LAMISIL CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC code:

D01AE15

Pharmaceutical form:

CREAM

Composition:

TERBINAFINE HYDROCHLORIDE 1 %

Administration route:

TOPICAL

Prescription type:

Not required

Manufactured by:

GSK CONSUMER HEALTHCARE SARL, SWITZERLAND

Therapeutic group:

TERBINAFINE

Therapeutic area:

TERBINAFINE

Therapeutic indications:

Fungal infections of the skin caused by dermatophytes such as trichophyton (e.g.T. rubrum T. mentagrophytes T. verrucosum T. violaceum) Microsporum canis and Epidemophyton floccosum. Yeast infections of the skin principally those caused by the genus Candida (e.g. candida albicans). Pityriasis ( tinea versicolor due to pityrosporum orbiculare (also known as malassezia furfur). For the treatment of plantar-type tinea pedis (Moccasin type)

Authorization date:

2023-07-31

Patient Information leaflet

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Summary of Product characteristics

LamCrm DR v0.1
LAMISIL
CREAM 1%
_ _
_PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE CONTENT PER UNIT _
_Cream: _
10 mg/g Terbinafine hydrochloride (corresponds to 8.8 mg/g
terbinafine).
_ _
_INDICATIONS/POSSIBLE USES _
Fungal infections of the skin caused by dermatophytes such as
trichophyton (e.g.T.
rubrum T. mentagrophytes T. verrucosum T. violaceum) Microsporum canis
and
Epidemophyton floccosum.
Yeast infections of the skin principally those caused by the genus
Candida (e.g.
candida albicans).
Pityriasis ( tinea versicolor due to pityrosporum orbiculare (also
known as malassezia
furfur).
For the treatment of plantar-type tinea pedis (Moccasin type).
_COMPOSITION _
_Active substance: _
Terbinafine hydrochloride.
_Excipients: Isopropyl myristate, Polysorbate 60, Cetyl_
alcohol, Stearyl alcohol, Cetyl
palmitate, Sorbitan Stearate, Benzyl alcohol, Sodium Hydroxide,
Purified Water
_POSOLOGY/USE _
_Usual posology _
Cleanse and dry the affected skin areas thoroughly before application
of Lamisil.
_Adults and children over 12 years of age _
Apply Lamisil Cream 1-2 times per day, based on indication. Apply the
cream to the
affected skin and surrounding area in a thin layer and rub-in lightly.
In case of
intertriginous infection (inframammary, interdigital, internatal,
inguinal) the
application site may be covered with a gauze strip, especially at
night.
_Usual treatment regimens _
Tinea pedis (interdigital), Tinea corporis/cruris:
ONCE
per day for 1 week.
Tinea pedis plantaris (moccasin-type): Twice per day for 2 weeks.
Skin candidiasis: 1-2 times per day for 1 week.
Tinea versicolor: 1-2 times per day for 2 weeks.
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 one week, the diagnosis should be verified.
The effectiveness of Lamisil Cream has not been studied in patients
with Tinea pedis
and concomitant severe Onychomycosis.
_ _
_Special dosage recommendations _
_Elderly patients _