ROXOLAC SMALL UNGHIE FL80MG/G

ROXOLAC 80 MG/G, MEDICAL SMALTO FOR UNGHIES

active ingredients

A nail polish gram contains 80 mg (80 mg/g) of cyclopirox. For the full list of excipients, see paragraph 6.1.

Excellent

Ethylacetate, isopropyl alcohol, methylvinyl copolymer ether and maleic acid monobutilestere.

Therapeutic indications

Treatment of the first line of the onicomycosis from mild to moderate without involvement of the matrix of the nail and caused by dermatophytes and/or other sensitive fungi to cyclopirox.

Contraindications

Hypersensitivity to the active ingredient or one of the excipients listed in paragraph 6.1.

Population

ROXOLAC 80 mg/g nail polish is suitable for adults. Pediatric population Since clinical data is not available, ROXOLAC is not indicated in children. For skin use. Method of administration Unless otherwise prescribed, ROXOLAC 80 mg/g nail polish is to be applied in thin layer on all nails affected by fungal infection once a day, preferably in the evening. The medicated enamel must be applied on the entire nail plate. Store the bottle carefully closed after use. Before starting the treatment, it is recommended to delete the parts detached from the bed of the infected nail, using a nail cutter, a file or nail scissors. The filmogen solution on the surface of the nail, which, long gone, could interfere with the penetration of the active ingredient, must be removed with the use of a cosmetic solvent for nail polish once a week, for the duration of the treatment. It is recommended to remove at the same time the parts detached from the bed of the infected nail. The treatment must be continued until complete mycological and clinical healing and until the growth of a healthy nail is observed. Control of fungal culture should be done after 4 weeks after the interruption of treatment to avoid interference with the results of cultivation by possible residues of active substance. As a topical treatment, different posology is not necessary for particular therapeutic groups. If symptomatology was refractory to therapy with ROXOLAC 80 mg/g nail polish and/or there was an extensive involvement of one or several nails of the hands and feet, it should be taken into account the addition of an oral therapy. The normal treatment lasts from 3 (oecomycosis of the nails of the hands) to 6 months (oecomycosis of the nails of the feet). However, the duration of treatment must not exceed 6 months.

Conservation

Store in the original packaging, to protect from light. After the first opening of the bottle: hold the bottle well closed in the box.

Warnings

The contact with the eyes and mucosa must be avoided. ROXOLAC 80 mg/g nail polish is only for external use. In case of systemic or local sensitization, the treatment must be stopped and the medicated enamel carefully removed with a solvent. As with all the topical treatments of theonmycosis, in case of many nails (> 5 nails), in case more than two-thirds of the germ layer of the nail is altered and in case of predisposable factors, such as diabetes and disorders of the immune system, it should be taken into account the addition of a systemic therapy. The risk of removal of an infected nail, detached from the bed, by a healthcare provider or by the patient during cleaning, must be carefully considered in patients with anamnesi of insulin-dependent diabetes or diabetic neuropathy. Do not apply on nails treated with ROXOLAC 80 mg/g nail polish, common nail polish or any other cosmetic nail polish.

Interactions

No interaction studies have been carried out.

Effects

The following table shows adverse reactions according to the classification for MedDRA systems and organs. The frequencies were defined according to the following convention: Very common (≥ 1/10) Common (≥1/100, Classification for organ systems References Frequency Immune system disorders Notable Hypersensitivity* Pathologies of skin and subcutaneous tissue Notable Contact dermatitis *requires the suspension of treatment. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No significant adverse events have been reported in relation to overdose.

Pregnancy Effects cannot be predicted during pregnancy, since systemic exposure to cyclopirox after application is negligible. ROXOLAC 80 mg/g nail polish can be used during pregnancy. Breastfeeding There is no sufficient information on the excretion of cyclopirox and its potential metabolites in breast milk. You cannot exclude a risk for infants/ infants. ROXOLAC 80 mg/g nail polish should not be used during breastfeeding. Fertility No effect on male and female fertility has been shown in experimental studies following oral administration of olamin cyclopirox in rats up to 5 mg/kg/die.

Source: Farmadati