MED 12ML

TIOCONAZOLO EG 28% MEDICAL SMALTO FOR UNGHIE

active ingredients

100 g of medicated enamel contain: Active ingredient: Tioconazole 28 g For the full list of excipients, see paragraph 6.1.

Excellent

Undecilenic acid, ethyl acetate.

Therapeutic indications

Onicomicosis supported by dermatophytes and yeasts. For concomitant antibacterial activity, it is particularly suitable in mixed infections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. TIOCONAZOLO EGè contraindicated in pregnancy (see paragraph 4.6).

Population

TIOCONAZOLO EG should be applied on the infected nail and in the periungueal region twice a day, morning and evening, using the appropriate brush. The duration of treatment required to obtain healing varies frompatient to patient, and is related to the infecting agent and the extent of injury. Ingenre therapy can last on average up to 6 months, but can be prolonged up to one year. Pediatric population There is no data on the safety and effectiveness of TIOCONAZOLO EG in children and adolescents. Method of administration Thesolvent content in TIOCONAZOLO EG dries in 5 minutes leaving a thin transparent and oily film. Although this film is accidentally removed this does not decrease the activity of the drug, and therefore it is not necessary to apply it again. It is recommended not to use occlusive unbendage.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The application of topical products, especially when protracted, can give rise to awareness-raising phenomena.

Interactions

Not so far known interactions or incompatibility with other medicines.

Effects

In very rare cases a slight and transitory local irritation was observed. However, in the presence of hypersensitivity reactions, you will have to stop treatment and establish appropriate therapy. 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 to the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose has been reported so far.

Although systemic absorption after topical administration is negligible, however, since the treatment of onicomycosis can last for many months, the use of TIOCONAZOLO EG in pregnancy and breastfeeding is contraindicated.

Source: Farmadati