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Amorolfine 5% W/V Medicated Nail Lacquer

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Amorolfine 5% w/v Medicated nail lacquer

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Amorolfine 5% w/v Medicated nail lacquer contains 5% w/v amorolfine in the form of hydrochloride.

1ml of nail lacquer contains 55.74 mg amorolfine hydrochloride (equivalent to 50mg of amorolfine).

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Medicated nail lacquer

Amorolfine 5% w/v Medicated nail lacquer is a clear colourless solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Onychomycoses caused by dermatophytes, yeasts and moulds.

4.2    Posology and method of administration

Adults and Elderly

The nail lacquer should be applied to the affected finger or toe nails once weekly. Twice weekly application may prove beneficial in some cases.

The patient should apply the nail lacquer as follows:

1. Before the first application Amorolfine 5% w/v Medicated nail lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using a nail file. The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad. Before repeat application of Amorolfine 5% w/v Medicated nail lacquer, the affected nails should be filed down

again as required, following cleansing with a cleaning pad to remove any remaining lacquer.

Caution: Nail files used for affected nails must not be used for healthy nails.

2. With one of the reusable applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the applicator with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.

For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck.

Caution: When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Amorolfine 5% w/v Medicated nail lacquer on the nails.

Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treatment depends essentially on intensity and localisation of the infection. In general, it is six months (finger nails) and nine to twelve months (toe nails). A review of the treatment is recommended at intervals of approximately three months.

Co-existent tinea pedis should be treated with an appropriate antimycotic cream.

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

Amorolfine 5% w/v Medicated nail lacquer 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 Amorolfine 5% w/v Medicated nail lacquer should be avoided during pregnancy and lactation.

4.4    Special warnings and precautions for use

Avoid contact of the lacquer with eyes, ears and mucous membranes.

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.

Fertility, Pregnancy and lactation

4.6


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, Amorolfine 5% w/v Medicated nail lacquer should be avoided during pregnancy and breast feeding.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Adverse drug reactions are rare. Nail disorders (e.g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself.

System Organ Class

Frequency

Adverse drug reaction

Skin and subcutaneous tissue disorders

Rare ( *1/10000, < 1/1000)

Nail disorder, nail

discoloration,

onychoclasis

Very rare ( i 1/10000)

Skin burning sensation, contact dermatitis

Unknown frequency

Erythema,pruritus, urticaria, blister

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Accidental oral ingestion

Amorolfine 5% w/v Medicated nail lacquer is for topical use. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Other antifungals for topical use ATC code: D01AE16

Amorolfine 5% w/v Medicated nail lacquer 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

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


yeasts:

dermatophytes:

moulds:

dematiacea:

dimorphic fungi:

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

5.2 Pharmacokinetic properties

Amorolfine from nail lacquer penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of the active ingredient is very low with this type of application.

Following prolonged use of Amorolfine 5% w/v Medicated nail lacquer, there is no indication of drug accumulation in the body.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

List of excipients

6.1


Ammonio methacrylate copolymer A,

triacetin,

butyl acetate,

ethyl acetate,

ethanol.

6.2 Incompatibilities

None.

6.3 Shelf life

3 years

6.4    Special precautions for storage

Protect from heat. Keep bottle tightly closed after use.

6.5    Nature and contents of container

Glass bottle.

Pack Sizes:    2.5 ml (1 x 2.5 ml)

5.0    ml (1 x 5.0 ml)

7.5 ml (1 x 2.5 ml & 1 x 5.0 ml)

10.0    ml (2 x 5.0 ml)

All packs contain cleansing swabs, spatulas and nail files.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special instructions.

7    MARKETING AUTHORISATION HOLDER

Aspire Pharma Limited Bellamy House Winton Road Petersfield Hampshire GU32 3HA

8    MARKETING AUTHORISATION NUMBER(S)

PL 35533/0018

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/08/2012

10    DATE OF REVISION OF THE TEXT

01/05/2014