Terbinorm

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

Composition:

Active substance: terbinafine;

1 ml of the preparation contains terbinafine hydrochloride 10.08 mg;

Excipients: propylene glycol, macrogol 300, ethanol 96%, purified water.

Pharmaceutical form. Topical spray, solution.

Main physico-chemical properties: clear or slightly opalescent solution, colorless or with a yellowish tint.

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 does not belong to 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 excipients of the product.

Interaction with other medicinal products and other forms of interaction.

Although there are no reports of any medicinal interactions, as a precautionary measure, it is not recommended to apply other medicinal products to the areas treated with this product.

Special precautions for use.

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

The product is intended for external use only. The spray must not be applied to the face.

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

Do not inhale. In case of accidental inhalation, 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 product also contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

Pregnancy

Animal studies have not revealed 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. Fetal toxicity studies in animals indicate absence of adverse effects.

The product should not be used during pregnancy except in cases of urgent medical need.

Breastfeeding period

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

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

Fertility

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

Ability to influence reaction rate while driving or operating machinery.

No influence.

Method of Administration and Dosage

Method of Administration

The medication is intended for external use only.

Before application, affected skin areas should be thoroughly cleaned and dried. Spray the product from a distance of 1–15 cm onto the affected areas in sufficient quantity to ensure thorough wetting, and also apply to adjacent areas of both affected and intact skin.

Dosage

Adults and children aged 16 years and older

Apply the medication once daily for one week.

Symptom relief is usually expected within a few days. Inconsistent application or premature discontinuation of treatment may lead to recurrence of the disease.

If there is no sign of improvement after one week of treatment, consult a physician.

Special Patient Populations

Elderly Patients

Dose adjustment is not required for elderly patients.

Children

Do not use the medication in children under 16 years of age. Experience with the use of 1% terbinafine spray in children is limited; therefore, use in children is not recommended.

Overdose

The low systemic absorption of terbinafine with topical application results in an extremely low risk of overdose.

In case of accidental ingestion, the contents of one bottle (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 amount of ethanol contained in the medication (4032.8 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.

Treatment of overdose consists primarily of removing the active substance by administering activated charcoal and providing symptomatic therapy as needed.

Adverse reactions.

Local symptoms such as itching, peeling or burning of the skin, pain and irritation at the application site, pigmentary changes, 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. Accidental contact with eyes may cause eye irritation. In rare cases, exacerbation of latent fungal infection is possible.

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

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 changes, erythema, sensation of skin burning; rare – sensation of dry skin, 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 authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years. Do not use after the expiry date.

Storage conditions.

Store at a temperature not exceeding 25 ºC. Keep out of reach and sight of children.

Packaging.

20 ml of the medicinal product in a polymer bottle with a spray pump and cap. One bottle per cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

K.O. Rompharm Company S.R.L./
S.C. Rompharm Company S.R.L.

Manufacturer's address and place of business.

Otopeni, Eroilor Street № 1A, 075100, Ilfov County, Romania/
Otopeni сity, Eroilor Street № 1A, 075100, jud. Ilfov, Romania.

Marketing Authorization Holder.

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