Lamisil Tablets 250mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

D01BA02

INN (International Name):

TERBINAFINE HYDROCHLORIDE 250 mg

Pharmaceutical form:

TABLET

Composition:

TERBINAFINE HYDROCHLORIDE 250 mg

Prescription type:

POM

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2006-11-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMISIL
®
250MG TABLETS
TERBINAFINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING LAMISIL

BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU
- Keep this leaflet. You may need to read it again.
- If you have further questions, please 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 illnesses 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.
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 tablets are used to treat fungal infections of the fingernails
and toenails, 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
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMISIL
Lamisil tablets will only be prescribed for you by a doctor. Follow
all your doctor’s
instructions carefully, even if they differ from the general
information contained in this leaflet.
DO NOT TAKE LAMISIL:
•
IF YOU ARE ALLERGIC
(hypersensitive) to Lamisil or any of the other ingredients of Lamisil
listed at the end of this leaflet
•
IF YOU HAVE OR HAD ANY LIVER PROBLEMS
•
IF YOU HAVE ANY KIDNEY PROBLEMS
•
IF YOU SUFFER FROM A CONDITION KNOWN AS PSORIASIS OR SYSTEMIC LUPUS
ERYTHEMATOSUS
•
IF YOU HAVE PROBLEMS OF GALACTOSE INTOLERANCE SEVERE LACTASE
DEFICIENCY OR GLUC

Summary of Product characteristics

Drug Regulatory Affairs
LAMISIL
®
(TERBINAFINE HYDROCHLORIDE)
250 mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LAMISIL
®
tablets: 250 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
The active substance is terbinafine hydrochloride.
250 mg tablets (scored):
Each tablet contains 250 mg terbinafine as the hydrochloride.
Excipient(s) with known effect
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets (scored) for oral administration.
The tablet can be divided into equal doses.
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 (also
known as
_Tinea versicolor)_
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The duration of treatment varies according to the indication and the
severity of the infection.
Use in 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
Use in 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.
ONY