Fungilak 50 mg/ml - nail polish for mycosis 3 ml

Product Description

Medicated nail polish for the treatment of fingernail and toenail fungus.

Indications

Fungilak 50 mg/ml is a medicated nail polish for the topical treatment of onychomycosis (without matrix involvement, e.g. superficial white onychomycosis, subungual onychomycosis, affecting less than 50% of the nail surface and less than 3 nails).

Ingredients

Active ingredients: 1 ml of medicated nail polish contains 55.74 mg of amorolfine hydrochloride (equivalent to 50 mg of amorolfine)
Excipients: Ethanol, Ethyl acetate, Ammonium methacrylate copolymer (type A), Butyl acetate, Triacetin.

How to use of use and Dosage

Dosage: The nail polish should be applied once a week to the affected fingernail or toenail.
Duration of treatment: 6 months (fingernails) and 9 to 12 months (toenails).
A treatment check at intervals of approximately 3 months is recommended.
Elderly: There are no specific recommendations on dosage adjustment in elderly patients.
Paediatric population: Fungilak is not recommended in infants, children and adolescents because it may cause serious side effects. Data on safety and/or efficacy are insufficient.
Method of administration: The product is intended to be applied to the nails.
Instructions for use: The user should use Fungilak as follows:
Warnings: Nail files used for treatment should no longer be used for the care of healthy nails.

1. When using the nail polish for the first time, the infected sections of the nail surfaces should be filed as soon as possible. possible.
   Before using the polish again, the nails should be re-filed if necessary (e.g. if the nails have thickened).
   The package contains disposable files.
2. To clean the surface of the nail, one of the included alcohol wipes should always be used.
   This will remove any residue of polish.
3. The medicated nail polish should be applied with one of the reusable spatulas provided.
   The package contains a spatula holder to facilitate the application of the medicated nail polish.
   The reusable spatulas must be inserted into the holder.
4. The nail polish should be taken up using one of the reusable spatulas provided.
   The spatula with the perforated surface must be re-dipped for each nail to be treated, avoiding rubbing it on the neck of the bottle (risk of the screw cap sticking to the bottle).
5. Using the spatula, Fungilak must be applied to the entire surface of the infected nail.
6. The particular shape of the spatula holder prevents the spatula from coming into contact with the surface (the fungal spores remain on the spatula).
   The spatula can be set aside without worrying about the fungal spores spreading.
7. The bottle must be tightly closed immediately after each use to prevent the solution from evaporating.
   It is necessary to wait 10 minutes for the solution to evaporate. Treated nails should dry.
8. To reuse it, the spatula should be cleaned with one of the alcohol wipes after use.

After applying Fungilak, wait for Fungilak to dry (at least 10 minutes) before using any cosmetic nail polish.
Before reusing Fungilak, carefully remove any cosmetic nail polish from the nail.
During treatment, however, the use of nail polish remover should be avoided.
Fungilak is particularly effective in cases of onychomycosis in distal regions, when less than 50% of the nail surface is involved.
Treatment should continue without interruption until the nail has regenerated and the affected areas are completely healed.
The frequency required and duration of treatment depend essentially on the intensity and location of the infection.
In general, 6 months are considered for fingernails and 9 to 12 months for toenails.
Treatment monitoring at intervals of approximately 3 months is recommended.
Coexisting tinea pedis should be treated with an appropriate antifungal cream.

Warnings

Fungilak should not be applied to the skin around the affected nail.
Experience is still needed in patients with inflammatory periungual changes, diabetes, circulatory diseases, malnutrition and alcoholism.
This product is flammable.
The solution must be kept away from fire and flames.
Any contact of the nail polish with eyes, ears and mucous membranes must be avoided.
With Fungilak, the use of artificial nails should be avoided during treatment.
People who work with organic solvents (thinners, petroleum ether, etc.) should wear waterproof gloves to protect the Fungilak layer on the fingernails.
Otherwise, Fungilak will be removed.
After applying Fungilak, an allergic reaction may occur, even outside the application area.
If this occurs, treatment should be stopped and a doctor should be consulted.
Fungilak should be removed immediately and carefully using nail polish remover or the alcohol wipes included in the package.
Fungilak should not be reapplied.
Since Fungilak is a natural product, it is important to avoid contact with the skin. There is no adequate clinical experience; patients under 18 years of age should not be treated with Fungilak.
Fungilak contains ethanol and may cause a burning sensation on damaged skin if it accidentally comes into contact with the surrounding skin.

Contraindications

Hypersensitivity to the active substance amorolfine or to any of the excipients.

Undesirable effects

Rare cases of nail disorders (e.g. nail discoloration, nail brittleness or nail splitting) have been reported following the use of medicated nail lacquer containing amorolfine.
These reactions may also be attributed to onychomycosis itself.

*Experience gained in the period after marketing.

Overdose

No cases of overdose have been reported.
Amorolfine is intended for topical use.
In case of accidental oral ingestion, appropriate gastric emptying measures can be taken.

Pregnancy and breastfeeding

Pregnancy: Since systemic exposure to amorolfine is negligible, amorolfine is not expected to cause any effects during pregnancy, therefore Fungilak can be used during pregnancy.
Breastfeeding: Since systemic exposure to amorolfine in breastfeeding women is negligible, amorolfine is not expected to cause any effects on newborns/infants, therefore FUNGILAK can be used during pregnancy. be used during breastfeeding.
Fertility: Since systemic exposure to amorolfine is negligible, amorolfine is not expected to cause any effects on fertility.

Storage

Do not store above 30°C.
Shelf life after first opening the bottle: 6 months.

Format

Package contents:

• 3 ml bottle;
• 10 reusable spatulas;
• A spatula holder;
• 30 cleansing wipes;
• 30 nail files.