Mykodermina
Poland
Table of Contents
Patient Information Leaflet: Information for the Patient
Mykodermina, (60 mg)g, ointment
Mono-N-ethanol-undecylenamidum
Please read this 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 for future reference.
- Consult your pharmacist if you need advice or further information.
- If any adverse reactions occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist.
- If there is no improvement after a few days, or if the patient feels worse, consult a doctor.
Table of Contents
- 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 an ointment containing the active substance - monoethanolamide of undecylenic acid. Mykodermina is used topically and acts against fungi of the genera Trichophyton, Microsporum, and Epidermophyton, as well as against yeast-like fungi. The medicine has 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:
- Superficial dermatophytosis of smooth and hairy skin,
- Athlete's foot (tinea pedis),
- Cutaneous candidiasis, fungal eczema,
- As supportive treatment for fungal skin infections and interdigital fissures, nail fungal infections, candidiasis, and for prophylactic use.
If there is no improvement after a few days, or if the patient feels worse, medical advice should be sought.
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
This is a topical medicine for use on the skin.
Do not apply this medicine to open wounds or mucous membranes.
This medicine may cause local skin reactions (e.g. contact dermatitis).
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 if you are currently using, have recently used, or plan to use any other medicines.
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 a 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 effect on the ability to drive and operate machinery has been observed.
Mykodermina contains lanolin, which may cause local skin reactions, e.g. contact dermatitis.
3. How to use Mykodermina
This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your 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 physician, affected or at-risk areas should be treated with the medicine once or twice daily.
After symptoms of infection have resolved, 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 medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
Transient, local skin irritation may occur – frequency cannot be determined from available data.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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 this 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 in use. This will help protect the environment.
6. Contents of the packaging and other information
What Mykodermina contains
- The active substance is undecylenic acid monoethanolamide.
- 1 gram of the ointment contains 60 mg of undecylenic acid monoethanolamide.
- Other components of the medicine are: white vaseline, lanolin, liquid paraffin, liquid paraffin, solid paraffin, cholesterol.
What Mykodermina looks like and contents of the pack
Mykodermina is an ointment.
The medicine is packed in a polyethylene container (HDPE – container, LD0 – lid).
The pack contains 50 g of ointment.
Marketing Authorisation Holder
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
tel. 22 756 76 21