ONILAQ SMALTH UNGHIE 2.5ML+TAP

ONILAQ 5% MEDICAL SMALL FOR UNGHIES

active ingredients

ONILAQ 5% nail polish contains 5% p/v (50 mg/ml) of amorolfina as amorolfina hydrochloride For the complete list of excipients, see paragraph 6.1.

Excellent

Copolymer of type A metacrilic acid (EUDRAGIT RL100),Triacetin Butile Acetate Etile Acetate 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

Population Apply ONILAQ on your nails once a week. Method of administration Apply the nail polish carefully by observing the following recommendations: A. Before starting the first treatment with ONILAQ, clean your nails thoroughly. Eliminate any enamel layers previously applied with a nail solvent; then, with a nail file, smooth the surface of the nail (especially the surface of the sliced nail) as accurately as possible. Pay attention not to limate the peri-ungueal skin area. B. The surface of the nail must be cleaned and degreased using one of the cleaning pads (supplied). C. With one of the supplied applicators (reusable) apply the enamel on the entire surface of the nail. Between an application on the nail and the other, clean the applicator with the supplied cleaning pad, so as to avoid contaminating the nail polish. Do not rub the applicator on the edge of the bottle itself. Q. To avoid contaminating the enamel, the applicator must be thoroughly cleaned with one of the cleaning pads provided, after each application, before proceeding with the treatment of another nail. E. If the nail polish comes in contact with the outside of the cap, clean with a cleaning pad provided to avoid contact with the skin. F. Keep the bottle closed. Repeat the procedure for each of the affected nails. After each application of ONILAQ, it is important to wash your hands. If the application takes place on the nails of the hands, wait for the enamel to be completed dry before proceeding to wash. Treatment must be continued without interruption until the nail has regenerated and the affected areas are finally healed. In general, the duration of the treatment is 6 months for the nails of the hands and 9 months for the nails of the feet (the duration depends essentially on the intensity, the location, the speed of growth of the nail and the extension of the infection). After a 3 month treatment without results, consult your doctor. Special instructions: • Lips used for sick nails should not be used for healthy nails. • Before each new application, remove any enamel residue, limate the affected nails, if necessary, and then always clean them with a cleansing tampon.

Conservation

Keep the bottle away from heat sources. Close the bottle by screwing thoroughly after use.

Warnings

Special warnings: Onilaq should not be applied on the skin around the nail. Avoid any contact ONILAQ with eyes, ears or mucosa. Due to the lack of clinical experience to date, children should not be treated with Onilaq. The treatment 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 must be planned. Patients with previous history of injury, skin conditions such as psoriasis or other chronic condition of the skin, edema, respiratory disorders (Jellow syndrome), sore nails, distorted/deformed nails or other symptoms should contact the doctor before starting treatment. During treatment with amorolphine should not be used cosmetic enamels or artificial nails. In case of use of organic solvents, it is good to wear waterproof gloves not to remove the layer of amorolfina nail polish medicated. After using this product, a systemic or local allergic reaction may occur. In this case, immediately stop the application of the product and consult a doctor. Carefully remove the product using a nail solvent. The product should not be reapplied. Precautions for use: In the absence of clinical data, use of ONILAQ is not recommended in patients under 18 years of age.

Interactions

The data currently available does not highlight the existence of clinically relevant interactions.

Effects

Classification of Organs	Frequency	Reaction
Immune system disorders	Notable	Hypersensitivity (systematic allergic reaction)
Pathologies of skin and subcutaneous tissue	Rare (≥ 1/10.000,	Nail disorders, discoloration of the nail, onicoclasia (ungueal fracture), onicoressi (ungueal brotherhood)
	Very rare (	Sensation of skin burning
	Notable	Erythema*, itching*, contact dermatitis*, hives*

* Post-marketing experiences Reporting 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: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

Following the topical administration of ONILAQ systemic overdose reactions are not expected. In case of accidental ingestion, 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 use of amorolfina have been reported in pregnant women during the post-authorization period, so the potential risk is not known. Studies in animals showed reproductive toxicity at high oral doses (see paragraph 5.3); it is not known if aamorolfina is excreted in breast milk. Amorolphine should not be used during pregnancy and/or nursing unless it is clearly necessary.

Source: Farmadati