Roxolac 80mg / g

Nail polish

First-line treatment of mild to moderate onychomycosis without involvement of the nail matrix and caused by dermatophytes and / or other fungi sensitive to ciclopirox.

Excipients :

No interaction studies have been performed.

Composition :

One gram of medicated nail polish contains 80 mg (80 mg / g) of ciclopirox. For the full list of excipients, see section 6.1.

Contraindications

Hypersensitivity to ciclopirox or to any of the excipients of ROXOLAC 80 mg / g medicated nail polish As no clinical data are available, ROXOLAC 80 mg / g medicated nail polish is not indicated in children.

Dosage

ROXOLAC 80 mg / g medicated nail polish is indicated for adults. There is no experience in children. For cutaneous use. Method of administration Unless otherwise prescribed, ROXOLAC 80 mg / g medicated nail polish should be applied in a thin layer to all nails affected by fungal infection once a day, preferably in the evening. Medicated nail polish should be applied to the entire nail plate. Keep the bottle tightly closed after use. Before starting the treatment, it is recommended to remove the detached parts from the infected nail bed, using a nail clipper, file or nail scissors. The film-forming solution on the nail surface, which, in the long run, could interfere with the penetration of the active ingredient, must be removed with the use of a cosmetic nail polish remover once a week, for the duration of the treatment. . It is recommended to remove the detached parts from the infected nail bed at the same time. Treatment should be continued until complete mycological and clinical recovery and until growth of a healthy nail is observed. The control of the fungal culture must be done 4 weeks after the interruption of the treatment to avoid interference with the results of the culture by possible residues of active substance. Being a topical treatment, a different dosage is not necessary for particular therapeutic groups. If symptoms are refractory to therapy with ROXOLAC 80 mg / g medicated nail polish and / or there is extensive involvement of one or several fingernails and toenails, the addition of oral therapy should be considered. Treatment usually lasts from 3 (onychomycosis of the fingernails) to 6 months (onychomycosis of the toenails). However, the duration of treatment should not exceed 6 months.

Warnings

Contact with eyes and mucous membranes must be avoided. ROXOLAC 80 mg / g medicated nail polish is for external use only. If sensitization occurs, treatment should be discontinued and appropriate therapy instituted. As with all topical treatments of onychomycosis, in the case of involvement of many nails (> 5 nails), in the case in which more than two thirds of the germinal layer of the nail is altered and in case of predisposing factors, such as diabetes and disorders of the immune system, the addition of systemic therapy should be considered. The risk of removal of an infected nail, detached from the bed, by a healthcare professional or by the patient during cleaning should be carefully considered in patients with a history of insulin-dependent diabetes mellitus or diabetic neuropathy. Do not apply to nails treated with ROXOLAC 80 mg / g medicated nail polish, common nail polish or any other cosmetic polish.

Pregnancy and breastfeeding

Effects during pregnancy cannot be anticipated as systemic exposure to ciclopirox is negligible. Effects on the breastfed infant cannot be anticipated as systemic exposure to ciclopirox of breastfeeding mothers is negligible. ROXOLAC 80 mg / g medicated nail polish can be used during pregnancy or while breastfeeding