Funtrol

Package Leaflet: Information for the User

Funtrol, 50 mg/mL, Medicinal Nail Lacquer

Amorolfin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Funtrol and what is it used for

Funtrol is used to treat fungal infections of the nails.

Funtrol contains the active substance amorolfine (as hydrochloride), which belongs to a group of medicines known as antifungals.

The medicine kills various fungi that can cause nail infections.

Funtrol is indicated for the treatment of fungal nail infections caused by dermatophytes (fungi that live on the skin, hair, and nails), yeasts, and molds.

Funtrol is indicated for the treatment of fungal nail infections that do not involve the nail matrix (the area where the nail plate is formed) and are limited to 2 nails.

The medicine may be used when a fungal nail infection has caused a change in the color of the nail plate (white, yellow, or brown discoloration) or thickening of the nail plate.

Funtrol is indicated for use in cases of fungal nail infections that only affect the upper part of the nail plate.

If the infection spreads to other parts of the nail plate, contact a doctor.

If there is no improvement or if you feel worse, contact your doctor.

2. Important information before using Funtrol

When not to use Funtrol

• If you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

The medicine may cause allergic reactions, some of which may be serious.

If an allergic reaction occurs, stop using the medicine immediately, remove it with a cotton swab dipped in nail varnish remover, and consult a doctor.

Do not reapply the medicine.

If you experience any of the following symptoms, seek medical attention immediately:

• difficulty breathing
• swelling of the face, lips, tongue, or throat
• severe skin rash

Before starting treatment with Funtrol, discuss this with your doctor or pharmacist.

If Funtrol gets into your eyes or ears, rinse them immediately with water and contact a doctor, pharmacist, or the nearest hospital.

Avoid contact between the nail lacquer and your eyes, ears, and mucous membranes (e.g., mouth and nose).

Do not sniff or inhale the lacquer.

Funtrol is for use on the nail plate only.

Do not apply the lacquer to the skin around the nail.

Use impermeable protective gloves if you come into contact with organic solvents, which will protect the applied medicinal lacquer from dissolving.

Using other nail products

• Do not apply artificial nails during treatment with Funtrol.
• You can use cosmetic nail varnish, but wait at least 10 minutes after applying Funtrol.
• Before reapplying Funtrol, remove the cosmetic nail varnish.

Children and adolescents

Do not use Funtrol in children due to a lack of data on safety.

Funtrol and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

No special studies have been conducted on the interaction of Funtrol with other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Do not use Funtrol in pregnant or breastfeeding women unless your doctor considers it absolutely necessary.

Driving and using machines

No effect of Funtrol on the ability to drive and use machines has been observed.

Funtrol contains ethanol

This medicine contains 482.53 mg of alcohol (ethanol) per mL of nail lacquer.

The medicine may cause burning of damaged skin.

Due to the presence of ethanol, the medicine is flammable.

Do not use it near open flames, lit cigarettes, or certain appliances (e.g., hair dryers).

3. How to use Funtrol

Always use this medicine exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

Before starting treatment

Mark the area of the nail affected by the fungal infection on the diagram below.

This will help assess the results of the treatment.

Once a month, mark the changed area until a healthy nail plate appears.

In the case of a fungal infection of 2 nail plates, choose the one that is more severely infected to assess the results of the treatment.

Before treatment month 1 month 2 month 3 month 6

Dosage

Apply Funtrol nail lacquer to the infected nail surface once or twice a week.

Duration of treatment

It is important to continue treatment with Funtrol until a fully healthy nail plate appears, which usually takes about 6 months for fingernails and 9 to 12 months for toenails.

Nail growth is a slow process, so the first signs of improvement in the nail plate are usually visible after 2-3 months of treatment.

If the appearance of the nail plate does not improve, contact your doctor.

Your doctor may recommend evaluating the effectiveness of the treatment at approximately 3-month intervals.

Instructions for use:

Step 1: Filing the nail Before the first application of the lacquer, remove any previously applied layers of lacquer (e.g., cosmetic nail varnish). File away as much of the infected part of the nail as possible, especially the surface of the nail, using a nail file. WARNING: do not use the same nail file for infected and healthy nails. Otherwise, you may spread the infection. To avoid transferring the infection, make sure that no one else uses your nail files.
Step 2: Cleaning the nail Clean and degrease the nail surface with a cotton swab dipped in nail varnish remover. Later, the swab can be used to remove the lacquer from the applicator. Before reapplying Funtrol, prepare the nail as described above and always clean it first to remove any remaining lacquer using files and swabs.
Step 3: Applying the lacquer Dip the applicator provided with the packaging into the bottle with the nail lacquer.

Do not wipe the lacquer off the edge of the bottle before applying it.

Apply the lacquer evenly to the entire nail surface.

Repeat the same step for each infected nail.

Let the lacquer dry on the nail for about 3 to 5 minutes.

Repeat steps 1 and 2 for each infected nail.

• Before reapplying the nail lacquer, first remove the old medicinal lacquer and any cosmetic nail varnish from the nails using a swab, and then file the nails if necessary.
• Reapply the lacquer as described earlier.
• Wait 10 minutes before reapplying cosmetic nail varnish.

After each application of Funtrol:

• Carefully clean the applicator with a swab dipped in nail varnish remover.
• Remove any lacquer residue from the bottle cap using a swab dipped in nail varnish remover.
• Close the bottle tightly after use.

Be careful when disposing of the swab as it is flammable.

After applying the lacquer and waiting for it to dry completely, wash your hands.

When in contact with organic solvents, wear impermeable gloves to protect the Funtrol lacquer on your nails.

Do not use nail files used for infected nails on healthy nails.

Concomitant fungal infection of the feet should be treated with an appropriate antifungal cream.

Use in children and adolescents

Do not use Funtrol in children due to a lack of data on safety.

Accidental ingestion of Funtrol

Funtrol is for use on the nail plate only.

If you or anyone else accidentally swallows the lacquer, contact a doctor, pharmacist, or hospital immediately.

Missing a dose of Funtrol

Do not worry if you forget to apply the lacquer at the right time.

As soon as you remember, start using the lacquer again as before.

Do not apply a double dose to make up for the missed dose.

Stopping treatment with Funtrol

Do not stop using Funtrol until the infection is cured and healthy nails have grown out, unless your doctor decides otherwise.

If you stop using the medicine too early, the infection may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop using the medicine and contact your doctor immediately if you experience any systemic allergic reaction (a serious allergic reaction that may be associated with swelling of the face, lips, tongue, or throat, difficulty breathing, and/or severe skin rash).

Unknown frequency (frequency cannot be estimated from the available data):

• nail damage, nail discoloration, brittle or fragile nails with a tendency to split.

Very rare (may affect up to 1 in 10,000 people):

• burning sensation of the skin.

Unknown frequency:

• redness (skin redness), itching, contact dermatitis, hives, skin blisters.

Side effects may also be caused by the development of the fungal nail infection.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Funtrol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month.

Store in a temperature below 30°C.

Protect from high temperatures.

Store the bottle in an upright position with the cap tightly closed.

Flammable product! Keep the solution away from fire and flames!

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Funtrol contains

• The active substance is 50 mg/mL amorolfine (corresponding to 55.74 mg/mL amorolfine hydrochloride).
• The other ingredients are: ammonio methacrylate copolymer (type A), triacetin, butyl acetate, ethyl acetate, ethanol, anhydrous.

What Funtrol looks like and contents of the pack

Funtrol is a clear, colorless to pale yellow solution.

Available pack sizes: 2.5 mL, 3 mL, 5 mL; 1 bottle with applicators.

Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma Sp. z o.o.

ul. Baletowa 30

02-867 Warsaw

Manufacturer

Chanelle Medical

Loughrea, Co. Galway

Ireland