TERBINORM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TERBINORM (TERBINORM)

Composition:

Active substance: terbinafine;

1 g of solution contains 10 mg of terbinafine hydrochloride;

Excipients: propylene glycol; ethanol 96 %; polyethylene glycol (macrogol) 1000 cetostearyl ether; citric acid monohydrate; purified water.

Pharmaceutical form. Topical spray, solution.

Main physicochemical properties: clear or slightly opalescent, 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 against skin infections caused by dermatophytes such as Trichophyton (e.g., T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum. At low concentrations, it exerts a fungicidal effect against dermatophytes and molds. Activity against yeasts is either fungicidal (e.g., Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine specifically inhibits an early step in 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 is not part of the cytochrome P450 system. Terbinafine does not affect hormone metabolism or that of other medicinal products.

Pharmacokinetics.

After topical application, less than 5% of the applied dose is absorbed, so systemic exposure to terbinafine is very low.

Clinical characteristics.

Indications.

Treatment of interdigital tinea pedis (athlete's foot) and tinea cruris (jock itch) caused by dermatophytes such as Trichophyton (e.g., T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

Contraindications.

Hypersensitivity to the active substance or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Although there are no reports of any drug interactions, as a precautionary measure, the application of other medicinal products to areas treated with Terbinorm should be avoided.

Special precautions for use

The medicinal product Terbinorm should be used with caution in patients with skin lesions, as ethanol contained in the formulation may cause irritation.

The medicinal product is intended for topical (cutaneous) use. The spray must not be applied to the face.

The medicinal product may cause eye irritation. In case of accidental contact with eyes, rinse thoroughly with running water.

Do not inhale. In case of accidental inhalation of the medicinal product, consult a physician if any adverse symptoms worsen or persist.

The spray contains 46.56 mg of alcohol (ethanol) in each daily dose, equivalent to 250 mg/g of 96% ethanol. It may cause a burning sensation on damaged skin.

The medicinal product also contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

Pregnancy

Animal studies have not shown teratogenic or embryotoxic effects of terbinafine. To date, there have been no reports of congenital malformations in humans. Clinical experience with use in pregnant women is limited. The medicinal product should not be used during pregnancy except in cases of clear necessity.

Breastfeeding period

Terbinafine passes into breast milk; therefore, the medicinal product should not be used during breastfeeding.

Contact between infants and any area of skin treated with the medicinal product should be avoided.

Fertility

Animal studies have not shown any effect of terbinafine on fertility.

Ability to influence the reaction rate while driving or operating machinery

The medicinal product has no influence on the ability to drive or operate machinery.

Method of Administration and Dosage

Method of Administration

The medicinal product is intended for topical (cutaneous) use only.

Before application, affected skin areas should be thoroughly cleaned and dried. Spray the product from a distance of 5–10 cm onto the affected areas in sufficient quantity to ensure thorough moistening, and additionally apply it to adjacent areas of both affected and intact skin.

Dosage

Adults

Apply the medicinal product once daily for one week.

Symptom relief is usually expected within a few days. Irregular use or premature discontinuation of treatment may lead to recurrence of the infection.

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

Special Patient Populations

Elderly Patients

There are no data indicating that elderly patients require different dosing or experience adverse reactions different from those observed in younger patients.

Children

The medicinal product should not be used in children under 16 years of age. Experience with 1% terbinafine spray in children is limited; therefore, its use in children is not recommended.

Overdose

Due to the low systemic absorption of terbinafine following topical application, the likelihood of overdose is extremely low.

In case of accidental ingestion, the contents of one bottle of the medicinal product (containing 200 mg of terbinafine) is comparable to taking one 250 mg terbinafine tablet (the single oral dose for adults).

In case of accidental ingestion, consider the presence of ethanol in the medicinal product (5000 mg per bottle).

Accidental ingestion of the contents of more than one bottle may result in adverse reactions such as headache, nausea, epigastric pain, and dizziness.

Management of overdose consists primarily of removing the active substance, preferably by administering activated charcoal, and providing symptomatic treatment as necessary.

Adverse reactions.

Local symptoms 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 symptoms should be differentiated from hypersensitivity reactions, including rash, widespread itching, bullous eruptions, and urticaria, which have been reported in isolated cases and require discontinuation of treatment. In case of accidental contact with eyes, the medicinal product may cause eye irritation. Rarely, exacerbation of underlying fungal infection may occur.

The adverse reactions listed below are classified by system organ class and frequency of occurrence: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency not known (frequency cannot be estimated from available data). Within each frequency group, adverse reactions are listed in order of decreasing severity.

Immune system disorders:

frequency not known – hypersensitivity reactions.

Eye disorders:

rare – eye irritation.

Skin and subcutaneous tissue disorders:

common – skin peeling, itching; uncommon – skin damage, crusting, skin lesions, pigmentary disturbances, erythema, skin burning sensation; rare – skin dryness sensation, contact dermatitis, eczema; frequency not known – rash.

General disorders and administration site conditions:

uncommon – pain, pain at application site, irritation at application site; rare – worsening of symptoms.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product registration is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

5 years.

After opening the bottle, use within 3 months.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

20 ml in a bottle with a spray pump and protective cap; 1 bottle per cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

UORLID MEDITSIN ILACH SAN. VE TIDJ. A.S./
WORLD MEDICINE ILAC SAN. VE TIC. A.S.

Manufacturer's address and location of business activity.

15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey/
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.

Marketing Authorization Holder.

WORLD MEDICINE, LLC, Ukraine/
WORLD MEDICINE, LLC, Ukraine.