Exoderil

Package Leaflet: Information for the Patient

Exoderil

10 mg/g, cream

Naftifine hydrochloride

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, 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. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Exoderil and what is it used for
• 2. Important information before using Exoderil
• 3. How to use Exoderil
• 4. Possible side effects
• 5. How to store Exoderil
• 6. Package contents and other information

1. What is Exoderil and what is it used for

Exoderil is a cream for topical use on the skin. It contains the active substance naftifine, which has antifungal properties and kills most fungi, yeasts, and molds that cause skin infections in humans.

Exoderil is used for the local treatment of fungal skin infections, such as:

• skin and skin fold fungus, e.g., smooth skin fungus, groin fungus (often itching, irregular, pink-red, slightly raised spots, which may have nodules and blisters on the edge);
• interdigital fungus (hand or foot fungus), usually manifested by excessive peeling and cracking of the skin, with itching and burning;
• skin infection caused by yeast (such an infection is also called candidiasis or yeast infection), manifested by itching, red, often peeling spots, with blisters that may form around them;
• pityriasis versicolor (spotted changes in color from white to brown, irregular, with a peeling surface, occurring mainly on the torso; these changes do not change color under the influence of the sun).

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, the patient should discuss it with their doctor or pharmacist.

• The medicine should not be used in the eye, mouth, or on mucous membranes and wounds, as it may cause irritation. These areas should be protected from contact with Exoderil.
• If symptoms of skin irritation occur, the patient should stop using the medicine and contact their doctor.

Exoderil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use, especially those for topical use.

No studies have been conducted on the interaction of Exoderil with other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Exoderil should not be used during pregnancy or breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

The medicine contains benzyl alcohol, cetyl alcohol, and stearyl alcohol

The medicine contains 10 mg of benzyl alcohol in 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 package leaflet for the patient or as directed by a doctor or pharmacist.

In case of doubt, the patient should consult their doctor or pharmacist.

The medicine is intended for topical use on the skin only.

A thin layer of Exoderil should be applied once a day to the affected skin and surrounding areas.

Before using the medicine, the skin should be washed and dried.

Exoderil should be used for at least 7 days.

Relief of infection symptoms (such as itching and burning) usually occurs quickly.

To prevent the recurrence of the disease, the patient should continue using Exoderil for 2 weeks after the symptoms have disappeared.

Not following this recommendation may lead to the recurrence of the infection.

If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Use in children

The medicine should not be used in children.

What to do while using Exoderil

Microorganisms that cause fungal infections can be found on parts of clothing that come into contact with affected areas of the skin.

Therefore, the patient should take care to change these parts of their clothing daily.

Healthy, dry skin is the best protective barrier against fungal infections.

The patient should remember to dry the affected skin thoroughly after washing and change their towel daily.

The patient should avoid wearing tight, non-breathable clothing (such as synthetic fiber socks in closed shoes) that comes into contact with the affected skin.

If the fungal infection affects the feet, the patient should avoid walking barefoot at home or in public places (e.g., at the pool).

This will help prevent the spread of the infection to others.

The patient should not use a sauna or steam room until the infection is fully cured.

Using more than the recommended dose of Exoderil

In case of using more than the recommended amount of Exoderil or accidental oral ingestion, the patient should contact their doctor immediately.

There is no specific antidote known.

The following overdose symptoms may occur: skin irritation, redness, dryness, and burning.

Missing a dose of Exoderil

The patient should continue using the medicine without increasing the next dose.

The patient should not use a double dose to make up for a missed dose.

Stopping the use of Exoderil

The patient should not stop using the medicine immediately after the symptoms have disappeared, as this may lead to the recurrence of the infection.

The patient should continue using Exoderil for 2 weeks after the symptoms have disappeared to ensure complete cure.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

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

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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, it is possible to gather more information on the safety of the medicine.

5. How to store Exoderil

The medicine should be stored out of sight and reach of children.

Store in a temperature 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 month stated.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Package contents and other information

What Exoderil contains

• The active substance of the medicine is naftifine hydrochloride.
• 1 gram of cream contains 10 mg of naftifine hydrochloride.
• The 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 what the package contains

The medicine is a cream.

Package: aluminum tube containing 15 g of cream, placed in a cardboard box with a leaflet.

Marketing authorization 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