Package leaflet: Information for the patient

Exoderil
10 mg/g, cream
Naftifine hydrochloride
Please read the entire leaflet carefully 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.

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 adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

What Exoderil is and what it is used for
Important information before using Exoderil
How to use Exoderil
Possible side effects
How to store Exoderil
Contents of the pack and other information

1. What Exoderil is and what it is used for

Exoderil is a topical cream. It contains the active substance naftifine, which has antifungal properties and kills most fungi, yeasts, and moulds that cause skin infections in humans.
Exoderil is used locally to treat fungal skin infections such as:

Dermatophytosis of skin and skin folds, e.g. tinea corporis, tinea cruris (often itchy, irregular, pink-red, slightly raised patches with papules and vesicles at the edges);
Interdigital fungal infection (tinea manuum, tinea pedis), most commonly presenting with excessive scaling and skin fissures, accompanied by itching and burning;
Fungal skin infection caused by yeasts (also known as candidiasis), manifesting as itchy, red, frequently desquamating patches, often surrounded by vesicles;
Pityriasis versicolor (discrete patches ranging in colour from white to brown, irregular, with a scaling surface, occurring mainly on the skin of the trunk; these lesions do not tan in response to sunlight).

2. Important information before using Exoderil

When not to use Exoderil

If the patient is allergic to naftifine or any of the other ingredients of this medicine (listed in section 6);
In children.

Warnings and precautions
Before starting to use Exoderil, discuss this with your doctor or pharmacist.

This medicine should not be used near the eyes, mouth, or on mucous membranes and open wounds, as it may cause irritation. These areas must be protected from contact with Exoderil.
If skin irritation symptoms occur, stop using the medicine and contact your doctor.

Exoderil and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using,
has recently used, or plans to use, especially those intended for topical use.
No studies have been conducted on interactions between Exoderil and other medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Exoderil should not be used during pregnancy or breastfeeding.

Driving and operating machinery
Exoderil has no influence on the ability to drive or operate machinery.

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

3. How to use Exoderil

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for external use on the skin only.
A thin layer of Exoderil should be applied once daily to the affected skin areas and surrounding regions. Before application, the skin should be washed and thoroughly dried.
Exoderil should be used for at least 7 days.
Symptoms of infection (such as itching and burning) usually improve quickly. To prevent recurrence of the disease, continue using Exoderil for 2 weeks after symptoms have disappeared. Failure to follow this recommendation may result in recurrence of infection.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Use in children
Exoderil should not be used in children.

Instructions for use of Exoderil
Microorganisms causing fungal infection may remain on clothing parts that are in contact with infected skin areas. Therefore, it is important to change such clothing daily.
Healthy, and especially dry skin, provides the best protective barrier against fungal infections. After washing, the affected skin should be thoroughly dried, and towels should be changed daily.
Avoid wearing tight, non-breathable clothing (e.g. synthetic socks worn with closed shoes) in contact with infected skin areas.
If the fungal infection affects the feet, avoid walking barefoot at home and in public places (e.g. swimming pools). This will help prevent spreading the infection to others.
Saunas or steam baths should not be used until the infection has completely resolved.

Use of a higher than recommended dose of Exoderil
In case of application of a larger than recommended amount of Exoderil or accidental oral ingestion, contact a doctor immediately. There is no known specific antidote.
Symptoms of overdose may include skin irritation, redness, dryness, and burning sensation.

Missed dose of Exoderil
Continue using the medicine as prescribed without increasing the next dose.
Do not use a double dose to make up for a missed dose.

Stopping treatment with Exoderil
Do not stop using Exoderil immediately after symptoms disappear, as this may lead to recurrence of infection. Continue using Exoderil for 2 weeks after symptoms have resolved to ensure complete cure.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Frequency unknown (cannot be estimated from available data):

contact dermatitis (skin rash or irritation at application site), erythema (redness of the skin);
redness, dryness of the skin, burning sensation of the skin; these symptoms are usually transient.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Exoderil

Keep the medicine out of the sight and reach of children.
Store below 30 °C, do not freeze.
Do not use Exoderil after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Exoderil contains

The active substance is naftifine hydrochloride. 1 gram of cream contains 10 mg of naftifine hydrochloride.
Other ingredients are: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

What Exoderil looks like and contents of the pack
The medicine is in the form of a cream.
Pack: aluminium tube containing 15 g of cream, placed in a cardboard box with a leaflet.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Salutas Pharma GmbH
Lange Goehren 3
D-39171 Osterweddingen, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel.: 22 209 70 00
e-mail: [email protected]