Fungilak

Package leaflet: Information for the user

FUNGILAK 50 mg/ml nail lacquer

amorolfine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Use this medicine exactly as described in this leaflet or as your pharmacist has told you to do.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 months.

Contents of this leaflet

1. What FUNGILAK is and what it is used for
2. What you need to know before using FUNGILAK
3. How to use FUNGILAK
4. Possible side effects
5. How to store FUNGILAK
6. Contents of the pack and other information

1. What FUNGILAK is and what it is used for

FUNGILAK is a medicinal product (broad-spectrum antifungal agent) for the local treatment of fungal infections (mycoses) of the nails (without involvement of the nail matrix, e.g. superficial white fungi, fungi beneath the nail, affecting less than 50% of the nail surface and fewer than three nails).
FUNGILAK contains the active substance amorolfine, an antifungal agent that kills a wide range of fungi responsible for nail infections.
The amorolfine-based medicated nail lacquer is used to treat fungal infections of the nails (caused by dermatophytes and yeasts) when up to 50% of the nail is infected (particularly the most distal area).

2. What you need to know before using FUNGILAK

Do not use FUNGILAK

• if you are allergic to the active substance amorolfine or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using FUNGILAK.
Nail files used on infected nails must not be used on healthy nails.
FUNGILAK must not be applied to the skin around the infected nail.
Avoid any contact of the medicinal nail lacquer with eyes, ears, and mucous membranes.
The use of artificial nails should be avoided during treatment.
Users who work with organic solvents (diluents, petroleum ether, etc.) must wear waterproof gloves to protect the layer of FUNGILAK on their fingernails. Otherwise, FUNGILAK will be removed.
All medicines can trigger allergic reactions, which are usually mild but may in some cases be severe. If this occurs, stop applying the product immediately, remove the product with a nail polish remover or with the cleansing wipes provided in the package, and consult your doctor. The product must not be reapplied.
If you experience any of the following symptoms, consult your doctor urgently:

• breathing difficulties
• swelling of the face, lips, tongue or throat
• severe skin rashes

There is currently no available information in patients with inflammatory conditions around the nail, diabetes, poor blood circulation, malnutrition, or alcoholism.
The product is flammable! Keep the solution away from fire and flames.
Paediatric population
No data are currently available in infants, children and adolescents. Therefore, patients under 18 years of age should not be treated with FUNGILAK.
Other medicines and FUNGILAK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are no known interactions of FUNGILAK with other medicinal products. You may use FUNGILAK together with other medicines.
For simultaneous use with cosmetic nail polish, see section 3.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
Since systemic exposure to amorolfine is negligible after topical administration of FUNGILAK, no risk is expected either during pregnancy or to the newborn/breastfed child.
Driving and using machines
FUNGILAK does not affect or affects negligibly the ability to drive and use machines.
FUNGILAK contains ethanol
FUNGILAK contains ethanol (alcohol) and may cause a burning sensation on damaged skin if accidentally comes into contact with the skin surrounding the nail.

3. How to use FUNGILAK

Use this medicine exactly as described in this leaflet or as your pharmacist has advised. If you have any doubts, consult your doctor or pharmacist.
If not otherwise prescribed by your doctor, FUNGILAK should be applied as follows:
Route of administration:
For application on the nails
Apply FUNGILAK once a week to the affected fingernail or toenail.
Continue treatment until healthy nails have fully regrown (nails with a normal appearance).
When using the medicated nail polish, always follow these instructions:
When using the nail polish for the first time, the infected parts of the

nail surface should be filed down as much as possible. When
reapplying the nail polish subsequently, file the nails again if necessary (e.g. if the nails have thickened). The package contains disposable nail files.
To clean the nail surface, always use one of the alcohol-impregnated wipes provided. This will also remove any residual polish.

Apply the medicated nail polish using one of the reusable spatulas provided.
The package contains a spatula holder to facilitate application of the medicated nail polish. The reusable spatulas should be placed into the spatula holder.
Take the nail polish using one of the reusable spatulas provided. The spatula with the perforated surface must be dipped again for each nail to be treated, avoiding rubbing it against the neck of the bottle (risk that the screw cap sticks to the bottle).

Using the spatula, FUNGILAK should be applied to the entire surface of the infected nail.
The special shape of the spatula holder prevents the spatula from touching the surface (fungal spores remain on the spatula). The spatula can be set aside without concern that fungal spores might spread.

The bottle must be tightly closed immediately after each use to prevent evaporation of the solution. Allow 10 minutes for the treated nails to dry.
After use, the spatula must be cleaned with a cleansing wipe before reuse.
After applying FUNGILAK, wait until FUNGILAK is completely dry (at least 10 minutes) before applying any cosmetic nail polish.
Before reapplying FUNGILAK, carefully remove any cosmetic nail polish. However, in the meantime, avoid using nail polish remover solvents.
Additional considerations during treatment of nail fungus
Nail files used for treatment must not be reused for caring for healthy nails, as healthy nails could become infected. Use the disposable nail files provided for treating infected nails.
The layer of FUNGILAK on fingernails may be eroded or removed when handling organic solvents (nitro thinners, turpentine, etc.). Therefore, wear waterproof gloves when working with these substances to protect the layer of medicated nail polish.
Additional recommendations to support treatment
Towels should be washed as frequently as possible at a minimum temperature of 60°C.
Keep shoes well ventilated and allow them to dry thoroughly.
Elderly patients: No specific dosage recommendations are available for elderly users.
Duration of treatment
Fungal infections are often very persistent. Therefore, continue weekly treatment (as described above) until the healthy nail has completely regrown. This generally takes about six months (for fingernails) and nine to twelve months (for toenails), depending on the extent of the infection. Nails grow at a rate of approximately 1 to 2 millimetres per month.
A treatment review is recommended approximately every three months.
Important note:
If you or someone else accidentally swallows the nail polish, contact your doctor, pharmacist, or the nearest hospital emergency department immediately.
Consult your doctor or pharmacist if you feel that the effect of FUNGILAK is too strong or too weak.
If you have further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects
Rare (may affect up to 1 in 1,000 people):
Nail disorders (e.g. discolouration, brittle or cracked nails)
This reaction could also be due to the fungal infection itself.

Very rare (may affect up to 1 in 10,000 people):
Mild, transient pricking sensation in the area surrounding the treated nail (periungual burning)

Not known (frequency cannot be estimated from the available data):
Severe allergic reactions have been reported, which may be associated with swelling of the face, lips, tongue or throat, breathing difficulties and/or severe skin rashes; skin allergic reactions (contact dermatitis*, at the application site or spreading beyond the application site), pruritus*, erythema*, urticaria*, vesicles*.
*Information obtained during the post-marketing period.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FUNGILAK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the box after "Exp." The expiry date refers to the last day of that month.
Do not store above 30 °C.
Notes on shelf life after opening:
After first opening, use the bottle within 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FUNGILAK contains
The active substance is:
Amorolfine
1 ml of medicated nail lacquer contains 55.74 mg of amorolfine hydrochloride (equivalent to 50 mg
of amorolfine).
The other components are:
Ethanol; ethyl acetate; methacrylic acid copolymer (type A) ammonium salt; butyl acetate; triacetin.

Description of the appearance of FUNGILAK and contents of the pack
FUNGILAK is a clear, colourless solution with a characteristic odour, contained in an amber glass bottle with a white HDPE screw cap.
FUNGILAK is available in packs containing 3 ml and 6 ml (2 x 3 ml) of medicated nail lacquer.
Each pack includes 10 reusable spatulas, a spatula holder as an application device, 30 nail files, and 30 cleansing wipes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
mibe pharma Italia S.r.l.
via Leonardo Da Vinci 20/B
39100 Bolzano
Italy

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
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Instructions for nail files and cleansing wipes
Distributor: Dermapharm AG, 82031 Grünwald, Germany

Read the instructions for use carefully

Do not reuse
For external use only