Summary of medicine characteristics - SCHOLLMED ONCE WEEKLY FUNGAL NAIL TREATMENT 5%W/V MEDICATED NAIL LACQUER
1 NAME OF THE MEDICINAL PRODUCT
Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
Excipients with known effect:
Ethanol 55.4 % w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated nail lacquer.
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds; treatment is limited to 2 nails.
4.2 Posology and method of administration
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).
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
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.
This medicine contains 55.4 % w/w alcohol (ethanol). It may cause burning sensation on damaged skin.
4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Use of nail varnish or artificial nails should be avoided during treatment.
4.6 Fertility, pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines Not relevant.
4.8 Undesirable effects
4.8 Undesirable effectsAdverse 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.
| System Organ Class | Frequency | Adverse drug reaction |
| Immune system disorders | Unknown frequency* | Hypersensitivity (systemic allergic reaction) * |
| Skin and subcutaneous tissue disorders | Rare (>1/10,000 to <1/1,000) | Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails) |
| Very rare (<1/10,000) | Skin burning sensation | |
| Not known (cannot be estimated from the available data) | Erythema, pruritus, contact dermatitis, urticaria, blisters |
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.
4.9 Overdose
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
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, there is no indication of drug accumulation in the body.
5.3 Preclinical safety data
5.3 Preclinical safety dataThere are no findings of relevance to the prescriber other than those mentioned elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Eudragit RL 100
Triacetin
Butyl acetate
Ethyl acetate
Ethanol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 30°C. Protect from heat. Keep the bottle tightly closed and upright.
6.5 Nature and contents of container
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.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
103–105 Bath Road
Slough, SL1 3UH
United Kingdom