Antifungal cream for feet

Package leaflet: Information for the user

Antifungal Cream for Feet, 10 mg/g, cream
Terbinafini hydrochloridum
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
the pharmacist.
This medicine is available without a prescription. However, to achieve the best treatment outcome,
Antifungal Cream for Feet should be used carefully.

• 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.
• If there is no improvement after 14 days of treatment, or if your condition worsens, consult your doctor.

Contents of the leaflet

1. What Antifungal Cream for Feet is and what it is used for
2. Important information before using Antifungal Cream for Feet
3. How to use Antifungal Cream for Feet
4. Possible side effects
5. How to store Antifungal Cream for Feet
6. Contents of the pack and other information

1. What Antifungal Cream for Feet is and what it is used for

Antifungal Cream for Feet contains terbinafine hydrochloride, an antifungal medicine used to treat fungal infections.
Antifungal Cream for Feet is used to treat athlete's foot (tinea pedis). Athlete's foot is a fungal infection affecting the feet (usually both, though not always).
This condition is caused by common fungi that thrive in warm and moist environments. Infections often occur in public showers at swimming pools or gyms.
Athlete's foot causes redness between the toes, accompanied by itching and burning. Untreated, it may lead to skin cracking and excessive peeling between the toes or on the soles of the feet.
If you are unsure whether you have athlete's foot, consult your doctor or pharmacist for advice.

2. Important information before using the medicinal product Antifungal Cream for Feet

When should the medicinal product Antifungal Cream for Feet not be used:

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

Warnings and precautions
Before starting to use the medicinal product Antifungal Cream for Feet, discuss this with your doctor or pharmacist.
Consult your doctor or pharmacist if the patient is under 16 years of age.
This medicinal product is intended for external use only – do not place it in the mouth and do not swallow. If the product is accidentally swallowed, contact a doctor or pharmacist immediately.
Avoid contact of the cream with eyes, face, and mucous membranes. If the cream gets into the eyes, wipe it off the eye area and rinse the eyes thoroughly with clean water, then contact a doctor or pharmacist immediately.
Discontinue use if irritation occurs.

Children and adolescents
Use of the medicinal product Antifungal Cream for Feet is not recommended in children under 16 years of age.

Antifungal Cream for Feet and other medicinal products
No interactions between Antifungal Cream for Feet and other medicinal products are known.

Pregnancy and breastfeeding

• If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicinal product. If the doctor has been informed, follow his or her instructions exactly.
• If the patient is breastfeeding, she should consult a doctor or pharmacist before using this medicinal product.

Driving and operating machinery
There are no data available regarding the effect on driving and operating machinery.

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

3. How to use the medicine Krem przeciwgrzybiczny do stóp

• Before each application, thoroughly wash and dry the affected areas (especially between the toes) and your hands.
• Before the first use, pierce the tube opening by pressing the top part of the cap into it. Apply a small amount of cream onto your fingertip.
• Apply a thin layer of cream to the affected areas and the surrounding skin, and gently rub in.
• Wash your hands. You may additionally apply a gauze dressing, especially at night, replacing it with a new one each time the cream is applied.

Apply the cream once or twice daily for exactly one week. If excessively long
intervals occur during treatment, the medicine may cease to be effective.
Symptoms of athlete's foot, such as itching or pain, should subside within a few days, but symptoms such
as redness and scaling may persist longer. These symptoms should gradually resolve,
even after discontinuing the use of the cream.
If there is no improvement observed two weeks after completing treatment, consult a
doctor or pharmacist. Treatment will be more effective if the following simple
recommendations are followed:

• Despite frequent itching, try not to scratch the affected area. Scratching may cause superficial skin damage, which could lead to the spread of infection.
• The affected areas should be kept clean and dry, but avoid excessive rubbing.
• To help prevent recurrence of infection, it is advisable to regularly wash used towels, socks, or stockings, and not to share them with other people.

Missed application of the medicine Krem przeciwgrzybiczny do stóp
It is very important to use the medicine Krem przeciwgrzybiczny do stóp regularly, as missing applications
may lead to a recurrence of the infection.
If a dose is missed, apply the cream as soon as possible and then continue treatment as previously directed.
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

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

Uncommon (may occur in up to 1 in 1,000 patients):

• redness, stinging, itching of the skin may occur.

Rare (may occur in up to 1 in 10,000 patients):

• allergic reaction to the medicine, which may cause swelling, pain or hives, may rarely occur.

Not known (frequency cannot be estimated from the available data):

• burning sensation after application of the cream and irritation at the application site.

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
Phone: +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 this medicine.

5. How to store the medicine Krem przeciwgrzybiczny do stóp

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer carton and tube.
• Shelf life after first opening of the tube: 2 weeks.
• Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. If the medicine has expired, return it to a pharmacist, who will dispose of it in accordance with local regulations.
• No special storage conditions apply.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What the medicine Krem przeciwgrzybiczny do stóp contains
The active substance 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 Krem przeciwgrzybiczny do stóp looks like and contents of the pack
The cream is uniformly white.
Available pack:
Aluminium tube containing 7.5 g or 15 g of cream. Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the European Economic Area countries 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% cream

2020-02-10