Sholl Zestav na gzhibicem paznokci

Leaflet accompanying the packaging: information for the user

Scholl Fungal Nail Set, 50 mg/mL, medicinal nail polish,

Amorolfine (in the form of amorolfine hydrochloride)

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
This medicine is available without a prescription. However, to achieve the best treatment results, the Scholl Fungal Nail Set should be used with caution.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after three months there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Scholl Fungal Nail Set and what is it used for

• Scholl Fungal Nail Set is used to treat fungal nail infections limited to two nails and affecting the upper half or sides of the nail (as shown in the first picture below). If the infection resembles the one shown in the second or third picture, you should consult a doctor.
• The active substance of Scholl Fungal Nail Set is amorolfine (in the form of amorolfine hydrochloride), which belongs to the group of antifungal medicines.
• Scholl Fungal Nail Set kills various types of fungi that can cause nail infections. Fungal nail infection can cause a change in the color of the nail plate (discoloration in white, yellow, or brown), thickening of the nail plate, or brittleness of the nails, although the appearance of the nails can vary greatly, as shown in the pictures below:

2. Important information before using Scholl Fungal Nail Set

When not to use Scholl Fungal Nail Set:

• if the patient is allergic (hypersensitive) to the active substance (amorolfine) or any of the other ingredients of Scholl Fungal Nail Set (listed in section 6);
• 6);
• if the patient is under 18 years of age.

Warnings and precautions

The medicine may cause allergic reactions, and some of them can be serious. In such a case, you should stop using the medicine, immediately remove it with a nail polish remover or cleaning pads, and consult a doctor. The medicine should not be reapplied.
If any of the following symptoms occur, urgent medical attention is required:

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

Before starting to use Scholl Fungal Nail Set, you should discuss it with your doctor, pharmacist, or nurse:

• if the patient has diabetes
• if the patient is being treated for a weakened immune system
• if the patient has poor circulation in the hands and feet
• if the nail is severely damaged or infected

If Scholl Fungal Nail Set gets into the eyes or ears, you should immediately rinse them with water and contact a doctor, pharmacist, or the nearest hospital.
You should avoid contact between the nail polish and mucous membranes (e.g., mouth and nostrils). You should not inhale the polish.
When using organic solvents, you should wear impermeable gloves to prevent the removal of the polish from the nails.
During treatment with amorolfine, you should not use cosmetic nail polish or apply artificial nails.

Scholl Fungal Nail Set and other medicines

You can use the nail polish while taking other medicines.

Using with other nail products

While using Scholl Fungal Nail Set, you should not use cosmetic nail polish or apply artificial nails.
You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

You should not use Scholl Fungal Nail Set. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor before using this medicine. The doctor will decide whether you should use Scholl Fungal Nail Set.
Before using any medicine, you should consult a doctor or pharmacist.

Scholl Fungal Nail Set contains ethanol

This medicine contains 482.53 mg of alcohol (ethanol) per mL of nail polish. The medicine may cause burning of damaged skin. Due to the presence of ethanol, the medicine is flammable. You should not use it near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).

3. How to use Scholl Fungal Nail Set

Scholl Fungal Nail Set should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.

Adults (including the elderly)

Before starting treatment

On the scheme below, you should shade the area affected by the fungal nail infection. This will help you remember the original appearance of the nail during treatment verification. Every three months, you should shade the changed area until a healthy nail grows out. If the fungal infection affects more than one nail, the scheme should reflect the appearance of the most affected nail. You should show this leaflet to your pharmacist or podologist during treatment verification to inform them about the progress of the treatment.

Before treatment Three months Six months Nine months

Instructions for use

• You should treat the infected nails according to the description below. NAILS SHOULD BE TREATED ONCE A WEEK.
• The polish should be applied once a week for a period of 6 months in the case of fingernails and for a period of 9 to 12 months in the case of toenails. It is recommended to verify the treatment at approximately three-month intervals.
• Nail growth is a slow process, so the first signs of improvement in the nail plate condition are usually visible after 2 to 3 months of treatment.
• You should continue using the polish until the infection disappears and healthy nails grow out.
• For each affected nail, you should carefully follow the following steps:

Step 1: Filing the nail

Before the first application of the polish, you should file the infected areas of the nail, including the surface of the nail, using the enclosed nail file.
WARNING: To avoid spreading the infection, files used for diseased nails should not be used for healthy nails. Additionally, you should ensure that no one else uses these files.

Step 2: Cleaning the nail

You should use one of the enclosed swabs (or nail polish remover) to clean the surface of the nail. You should repeat steps 1 and 2 for each affected nail.

Step 3: Applying the polish

You should dip one of the reusable applicators into the bottle with the polish. Before applying the polish, you should not wipe it against the edge of the bottle. The polish should be applied evenly to the entire surface of the nail. You should repeat this step for each affected nail.
You should leave the polish on the treated nail (nails) to dry for about 3 minutes.

Step 4: Cleaning the applicator

The enclosed applicators are for multiple use. However, it is essential to clean them thoroughly after each treatment with the same swab used for cleaning the nails. You should avoid touching the swab to freshly polished nails. You should close the bottle with the nail polish tightly and carefully dispose of the swab, as it is flammable.

• Before reusing the polish, you should remove the old polish from the nail using a swab, and then re-file the nails if necessary.
• You should reapply the polish according to the above description.
• After drying, the applied polish is resistant to soap and water, so you can wash your hands and feet as usual. If you need to use chemicals, such as paint thinners or mineral spirits, you should wear rubber or other impermeable (waterproof) gloves to protect the polish on your nails.
• You should continue using the polish until the infection disappears and healthy nails grow out. This usually takes 6 months for fingernails and 9 to 12 months for toenails. You will be able to observe the growth of a healthy nail as the diseased nail grows out.

Before treatment
After treatment

Accidental ingestion of Scholl Fungal Nail Set

If you or someone else swallows the polish, you should immediately contact a doctor, pharmacist, or the nearest hospital.

Missing a dose of Scholl Fungal Nail Set

You should not worry if you forget to use the polish at the right time. As soon as you remember, you should start using the medicine again in the same way as before.

Stopping the use of Scholl Fungal Nail Set

You should not stop using Scholl Fungal Nail Set until your doctor decides to, as the infection may recur.
If you have any further questions about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

Rare (may affect up to 1 in 1000 people)

The nail may become discolored, brittle, or fragile.

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

A burning sensation may occur in the nail area.

Frequency not known (frequency cannot be estimated from the available data)

Redness, itching, hives, blisters, and allergic skin reaction (contact dermatitis).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
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 Scholl Fungal Nail Set

• The medicine should be stored out of sight and reach of children.
• You should not use Scholl Fungal Nail Set after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the specified month.
• Store in a temperature below 30°C. Store the bottle tightly closed, in an upright position.

This product is flammable! You should store the solution away from fire and flames!

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Scholl Fungal Nail Set contains

1 mL of Scholl Fungal Nail Set contains 55.74 mg of amorolfine hydrochloride (which corresponds to 50 mg of amorolfine). The excipients are: Eudragit RL 100 (ammonio methacrylate copolymer, type A), triacetin, butyl acetate, ethyl acetate, anhydrous ethanol.

What Scholl Fungal Nail Set looks like and what the pack contains

Scholl Fungal Nail Set is a clear, colorless to pale yellow solution. It is available in 2.5 mL and 3 mL packs; 1 bottle with enclosed spatulas, swabs soaked in isopropyl alcohol, and single-use paper nail files in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Scholl’s Wellness Company B.V.
Herikerbergweg 238, Luna Arena,
1101 CM Amsterdam, Netherlands
Phone: +31205755600

Manufacturer:

Chanelle Medical Unlimited Company
Dublin Road
Loughrea
Co. Galway
H62 FH90
Ireland
Date of last revision of the leaflet:17.08.2023