Lamisil AT Cream

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Terbinafine hydrochloride

Boleh didapati daripada:

Karo Pharma AB

Kod ATC:

D01AE; D01AE15

INN (Nama Antarabangsa):

Terbinafine hydrochloride

Borang farmaseutikal:

Cream

Kawasan terapeutik:

Other antifungals for topical use; terbinafine

Status kebenaran:

Marketed

Tarikh kebenaran:

2003-01-24

Risalah maklumat

The most common type of athlete’s foot causes
cracking or scaling of the skin, but you may also
have mild swelling, blisters, or weeping ulcers.
Lamisil AT Cream is recommended for athlete’s
foot when it occurs between the toes. If you have
a fungal nail infection (fungus inside and under the
nail) with discolouration of the nails and changes in
nail texture (thick or flaky), you should consult your
doctor because Lamisil AT Cream is not appropriate
for this type of infection.
• Dhobie itch/jock itch (tinea cruris)
Dhobie itch appears in the groin and inner thigh
area, usually on both sides but often with one side
more than the other, where it can spread further
between the legs to the buttocks, or up towards
the stomach. Dhobie itch looks like a clearly
bordered rash, which may have blisters.
2. Before you use Lamisil AT Cream
Do NOT use Lamisil AT Cream if you:
• are allergic (hypersensitive) to any of the ingredients
in the product (see Section 6)
Take special care with Lamisil AT Cream
The cream is for external use only. Do not use on the face.
Avoid contact with eyes. In case of accidental contact
with the eyes, rinse thoroughly with running water.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
those obtained without a prescription.
Pregnancy and breast-feeding
Do not use the cream if you are pregnant or breast-
feeding, unless advised to by your doctor.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Lamisil AT Cream is not expected to affect your ability
to drive or operate machinery.
Important information about some of the ingredients
of Lamisil AT Cream
The cream contains some ingredients which you may
need to be aware of:
• This medicine contains 75 mg benzyl alcohol in
each tube which is equivalent to 10 mg/g. Benzyl
alcohol may cause mild local irritation.
• cetyl alcohol and stearyl alcohol: may cause
local skin reactions (e.g. contact dermatitis).
For othe

Ciri produk

Health Products Regulatory Authority
28 March 2024
CRN00F117
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil AT Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine hydrochloride 1.0% w/w.
Excipients with known effects: Each gram of cream contains 40mg
stearyl alcohol, 40mg cetyl alcohol and 10mg benzyl alcohol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White smooth or almost smooth, glossy cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of tinea pedis (athlete’s foot) and tinea cruris
(dhobie itch/jock itch) caused by Trichophyton_ (e.g. T. rubrum, T. _
_mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton
floccosum_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS OVER 16 YEARS OF AGE
LAMISIL AT Cream is applied once daily.
DURATION AND FREQUENCY OF TREATMENT
Duration of treatment is one week for tinea pedis and tinea cruris.
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 by a physician.
DOSING IN SPECIAL POPULATIONS:
PAEDIATRIC POPULATION
The experience with topical LAMISIL AT Cream in children is still
limited and its use in children under 16 years cannot therefore
be recommended.
ELDERLY PATIENTS
There is no evidence to suggest that elderly patients require
different dosages or experience side-effects different to those of
younger patients.
METHOD OF ADMINISTRATION
For cutaneous use: The affected area should be cleaned and dried
thoroughly before application of LAMISIL AT Cream. The
cream should be applied to the affected skin and surrounding area in a
thin layer and rubbed in lightly. In the case of
intertriginous infections (interdigital, intergluteal, inguinal) the
application may be covered with a gauze strip, especially at
night.
4.3 CONTRAINDICATIONS
Hypersensitivity to terbinafine o