Lamisil 1%, cream

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

TERBINAFINE HYDROCHLORIDE

Доступна с:

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

код АТС:

D01AE15

ИНН (Международная Имя):

TERBINAFINE HYDROCHLORIDE 10 mg

Фармацевтическая форма:

CREAM

состав:

TERBINAFINE HYDROCHLORIDE 10 mg

Тип рецепта:

POM

Терапевтические области:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Статус Авторизация:

Authorised

Дата Авторизация:

2006-04-17

тонкая брошюра

LAMISIL® CREAM
PROPERTIES/THERAPEUTIC USE
WHAT IS LAMISIL AND WHEN IS IT USED?
LAMISIL cream is medicine (antifungal agents) intended for treatment
of skin
infections caused by fungi (mycoses) such as athlete’s foot or other
superficial
mycoses of the skin and pityriasis versicolor.
LAMISIL cream is also effective against infections caused by yeasts
(candidoses of
the skin).
LAMISIL cream rapidly suppresses symptoms such as itching,
desquamation
(scaling) and red blotches.
ADDITIONAL INFORMATION
APART FROM TREATMENT WHAT STEPS CAN BE TAKEN?
In order to prevent mycoses, observe the following rules:
Change your clothes every day because it is possible that the germs
remain attached to
parts of the clothes which are in contact with infected
regions of the skin.
Avoid wearing clothes which fit too tightly or have little
permeability to air.
Carefully dry the affected parts after washing.
Change your flannel and towel every day.
If you are suffering from athlete’s foot, do not walk barefoot. In
addition, sprinkle or
spray the inside of your socks or shoes every day with a powder or
spray which is
effective against fungal infections.
CONTRAINDICATIONS
WHEN SHOULD LAMISIL NOT BE USED?
Do not use this product if you are allergic to one of its components.
As the experience in children under 12 years of age is limited, the
use of LAMISIL
cream is not recommended in children under 12 years of age.
PRECAUTIONS
WHAT PRECAUTIONARY MEASURES SHOULD BE OBSERVED WHEN USING LAMISIL?
LAMISIL cream should only be used externally.
Consult your doctor in the case of large-scale mycoses or when the
mycosis involves
the nails.
Please inform your doctor or pharmacist if you suffer from other
illnesses, allergies or
use other medicines for internal or external use (even under
self-medication!).
PREGNANCY/LACTATION
Can LAMISIL be used during pregnancy or lactation?
Only under medical authorisation.
DOSAGE/METHOD OF USE
HOW IS LAMISIL USED?
For adults and children above 12 years: before applying LAMISIL,
carefully wash the
affected part

Характеристики продукта

1
1.
NAME OF THE MEDICINAL PRODUCT
Lamisil
®
1%, cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains 10 mg terbinafine hydrochloride.
For excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White, smooth, glossy cream.
4.
CLINICAL PARTICULARS
4.1.
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
_Epidermophyton floccosum_
, e.g. tinea pedis (athlete’s foot), tinea cruris (dhobie (jock)
itch) and tinea corporis (ringworm).
Yeasts 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_
).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use
Adults and children aged 12 years and over
_Duration and frequency of treatment _
•
Tinea pedis: 1 week once a day
•
Tinea cruris and tinea corporis: 1 week once a day
•
Cutaneous candidiasis: 1 week, once or twice daily
•
Pityriasis versicolor: 2 weeks, once or twice daily
The affected area should be cleaned and dried thoroughly before
application of Lamisil
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
(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, patients should see a doctor.
_ _
_Children _
Experience with Lamisil Cream in children below 12 years is limited,
and its use is
therefore not recommended in this age group.
_Use in the elderly _
There
is
no
evidence
to
suggest
that
elderly
patients
require
different
dosages
or
experience side-effect