH

Authorization status:

ACTIVE

Authorization date:

1992-04-13

Patient Information leaflet

LAMISIL


Oral antifungal agent 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Tablets (scored) for oral administration. 
ACTIVE SUBSTANCE 
Terbinafine hydrochloride 
125 mg tablets (scored) for use in children:
Each tablet contains 125 mg terbinafine as the 
hydrochloride. 
250 mg tablets (scored): Each tablet contains
250 mg terbinafine as the hydrochloride. 
Certain dosage strengths may not be available in all countries. 
ACTIVE MOIETY 
Terbinafine 
EXCIPIENTS 
125 mg: magnesium stearate; hydroxypropylmethyl cellulose;
microcrystalline cellulose; 
lactose; sodium carboxymethyl starch. 
250 mg: magnesium stearate; silica colloidal anhydrous;
hydroxypropylmethyl cellulose; 
microcrystalline cellulose; sodium carboxymethyl starch. 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
Treatment of: 
  Onychomycosis (fungal infection of the nail) caused
by dermatophyte fungi. 
  Tinea capitis. 
  Fungal infections of the skin (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. 
DOSAGE AND ADMINISTRATION 
DOSAGE 
The duration of treatment varies according to the indication and
the severity of the infection. 
Novartis   Page 
2 
International Package Leaflet 
16-Feb-2012 
Lamisil
®
 tablets  

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 several 
weeks after

Summary of Product characteristics

Lamisil Jan 2021.SIN
Page 1 of 14
LAMISIL

Oral antifungal agent
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Tablets (scored) for oral administration.
ACTIVE SUBSTANCE
Terbinafine hydrochloride
125 mg tablets (scored) for use in children: Each tablet contains 125
mg terbinafine as the
hydrochloride.
250 mg tablets (scored): Each tablet contains 250 mg terbinafine as
the hydrochloride.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
125 mg: magnesium stearate; hydroxypropylmethyl cellulose;
microcrystalline cellulose;
lactose; sodium carboxymethyl starch.
250 mg: magnesium stearate; silica colloidal anhydrous;
hydroxypropylmethyl cellulose;
microcrystalline cellulose; sodium carboxymethyl starch.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of:

Onychomycosis (fungal infection of the nail) caused by dermatophyte
fungi.

Tinea capitis.

Fungal infections of the skin (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 (also
known as
_Tinea versicolor_
).
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
Lamisil Jan 2021.SIN
Page 2 of 14
The duration of treatment varies according to the indication and the
severity of the infection.
ADULTS
250 mg once daily.
SKIN INFECTIONS
Recommended duration of treatment:

Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks.

Tinea corporis, T. cruris: 2 to 4 weeks.

Cutaneous candidiasis: 2 to 4 weeks.
Complete resolution of the signs and symptoms of infection may not
occur until several weeks
after mycological cure.
HAIR AND SCALP
INFECTIONS
Recommended duration of treatment:

Tinea capitis: 4 weeks.
Tinea capitis occurs primarily in children.
ONYCHOMYCOSIS
For most patients the duration of successful treat