MYCOSTER 8% Ciclopirox, Filmogenic Solution for local application, Nail Mycosis, 3ml

1. NAME OF DRUG MYCOSTER 8%, filmogenic solution for local application. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ciclopirox: 8 g Per 100g of filmogenic solution. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Filmogenic solution for local application. Colourless and transparent solution. 4. CLINICAL DATA 4.1. Therapeutic Indications First-line treatment of onychomycosis without matrix damage due to dermatophytes and / or other fungi sensitive to ciclopirox. 4.2. Dosage and how to use Apply a thin layer of MYCOSTER onto the infected nails once per day in the evening. The medical varnish must be applied all over the nail area. Close bottle well after use. Before starting treatment, it is recommended to remove the infected parts of the nails by using nail clippers, a nail file or scissors. During treatment once per week a cosmetic nail varnish remover should be used to take off the filmogenic layer on the nail surface which could prevent the active substance going through. At the same it is recommended to remove the infected parts of the nails Treatment must be continue until the nail has healed and grown back healthily. Treatment lasts between 3 (finger onychomycosis) and 6 (toe onychomycosis months). The length of the treatment should not exceed 6 months. MYCOSTER is for adults. 4.3. Contraindications Over-sensitivity to ciclopirox or one of its dilutants. MYCOSTER is not suitable for children due to the lack of available data. 4.4. Special warnings and side effects Avoid contact with eyes and mucous membranes. The MYCOSTER nail varnish is for external use only. Do not apply the nail varnish or other cosmetic products on the treated nails. 4.5. Interactions with other drugs No study has been carried out. 4.6. Pregnancy and breast feeding No embryotoxic or teratogenic effects were observed after oral, topical or subcutaneous administration of ciclopiroxolamine in animals. No effects of ciclopirox are expected during pregnancy and breast-feeding due to negligible systemic exposure. Ciclopirox can be used during the whole length of pregnancy and breast feeding. 4.7. Effects on the ability to drive and operate machinery MYCOSTER has no effects on the ability to drive and operate machinery 4.8. Side effects Side effects are listed below by organ system class and frequency. Frequencies are defined as follows: very common (≥ 1/10), frequent (≥ 1/100,