FL 3ML

FUNGILAK 50 MG/ML MEDICAL SMALTO FOR UNGHIES

active ingredients

1 ml nail polish contains 55.74 mg of amorolphine hydrochloride (equivalent to 50 mg of amorolphine) For the full list of excipients, see paragraph 6.1.

Excellent

Ethanol, Acetate ethyl, Ammonium methacrylate copolymer (type A), Butile Acetate, Triacetin.

Therapeutic indications

Topical treatment of onicomycosis (without the involvement of the matrix, e.g. superficial white onicomycosis, subungueal onicomycosis, which concerns less than 50% of the surface of the nail and less than 3 nails).

Contraindications

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

Population

Population: Nail polish should be applied 1 time a week on the nail affected by the hands or feet. Duration of treatment: 6 months (hand nails) and from 9 to 12 months (foot nails). A treatment control is recommended at intervals of about 3 months. Seniors: There are no specific recommendations on the adjustment of the dosage in older patients. Pediatric population: FUNGILAK is not recommended in infants, children and adolescents because data on safety and/or effectiveness are insufficient. Method of administration: The product is intended to be applied on the nails.Operating instructions: The user must use FUNGILAK as follows: Warnings: Nail files used for treatment, must not be used anymore for the care of healthy nails. 1. When using enamel for the first time, the infected sections of the nail surfaces must be as smooth as possible. Before using enamel again, the nails will have to be filed again if necessary (e.g. if the nails are thickened). The package contains disposable files. 2. To clean the surface of the nail, one of the soaked soaps of alcohol must always be used. This will remove any enamel residue. 3. The nail polish must be applied with one of the reusable brushes provided. The package contains a spatula holder to facilitate the application of medicated nail polish. Reusable spatulas must be inserted into the support. 4. Nail polish should be taken using one of the reusable spatulas provided. The spatula with the perforated surface must be again immersed in each nail to be treated, avoiding to rub it on the neck of the bottle (risk that the screw cap is attached to the bottle). 5. Using the spatula, FUNGILAK must be applied on the entire surface of the infected nail. 6. The particular shape of the spatula holder avoids the contact of the spatula with the shelf (the fungal spores remain on the spatula). The spatula can be set aside without worrying that the fungal spores can spread. 7. The bottle must be well closed, immediately after each use, to prevent the solution from evaporating. It is necessary to wait 10 minutes for the treated nails to dry. 8. To reuse it, the spatula must be cleaned with one of the soaps filled with alcohol after use. After applying FUNGILAK, you must wait for FUNGILAK to dry (at least 10 minutes) before using any cosmetic nail polish. Before reusing FUNGILAK, you must carefully remove the cosmetic nail from the nail. During the treatment, however, the use of a solvent for the enamel must be avoided. FUNGILAK is particularly effective in case of onicomycosis in distant regions, when less than 50% of the nail surface is involved. The treatment must continue without interruption until the nail is regenerated and the affected areas are completely healed. The required frequency and duration of treatment depend essentially on the intensity and location of the infection. In general it is considered 6 months for the nails of the hands and from 9 to 12 months for the nails of the feet. A treatment control is recommended at intervals of about 3 months. The coexistence of tinea pedis should be treated with an appropriate antifungal cream.

Conservation

Do not store above 30 °C

Warnings

FUNGILAK should not be applied on the skin around the nail concerned. It must still be acquired experience in patients with inflammatory periungueal alterations, diabetes, circulatory pathologies, malnutrition and alcoholism. This product is flammable! The solution must be kept away from fire and flames. Any contact of the enamel with eyes, ears and mucous membranes must be avoided. With FUNGILAK the use of artificial nails must be avoided during treatment. Subjects working with organic solvents (diluents, oil ethers etc.) must wear waterproof gloves to protect the layer of FUNGILAK present on the nails of the hand. Otherwise FUNGILAK will be removed. After applying FUNGILAK, an allergic reaction may occur, even outside the application area. In this case, the treatment will have to be stopped and you will need to contact your doctor. FUNGILAK must be removed immediately and carefully using a nail solvent or soaked alcohol wipes included in the package. FUNGILAK should not be applied again. Because adequate clinical experience is not available, patients under 18 years of age should not be treated with FUNGILAK. FUNGILAK contains ethanol and could cause a burning sensation on damaged skin, if accidentally comes in contact with the surrounding skin.

Interactions

Interaction studies have not been carried out. For contemporary use with cosmetic enamel, refer to the section 4.2.

Effects

As a result of the use of nail polish containing amorolphine, rare cases of nail disorders have been reported (e.g. discoloration of the nail, nail fragility or nail break). These reactions can also be attributed to the same person.

Classification for systems and organs	Frequency	References
Immune system disorders	Notable	Hypersensitivity reactions (even outside the application site, which may be associated with swelling of the face, lips, tongue or throat, respiratory problems and/or severe rashes)*
Pathologies of skin and subcutaneous tissue	Rare (≥ 1/10.000 to	Nail disorders, ointment discoloration, onicoclasy (ogueal fracture), onicoresis (ogueal brotherhood)
	Very rare (	Sensation of skin burning
	Notable	Erythema*, itching*, contact dermatitis* (irritative or allergic) (including allergic contact dermatitis, with diffusion reaction), hives*, blisters*

*Experiences obtained during the period after marketing 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-reazioni-avverse.

Overdosing

There are no overdose cases. Amorolfina is designed for topical use. In case of accidental oral ingestion, an appropriate measure of gastric emptying may be taken.

Pregnancy

: Since systemic exposure to amorolfina is negligible, it is not believed that amorolfina can cause effects during pregnancy, so FUNGILAK can be used during pregnancy.

Nursing:

Since systemic exposure to amorolphine in nursing women is negligible, it is not believed that amorolphine can cause effects on infants/ infants, so FUNGILAK can be used during breastfeeding.

Fertility

: Since systemic exposure to amorolfina is negligible, it is not believed that amorolfina can cause effects on fertility.

Source: Farmadati