LAMISIL 250 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

B & S Healthcare

ATC code:

D01BA02

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Dosage:

250 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antifungals for systemic use

Authorization status:

Authorised

Authorization date:

2013-10-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
LAMISIL
®
 250MG TABLETS 
(terbinafine) 

BASIC PATIENT LEAFLET 

IN THIS LEAFLET 
1.  What Lamisil is 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 

LAMISIL 250MG TABLETS 
•  The ACTIVE SUBSTANCE of Lamisil is terbinafine 
hydrochloride 
•  Each tablet contains 250mg
terbinafine (as hydrochloride) 
•  The OTHER INGREDIENTS are magnesium stearate, colloidal 
silica anhydrous, hypromellose, microcrystalline cellulose 
and sodium carboxymethyl starch (potato without gluten). 

Lamisil are Circular, biconvex, bevelled-edge, white or off-
white tablets about 11mm in diameter. One face is scored 
and the reverse is marked ‘LAMISIL
250’. Lamisil is available 
in calendar blister packs containing 28 tablets. 

MANUFACTURED BY: Novartis Farmaceutica, S.A., Gran Via de 
les Corts Catalanes, 764, 08013, Barcelona, Spain. 

PROCURED FROM WITHIN THE EU AND REPACKAGED BY THE 
PPA HOLDER: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, 
Middlesex, HA4 0NU, UK.  

LAMISIL
® 
250MG TABLETS, PPA NO: 1328/120/002 

1.  WHAT LAMISIL IS AND WHAT IT IS USED FOR 
Lamisil is used to treat fungal infections of the
fingernails and 
toenails. Lamisil is also used to treat tinea (ringworm) 
infections of the scalp and hair, groin and other body areas 
and the feet (athlete’s foot), as well as yeast infections
of the 
skin.  

Terbinafine belongs to the group of medicines called 
antifungal agents and is used to treat fungal infections of the 
skin, hair and nails. When taken by mouth,
it reaches the site 
of infection in concentrations strong enough to kill the fungus 
or stop it growing. 

2.    BEFORE YOU TAKE LAMISIL 
Lamisil will only be prescribed for you by a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 250mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terbinafine hydrochloride, equivalent to 250mg terbinafine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Spain:_
Circular, biconvex, bevelled-edge, white or off-white tablets about 11mm in diameter. One face is scored and the
reverse is marked ‘LAMISIL 250’. 
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of the skin caused by _Trichophyton (eg. T. rubrum, T.mentagrophytes, T. Verrucosum, T._
_Violaceum). Microsporum canis and Epidermophyton floccosum._
Oral LAMISIL is indicated in the treatment of ringworm (tinea corporis, tinea cruris and tinea pedis) where oral
therapy is considered appropriate due to the site, severity or extent of the infection.
Onychomycosis (nail infections) caused by dermatophyte fungi.
Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
250mg once daily.
The bioavailability of terbinafine is not affected by food.
The duration of treatment varies according to the indication and the severity of the infection.
_Skin infections_
Likely durations of treatment are as follows:
Tinea pedis (interdigital, plantar/moccasin type):
2 to 6 weeks
Tinea corporis:
4 weeks
Tinea cruris:
2 to 4 weeks
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/10/2013_
_CRN 2135102_
_page number: 1_
_Onychomycosis_
The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months
can be anticipated in patients wi