Miconolak

Package Leaflet: Information for the User

Myconolak, 50 mg/ml, Medicinal Nail Lacquer

Amorolfin

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Myconolak and What is it Used For
• 2. Important Information Before Using Myconolak
• 3. How to Use Myconolak
• 4. Possible Side Effects
• 5. How to Store Myconolak
• 6. Contents of the Package and Other Information

1. What is Myconolak and What is it Used For

• Myconolak is used to treat fungal infections of the nails.
• Myconolak contains the active substance amorolfine (as hydrochloride), which belongs to a group of medicines known as antifungals.
• It kills various fungi that can cause nail infections.

2. Important Information Before Using Myconolak

When Not to Use Myconolak

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

Warnings and Precautions

The medicinal product may cause allergic reactions, and some of them may be serious. If an allergic reaction occurs, stop using the medicinal product immediately, remove it using a nail cleaner or the swabs provided with the package, and consult a doctor. Do not reapply the medicinal product. If you experience any of the following symptoms, seek medical attention:

• Difficulty breathing
• Swelling of the face, lips, tongue, or throat
• Severe skin rash

Before starting to use Myconolak, discuss it with your doctor or pharmacist.

• If you have diabetes.
• If you are being treated for a weakened immune system.
• If you have poor blood circulation in your hands and feet.
• If your nails are severely damaged or infected.
• If Myconolak gets into your eyes or ears, rinse them immediately with water and contact a doctor, pharmacist, or the nearest hospital.
• Avoid contact with the lacquer and mucous membranes (e.g., mouth and nostrils).
• Do not inhale the medicinal product.
• Do not apply the lacquer to the skin around the nail.

Myconolak and Other Medicinal Products

You can use the nail lacquer while taking other medicines.

Using Other Nail Products

Do not attach artificial nails while using Myconolak. You can use a cosmetic nail lacquer, but wait at least 10 minutes after applying Myconolak before doing so. Remove the cosmetic nail lacquer before reapplying Myconolak.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicinal product. Before using any medicinal product, ask your doctor or pharmacist for advice.

3. How to Use Myconolak

Always use this medicinal product exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Apply the Myconolak nail lacquer to the infected nail surface once or twice a week, exactly as your doctor has told you.

Instructions for Use:

Step 1: Filing the Nail Before the first application of the lacquer, file away as much of the infected part of the nail as possible, including the nail surface, using the nail file provided. WARNING: Do not use nail files that have been used to file infected nails on healthy nails, as this may spread the infection. To avoid spreading the infection, make sure that no one else uses the nail files from your kit.

Step 2: Cleaning the Nail Use one of the swabs provided (or a nail cleaner) to clean the nail surface.

Repeat steps 1 and 2 for each infected nail.

Step 3: Taking a Small Amount of Lacquer from the Bottle

Dip the spatula into the bottle with the nail lacquer. Do not wipe the lacquer against the edge of the bottle before applying it.

Step 4: Applying the Lacquer

Apply the lacquer evenly to the entire nail surface. Repeat this step for each infected nail. Let the lacquer dry for about 3 minutes. Wait at least 10 minutes before applying a cosmetic nail lacquer.

Step 5: Cleaning the Spatulas

The provided spatulas are for repeated use. However, it is essential to clean the spatula with the same swab used to wipe the nail surface after each use. Avoid touching the swab to the nails that have just been treated. Close the bottle with the lacquer tightly. Carefully dispose of the swab, as it is flammable.

• Before reapplying the nail lacquer, first remove the old medicinal lacquer and any cosmetic lacquer from the nails using a swab, and then file the nails if necessary.
• Reapply the lacquer as described earlier.
• After drying, the applied lacquer is resistant to soap and water, so you can wash your hands and feet as usual. If you need to use chemical substances such as paint thinners or nail polish remover, wear rubber gloves or other impermeable (waterproof) gloves to protect the lacquer on your nails.
• It is essential to continue using Myconolak until the infection has cleared and healthy nails have grown out. This usually takes 6 months for fingernails and 9-12 months for toenails.

Your doctor will probably check the progress of the treatment, approximately every 3 months.

Accidental Ingestion of Myconolak

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

Missing an Application of Myconolak

Do not worry if you forget to apply the lacquer at the right time. As soon as you remember, start using the lacquer again in the same way as before.

Stopping the Use of Myconolak

Do not stop the treatment until your doctor tells you to, as the infection may return. If you have any further questions about using this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Myconolak can cause side effects, although not everybody gets them. Stop using the medicinal product and contact a doctor immediately if you experience:

• A 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).

Rare (May Affect Up to 1 in 1,000 People):

• Nail damage, nail discoloration, brittle or fragile nails.

Very Rare (May Affect Up to 1 in 10,000 People):

• Burning sensation of the skin.

Frequency Not Known (Cannot be Estimated from the Available Data):

• Redness, itching, hives, blisters, and allergic skin reactions.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 medicinal product.

5. How to Store Myconolak

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
• Store in a temperature below 30°C. Protect from high temperatures. Store the bottle in an upright position, tightly closed.

Flammable Product! Keep 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 Package and Other Information

What Myconolak Contains

The active substance of Myconolak 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, and anhydrous ethanol.

What Myconolak Looks Like and Contents of the Package

Myconolak is a clear, colorless to pale yellow solution. Available pack sizes: 2.5 ml, 3 ml, 5 ml; 1 bottle packaged with swabs (or without swabs), spatulas, and nail files (or without nail files). Myconolak is also available in pack sizes of 7.5 ml and 10 ml; 2 bottles packaged with swabs (or without swabs), spatulas, and nail files (or without nail files). 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 For more information on this medicinal product, including its names in the Member States of the European Economic Area, please contact the marketing authorization holder: Aristo Pharma Sp. z o.o., ul. Baletowa 30, 02-867 Warsaw tel.: +48 22 855 40 93 fax: +48 22 855 40 95 Date of Last Revision of the Package Leaflet:April 2021