Package leaflet: Information for the patient

Mykodermina, (30 mg + 100 mg)g, medicinal powder
Mono-N-ethanol-undecylenamidum + Zinci undecylenas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used according to the instructions provided in this patient leaflet or as directed by a physician or pharmacist.

Keep this leaflet so that you can read it again if necessary.
Consult your pharmacist if you need advice or further information.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
If there is no improvement after several days, or if the patient feels worse, consult a doctor.

Table of contents of the leaflet

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

1. What Mykodermina is and what it is used for

Mykodermina is a powder formulation containing the active substances monoethanolamide of undecylenic acid and zinc undecylenate. When applied topically, Mykodermina acts against fungi of the genera Trichophyton, Microsporum, and Epidermophyton, as well as against yeast-like fungi. The medicine exerts a fungistatic effect (inhibiting fungal growth) and, at higher concentrations, a fungicidal effect. It acts on fungal hyphae and spores.

Mykodermina is indicated for the treatment of:

Cutaneous microsporosis (superficial fungal infection of smooth skin),
Athlete's foot (tinea pedis),
Cutaneous candidiasis, fungal eczema,
As an adjunctive treatment for fungal infections of the skin and interdigital folds, fungal nail infections, candidiasis, and for prophylactic use. If there is no improvement after several days, or if the patient feels worse, consult a doctor.

2. Important information before using Mykodermina

When not to use Mykodermina:

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

Warnings and precautions
This is a topical medicine for use on the skin.
Do not apply this medicine on open wounds or mucous membranes.
Children and adolescents
Mykodermina may be used in children over 2 years of age.
Do not use in children under 2 years of age.
Mykodermina and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Mykodermina enhances the action of nystatin and griseofulvin.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There is no data available on the use of Mykodermina during pregnancy and breastfeeding.
Driving and operating machinery
No adverse effects on driving and operating machinery have been observed.

3. How to use Mykodermina

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Mykodermina is intended for external use only.
The medicine should be applied to clean and thoroughly dried skin. Unless otherwise directed by a doctor, affected or at-risk areas should be dusted with the medicine 2 or 3 times daily.
After symptoms have subsided, treatment with Mykodermina should be continued for at least 4 weeks.
If you feel that the effect of Mykodermina is too strong or too weak, consult your doctor.
Use in children and adolescents
Adolescents and children above 2 years of age – use as in adults.
Do not use in children under 2 years of age.
Use of a higher than recommended dose of Mykodermina
No data available. No cases of overdose have been reported.
Missed dose of Mykodermina
Do not use a double dose to make up for a missed dose.
Discontinuation of Mykodermina
If you have any further doubts 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 gets them.
Transient, local skin irritation may occur – frequency cannot be determined from available data.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please 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
e-mail: [email protected] .
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mykodermina

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Mykodermina contains

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

What Mykodermina looks like and contents of the pack
Mykodermina is a medicinal powder.
The medicine comes in a white polyethylene container fitted with a cap containing a sieve for easy powder dosing, closed with a polyethylene flip-top cap.
The pack contains 15 g of medicinal powder.
Marketing Authorisation Holder
Starpharma Sp. z o.o.
9 Jedności Street,
05-506 Lesznowola
Manufacturer:
Starpharma Sp. z o.o.
24 Kościuszki Street
05-500 Piaseczno
tel. 22 756 76 21