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Summary of Product Characteristics Amorolfine medicated nail lacquer SmPC, page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented name> 50 mg/ml medicated nail lacquer 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml medicated nail lacquer contains 55.74 mg amorolfine hydrochloride equivalent to 50 mg amorolfine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Medicated nail lacquer Clear, colourless solution with a characteristic odour. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of onychomycosis without involvement of the matrix (particularly in the distal region, affecting less than 80% of the nail surface), caused by dermatophytes and yeasts. 4.2 Posology and method of administration Posology The nail lacquer should be applied once weekly to the affected finger- or toenails. Elderly: There are no specific dosage recommendations for use in elderly patients. Paediatric population: <Invented name> is not recommended for use in infants, children and adoles- cents due to insufficient data on safety and/or efficacy. Method of administration The medicinal product is intended for application to the nails. Instructions on use: Amorolfine medicated nail lacquer SmPC, page 2 of 8 The patient should apply <Invented name> as follows. Warning: Nail files used for treatment must no longer be used for the care of healthy nails. 1. Before using the lacquer for the first time, diseased sections of nail surfaces should be filed down as much as possible. When using the lacquer again in future, it should be filed again as required (e.g. if the nails have grown thicker). The pack contains disposable files. 2. For cleansing the nail surface, always one of the alcohol swabs supplied should be used. This will also remove any remnants of lacquer. 3. The medicated nail lacquer should be applied with one of the enclosed reusable spatulas. The pack contains a spatula holder in order to facilitate the application of the medicated nail lacquer. The reusable spatulas should be put into the spatula holder. 4. The nail lacquer should be removed by using one of the reusable spatulas sup- plied. The spatula should be re-dipped for each nail to be treated (with the surface perforated), without wiping it off on the bottle neck (risk of screw top sticking to the bottle). 5. Using the spatula, <Invented name> should be evenly applied over the entire surface of the diseased nail. 6. Due to the special shape of the spatula holder a contact of the spatula with the surface/shelf space is avoided (fungal spores remain on the spatula). Intermedi- ately the spatula can be put aside without worrying that fungal spores could be transmitted. 7. The bottle should be tightly closed immediately after each use, to prevent the solution from drying out. The treated nails should be allowed to dry for 10 minutes. 8. For reuse, the spatula should be cleaned after use with an alcohol swab. After application of <Invented name> cosmetic nail polish can be applied as soon as <Invented name> has dried (after 10 minutes). Before re-application of <Invented name> the cosmetic nail polish should be re- moved carefully. In between, however, the use of nail polish remover should be avoided. <Invented name> is particularly effective in onychomycoses in the distal region, affecting less than 80 % of the nail surface. Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treat- ment 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. Amorolfine medicated nail lacquer SmPC, page 3 of 8 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 <Invented name> should not be applied to the skin around the affected nail. Experience has yet to be gained in patients with inflammatory periungual changes, diabetes, circulatory disorders, malnutrition, alcohol abuse.This product is flamma- ble! The solution should be kept away from fire and flames. Any contact of the lacquer with eyes, ears and mucous membranes should be avoided. Owing to the lack of clinical experience available to date, patients under 18 years of age should not be treated with <Invented name>. The use of artificial nails should be avoided during treatment. Patients who work with organic solvents (diluents, petroleum ether etc.) should wear impermeable gloves to protect the layer of <Invented name> on the finger nails. Otherwise <Invented name> will be removed.After application of <Invented name> an allergic reaction may occur, even outside the application site. In this case, the application should be terminated immediately and medical advice should be obtained. <Invented name> should be removed immediately with nail polish remover or the alcohol swabs included in the package. <Invented name> must not be applied again. 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. For simultaneous use with cosmetic nail polish refer to section 4.2. 4.6 Fertility, pregnancy and lactation Experience with amorolfine use during pregnancy and/or lactation is limited. Only a few cases of exposure to topical amorolfine use in pregnant women have been reported in the post-authorisation setting, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses (see section 5.3); it is unknown whether amorolfine is excreted in human milk. Amorolfine should not be used during pregnancy and/or lactation unless clearly necessary. Pregnancy No effects during pregnancy are anticipated, since systemic exposure to amo- rolfine is negligible. <Invented name> can be used during pregnancy. Breast-feeding No effects on the breastfed newborn/infant are anticipated since the systemic ex- posure of the breast-feeding woman to amorolfine is negligible. <Invented name> can be used during breast-feeding. Fertility No effects are anticipated, since systemic exposure to amorolfine is negligible. Amorolfine medicated nail lacquer SmPC, page 4 of 8 4.7 Effects on ability to drive and use machines <Invented name> has no or negligible influence on the ability to drive and use ma- chines. 4.8 Undesirable effects Rare cases of nail changes (e.g. discolouration, brittle or broken nails) have been reported with the use of amorolfine containing nail lacquer. These reactions can also be attributed to the onychomycosis itself. System Organ Class Frequency Adverse reactions Immune system disor- Not known Hypersensitivity reac- ders tions (also outside the (cannot be estimated site of application, which from the available data)* may be associated with a swelling of the face, lips, tongue or throat, respira- tory problems and/or se- vere rash)* Skin and subcutaneous Rare Nail disorder, nail discol- tissue disorders oration, onychoclasis (≥ 1/10000, < 1/1000) (broken nails), onychor- rhexis (brittle nails) Very rare ( < 1/10000) Skin burning sensation Not known Erythema*, pruritus*, contact dermatitis* (irrita- (cannot be estimated tive or allergic) (including from the available data)* allergic contact dermati- tis with spreading reac- tion), urticaria*, blister* *Experience from post-marketing period 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 me- dicinal product. Healthcare professionals are asked to report any suspected ad- verse reactions via the national reporting system listed in Appendix V. 4.9 Overdose No case of overdose has been reported. Amorolfine is intended for topical use. In case of accidental oral ingestion appropriate measure for gastric emptying can be taken. Amorolfine medicated nail lacquer SmPC, page 5 of 8 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antifungals for dermatological use; other antifungals for topical use ATC code: D01AE16 Amorolfine hydrochloride is a morpholine derivative. As such, it belongs to a new substance class of antifungal agents and possesses a broad spectrum of activity. Amorolfine intervenes in ergosterol biosynthesis in the fungal cell membrane and thereby develops both fungistatic and fungicidal efficacy. It is highly effective against: Yeasts: Candida, Malassezia or Pityrosporum, Cryptococcus Dermatophytes: Trichophyton, Microsporum, Epidermophyton Moulds: Alternaria, Hendersonula, Scopulariopsis Dematiaceae: Cladosporium, Fonsecaea, Wangiella Dimorphic fungi: Coccidioides, Histoplasma, Sporothrix 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 absorp- tion of the active ingredient is very low with this type of application. Following pro- longed use of <Invented name>, there is no indication of drug accumulation in the body. 5.3 Preclinical safety data Acute toxicity: Species Application LD50 mg amorolfine hydrochlo- ride/kg body weight Mouse intravenous 130 Mouse intraperitoneal 200 Mouse oral 2500 Amorolfine medicated nail lacquer SmPC, page 6 of 8 Rat intraperitoneal
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