Loceryl 0.25% cream

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Amorolfine hydrochloride

Boleh didapati daripada:

Galderma (UK) Ltd

Kod ATC:

D01AE16

INN (Nama Antarabangsa):

Amorolfine hydrochloride

Dos:

2.5mg/1gram

Borang farmaseutikal:

Cutaneous cream

Laluan pentadbiran:

Cutaneous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 13100200; GTIN: 5020465000914

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loceryl 0.25% w/w cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Loceryl cream contains 0.25% w/w amorolfine in the form of
hydrochloride.
Amorolfine is chemically described as
_cis_-4-[(RS)-3[4-(1,1-Dimethylpropyl)phenyl]-
2-methylpropyl]-2,6-dimethylmorpholine.
Amorolfine hydrochloride HSE 0.279 w/w
(equivalent to 0.25% w/w base)
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Dermatomycoses caused by dermatophytes: _ tinea pedis (athlete's
foot), tinea cruris,
tinea inguinalis, tinea corporis, tinea manuum. Pityriasis versicolor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_DERMATOMYCOSES_
_Cream: _ To be applied to affected skin areas once daily following
cleansing (in the
evening).
The treatment should be continued without interruption until clinical
cure, and for 3 -
5 days thereafter. The required duration of treatment depends on the
species of fungi
and on the localisation of the infection. In general, treatment should
be continued for
at least two to three weeks. With foot mycoses, up to six weeks of
therapy may be
necessary.
_ELDERLY _
There are no specific dosage recommendations for use in elderly
patients.
_CHILDREN _
There are no specific dosage recommendations for children owing to the
lack of
clinical experience available to date.
4.3
CONTRAINDICATIONS
Loceryl cream must not be reused by patients who have shown
hypersensitivity to the
active substance or to any of the excipients.
No experience exists of use during pregnancy and nursing, therefore,
the use of
Loceryl should be avoided during pregnancy and lactation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact of Loceryl cream with eyes, ears and mucous membranes.
This medicinal product contains stearyl alcohol which may cause local
skin reaction
(e.g. contact dermatitis)
Owing to the lack of clinical experience available to date, the use of
Loceryl 0.25%
cream in children is not recommended