MYCONAFINE 10 mg /G Cream

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Myconafine 1%, 10 mg/g, cream
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Myconafine 1% and what is it used for
4. Important information before using Myconafine 1%
   1. When not to use Myconafine 1%
   2. Warnings and precautions
   3. Children and adolescents
   4. Myconafine 1% and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Myconafine 1% contains cetyl alcohol and stearyl alcohol
5. How to use Myconafine 1%
   1. Method of use
   2. Recommended dosage regimen
   3. How to proceed during treatment with Myconafine 1%
   4. Using a higher dose of Myconafine 1% than recommended
   5. Missing a dose of Myconafine 1%
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people)
   2. Uncommon side effects (may affect up to 1 in 100 people)
   3. Rare side effects (may affect up to 1 in 1,000 people)
   4. Frequency not known (frequency cannot be estimated from the available data)
   5. Reporting side effects
7. How to store Myconafine 1%
8. Contents of the pack and other information
   1. What Myconafine 1% contains
   2. What Myconafine 1% looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer

Leaflet attached to the packaging: patient information

Myconafine 1%, 10 mg/g, cream

Terbinafine hydrochloride

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 advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Myconafine 1% and what is it used for

Myconafine 1% cream contains the active substance terbinafine hydrochloride.
The medicine has antifungal properties and acts on various species of fungi that cause skin diseases.
Terbinafine in Myconafine 1% has a fungicidal effect (causes the death of fungal cells) on dermatophytes and molds. On yeasts, depending on the species, it has a fungicidal or fungistatic effect (inhibits fungal growth).
Myconafine 1% is intended for use on the skin only.
Myconafine 1% cream is indicated for local treatment of:

• athlete's foot,
• foot sole fungus (moccasin-type fungus),
• fungal infections of skin folds and smooth skin,
• skin candidiasis,
• pityriasis versicolor .

Athlete's foot –occurs on one or both feet, most often between the toes. In the case of foot sole fungus (moccasin-type fungus), it also appears on the sole, heel, or other parts of the foot. Fungal changes between the toes are characterized by maceration and peeling, and may also have a vesicular character. Sudden exacerbations with the eruption of numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and the eruption of vesicles may be mild or severe.
In the case of long-standing athlete's foot, nail infection (fungal infection on the surface or under the nail plate) may occur. The nails become thickened, dull, and under their free edge, there is an accumulation of horny masses. The nail plate becomes layered, as a result of which the nail may be destroyed. If the above-mentioned changes occur in the nails, you should consult a doctor, as Myconafine 1% cream is not effective in treating nail fungus.
Fungal infections of skin folds –may appear on skin areas that are folded and moist, i.e.:

• in the groin,
• on the inner surface of the thighs (bilateral changes, but often more severe on one side; these changes may spread to the buttocks or up the abdomen),
• under the breasts,
• in the armpits. Fungal changes that appear on the skin in these areas cause redness, itching, and peeling of the epidermis.

Fungal infections of smooth skin –may occur on the entire body, most often on the non-hairy skin of the head, neck, face, and arms. Characteristic are ring-shaped foci with a pink to red color. They are covered with granules and scales, spread peripherally, and tend to regress in the central part.
Skin candidiasis –occurs mainly in skin folds, in moist areas prone to sweating, e.g. under the breasts and in the armpits, especially in obese or diabetic individuals. These changes cause redness, itching, and peeling of the skin.
Pityriasis versicolor –occurs on the skin in the form of scaly, patchy foci. These changes may be visible only in the summer, as the fungal foci do not tan under the influence of sunbathing, they become visible as sunspots of various sizes. Pityriasis versicolor usually appears on the torso, neck, and arms, especially during heatwaves, with increased skin sweating.
If there is no improvement after 14 days or the patient feels worse, they should consult a doctor.

2. Important information before using Myconafine 1%

When not to use Myconafine 1%

If the patient is allergic to terbinafine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Myconafine 1%, discuss it with your doctor, pharmacist, or nurse.

• The medicine is intended for use on the skin only.
• Do not use the medicine in the mouth, do not swallow.
• Avoid contact of the medicine with the eyes. If the medicine accidentally gets into the eyes, rinse them with running water. If discomfort persists in the eyes, consult a doctor.

Children and adolescents

Do not use in children under 12 years of age.

Myconafine 1% and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interactions of Myconafine 1% cream with other medicines are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
During pregnancy, Myconafine 1% cream can be used only in justified cases.
Do not use Myconafine 1% cream during breastfeeding.
Infants and young children should not come into contact with the skin treated with Myconafine 1%, including the skin of the breast.

Driving and using machines

Myconafine 1% has no effect on the ability to drive and use machines.

Myconafine 1% contains cetyl alcohol and stearyl alcohol

Due to the presence of excipients – cetyl alcohol and stearyl alcohol, the medicine may cause a local skin reaction (e.g. contact dermatitis).

3. How to use Myconafine 1%

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
In the case of fungal nail infection(fungal infection inside the nail plate or under the nail), which occurs with discoloration and changes in the nail structure (thickening, peeling), you should consult a doctor, as Myconafine 1% is not effective in treating this type of infection.
The medicine is intended for use on the skin.

Method of use

Adults and children over 12 years of age:

• Before using the medicine, wash and dry your hands and the affected areas of the skin.
• Then apply a small amount of cream to the affected areas of the skin and gently rub it in.
• After each application of the medicine, wash your hands thoroughly.
• When using the medicine in skin folds, these areas should be covered with a fresh and clean dressing, especially when applying the cream at night.

Recommended dosage regimen

• Athlete's foot (excluding the sole and lateral surfaces of the foot): apply once a day for 1 week.
• Moccasin-type foot fungus (including the soles and lateral surfaces of the foot): apply twice a day for 2 weeks.
• Fungal infections of skin folds: apply once a day for 1 week.
• Fungal infections of smooth skin: apply once a day for 1 week.
• Skin candidiasis: apply once a day for 1 week.
• Pityriasis versicolor: apply once a day for 2 weeks.

The medicine should be used in the recommended doses for the recommended period, even if the symptoms of the infection disappear after a few days of using the cream. This will prevent the recurrence of the disease, which may occur if the medicine is not used regularly or is used for a shorter period than recommended.
After using Myconafine 1%, improvement should occur within a few days. After completing the 7-day therapy, the medicine continues to have a fungicidal effect on the skin. Therefore, even after completing the treatment, improvement should continue to occur.
If there is no improvement after 14 days of starting treatment, consult a doctor.

How to proceed during treatment with Myconafine 1%

• Affected skin should be kept clean by regular washing,
• the cream should be applied to the skin gently, without rubbing,
• avoid scratching the treated areas, as this may slow down the healing process or spread the infection.

The basis for the prevention of fungal skin diseases is the use of your own towel, personal clothing, and frequent washing.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Myconafine 1% than recommended

If a higher dose of the medicine than recommended is used, consult a doctor.

Missing a dose of Myconafine 1%

If a dose of the medicine is missed, use it as soon as possible and then use the cream according to the dosage regimen. Do not use a double dose to make up for the missed dose.
The medicine should be used regularly, as recommended, as this reduces the risk of recurrence of the infection and is the basis for the success of the treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, which may indicate an allergic reaction, stop using the medicine and consult your doctor immediately:

• difficulty breathing or swallowing,
• swelling of the face, lips, tongue, or throat,
• persistent itching, occurring with a red rash or bumps.

Common side effects (may affect up to 1 in 10 people)

Peeling of the skin, itching.

Uncommon side effects (may affect up to 1 in 100 people)

Skin changes, crusts, skin disorders, changes in skin color, severe redness, burning sensation of the skin, pain, pain at the application site, irritation at the application site.

Rare side effects (may affect up to 1 in 1,000 people)

Dryness of the skin, contact dermatitis, rash, exacerbation of fungal infection symptoms, eye irritation (in case of contact of the medicine with the eyes).

Frequency not known (frequency cannot be estimated from the available data)

Hypersensitivity, rash.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Myconafine 1%

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after: EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Myconafine 1% contains

• The active substance of the medicine is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride.
• The other ingredients are: benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, sodium hydroxide, purified water.

What Myconafine 1% looks like and contents of the pack

The medicine is a cream, packaged in an aluminum tube with a polyethylene cap, in a cardboard box.
The tube contains 15 g of cream.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw

Manufacturer/Importer

LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, No 7
Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
To obtain more detailed information, contact the marketing authorization holder.
Date of last revision of the leaflet:January 2020