Mycofin

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

Composition:

Active substance: terbinafine hydrochloride;

1 g of spray contains 10 mg of terbinafine hydrochloride;

Excipients: ethanol 96%, cetostearyl polyethylene glycol ether, propylene glycol, purified water.

Pharmaceutical form. Topical spray.

Main physicochemical properties: clear, colorless solution.

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 exerts a fungicidal effect at appropriate concentrations against dermatophytes, molds, and some dimorphic fungi. Activity against yeast fungi may be either fungicidal or fungistatic, depending on the species.

Terbinafine specifically inhibits an early stage of sterol biosynthesis in 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 does not belong to the cytochrome P450 system. Terbinafine does not affect hormone metabolism or the metabolism of other medicinal agents.

Pharmacokinetics.

When applied topically, the drug is poorly absorbed, acts rapidly, and demonstrates efficacy with short-term treatment (7 days).

With topical application, less than 5% of the applied dose is absorbed, so systemic exposure to terbinafine is negligible.

Clinical characteristics.

Indications.

Fungal skin infections caused by dermatophytes such as Trichophyton (e.g. 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). Pityriasis versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications.

Hypersensitivity to terbinafine or any component of the product.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use

This is a topical preparation. Use with caution in patients with damaged skin, as the ethanol contained in the product may cause irritation. Do not inhale. If accidental inhalation occurs, consult a doctor if any adverse symptoms worsen or persist. Avoid contact with eyes. Do not apply to the face. In case of accidental contact with eyes or face, rinse immediately with running water.

Mikofin**®**, topical spray, contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

No effects of terbinafine on fertility or embryotoxic effects have been observed. Use in pregnant women is limited; therefore, Mikofin**®** spray should be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. Terbinafine passes into breast milk in small amounts; thus, the product should not be used by women who are breastfeeding.

Avoid contact between infants and any area of skin to which the product has been applied.

Effect on the ability to drive or operate machinery

No effect.

Method of Administration and Dosage

Mikofin®, topical spray, is intended for external use only.

The duration of treatment depends on the severity of the disease.

Before application, it is necessary to thoroughly clean and dry the affected skin areas. Spray the medication onto the affected areas in an amount sufficient to ensure adequate moistening, and also apply it to adjacent areas of both affected and intact skin.

The duration of treatment and frequency of application are determined according to the indication:

• Tinea pedis and tinea corporis – once daily for one week;
• Pityriasis versicolor – twice daily for one week.

Dose adjustment is not required for elderly patients.

Symptom relief is usually expected within a few days. Inconsistent application or premature discontinuation of treatment may lead to disease recurrence. If there is no sign of improvement after one week of treatment, consult a physician.

Children

Safety and efficacy in children have not been established; therefore, the use of Mikofin® topical spray is not recommended in children (under 18 years of age).

Overdose

Due to the low systemic absorption of terbinafine with topical application, the likelihood of overdose is extremely low. Accidental ingestion of the contents of one 30 ml bottle of Mikofin® topical spray (containing 300 mg of terbinafine hydrochloride) is comparable to taking one tablet of Mikofin® 250 mg (the oral dosage form). If a larger amount of Mikofin® topical spray is accidentally ingested, adverse effects would be similar to those observed with an overdose of Mikofin® tablets (e.g., headache, nausea, epigastric pain, and dizziness). In case of accidental ingestion, the ethanol content of the medicinal product should be taken into account.

Treatment of overdose following accidental ingestion consists of removing the active substance, primarily by administering activated charcoal, and providing symptomatic therapy if necessary.

Adverse reactions.

Local symptoms such as itching, scaling or burning of the skin, pain and irritation at the application site, pigmentary disturbances, erythema, crusting, may occur at the site of application. These mild symptoms should be differentiated from hypersensitivity reactions, including rash, which have been reported rarely and 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.

Immune system disorders: Hypersensitivity reactions, including urticaria.

Eye disorders: Eye irritation.

Skin and subcutaneous tissue disorders: Skin peeling, pruritus; skin injury, crusting, skin lesions, pigmentary disturbances, erythema, sensation of skin burning. Skin dryness, contact dermatitis, eczema, rash.

General disorders and administration site conditions: Pain, pain at application site, irritation at application site; exacerbation of symptoms.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

30 mL of the preparation in a bottle with a spray dispenser. One bottle per cardboard pack.

Availability category. Over-the-counter (without prescription).

Manufacturer.

NOBEL ILAC SANAYI VE TICARET A.S.

Manufacturer's address and place of business:

Sankaklar Koey 81100 m., Duzce, Turkey.