Lamisil AT 1% spray

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Terbinafine hydrochloride

Tersedia dari:

Karo Healthcare UK Ltd

Kode ATC:

D01AE15

INN (Nama Internasional):

Terbinafine hydrochloride

Dosis:

10mg/1gram

Bentuk farmasi:

Spray

Rute administrasi :

Cutaneous

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 13100200; GTIN: 5012131742501

Selebaran informasi

Lamisil AT 1% Spray
Terbinafine Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Lamisil AT 1% Spray
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% Spray is and what it is used for
2. Before you use Lamisil AT 1% Spray
3. How to use Lamisil AT 1% Spray
4. Possible side effects
5. How to store Lamisil AT 1% Spray
6. Further information
1. WHAT LAMISIL AT 1% SPRAY IS AND WHAT IT IS USED FOR
Lamisil AT 1% Spray 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%
Spray 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% Spray 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 clearl

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lamisil AT 1% Spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
10mg terbinafine hydrochloride per 1g spray solution
Excipients with known effect
Each gram of spray contains 250 mg ethanol and 50 mg propylene glycol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cutaneous spray, solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of tinea pedis (athlete’s foot) and tinea cruris
(dhobie (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
Lamisil AT 1% Spray is applied once daily, for one week.
DURATION AND FREQUENCY OF TREATMENT:
Interdigital type tinea pedis, and tinea cruris: Once a day for one
week.
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, a physician should be consulted.
DOSING IN SPECIAL POPULATIONS:
Paediatric population
Not to be used in children under 16 years of age. Experience with
Lamisil AT 1%
Spray in children is limited and its use cannot, therefore, be
recommended.
Elderly patients
There is no evidence to suggest that elderly patients require
different dosages or
experience side effects different from those in younger patients.
METHOD OF ADMINISTRATION
For cutaneous use.
Cleanse and dry the affected areas thoroughly before applying Lamisil
AT 1% Spray
from a distance of 5 to 10 cm. A sufficient amount of spray solution
should be
applied to wet the treatment area(s) thoroughly, and to cover the
affected skin and
surrounding area.
4.3
CONTRAINDICATIONS
Known hypersensitivity to terbinafine or any of the excipients
contained in the spray
solution (see section 6.1 List of excipients).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lamisil AT 1% Spray should be used with caution in patients with
les