MYCOFIN®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MICOFIN® (MYCOFIN)

Composition:

Active substance: terbinafine;

1 g of cream contains 10 mg of terbinafine hydrochloride;

Excipients: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white homogeneous cream with a mild odor.

Pharmacotherapeutic group.

Antifungal agents for topical use. ATC code D01AE15.

Pharmacological properties.

Pharmacodynamics.

Terbinafine is an allylamine with a broad spectrum of antifungal activity.

Terbinafine exhibits fungicidal activity at low concentrations against dermatophytes and molds. Its activity against yeasts varies depending on the species and may be either fungicidal (e.g., Pityrosporum orbiculare or Malassezia furfur) or fungistatic.

Terbinafine specifically inhibits an early step in sterol biosynthesis within the fungal cell membrane. This leads to ergosterol deficiency and intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibiting the enzyme squalene epoxidase in the fungal cell membrane. This enzyme is not part of the cytochrome P450 system. Therefore, terbinafine does not affect the metabolism of hormonal agents or other medicinal drugs.

Pharmacokinetics.

When applied topically, less than 5% of the terbinafine dose is absorbed, so systemic absorption is minimal. The concentration of terbinafine in the stratum corneum reaches fungicidal levels by day 7 of treatment and remains effective for up to 7 days after discontinuation of therapy.

Clinical characteristics.

Indications.

Fungal infections of the skin caused by dermatophytes such as Trichophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum, for example, tinea pedis (athlete's foot); tinea cruris (jock itch); tinea corporis (ringworm); cutaneous candidiasis caused by Candida species, usually Candida albicans; pityriasis versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications.

Hypersensitivity to terbinafine or to any other component of the product.

Interaction with other medicinal products and other forms of interaction.

Do not use concurrently with other creams.

Special precautions for use.

Mikofin® cream is intended for topical use only. It may cause irritation upon contact with the eyes. In case of accidental contact with the eyes, they should be thoroughly rinsed with running water. If irritation persists, medical advice should be sought.

Mikofin® cream contains cetyl alcohol and stearyl alcohol, which may cause local skin irritation (e.g., contact dermatitis).

If irritation, hypersensitivity reactions, or worsening of symptoms occur, application of Mikofin® cream should be discontinued and appropriate treatment initiated.

Fertility studies in animals have not shown any effect of terbinafine on fertility.

To prevent skin mycoses, the following measures are recommended: change underwear daily, as microorganisms may remain on clothing parts that have been in contact with infected skin areas; avoid wearing tight-fitting or poorly ventilated clothing; thoroughly dry affected skin areas after washing; use a clean personal towel daily. In case of foot mycosis, walking barefoot should be avoided. In addition to topical treatment, it is recommended to treat socks or footwear once daily with an antifungal powder.

Use during pregnancy or breastfeeding.

Animal studies have not shown embryotoxic effects of terbinafine. However, because clinical experience with the use of the drug in pregnant women is limited, Mikofin® cream should not be used during pregnancy unless, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus.

Terbinafine passes into breast milk; therefore, the product should not be used during breastfeeding. Contact between infants and skin areas treated with the cream should be avoided.

Ability to influence reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

For adults and children aged 12 years and older. Apply terbinafine once or twice daily depending on the condition. Before application, thoroughly clean and dry the affected areas. Apply the cream in a thin layer to the affected skin and surrounding areas, gently rubbing it in. In infections accompanied by intertrigo (under the breasts, between fingers, between buttocks, in the groin area), the treated areas may be covered with gauze, especially at night.

Duration and frequency of treatment (depends on the severity of the condition):

• Tinea pedis (interdigital): once daily for 1 week.
• Tinea cruris and tinea corporis: once daily for 1 week.
• Cutaneous candidiasis: once or twice daily for 1–2 weeks.
• Pityriasis versicolor: once or twice daily for 2 weeks.

Symptomatic improvement usually occurs within a few days. Irregular use or premature discontinuation of treatment may lead to relapse.

Dosage adjustment is not required for elderly patients.

If there is no sign of improvement after 2 weeks of treatment, consult a physician.

Children.

Due to insufficient experience of use, the product should not be administered to children under 12 years of age.

Overdose.

The low systemic absorption of topical terbinafine cream results in an extremely low risk of overdose. In case of accidental oral ingestion, adverse effects may be expected similar to those observed with overdose of the drug Mycofin® tablets: headache, nausea, epigastric pain, and dizziness.

Treatment is symptomatic. If the cream is ingested, induce vomiting if necessary.

Side effects.

Local reactions such as itching, peeling or burning of the skin, pain and irritation at the application site, pigmentary disturbances, erythema, crusting, and others may occur at the site of application. These mild reactions should be differentiated from hypersensitivity reactions, including rash, which have been reported in isolated cases and which require discontinuation of treatment. In case of accidental contact with eyes, terbinafine hydrochloride may cause eye irritation. In rare cases, underlying fungal infection may worsen.

Possible side effects:

• Immune system disorders: Frequency unknown (cannot be estimated from available data) – hypersensitivity reactions, including urticaria*;
• Eye disorders: Rare (≥ 1/10,000, < 1/1,000) – eye irritation;
• Skin and subcutaneous tissue disorders: Common (≥ 1/100, < 1/10) – skin peeling, itching; uncommon (≥ 1/1,000, < 1/100) – skin injury, crusting, skin lesions, pigmentary disturbances, erythema, skin burning sensation; rare (≥ 1/10,000, < 1/1,000) – skin dryness sensation, contact dermatitis (including bullous dermatitis), eczema; frequency unknown (cannot be estimated from available data) – rash*;
• General disorders and administration site conditions: Uncommon (≥ 1/1,000, < 1/100) – pain, application site pain, application site irritation; rare (≥ 1/10,000, < 1/1,000) – worsening of symptoms.

* Data obtained from post-marketing surveillance.

Shelf life.

2 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

15 g in a tube. 1 tube in a cardboard box.

Pharmaceutical category.

Over-the-counter.

Manufacturer.

NOBEL ILAC SANAYI VE TICARET A.S.

Manufacturer's address and place of business.

Sankaklar Quarter, Eskisehir Yolu Akcakoca Road No: 299, 81100 Duzce, Turkey