Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer

Each bottle contains 5% w/v amorolfine in the form of hydrochloride. 1 ml solution contains 55.74 mg amorolfine hydrochloride (equivalent to 50 mg amorolfine).

For the full list of excipients, see section 6.1.

Medicated nail lacquer.

Clear, colourless to pale yellow solution.

Treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds; treatment is limited to 2 nails.

Posology

Adults and elderly

The nail lacquer should be applied to the affected finger or toe nails once weekly.

The patient should apply the nail lacquer as follows:

1. Before the first application of Schollmed Once Weekly Fungal Nail Treatment 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 the nail file supplied. The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad. Cosmetic nail lacquer may be applied at least 10 min after amorolfine 5% nail lacquer application. Before repeat application of Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer, any remaining nail lacquer, and cosmetic lacquer if any, should be removed carefully, then 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.

Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. Non-compliance with frequency of administration and recommended treatment duration might result in treatment failure, and development of resistance. 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. If the infection has not cleared after six months (finger nails) and twelve months (toe nails) medical advice should be sought.

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

Paediatric population

Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer is not recommended for use in children and adolescents below 18 years due to a lack of data on safety or efficacy.

Method of administration

Cutaneous use (application on the nail).

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Amorolfine 5% Nail Lacquer should not be applied on the skin around the nail.

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

Patients with underlying conditions predisposing to fungal nail infections should be referred to a doctor. Such conditions include peripheral circulatory disorders, diabetes mellitus, and immunosuppression.

Patients with nail dystrophy and destroyed nail plate, nail pain or inflammation should be referred to their doctor.

Owing to the lack of clinical experience available to date, children should not be treated with amorolfine 5% nail lacquer.

When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the amorolfine lacquer on the nails.

During the application of Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer no artificial nails shall be used. After applying amorolfine 5% nail lacquer, an interval of at least 10 min should be respected before application of any cosmetic nail lacquer. Before repeat application of amorolfine 5% nail lacquer, the cosmetic nail lacquer should be removed carefully.

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 using a nail remover solution. The product should not be reapplied.

No interaction studies have been performed.

Use of nail varnish or artificial nails should be avoided during treatment.

Pregnancy

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 fetus appears to be negligible. However, because there is no relevant experience, amorolfine should be avoided during pregnancy.

Breastfeeding

It is unknown whether amorolfine is excreted in human milk. Because there is no relevant experience, amorolfine should be avoided during breast feeding.

Fertility

No data are available.

Not relevant.

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

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Accidental oral ingestion

Schollmed Once Weekly Fungal Nail Treatment 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.

Pharmacotherapeutic group: other antifungals for topical use, ATC code: D01AE16

Amorolfine is a topical antimycotic. It 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: Candida, Cryptococcus, Malassezia

- dermatophytes: Trichophyton, Microsporum, Epidermophyton

- moulds: Hendersonula, Alternaria, Scopulariopsis

- dematiacea: Cladosporium, Fonsecaea, Wangiella

- dimorphic fungi: Coccidioides, Histoplasma, Sporothrix

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

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, there is no indication of drug accumulation in the body.

There are no findings of relevance to the prescriber other than those mentioned elsewhere in the SPC.

Eudragit RL 100

Triacetin

Butyl acetate

Ethyl acetate

Ethanol

Not applicable.

3 years.

Store below 30°C. Protect from heat. Keep the bottle tightly closed and upright.

The lacquer is available in a glass bottle of 2.5 ml. The bottle is made of amber glass (type I or type III) bottle with a HDPE cap, PTFE liner and tamper evident ring.

Each pack consists of 1 bottle and cleansing swabs, spatulas and nail files.

No special requirements.

Reckitt Benckiser Healthcare (UK) Limited

103-105 Bath Road

Slough, SL1 3UH

United Kingdom

PL 00063/0740

11/07/2017

11/07/2019