ONILAQARE UNGHIE 2.5ML

ONILAQARE 5% MEDICAL SMALTO FOR UNGHIE

active ingredients

100 ml nail polish at 5% contain: active ingredient: amorolfina hydrochloride 5.574 g equal to amorolfina base 5,0 g. For the full list of excipients, see paragraph 6.1.

Excellent

Copolymer of metacrilic acid, triacetin, butyl acetate, acetate ethyl, absolute ethyl alcohol.

Therapeutic indications

Treatment of distal and lateral subungueal onicomycosis, of a slight entity caused by dermatophytes, yeasts and molds that involve no more than two nails of the adult subject.

Contraindications

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

Population

Apply once a week on your nails with your hands or feet. Apply the polish as follows: 1. Before starting the treatment with Onilaqare 5% nail polish thoroughly clean your nails, eliminating any layers of enamel previously applied with a nail solvent. Subsequently, smooth the affected surfaces of the nail as thoroughly as possible using a nail file. The surface must then be cleaned and degreased with one of the cleaning pads supplied or with a normal nail solvent. Before repeating the application of Onilaqare 5% nail polish, the affected nails must be lied again, and in any case should be cleaned with solvent to remove any trace of nail polish including cosmetic nail polish. The flaws used on the nails affixed should not be used on healthy nails. 2. With the supplied applicator, apply the enamel on the entire surface of the sick nail and let it dry. For each nail to be treated, immerse the applicator in the bottle containing the enamel without rubbing it on the edge of the bottle itself. The bottle should be closed quickly to avoid evaporation. After each use, clean the applicator with one of the cleaning pads provided, to avoid contaminating the enamel. 3. The treatment must be continued without interruption until the nail has regenerated and the affected area is completely healed. The duration of the treatment depends essentially on the intensity and location of the infection. In general, it takes six months of nail care of the hands and from nine to twelve months for the nails of the feet. After a 3 month treatment without results, consult your doctor. Onilaqare 5% nail polish is colorless and, once dried, does not stain, and is not removed during normal washing of hands and feet. A cosmetic nail polish can be used after at least 10 minutes from the application of Onilaqare 5% nail polish.

Conservation

This medicine does not require any special condition for conservation.

Warnings

Avoid any contact of Onilaqare 5% nail polish with eyes, ears or mucosa. Do not apply Onilaqare 5% nail polish on the skin around the nail. In case of contact with organic solvents ( nitro thinners, aquaragia, etc.) it is good to wear waterproof gloves to protect the layer of Onilaqare 5% medicated nail polish applied on the nails. The file used for sick nails should not be used for healthy nails. During treatment with Onilaqare 5% nail polish medicated use of artificial nails should be avoided. After the application of Onilaqare 5% nail polish, a range of at least 10 minutes must be respected before using any cosmetic nail polish. Before repeating the application with Onilaqare 5% nail polish, cosmetic nail polish should be removed carefully. The therapy must be established by the doctor in the case of patients suffering from peripheral vascular diseases, diabetes, immune system diseases, as well as in patients with ointment dystrophy or severely damaged nails (with injuries greater than two-thirds of the nail). In these cases, systemic therapy may be necessary. Patients with previous history of injury, skin conditions such as psoriasis or other chronic condition of the skin, edema, respiratory disorders (Jineal Nails syndrome), sore nails, distorted/deformed nails or other symptoms and signs should contact the doctor before starting treatment. After use of this medicine, a systemic or local allergic reaction may occur. In this case, stop the use of the medicine immediately and consult a medico.Rimuovere carefully the medicine using a nail solvent. The medicinal product should not be reapplied. Pediatric population: As adequate clinical data is not available, the medicine is not recommended in patients under 18 years of age. Onilaqare 5% nail polish contains 0.552 mg of ethanol in each mg.

Interactions

Interaction studies have not been carried out

Effects

The adverse reactions shown are listed in the following table according to the Classification for systems and organs and by frequency. The frequency is defined as follows: very common (≥ 1/10);comune (≥1/100, Classification for systems and organs according to Medra Frequency Reaction Immune system disorders Notable Hypersensitivity (allergic reaction (system)* Pathologies of skin and subcutaneous tissue Rare (≥ 1/10.000, 1/1.000) Nail disorders, ointment discoloration, onicoclasy (uncial brotherhood) Very rare ( 1/10.000) Sensation of skin burning Frequency not known* Erythema*, itching*, contact dermatitis*, hives* * Post-marketing experiences 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No known overdose symptoms as a result of the topical application of Onilaqare 5% nail polish. In case of accidental ingestion, if necessary, all appropriate measures should be taken to treat symptoms.

The clinical experience related to the use of amorolfina during pregnancy and/or lactation is limited. Only a few cases of exposure to topical amyrolphine were reported in pregnant women during the post-authorization period, so the potential risk is not known. Animal studies showed reproductive toxicity at high oral doses (see paragraph 5.3 of the CPR); it is not known if aamorolfina is excreted in breast milk. Therefore the use of Onilaqare 5% nail polish should be avoided during pregnancy or nursing, unless it is clearly necessary.

Source: Farmadati