Mikodermina

Leaflet attached to the packaging: patient information

Mykodermina, (60 mg)g, ointment
Mono-N-ethanol-undecylenamide

Read the contents of 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 information 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 after a few days or the patient feels worse, 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 an ointment that contains the active substance monoethanolamide of undecylenic acid. 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 of smooth and hairy skin,
• athlete's foot,
• skin fungus, ringworm,
• supporting skin and interdigital fungal infections, nail fungus, in yeast infections, and as a preventive measure. If there is no improvement after a few days or the patient feels worse, 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 or any of the other ingredients of this medicine (listed in section 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.
The medicine may cause local skin reactions (e.g., contact dermatitis).

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, thinks they may be pregnant, or plans to have a child, they 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 effects on driving or using machines have been reported.
Mykodermina contains lanolin, which may cause local skin reactions, such as contact dermatitis.

3. How to use Mykodermina

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.
Mykodermina is 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 rubbed with the medicine 1 or 2 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, they should consult a doctor.

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 use of Mykodermina

If there are any further doubts about using this medicine, the 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 estimated from the 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 to 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 stated is the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Mykodermina contains

• The active substance of the medicine is monoethanolamide of undecylenic acid.
• 1 gram of ointment contains 60 mg of monoethanolamide of undecylenic acid.
• The other ingredients of the medicine are: white petrolatum, lanolin, liquid paraffin, solid paraffin, cholesterol.

What Mykodermina looks like and what the package contains

Mykodermina is an ointment.
The package is a polyethylene container (HDPE - container, LDPE - cap).
The package contains 50 g of ointment.

Responsible entity

Starpharma Sp. z o.o.
ul. Stawki 2, 23rd floor
00-193 Warsaw

Manufacturer

Starpharma Sp. z o.o.
ul. Kościuszki 24
05-500 Piaseczno
phone: 22 756 76 21

Date of last update of the leaflet: