Lamisil 250 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terbinafine

Available from:

Novartis Ireland Limited

ATC code:

D01BA; D01BA02

INN (International Name):

Terbinafine

Dosage:

250 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antifungals for systemic use; terbinafine

Authorization status:

Marketed

Authorization date:

1994-12-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMISIL® 250 MG TABLETS
Terbinafine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE - BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

This medicine will be referred to as Lamisil in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Lamisil is and what it is used for
2. What you need to know before you take Lamisil
3. How to take Lamisil
4. Possible side effects
5. How to store Lamisil
6. Contents of the pack and other information
1. WHAT LAMISIL IS AND WHAT IT IS USED FOR
Lamisil contains a medicine called terbinafine. It is an
“anti-fungal” medicine.
Lamisil is used in adults and older people to treat a number of fungal
infections of the skin and nails.
It kills the fungus or stops it growing.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMISIL
DO NOT TAKE LAMISIL IF:

you are allergic to terbinafine or any of the other ingredients of
this medicine (listed in section 6)

you have or had any liver problems

you are breast-feeding

you are pregnant or trying to become pregnant.
Do not take Lamisil if any of the above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Lamisil.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lamisil if:

you have ever had liver or kidney problems

you have or experienced thickened patches of red/silver skin
(psoriasis) or facial rash, joint pain,
muscle disorder, fever (cutaneous and systemic lupus erythematosus).
Lamisil can make these
problems worse.
If any of the above apply to you (or you are not sure), talk to

Summary of Product characteristics

Health Products Regulatory Authority
22 July 2020
CRN009VPW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terbinafine hydrochloride, equivalent to 250mg
terbinafine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Circular, biconvex, bevelled-edge, white or off-white tablets about
11mm in diameter. One face is scored and the reverse is
marked ‘Lamisil 250’. The tablet can de divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of the skin caused by Trichophyton (e.g. _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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
250mg once daily.
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
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 with fingernail infection, toenail infection
other than of the big toe, or patients of younger age.
In the treatment of toenail infections, 3 months is usually sufficient
although a few patients may require treatment of 6 months
or longer. Poor nail outgrowth during the first weeks of treatment may
enable identification of those patients in whom longer
therapy is required.
Complete resolution of the signs and symptoms of infection may not
occur until several weeks after mycological cure.
He