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LOCERYL 0.25% W/W CREAM

Active substance(s): AMOROLFINE HYDROCHLORIDE / AMOROLFINE HYDROCHLORIDE / AMOROLFINE HYDROCHLORIDE

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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.
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.

4.6 Pregnancy and lactation
Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals but
embryotoxicity was observed at high oral doses. The systemic absorption of amorolfine during and after
topical administration is very low and therefore the risk to the human foetus appears to be negligible.
However, because there is no relevant experience Loceryl should be avoided during pregnancy and breast
feeding. Breast-feeding women must not use the cream in the breast area.

4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
Adverse drug reactions are rare and mostly mild in nature.
System Organ Class
Immune system
disorders
Skin and
subcutaneous tissue
disorders

Frequency
Unknown frequency*
Rare ( ≥1/10 000, <1/1000)

Unknown frequency*
* post marketing experience

4.9

Adverse drug reaction
Hypersensitivity (systemic
allergic reaction)*
Skin Irritation, erythema,
pruritus, skin burning
sensation
Dermatitis contact *

Overdose
Accidental oral Ingestion
Loceryl is for topical use. In the event of accidental oral ingestion, an appropriate
method of gastric emptying may be used.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Other antifungals for topical use ATC code: D01AE16
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 is a broad spectrum antimycotic. It is highly active (MIC < 2mcg/ml) in
vitro against

yeasts:
dermatophytes:
moulds:
dematiacea:
dimorphic fungi:

Candida, Cryptococcus, Malassezia
Trichophyton, Microsporum, Epidermophyton
Hendersonula, Alternaria, Scopulariopsis
Cladosporium, Fonsecaea, Wangiella
Coccidioides, Histoplasma, Sporothrix

With the exception of Actinomyces, bacteria are not sensitive to amorolfine.
Propionibacterium acnes is only slightly sensitive.

5.2

Pharmacokinetic properties
Amorolfine from cream penetrates into the stratum corneum. Nevertheless, systemic
absorption is extremely low during and after therapeutic use.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Polyoxyl 40 stearate, stearyl alcohol, paraffin liquid, white soft paraffin, carbomer,
sodium hydroxide, disodium edetate, 2 phenoxyethanol.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Loceryl cream should be stored below 30°C.

6.5

Nature and contents of container
20 g collapsible aluminium tube, sealed with an aluminium membrane and
fitted with a plastic screw cap.

6.6

Special precautions for disposal and other handling
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Galderma (UK) Limited,
Meridien House
69-71 Clarendon Road
Watford
Herts
WD17 1DS
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 10590/0041

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19 April 1999

10

DATE OF REVISION OF THE TEXT
05/05/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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