SOFTENZIF

INSTRUCTIONS for medical use of the medicinal product TERBINORM (TERBINORM)

Composition

active substance: terbinafine; 1 ml of the preparation contains 10.08 mg of terbinafine hydrochloride; excipients: propylene glycol, macrogol 300, ethanol 96%, purified water.

Pharmaceutical form

Spray for external use, solution.

Main physical and chemical properties

Transparent or slightly opalescent solution, colorless or with a yellowish tint.

Pharmacotherapeutic group

Antifungal agents for topical use. ATC code D01A E15.

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 has a fungicidal effect on dermatophytes and mold fungi. The activity against yeast fungi is either fungicidal (e.g., Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine specifically inhibits the early stage of sterol biosynthesis in the fungal cell membrane. This leads to a deficiency of ergosterol and an intracellular accumulation of squalene, resulting in the death of the fungal cell. The effect of terbinafine is exerted 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 the metabolism of hormones or other medicinal products.

Pharmacokinetics

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

Clinical characteristics

Indications

Treatment of interdigital epidermophytosis of the feet ("athlete's foot") and inguinal dermatophytosis ("jockey's itch"), caused by dermatophytes such as Trichophyton (e.g., T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

Contraindications

Increased sensitivity to the active substance or to other components of the preparation.

Interaction with other medicinal products and other types of interactions

Although there is no information about the occurrence of any medicinal interactions, as a precautionary measure, it is not recommended to apply other medicinal products to areas treated with the preparation.

Special instructions

The preparation should be used with caution in patients with skin lesions, as ethanol, which is part of its composition, can cause irritation.

The preparation is intended for external use only. The spray should not be applied to the face.

The preparation may cause eye irritation. In case of accidental contact with the eyes, they should be rinsed immediately with running water.

Do not inhale. In case of accidental inhalation of the preparation, consult a doctor if any side symptoms worsen or persist.

The spray contains 46.56 mg of alcohol (ethanol) per daily dose, which is equivalent to 250 mg/g of 96% ethanol. May cause a burning sensation on damaged skin.

The preparation also contains propylene glycol, which can cause skin irritation.

Use during pregnancy or breastfeeding

Pregnancy

Animal studies have not revealed any teratogenic or embryotoxic effects of terbinafine. To date, there have been no reports of birth defects in humans. Clinical experience with the use of the preparation in pregnant women is limited. Studies of fetal toxicity in animals indicate no adverse effects.

The preparation should not be used during pregnancy, except in cases of urgent need.

Breastfeeding period

Terbinafine penetrates into breast milk, so the preparation should not be used during breastfeeding.

Avoid contact between infants and any area of skin where the preparation has been applied.

Fertility

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

Ability to affect reaction speed when driving vehicles or operating other mechanisms

Does not affect.

Method of application and dosage

Method of application

The preparation is intended for external use only.

Before its application, the affected areas of the skin should be thoroughly cleaned and dried. The spray should be sprayed at a distance of 1-15 cm onto the affected areas in an amount sufficient to thoroughly moisten them, and also applied to adjacent areas of both affected and intact skin.

Dosage

Adults and children over 16 years old

The preparation should be applied once a day for a week.

Relief of disease symptoms is usually expected within a few days. Non-systematic application or premature termination of treatment can lead to the occurrence of relapses of the disease.

If there are no signs of improvement after a week of treatment, consult a doctor.

Special categories of patients

Elderly patients

No dose adjustment is required for elderly patients.

Children.

Do not use the preparation in children under 16 years old. Experience with the use of terbinafine 1% spray in children is limited, so it is not recommended to use the preparation in children.

Overdose

Low systemic absorption of terbinafine during local application makes the likelihood of overdose extremely low.

In case of accidental ingestion, the contents of one vial of the medicinal product (containing 200 mg of terbinafine) can be compared to the use of one tablet of terbinafine 250 mg (single dose for adults for oral use).

In case of accidental ingestion, consider the content of ethyl alcohol in the medicinal product (4032.8 mg/vial).

In case of accidental ingestion of more than one vial, manifestations of such side reactions as headache, nausea, epigastric pain, dizziness are possible.

Treatment of overdose consists in removing the active substance, primarily by using activated charcoal, and conducting symptomatic therapy if necessary.

Side reactions

Local symptoms such as itching, peeling, or burning of the skin, pain, and irritation at the site of application, pigmentation disorders, erythema, crust formation, and others may be observed at the site of application. These minor symptoms should be distinguished from hypersensitivity reactions, including rash, widespread itching, bullous eruptions, and urticaria, which are reported in individual cases and require discontinuation of treatment. In case of accidental contact with the eyes, the preparation may cause eye irritation. In rare cases, exacerbation of hidden fungal infection is possible.

Side reactions listed below are classified by organs and systems and by frequency of occurrence (very often: ≥1/10; often: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10000 to <1/1000; very rare: <1/10000), frequency unknown (frequency cannot be calculated from available data).

Immune system disorders

Frequency unknown - hypersensitivity reactions.

Eye disorders

Rare - eye irritation.

Skin and subcutaneous tissue disorders

Often - peeling of the skin, itching; uncommon - skin damage, crust formation, skin lesions, pigmentation disorders, erythema, burning sensation; rare - dryness of the skin, contact dermatitis, eczema; frequency unknown - rash.

General disorders and administration site reactions

Uncommon - pain, pain at the site of application, irritation at the site of application; rare - exacerbation of symptoms.

Reporting suspected side reactions

Reporting side reactions after registration of the medicinal product is important. This allows monitoring the benefit/risk ratio of using this medicinal product. Medical and pharmaceutical workers, as well as patients or their authorized representatives, should report all cases of suspected side reactions and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life

3 years. Do not use after the expiration date.

Storage conditions

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

Packaging

20 ml of the preparation in a polymer vial with a sprayer and a cap. One vial in a cardboard box.

Release category

Without prescription.

Manufacturer

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

Location of the manufacturer and address of the place of its activity

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

Applicant

WORLD MEDICINE, LLC, Ukraine.