Myconafine 1%

Package leaflet: Information for the patient

Myconafine 1%, 10 mg/g, cream
Terbinafini hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet, so that you may read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days of treatment, or if your condition worsens, contact your doctor.

Leaflet contents

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

Myconafine 1% cream contains the active substance terbinafine hydrochloride.
The medicine has antifungal properties and acts against various species of fungi causing skin
diseases.
Terbinafine contained in Myconafine 1% exerts a fungicidal effect (causing fungal cell death) against dermatophytes and moulds. Against yeasts, depending on the species, it acts either fungicidally or fungistatically (inhibiting fungal growth).
Myconafine 1% is intended for topical use only.
Myconafine 1% cream is indicated for the local treatment of:

• athlete's foot (tinea pedis),
• moccasin-type tinea pedis,
• cutaneous candidiasis (fungal infection of skin folds and smooth skin),
• cutaneous candidiasis,
• pityriasis versicolor.

Athlete's foot – occurs on one or both feet, most commonly between the toes. In moccasin-type tinea pedis, lesions also appear on the heel, sole, or other parts of the feet. Fungal lesions between the toes are characterized by maceration and desquamation, and may also present as vesicular eruptions. Acute flare-ups with numerous vesicles typically occur during hot weather. Itching, pain, inflammation, and vesicle formation may be mild or severe.
In chronic athlete's foot, nail infection (onychomycosis) may develop, affecting either the surface or the area beneath the nail plate. Nails become thickened, dull, and subungual accumulation of keratinous material occurs. Nail plate layering may follow, potentially leading to nail destruction. If nail changes as described above occur, medical advice should be sought, as Myconafine 1% cream is not effective in treating onychomycosis.
Fungal infection of skin folds – may appear in skin areas that are folded and moist, such as:

• groin,
• inner thighs (lesions are often bilateral but may be more pronounced on one side; they may spread to the buttocks or upwards towards the abdomen),
• under the breasts,
• armpits.
  Fungal lesions in these areas cause redness, itching, and desquamation of the epidermis.

Fungal infection of smooth skin – may occur anywhere on the body, but is most commonly seen on the non-hairy skin of the head, neck, face, and arms. Characteristic lesions are annular, pink to red in color, covered with papules and scales, spreading peripherally and tending to clear centrally.
Cutaneous candidiasis – occurs mainly in skin folds and moist, sweating-prone areas such as under the breasts and in the armpits, especially in obese individuals or those with diabetes. These lesions cause redness, itching, and desquamation of the skin.
Pityriasis versicolor – appears on the skin as scaly, patchy lesions. These lesions may become visible only during summer, as the affected areas do not tan upon sun exposure and appear as hypopigmented spots of varying size. Pityriasis versicolor mainly affects the trunk, neck, and arms, particularly during hot weather and increased sweating.
If there is no improvement after 14 days of treatment, or if your condition worsens, contact your 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 treatment with Myconafine 1%, discuss this with your doctor, pharmacist, or
nurse.

• This medicine is intended for external use on the skin only.
• Do not use inside the mouth; do not swallow.
• Avoid contact with the eyes. If the medicine accidentally gets into the eyes, rinse thoroughly with running water. If eye discomfort persists, contact 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 the patient is currently using, has recently used, or plans to use.
No interactions between Myconafine 1% cream and other medicines are known.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
During pregnancy, Myconafine 1% cream should be used only if clearly necessary.
Do not use Myconafine 1% cream during breastfeeding.
Infants and young children should not come into contact with treated skin areas, including the breast area.

Driving and operating machinery
Myconafine 1% does not affect the ability to drive or operate machinery.

Myconafine 1% contains cetyl alcohol and stearyl alcohol
Due to the presence of excipients – cetyl alcohol and stearyl alcohol – this medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Myconafine 1%

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
In case of fungal nail infection (fungal infection within or under the nail plate), associated with discoloration and structural changes of the nail (thickening, scaling), consult a doctor, as Myconafine 1% is not effective in treating this type of infection.
This medicine is for topical use on the skin only.
Instructions for use
Adults and children over 12 years of age:

• Before applying the medicine, wash and dry your hands and the affected skin areas thoroughly.
• Apply a small amount of cream to the affected skin areas and gently rub in.
• After each application, wash your hands thoroughly.
• When applying the cream to skin folds, cover these areas with fresh, clean gauze, especially when using the cream overnight.

Recommended dosing regimen:

• Athlete's foot (excluding soles and lateral surfaces of the feet): once daily for 1 week.
• Moccasin-type athlete's foot (affecting soles and lateral surfaces of the feet): twice daily for 2 weeks.
• Fungal infection of skin folds: once daily for 1 week.
• Cutaneous fungal infection (smooth skin): once daily for 1 week.
• Cutaneous candidiasis: once daily for 1 week.
• Pityriasis versicolor: once daily for 2 weeks.

The medicine should be used at the recommended dose for the recommended duration, even if symptoms improve within a few days of starting treatment. This helps prevent recurrence, which may occur if the medicine is not used regularly or for a shorter duration than recommended.
After using Myconafine 1%, improvement should be noticeable within a few days. After completing a 7-day treatment course, the medicine continues to exert antifungal activity in the skin. Therefore, improvement may continue even after treatment has ended.
If no improvement is observed after 14 days of treatment, consult your doctor.
What to do during treatment with Myconafine 1%

• Keep the affected skin areas clean by washing regularly.
• Apply the cream gently to the skin; do not rub.
• Avoid scratching treated areas, as this may delay healing or spread the infection.

The basis of prevention of fungal skin infections includes using personal towels and clothing, and frequent washing.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Overdose of Myconafine 1%
If more than the recommended dose is applied, contact your doctor.
Missed dose of Myconafine 1%
If you miss a dose, apply it as soon as possible and then continue treatment according to the recommended dosing schedule. Do not apply a double dose to make up for a missed dose.
Use the medicine regularly as directed, as this reduces the risk of infection recurrence and is essential for successful treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following adverse reactions, which may
indicate an allergic reaction, use of the medicine should be discontinued and medical advice should be sought immediately:

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

Common adverse reactions (may affect up to 1 in 10 patients)
Skin peeling, itching.
Uncommon adverse reactions (may affect up to 1 in 100 patients)
Skin changes, crusts, skin disorders, change in skin colour, severe redness, burning sensation of the skin, pain, pain at application site, irritation at application site.
Rare adverse reactions (may affect up to 1 in 1,000 patients)
Dry skin, contact dermatitis, rash, worsening of fungal infection symptoms, eye irritation (in case of contact with the medicine in the eyes).
Frequency not known (frequency cannot be estimated from available data)
Hypersensitivity, rash.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Myconafine 1%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Myconafine 1% contains

• The active substance 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, packed in an aluminium tube with a polyethylene cap, placed in a cardboard box.
The tube contains 15 g of cream.
Marketing Authorisation 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
For further information, please contact the marketing authorisation holder.