LAMISIL 1 %w/w Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

D01AE15

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Dosage:

1 %w/w

Pharmaceutical form:

Cutaneous Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antifungals for systemic use

Authorization status:

Authorised

Authorization date:

1997-11-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 1% cutaneous solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: 10 mg terbinafine hydrochloride per 1 g solution (1% w/w).
Excipient(s) with known effect: propylene glycol (E1520) (50 mg/g)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous solution
Clear, colourless to faintly yellow liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lamisil solution is indicated in the treatment of fungal infections of the skin caused by dermatophytes and pityriasis
(tinea) versicolor in adults (see section 4.4)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cutaneous use.
POSOLOGY
Adults.
Lamisil solution is applied once or twice daily, depending on the indication.
Duration and frequency of treatment.
Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment
carries the risk of recurrence.
METHOD OF ADMINISTRATION
The affected area should be cleaned and dried thoroughly before the application of Lamisil Solution. A sufficient
amount of solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and
surrounding area.
DOSING IN SPECIAL POPULATIONS:
PEDIATRIC POPULATION
Lamisil solution is not recommended for use in children due to insufficient data on safety and efficacy.
ELDERLY PATIENTS
There is no evidence to suggest that elderly patients require different dosages or experience side effects different from
Interdigital type tinea pedis:
Once a day for 1 week
Tinea corporis, cruris:
Once a day for 1 week
Pityriasis versicolor:
Twice a day for 1 week
HEALTH PRODUCTS REGULATORY AUTHORITY
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