MYCOSOLON 20 mg /2.5 Mg Ointment

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient
   2. Contents of the package leaflet:
2. What is Mycosolon and what is it used for
3. Important information before using Mycosolon
   1. When not to use Mycosolon:
   2. Warnings and precautions
   3. Children
   4. Mycosolon and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Mycosolon contains methyl parahydroxybenzoate (E 218), cetearyl alcohol, and propylene glycol (E 1520).
4. How to use Mycosolon
   1. Use in children and adolescents
   2. Using more than the recommended dose of Mycosolon
   3. Missing a dose of Mycosolon
5. Possible side effects
   1. Additional side effects in children
   2. Reporting side effects
6. How to store Mycosolon
7. Contents of the pack and other information
   1. What Mycosolon contains
   2. What Mycosolon looks like and contents of the pack
   3. Marketing authorization holder:
   4. For further information about this medicine, please contact the local representative of the marketing authorization holder.
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

MYCOSOLON (20 mg + 2.5 mg)/g, ointment
Miconazole + MaziPredoni hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

• 1. What is Mycosolon and what is it used for
• 2. Important information before using Mycosolon
• 3. How to use Mycosolon
• 4. Possible side effects
• 5. How to store Mycosolon
• 6. Contents of the pack and other information

1. What is Mycosolon and what is it used for

Mycosolon is an ointment that contains the active substances miconazole and maziPredoni.
Miconazole, when applied topically, has antifungal effects on dermatophytes, yeasts, and other fungi,
as well as antibacterial effects on Gram-positive bacteria and bacilli.
MaziPredoni belongs to a group of medicines called corticosteroids; when applied topically, it has
anti-inflammatory and antipruritic effects.
Mycosolon is indicated for the treatment of: inflammatory eczema, eczema, interdigital foot mycosis (athlete's foot), onychomycosis caused by dermatophytes and other fungi (e.g., Candida albicans), fungal infections with bacterial superinfection, and external ear canal mycosis.

2. Important information before using Mycosolon

When not to use Mycosolon:

• if you are allergic to maziPredoni, miconazole, other similar antifungal medicines, or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to isoconazole, tioconazole, or oxiconazole;
• on skin with tuberculosis, common herpes, chickenpox, and other viral and bacterial infectious skin diseases;
• in fungal infections of the hairy scalp, mucous membranes, and damaged skin.

Warnings and precautions

Before starting to use Mycosolon, discuss it with your doctor or pharmacist.
If an allergic reaction, skin irritation, skin atrophy, or systemic hypersensitivity reactions occur, discontinue use and contact your doctor immediately.
In case of hypersensitivity to isoconazole, tioconazole, or oxiconazole, cross-allergy may occur.
Avoid contact of the medicine with the eyes and mucous membranes.
Corticosteroids are absorbed through the skin, so during treatment, there is a risk of systemic side effects of maziPredoni, characteristic of corticosteroids, including adrenal cortex suppression. Therefore, you should also avoid using Mycosolon on a large skin surface, using it in large doses, and long-term use of the medicine.
On facial skin and skin of the armpits and groin, use only in cases where it is absolutely necessary, due to increased absorption of Mycosolon through delicate skin and the associated increased risk of vasodilation, perioral dermatitis, and skin atrophy, even after short-term use.
Avoid using the ointment under a tightly sealing dressing (e.g., cerate, diaper), as the dressing increases the absorption of the medicine into the body.

Children

No available data.

Mycosolon and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
Interactions with other medicines are very rare. You should be particularly careful if you are taking other medicines, especially anticoagulants such as warfarin, oral antidiabetic medicines, or phenytoin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
Mycosolon may be used during pregnancy only on the advice of a doctor, when the benefits of using the medicine for the mother outweigh the risk to the fetus.
Mycosolon may be used during breastfeeding only on the advice of a doctor.

Driving and using machines

Mycosolon has no influence on the ability to drive and use machines.

Mycosolon contains methyl parahydroxybenzoate (E 218), cetearyl alcohol, and propylene glycol (E 1520).

Methyl parahydroxybenzoate may cause allergic reactions (possible late reactions).
Cetearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
The medicine contains 80 mg of propylene glycol in each gram of ointment. Propylene glycol may cause skin irritation.

3. How to use Mycosolon

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for external use on the skin only.
Fungal skin and nail infections
Usually, the ointment is rubbed in once or twice a day into the infected skin area. In fungal nail infections, after removing the damaged part of the nail, Mycosolon should be applied with a bandage dressing. After removing the damaged part of the nail, treatment should be continued without interruption until the nail is completely renewed.
External ear canal mycosis
A gauze impregnated with the ointment is inserted into the external ear canal twice a day until complete healing.

Use in children and adolescents

Do not use in children and adolescents due to lack of data.

Using more than the recommended dose of Mycosolon

Prolonged or improper local use of the medicine (e.g., under a tightly sealing dressing, such as cerate or diaper) or using it on large skin surfaces may lead to adrenal cortex suppression and growth and development suppression in children.
Mycosolon should be used locally. If you accidentally swallow the medicine, contact your doctor immediately.

Missing a dose of Mycosolon

Do not use a double dose to make up for a forgotten dose. Apply the ointment as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with the recommended dosing schedule.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The ointment is generally well tolerated.
The most common side effects are local skin changes.
Rare side effects (may affect up to 1 in 1000 people):
hypersensitivity reactions, including anaphylactic reactions (severe allergic reaction) or angioedema (swelling of the face, lips, tongue, throat, or eyelids, which may cause difficulty in swallowing and breathing), urticaria, local skin irritation, burning sensation of the skin, redness of the skin, contact dermatitis, pruritus, rash.
Side effects of unknown frequency (frequency cannot be estimated from the available data):
secondary infections, skin atrophy, striae, post-steroid acne, and perioral dermatitis (when using the medicine on the same skin surface, especially for a longer period), eruptions, dryness of the skin, folliculitis, and skin discoloration, superficial vasodilation.
Due to the presence of maziPredoni, typical side effects associated with corticosteroid use may occur, especially with long-term use, use on a large skin surface, under occlusive dressing, and adrenal cortex suppression.

Additional side effects in children

In children, due to increased absorption of corticosteroids into the body compared to adults, it is easier to suppress the function of the hypothalamic-pituitary-adrenal axis and cause general side effects of corticosteroids, including growth and development disorders.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mycosolon

Store in a refrigerator (2°C – 8°C).
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expiry date (EXP)”. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Mycosolon contains

The active substances are miconazole and maziPredoni hydrochloride.
1 g of ointment contains 20 mg of miconazole and 2.5 mg of maziPredoni hydrochloride.
The other ingredients are methyl parahydroxybenzoate (E 218), polysorbate 60, liquid paraffin, propylene glycol (E 1520), cetearyl alcohol, purified water.

What Mycosolon looks like and contents of the pack

White or almost white, homogeneous ointment with a mild, characteristic odor.
An aluminum tube contains 15 g of ointment and is placed in a cardboard box.

Marketing authorization holder:

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

For further information about this medicine, please contact the local representative of the marketing authorization holder.

GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]

Date of last revision of the package leaflet: