Scholl set for nail fungus

Patient Information Leaflet

Scholl Nail Fungus Treatment Kit, 50 mg/mL, medicinal nail lacquer
Amorolfine (as amorolfine hydrochloride)
Please read this leaflet carefully before using this medicine, as it contains
important information for you.
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 outcome, Scholl Nail Fungus Treatment Kit should be used carefully.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after three months, or if you feel worse, consult your doctor.

Leaflet Contents

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

1. What Scholl Nail Fungus Treatment Kit is and what it is used for

• Scholl Nail Fungus Treatment Kit is used to treat fungal infections affecting up to two nails, limited to the upper half or sides of the nail (as shown in the first picture below). If the infection looks more like the one shown in the second or third picture, you should consult your doctor.
• The active substance in Scholl Nail Fungus Treatment Kit is amorolfine (as amorolfine hydrochloride), which belongs to a group of antifungal medicines.
• Scholl Nail Fungus Treatment Kit kills various types of fungi that may cause nail infections. Fungal nail infection can cause discoloration of the nail plate (white, yellow or brown spots), thickening of the nail, or brittle nails, although the appearance of nails may vary significantly, as shown in the pictures below:

2. Important information before using Scholl Nail Fungus Treatment Set

When not to use Scholl Nail Fungus Treatment Set:

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

Warnings and precautions
The medicine may cause allergic reactions, some of which may be serious. In such a case,
treatment should be stopped immediately, the medicine should be removed immediately using nail polish remover or cleansing pads, and medical advice should be sought. The medicine must not be used again.
Urgent medical attention is required if any of the following symptoms occur:

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

Before starting treatment with Scholl Nail Fungus Treatment Set, discuss the following 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 hands and feet
• if the nail is severely damaged or infected

If Scholl Nail Fungus Treatment Set gets into the eyes or ears, rinse immediately with water and contact a doctor, pharmacist or nearest hospital without delay.
Avoid contact of the nail lacquer with mucous membranes (e.g. mouth and nostrils). Do not inhale the nail lacquer.
When using organic solvents, wear impermeable gloves to prevent removal of the nail lacquer.
During treatment with amorolfine, do not use cosmetic nail polish or apply artificial nails.
Scholl Nail Fungus Treatment Set and other medicines
The nail lacquer may be used while taking other medicines.
Use with other nail products
During treatment with Scholl Nail Fungus Treatment Set, do not use cosmetic nail polish or apply artificial nails.
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
Do not use Scholl Nail Fungus Treatment Set. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine. The doctor will decide whether Scholl Nail Fungus Treatment Set should be used.
Before using any medicine, consult a doctor or pharmacist.
Scholl Nail Fungus Treatment Set contains ethanol
This medicine contains 482.53 mg of alcohol (ethanol) per mL of nail lacquer. The medicine may cause a stinging 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 Scholl Nail Fungus Treatment Set

The Scholl Nail Fungus Treatment Set should always be used as directed by a doctor or
pharmacist. If in doubt, consult a doctor or pharmacist.
Adults (including elderly people)
Before starting treatment
Shade the area affected by nail fungus on the diagram below. This will help you remember the
original appearance of the nail during treatment assessment. Every three months, re-shade the
diseased area until healthy nails have fully regrown. If fungal infection affects more than one nail,
the diagram should reflect the appearance of the nail most severely affected. Show this leaflet to
your pharmacist or podiatrist during treatment review to inform them about your treatment progress.

Before treatment Three months Six months Nine months
Instructions for use

• Treat infected nails according to the description below. NAILS SHOULD BE TREATED ONCE A WEEK.
• Apply the nail lacquer once a week for 6 months for fingernails and for 9 to 12 months for toenails. Treatment review every approximately three months is recommended.
• Nail growth is a slow process, so first signs of improvement in the nail plate are usually visible after 2 to 3 months of treatment.
• Continue using the lacquer until the infection has cleared and healthy nails have regrown.
• For each diseased nail, strictly follow the steps described below:

Step 1: Filing the nail

Before the first application of the lacquer, file down the infected areas of the nail, including the nail surface, as much as possible using the provided nail file.
WARNING: To avoid spreading the infection, do not use nail files intended for infected nails on healthy nails. Also ensure that no one else uses these nail files.
Step 2: Cleaning the nail
Use one of the included swabs (or nail cleanser) to clean the nail surface. Repeat steps 1 and 2 for each diseased nail.

Step 3: Applying the lacquer

Dip one of the reusable applicators into the nail lacquer bottle. Do not wipe the applicator against the rim of the bottle before applying. Apply the lacquer evenly over the entire nail surface. Repeat this step for each diseased nail.
Leave the lacquer on the treated nail(s) to dry for approximately 3 minutes.
Step 4: Cleaning the applicator

The provided applicators are reusable. However, it is important to clean them thoroughly after each use with the same swab used to clean the nail. Avoid touching freshly painted nails with the swab. Close the nail lacquer bottle tightly and dispose of the swab carefully, as it is flammable.

• Before reapplying the lacquer, remove the old lacquer from the nails using a swab, and if necessary, file the nails again.
• Reapply the lacquer according to the instructions above.
• Once dry, the applied lacquer is resistant to soap and water, so the patient may wash their hands and feet as usual. If chemicals such as paint thinners or mineral spirits must be used, wear rubber or other impermeable (waterproof) gloves to protect the nail lacquer.
• Continue using the lacquer until the infection has cleared and healthy nails have regrown. This usually takes 6 months for fingernails and 9 to 12 months for toenails. The patient will observe the growth of healthy nail as the infected nail grows out.

Before treatment After treatment
Accidental ingestion of Scholl Nail Fungus Treatment Set
If the patient or anyone else swallows the lacquer, contact a doctor, pharmacist, or nearest hospital immediately.
Missed application of Scholl Nail Fungus Treatment Set
Do not worry if the patient forgets to use the lacquer at the scheduled time. As soon as they remember, they should resume using the product in the same way as before.
Stopping use of Scholl Nail Fungus Treatment Set
Do not stop using Scholl Nail Fungus Treatment Set unless advised by a doctor, as the infection may otherwise return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone will experience them.
Rare (may affect up to 1 in 1,000 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 around the nail.
Frequency not known (frequency cannot be estimated from the available data)
Redness, itching, hives, blistering, and skin allergic reactions (contact dermatitis).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Adverse effects 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Scholl Nail Fungus Treatment Set

• Keep the medicine out of sight and reach of children.
• Do not use Scholl Nail Fungus Treatment Set 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. Keep the bottle tightly closed and in an upright position.

This product is flammable! 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Scholl Nail Fungus Treatment Kit contains
1 mL of Scholl Nail Fungus Treatment Kit contains 55.74 mg of amorolfine hydrochloride (corresponding
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 Nail Fungus Treatment Kit looks like and contents of the pack
Scholl Nail Fungus Treatment Kit is a clear, colourless to pale yellow solution. It is available in 2.5 mL and
3 mL packs; 1 bottle with applicators, swabs impregnated with isopropyl alcohol, and single-use nail files
in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Scholl’s Wellness Company B.V.
Herikerbergweg 238, Luna Arena,
1101 CM Amsterdam, The Netherlands
Tel. +31205755600
Manufacturer:
Chanelle Medical Unlimited Company
Dublin Road
Loughrea
Co. Galway
H62 FH90
Ireland