Lamisil 1% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

Imbat Limited

ATC code:

D01AE; D01AE15

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Dosage:

1 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antifungals for topical use; terbinafine

Authorization status:

Authorised

Authorization date:

2011-09-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine hydrochloride 1% w/w.
Excipients: Each gram of cream contains 40mg cetyl alcohol and 40mg
stearyl alcohol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
_Product imported from Greece_
White, smooth to almost smooth, glossy cream.
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._
Yeast infections of the skin, principally those caused by the genus_
Candida_ (e.g._ C_._albicans_).
Pityriasis (tinea) versicolor due to_ Pityrosporum orbiculare_ (also
known as_ Malassezia furfur_).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
LAMISIL can be applied once or twice daily.
Cleanse and dry the affected areas thoroughly before application of
Lamisil.
Apply the cream to the affected skin and surrounding area in a thin
layer and rub in lightly.
In the case of
intertriginous infections (submammary,
interdigital,
intergluteal,
inguinal) the application may be covered with a gauze
strip, especially at night.
The likely durations of treatment are as follows:
In the case of intertriginous infections (submammary, interdigital,
intergluteal, inguinal), the application may be covered
with a gauze strip, especially at night.
Relief of clinical symptoms usually occurs within a few days.
Irregular use or premature discontinuation of treatment
carries the risk of recurrence.
If there are no signs of improvement after two weeks the diagnosis
should be verified.
_Use in the elderly_
There is no evidence to suggest that elderly patients require
different dosages or experience side effects different to those
of younger patients.
Tinea pedis:
1 week
Tinea corporis, cruris:
1 to 2 weeks
Cutaneous candidiasis:
1 to 2 weeks
Pityriasis versicolor:
2 weeks
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