Funtrol

Package leaflet: Information for the user

Funtrol, 50 mg/mL, medicinal nail lacquer
Amorolfinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

1. What Funtrol is and what it is 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 Funtrol is and what it is used for

Funtrol is used in the treatment of fungal nail infections.
Funtrol contains the active substance amorolfine (as hydrochloride), which belongs to a group of medicines known as antifungals.
The medicine kills various fungi that may cause nail infections.
Funtrol is indicated for the treatment of nail fungal infections caused by dermatophytes (fungi living on skin, hair, and nails), yeasts, and moulds. Funtrol is indicated for the treatment of nail fungus not involving the nail matrix (the area where the nail plate is formed) and limited to 2 nails.
The medicine may be used when fungal infection of the nail plate has led to a change in nail color (white, yellow, or brown discoloration) or nail plate thickening.
Funtrol is indicated for use in fungal infections affecting only the upper part of the nail plate. If the infection spreads to other parts of the nail plate, consult your doctor.
If there is no improvement or if the patient feels worse, medical advice should be sought.

2. Important information before using Funtrol

When not to use Funtrol

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

Warnings and precautions
This medicine may cause allergic reactions, some of which may be serious. If an allergic reaction occurs, stop using the medicine immediately, remove it promptly with a cotton swab soaked in nail polish remover, and consult a doctor. Do not reapply the medicine. If any of the following symptoms occur, seek immediate medical help:

• 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 the eyes or ears, immediately rinse thoroughly with water and contact your doctor, pharmacist or nearest hospital.
Avoid contact of the nail polish with eyes, ears and mucous membranes (e.g. mouth and nose).
Do not sniff or inhale the nail polish.
Funtrol is intended solely for application to the nail plate. Do not apply the polish to the skin surrounding the nail.
Wear impermeable protective gloves when in contact with organic solvents, to protect the applied medicinal polish from dissolving.

Use of other nail products

• Do not attach artificial nails during treatment with Funtrol.
• Cosmetic nail polish may be used, but at least 10 minutes should elapse after application of Funtrol before applying cosmetic nail polish.
• Cosmetic nail polish must be removed before reapplying Funtrol.

Children and adolescents
Funtrol should not be used in children due to lack of safety data.

Funtrol and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No specific studies on interactions between Funtrol and other medicines have been conducted.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not use Funtrol during pregnancy or breastfeeding unless the doctor considers it absolutely necessary.

Driving and operating machinery
Funtrol has no known effect on the ability to drive or operate machinery.

Funtrol contains ethanol
This medicine contains 482.53 mg of alcohol (ethanol) per mL of nail polish. The medicine may cause a burning sensation on damaged skin. Due to the presence of ethanol, the medicine is flammable.
Do not use near open flames, lit cigarettes or certain devices (e.g. hair dryers).

3. How to use Funtrol

This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician. If in doubt, consult your doctor or pharmacist.
Before starting treatment
Mark the area affected by fungal infection on the diagram below. This will help assess treatment outcomes.
Each month, outline the diseased area until healthy nail tissue appears. In case of fungal infection affecting two nails, select the more severely infected one for treatment evaluation.

Before treatment Month 1 Month 2 Month 3 Month 6
Dosage
Funtrol nail lacquer should be applied to the infected nail surface of the hands or feet once or twice weekly.
Duration of treatment
It is important to continue treatment with Funtrol until a fully healthy nail has regrown, which usually takes about 6 months for fingernails and 9 to 12 months for toenails. Nail growth is a slow process; therefore, the first signs of improvement in the nail plate are usually visible after 2–3 months of treatment.
If there is no improvement in the appearance of the nail, consult your doctor.
Evaluation of treatment efficacy by a physician is recommended approximately every 3 months.
Instructions for use:

Step 1: Filing the nail Before the first application of the nail polish, any previously applied polish layers (e.g. cosmetic nail polish) should be removed. As much of the infected part of the nail as possible, especially the nail surface, should be filed down using a nail file. WARNING: Do not use the same nail file for infected and healthy nails. Otherwise, the patient may spread the infection. To avoid transmission of infection, ensure that no one else uses the patient's nail files.
Step 2: Cleaning the nails Clean and degrease the nail surface using a cotton swab soaked in nail polish remover. The soaked swab may then be used to remove the polish from the spatula. Before reapplying Funtrol medication, the nail must be prepared as described above and must always be cleaned of any remaining polish first, using nail files and cotton swabs.
Step 3: Applying the nail polish Dip the spatula provided in the package into the bottle containing the nail polish.

Do not wipe the nail lacquer onto the rim of the bottle

before application.
Apply the lacquer evenly over the entire nail surface.
Repeat this step for each infected nail.
Leave the lacquer on the nail to dry for approximately 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 cosmetic nail polish from the nails using a swab, and then, if necessary, file the nails.
• Reapply the lacquer as described previously.
• Wait 10 minutes before reapplying cosmetic nail polish. Before reapplying the medicinal Funtrol lacquer, the cosmetic nail polish should be carefully removed.

After each application of Funtrol lacquer:

• Carefully clean the spatula using a solvent-soaked swab. The spatula may be reused if cleaned after each use. The same swab used to clean the nail may be used to clean the spatula.
• Remove any traces of lacquer from the cap using a solvent-soaked swab.
• After applying the lacquer, close the bottle tightly as quickly as possible. Carefully dispose of the swab, as it is flammable. After application and once the lacquer has completely dried, wash your hands.

When in contact with organic solvents, wear impermeable gloves
to protect the Funtrol lacquer layer on the nails.
Files used for infected nails must not be used for healthy nails.
Concomitant fungal infection of the feet should be treated with an appropriate antifungal cream.
Use in children and adolescents
Funtrol should not be used in children due to lack of safety data.
Accidental ingestion of Funtrol
Funtrol is intended for topical application on the nail plate only. If the patient or anyone else accidentally ingests the lacquer, seek immediate medical advice from a doctor, pharmacist, or hospital.
Missed dose of Funtrol
Do not be concerned if you forget to apply the lacquer at the scheduled time. As soon as you remember, resume treatment in the same manner as before.
Do not apply a double dose to make up for a missed dose.
Stopping treatment with Funtrol
Do not discontinue treatment with Funtrol until the infection has resolved and healthy nails have fully regrown, unless otherwise directed by a doctor. Premature discontinuation of treatment may result in recurrence of infection.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop using the medicine and contact your doctor immediately if any systemic allergic reaction occurs (a serious allergic reaction which may involve swelling of the face, lips, tongue or throat, difficulty breathing and/or severe skin rash). Frequency unknown (frequency cannot be estimated from the available data).
Rare (may affect up to 1 in 1,000 patients):

• Nail damage, nail discoloration, brittle or fragile nails prone to splitting.

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

• Skin burning sensation.

Frequency unknown:

• Erythema (skin redness), itching, contact dermatitis, urticaria, skin blisters.

Adverse reactions may also be caused by the development of onychomycosis (fungal nail infection).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Funtrol

Keep the medicine out of 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 specified month.
Store below 30°C. Protect from high temperatures. Store the bottle in an upright position, tightly closed.
Flammable product! The solution must be stored away from fire and flames!
Medicines must 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 package and other information

What Funtrol contains

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

What Funtrol looks like and contents of the pack
Funtrol is a clear solution, colourless to pale yellow.
Available pack sizes: 2.5 mL, 3 mL, 5 mL; 1 bottle supplied with spatulas.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Manufacturer
Chanelle Medical
Loughrea, Co. Galway
Ireland
For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o., Baletowa Street 30, 02-867 Warsaw
tel.: +48 22 855 40 93
fax: +48 22 855 40 95