Lamisil AT 1% Gel

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

TERBINAFINE

Dostępny od:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

Kod ATC:

D01AE15

INN (International Nazwa):

TERBINAFINE 1 % (W/W)

Forma farmaceutyczna:

GEL

Skład:

TERBINAFINE 1 % (W/W)

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Status autoryzacji:

Authorised

Data autoryzacji:

2008-07-23

Ulotka dla pacjenta

_ _
_ _
_ _
_ _
_READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. _
_ _
_ Use Lamisil AT 1% Gel carefully to get the best results from it. _
_- Please keep this leaflet. You may need to read it again. _
_- Ask your pharmacist if you need more information or _
_advice. _
_- You must contact a doctor if your symptoms worsen or _
_do not improve after 7 days. _
_- If any of the side effects get serious, or if you notice any _
_side effect not listed in this leaflet, please tell your doctor _
_or pharmacist. _
_ _
_IN THIS LEAFLET: _
_1. What Lamisil AT 1% Gel is and what it is used for _
_2. Before you use Lamisil AT 1% Gel _
_3. How to use Lamisil AT 1% Gel _
_4. Possible side effects _
_5. How to store Lamisil AT 1% Gel _
_6. Further information _
_ _
_1. WHAT LAMISIL AT 1% GEL IS AND WHAT IT IS USED FOR _
_ _
Lamisil AT 1% Gel contains the active ingredient terbinafine which is
an antifungal used to treat skin
problems caused by fungi in:
• Athlete’s foot (tinea pedis) - athlete’s foot appears only on
the feet (usually both, but not always),
where it often appears in-between the toes. It can also appear on the
instep, soles, or other areas of
the feet. 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
1% Gel 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 1% Gel 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.
• Ringworm (tinea

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lamisil AT 1% gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine 1.0% w/w
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The treatment of tinea pedis (athlete’s foot), tinea cruris (dhobie
(jock) itch) and tinea corporis
(ringworm) caused
by
_Trichophyton _
(e.g.
_T. _
_rubrum, _
_T. _
_mentagrophytes, _
_T. _
_verrucosum, _
_T. _
_violaceum_
) and
_Epidermophyton floccosum. _
_ _
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use
ADULTS
Lamisil AT 1% Gel is applied once daily for all indications. Cleanse
and dry the affected areas
thoroughly before applying Lamisil AT 1% Gel. The gel should be rubbed
in lightly to the affected
skin and surrounding area. In the case of intertriginous infection
(submammary, interdigital,
intergluteal, inguinal) the application may be covered with gauze,
especially at night.
Duration and frequency of treatment:
•
Interdigital type tinea pedis:
1 week once a day
•
Tinea corporis, tinea cruris: 1 week once a day
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.
USE OF LAMISIL AT 1% GEL IN THE ELDERLY
There is no evidence to suggest that elderly patients require
different dosages or experience side
effects different from those in younger patients.
USE OF LAMISIL AT 1% GEL IN CHILDREN
Not to be used in children under 16 years of age. Experience with
lamisil AT 1% Gel in children is
limited and its use cannot therefore be recommended.
4.3.
CONTRAINDICATIONS
Known hypersensitivity to terbinafine or any of the excipients
contained in the gel (see 6.1. List of
excipients).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lamisil AT 1% Gel should be used with caution in patients with lesions
where alcohol could be
irritating, such as l