ONICOTER MED 1FL 6,6ML

ONICOTER 78,22 MG/ML MEDICAL SMALTO FOR UNGHIE

active ingredients

Each ml of nail polish contains terbinaphine hydrochloride equivalent to 78.22 mg terbinaphine. Excipient with known effect: Each ml of nail polish contains 616 mg of ethanol (96%). For the full list of excipients, see paragraph 6.1.

Excellent

Ethanol (96%) Hydroxypropyl-Chitosan Purified Water

Therapeutic indications

Fungal infections of light to moderate nails caused by dermatophytes and/or other fungi sensitive to terbinaphine. Onicoter is indicated in adults. The official guidelines on the appropriate use of antifungal agents must be considered.

Contraindications

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

Population

The nail polish is intended for use on finger nails of the hand or foot. Population After an initial daily treatment for a period of 4 weeks, Onicoter must be applied to the nails concerned once a week. In general, the duration of treatment is 6 months of treatment for nails of the hands and from 9 to 12 months for nails of the feet. An additional oral therapy should be taken into consideration in case of inadequate response to topical treatment at the end of the treatment period and in case of severe nail infection, which involves one or more fingers of the hands and/or the foot and/or the nail matrix. In such situations, it is necessary to contact a doctor. Dosage in special populations: Pediatric population Onicoter's safety and effectiveness has not yet been established in children and adolescents aged between 2 and 17 years. The data available on children and adolescents are described in paragraph 4.8 and 5.1. Method of administration Only for topical use (for application on nails). Before any application of Onicoter, remove any cosmetic nail polish or other cosmetic product from the nails and the nearby skin. Clean and dry the affected areas carefully. Apply a thin layer of Onicoter using the applicator on the entire surface of the affected nails, 5 mm of surrounding skin and, if possible, under the free edge of the nail and on the skin under the nail. Wait about 30 seconds until the enamel has completely dried. Nails treated should not be washed or wet for at least 6 hours. We recommend, therefore, the application in the evening before bedtime and after shower or bath. After this time, you can continue normal hygienic practices. Onicoter should not be removed with solvents or abrasives (for example, nail polish). Simply wash your nails thoroughly with water.

Conservation

This medicine does not require any special storage temperature. Keep the bottle well closed to prevent the enamel from drying. Keep the bottle in the box to protect the medicine from light. This medicine is flammable. Keep it away from heat or free flame. For storage conditions after the first opening of the medicinal product, see the paragraph 6.3.

Warnings

As with all the topical treatments of organomycosis, the addition of a systemic therapy should be taken into account in case of involvement of more than 3 nails or an alteration of more than half of the nail or an involvement of the nail matrix, and in case of predisposable factors, such as diabetes and immune disorders. The duration of the disease, the extent of the involvement of the nail and the thickness of the nail can affect the results of the therapy. Onicoter is only for external use. Patients with a history of diabetes, immune disorders, peripheral vascular diseases, injured nails, sore or severely damaged, skin conditions such as psoriasis or any other chronic condition of the skin and yellow nail syndrome (edema to the lower limbs, respiratory disorders and yellowish discoloration of the nails) should consult a doctor before starting treatment. Contact with any part of the body other than the affected area should be avoided until the enamel has completely dried. It may occur irritation in case of accidental contact with eyes or mucosa. In case of accidental contact with these areas, rinse thoroughly with running water. The impact of cosmetic nail polish or other cosmetic nail products on the effectiveness of Onicoter has not been evaluated. Pediatric population Onicoter should not be used in children and adolescents under 18 years of age due to lack of clinical experience in this age group. Onicoter contains 616 mg of alcohol (ethanol) in every ml of solution. It can cause burning sensation on damaged skin.

Interactions

No interaction studies have been carried out. However, after the application as recommended, systemic bioavailability of terbinafina is considered negligible (see paragraph 5.2), so systemic interactions are not foreseen. Other medicines should not be used on affected areas.

Effects

Summary of security profile Adults Onicoter's safety profile in adults is based on aggregate data of 2 randomized, double-blind, placebo controlled trials (PM1331 and PM0731) in patients with mild to moderate onicomycosis. A total of 556 patients were treated with Onicoter with the recommended dose and 454 patients were treated with the placebo. The reaction to the most commonly reported medicinal product was erythema (0.9% in the Onicoter group; no erythema event was reported in the placebo group) on the application site. All erythema events were mild and transient. Tabulated list of adverse reactions Table 1 summarizes reported adverse reactions in patients with onicomycosis receiving Onicoter. The frequencies are defined as: very common (≥ 1/10); common (from ≥ 1/100 to non-common (from ≥ 1 / 1,000 to rare (from ≥ 1 / 10,000 to very rare (not known (frequency cannot be defined on the basis of available data). Table 1: adverse reactions in patients with onicomycosis treated with Onicoter

Classification for systems and organs	Frequency	Adverse reactions
Pathologies of skin and subcutaneous tissue	Not common	Eritema, Skin irritation

Pediatric population Onicoter's safety has been assessed in 20 pediatric patients with mild to moderate onicomycosis between 2 and 17 years of age who participated in an open study of Phase III (PM Ped 004). The reaction to the most commonly reported medicinal product in pediatric patients was the irritation of the skin in 3 of the 16 children (18.8%) aged 2 to 11, located on the application site. No adverse events were reported in the 4 teenagers aged 12 to 17 years. Skin irritation events in children were mild and transient. 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-reazioniavverse.

Overdosing

Due to the route of administration, overdose is very unlikely. Systemic signs of overdose are not expected following the topical application of Onicoter. In case of accidental oral ingestion, appropriate symptomatic measures must be taken.

Pregnancy

There is no data available on the use of terbinafina in pregnant women. Animal studies indicate no harmful effect on pregnancy or health of the fetus (see paragraph 5.3). Onicoter should not be used during pregnancy if not strictly necessary.

Food

Terbinafina is excreted in breast milk. After topical use only low systemic exposure is expected. Terbinaphine should be used in a breast-feeding mother only if the expected benefit justifies the risk for the child. Furthermore, children should not be allowed to contact any treated area.

Fertility

The effects of terbinaphine on fertility have not been observed in animal studies (see paragraph 5.3).

Source: Farmadati