Summary of Product Characteristics: 4.1 Therapeutic Indications
Summary of Product Characteristics: 4.1 Therapeutic Indications
Summary of Product Characteristics: 4.1 Therapeutic Indications
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
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.
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.
A systemic or local allergic reaction could possibly occur after use of this product. If
this happens, the product should be stopped immediately and medical advice should
be sought.
Remove the product carefully by cleaning the skin.
The product should not be reapplied.
4.5 Interaction with other medicinal products and other forms of interaction
There are no specific studies involving concomitant treatment with other topical
medicines. Use of nail varnish or artificial nails should be avoided during treatment.
Not relevant.
4.9 Overdose
5 PHARMACOLOGICAL PROPERTIES
Loceryl is a topical antimycotic. Amorolfine belongs to a new chemical class, and its
fungicidal action is based on an alteration of the fungal cell membrane targeted
primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same
time unusual sterically nonplanar sterols accumulate.
Amorolfine from cream penetrates into the stratum corneum. Nevertheless, systemic
absorption is extremely low during and after therapeutic use.
None stated.
6 PHARMACEUTICAL PARTICULARS
Polyoxyl 40 stearate, stearyl alcohol, paraffin liquid, white soft paraffin, carbomer,
sodium hydroxide, disodium edetate, 2 phenoxyethanol.
6.2 Incompatibilities
Not applicable.
3 years.
No special requirements.
PL 10590/0041
19 April 1999
05/05/2017