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Leaflet attached to the packaging: information for the user

Athlete's foot antifungal cream, 10 mg/g, cream

Terbinafine 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 taken exactly as described in this patient leaflet or as advised by the pharmacist. This medicine is available without a prescription. However, to achieve the best treatment result, the Athlete's foot antifungal cream should be used cautiously.

• Please 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 inform their doctor or pharmacist.
• If after 14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Athlete's foot antifungal cream and what is it used for
• 2. Important information before using Athlete's foot antifungal cream
• 3. How to use Athlete's foot antifungal cream
• 4. Possible side effects
• 5. How to store Athlete's foot antifungal cream
• 6. Contents of the packaging and other information

1. What is Athlete's foot antifungal cream and what is it used for

Athlete's foot antifungal cream contains terbinafine hydrochloride, a medicine from the group of antifungal medicines, used to treat fungal infections. Athlete's foot antifungal cream is used to treat "athlete's foot"(foot fungus). "Athlete's foot" is a fungal infection that affects only the feet (usually both, but not always). This disease is caused by common fungi that multiply well in warm and humid conditions. Infections can easily occur in public showers at swimming pools or gyms. "Athlete's foot" is characterized by redness between the toes, itching, and burning. Untreated foot fungus can lead to skin cracking and excessive peeling between the toes or on the soles of the feet. In case of doubt whether we are dealing with athlete's foot, you should consult a doctor or pharmacist.

2. Important information before using Athlete's foot antifungal cream

When not to use Athlete's foot antifungal cream:

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

Warnings and precautions

Before starting to use Athlete's foot antifungal cream, you should discuss it with your doctor or pharmacist. You should consult a doctor or pharmacist if the patient is under 16 years old. This medicine is intended for external use only- do not put it in the mouth or swallow it. If the medicine is accidentally swallowed, you should immediately contact a doctor or pharmacist. You should avoid contact of the medicine with the eyes, face, and mucous membranes. If the cream gets into the eyes, you should wipe the cream from the eye area, then rinse the eyes with clean water and immediately contact a doctor or pharmacist. You should stop using the medicine if irritation occurs.

Children and adolescents

It is not recommended to use Athlete's foot antifungal cream in children under 16 years old.

Athlete's foot antifungal cream and other medicines

No interactions of Athlete's foot antifungal cream with other medicines are known.

Pregnancy and breastfeeding

• If the patient is pregnant, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. If the doctor has been informed, the patient should follow their advice carefully.
• If the patient is breastfeeding, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

There is no available data on the effect on driving and using machines.

Warnings about excipients

This medicine contains 10 mg of benzyl alcohol in 1 g of cream. Benzyl alcohol may cause allergic reactions. The medicine may cause mild local irritation. This medicine contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Athlete's foot antifungal cream

• Before each use of the medicine, you should wash and dry the affected areas (especially between the toes) and your hands.
• Before the first use, pierce the tube by pressing the top of the cap into it. Apply a small amount of cream to your finger.
• Apply a thin layer of cream to the affected areas and the surrounding skin and gently rub it in.
• Wash your hands. You can also apply a gauze dressing, especially at night, changing it with each subsequent application of the cream.

Use the cream once or twice a day for exactly one week.If you make too long breaks during treatment, the medicine may stop working. The symptoms of foot fungus, such as itching or pain, should disappear after a few days, but symptoms such as redness and peeling may persist longer. These symptoms should gradually disappear, even after stopping the use of the cream.

If no improvement is observed after 2 weeks from the end of treatment, you should consult a

doctor or pharmacist. The treatment will be more effective if you follow these simple guidelines:

• Despite frequent itching, try not to scratch the affected area. Scratching can cause superficial skin damage, which can lead to the spread of the disease.
• The affected areas should be clean and dry, but you should avoid excessive rubbing.
• To protect yourself from the recurrence of infection, it is recommended to regularly wash used towels, socks, or tights and not to share them with other people.

Missing a dose of Athlete's foot antifungal cream

It is very important to use Athlete's foot antifungal cream regularly, as missing a dose may lead to the recurrence of the disease. If you miss a dose, you should apply the medicine as soon as possible and then continue the treatment as before. If you have any further doubts 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. Uncommon (may affect up to 1 in 100 patients)

• may cause redness, stinging, itching of the skin. Rare (may affect up to 1 in 10,000 patients)
• rarely may cause an allergic reaction to the medicine, which can cause swelling, pain, or hives. Unknown (frequency cannot be estimated from the available data)
• burning sensation after applying the cream and irritation at the application site.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, 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.: +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 Athlete's foot antifungal cream

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and tube.
• Shelf life after first opening the tube: 2 weeks.
• 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. If the expiry date of the medicine has passed, you should return it to the pharmacist, who will dispose of it in accordance with local regulations.
• There are no special precautions for storage.

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 Athlete's foot antifungal cream contains

The active substance of the medicine is terbinafine hydrochloride 10 mg/g. Excipients: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

What Athlete's foot antifungal cream looks like and what the pack contains

The cream is uniformly white. Available packaging Aluminum tube containing 7.5 g or 15 g of cream. Not all sizes may be marketed.

Marketing authorization holder

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

Manufacturer:

Laboratorios Liconsa, S.A. Avda. Miralcampo, Nº 7 Polígono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara) Spain

This medicine is authorized for marketing in the Member States of the European Economic Area under the following names:

United Kingdom Scholl Advance Athlete’s Foot Cream Germany Terbinafin Schollmed gegen Fußpilz Poland Krem przeciwgrzybiczny do stóp Romania Terbinafină Scholl 1% cremă

Date of last revision of the leaflet:

2020-02-10