Mikodermina

Leaflet attached to the packaging: patient information

Mykodermina, (30 mg + 100 mg)g, medicinal powder
Mono-N-ethanol-undecylenamide + Zinc undecylenate

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor
or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• A pharmacist should be consulted if advice or additional information is needed.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed.
• If there is no improvement or the patient feels worse after a few days, a doctor should be consulted.

Table of contents of the leaflet

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

1. What is Mykodermina and what is it used for

Mykodermina is a powder that contains the active substances monoethanolamide of undecylenic acid and zinc undecylenate. Mykodermina is used topically and acts on fungi of the genus Trichophyton, Microsporium, and Epidermophyton, as well as on yeast-like fungi. The medicine has a fungistatic effect (inhibiting fungal growth) and, at high concentrations, a fungicidal effect. The medicine acts on the mycelium and spores.
Mykodermina is used to treat:

• fine-spored skin fungus,
• athlete's foot,
• skin fungus, fungal eczema,
• supporting fungal infections of the skin and interdigital spaces, nail fungus, in yeast infections, and as a preventive measure. If there is no improvement or the patient feels worse after a few days, a doctor should be consulted.

2. Important information before using Mykodermina

When not to use Mykodermina:

• if the patient is allergic to monoethanolamide of undecylenic acid, zinc undecylenate, or any of the other ingredients of this medicine (listed in point 6).

Warnings and precautions

The medicine is for external use on the skin.
The medicine should not be used on open wounds and mucous membranes.

Children and adolescents

The medicine can be used in children over 2 years of age.
Do not use in children under 2 years of age.

Mykodermina and other medicines

The doctor or pharmacist should be informed about all medicines currently being used or recently used, as well as any medicines the patient plans to use.
Mykodermina enhances the effect of nystatin and griseofulvin.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
There is no data on the use of Mykodermina during pregnancy and breastfeeding.

Driving and using machines

No adverse effect on driving or using machines has been observed.

3. How to use Mykodermina

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor
or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
Mykodermina is intended for external use only.
The medicine should be applied to clean and thoroughly dried skin. Unless otherwise directed by a doctor, areas affected by fungus or at risk of fungus should be dusted with the medicine 2 or 3 times a day.
After the symptoms of the infection have disappeared, treatment with Mykodermina should be continued for at least 4 weeks.
If the patient feels that the effect of Mykodermina is too strong or too weak, a doctor should be consulted.

Use in children and adolescents

Adolescents and children over 2 years of age - use as in adults.
Do not use in children under 2 years of age.

Using more than the recommended dose of Mykodermina

No data available. No cases of overdose have been reported.

Missing a dose of Mykodermina

A double dose should not be used to make up for a missed dose.

Stopping the use of Mykodermina

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Transient, local skin irritation may occur - the frequency is not known and cannot be determined based on available data.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl.
Reporting side effects will help gather more information on the safety of the medicine

5. How to store Mykodermina

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the label after "Expiry date": the expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Mykodermina contains

• The active substances of the medicine are monoethanolamide of undecylenic acid and zinc undecylenate.
• 1 gram of medicinal powder contains 30 mg of monoethanolamide of undecylenic acid and 100 mg of zinc undecylenate.
• The other ingredient of the medicine is talc.

What Mykodermina looks like and what the package contains

Mykodermina is a medicinal powder.
The package is a white polyethylene container with a lid and a sieve to facilitate dosing of the powder, closed with a flip-top polyethylene lid.
The package contains 15 g of medicinal powder.

Responsible entity

Starpharma Sp. z o.o.
ul. Jedności 9,
05-506 Lesznowola

Manufacturer:

Starpharma Sp. z o.o.
ul. Kościuszki 24
05-500 Piaseczno
phone: 22 756 76 21
Date of last update of the leaflet:09/2023