Onilaqare Medicated Nail Polish Bottle 2.5ml 5% With Applicator Cap

Avoid any contact of Onilaqare 5% medicated nail polish with eyes, ears or mucous membranes. Do not apply Onilaqare 5% medicated nail polish to the skin around the nail. In case of contact with organic solvents (nitro thinners, white spirit, etc.) it is advisable to wear waterproof gloves to protect the layer of Onilaqare 5% medicated nail polish applied to the nails. The file used for diseased nails should not be used for healthy nails. During treatment with Onilaqare 5% medicated nail polish the use of artificial nails should be avoided. After applying Onilaqare 5% medicated nail polish, an interval of at least 10 minutes must be respected before using any cosmetic polish. Before repeating the application with Onilaqare 5% medicated nail polish, the cosmetic polish should be carefully removed. Therapy should be established by the physician in the case of patients with peripheral vascular disease, diabetes, diseases of the immune system, as well as in patients with nail dystrophy or severely damaged nails (with lesions of more than two thirds of the nail plate). In these cases, systemic therapy may be required. Patients with a history of lesions, skin conditions such as psoriasis or other chronic skin conditions, edema, respiratory distress (Yellow Nail Syndrome), sore nails, distorted / deformed nails or other symptoms and signs should seek medical attention before starting treatment. A systemic or local allergic reaction may occur after use of this medicine. In this case, stop using the medicine immediately and consult a doctor. Remove the medicine carefully using a nail polish remover. The medicine must not be reapplied. Pediatric population: since adequate clinical data are not available, the medicinal product is not recommended in patients younger than 18 years. Onilaqare 5% medicated nail polish contains 0.552 mg of ethanol in each mg.
PHARMACOTHERAPEUTIC CATEGORY
Topical antifungal.
STORAGE
This medicinal product does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
NAME
ONILAQARE 5% MEDICATED NAIL POLISH
EXCIPIENTS
Copolymer of methacrylic acid, triacetin, butyl acetate, ethyl acetate, absolute ethyl alcohol.
SIDE EFFECTS
Adverse reactions reported are listed in the following table by System Organ Class and Frequency. The frequency is defined as follows: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1/1000) and very rare (<1/10000). Adverse reactions noted are rare. Following the use of Onilaqare 5% medicated nail polish, there have been reports of nail disorders (e.g. nail discoloration, nail breakage or nail brittleness). These reactions may be related to the presence of the onychomycotic pathology itself. Disorders of the immune system. Not known *: hypersensitivity (allergic reaction (systemic) *. Skin and subcutaneous tissue disorders Rare (> = 1 / 10,000, <1 / 1,000): nail disorder, nail discoloration, onychoclasis (nail fragility); very rare ( <1 / 10,000): skin burning sensation. Frequency not known *: erythema *, pruritus *, contact dermatitis *, urticaria *, blistering *. * Post-marketing experience Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are required to report any suspected adverse reactions via the national reporting system at www.aifa.gov .it / content / reports-adverse-reactions.
PREGNANCY AND BREASTFEEDING
Clinical experience regarding the use of amorolfine during pregnancy and / or lactation is limited. Only a few cases of exposure to topical amorolfine in pregnant women have been reported during the post-authorization period, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses (see section 5.3 of the SmPC); it is not known whether amorolfine is excreted in breast milk. Therefore the use of Onilaqare 5% medicated nail polish should be avoided during pregnancy or breastfeeding unless clearly necessary.
INDICATIONS
Treatment of distal and lateral subungual onychomycosis, mildness caused by dermatophytes, yeasts and molds involving no more than two nails of the adult subject.
INTERACTIONS
No interaction studies have been performed.
DOSAGE
Apply once a week to affected fingernails or toenails. Apply the nail polish as follows: 1. Before starting the treatment with Onilaqare 5% medicated nail polish, carefully clean the nails, removing any layers of polish previously applied with a nail polish remover. Next, file the affected nail surfaces 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 polish remover. Before repeating the application of Onilaqare 5% medicated nail polish, the affected nails should be filed again, and in any case they should be cleaned with solvent to remove all traces of polish including cosmetic nail polish. Files used on affected nails should not be used on healthy nails. 2. With the applicator supplied, apply the enamel on the entire surface of the diseased nail and let it dry. For each nail to be treated, dip the applicator into the bottle containing the nail polish without rubbing it on the edge of the bottle itself. The bottle must 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 should be continued without interruption until the nail has regenerated and the affected area is completely healed. The duration of treatment essentially depends on the intensity and localization of the infection. Generally, it takes six months of mania nail therapy and nine to twelve months for toenails. After 3 months of treatment without results, consult your doctor. Onilaqare 5% medicated nail polish is colorless and, once dried, does not stain, and is not removed during normal washing of hands and feet. A cosmetic polish can be used at least 10 minutes after the application of Onilaqare 5% medicated nail polish.
ACTIVE PRINCIPLES
100 ml of 5% medicated nail polish contain: active ingredient: amorolfine hydrochloride 5.574 g equal to amorolfine base 5.0 g. For the full list of excipients, see section 6.1.