Terbizil

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

Composition:

Active substance: terbinafine hydrochloride;

1 g of cream contains 10 mg of terbinafine hydrochloride;

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

Pharmaceutical form. Cream.

Main physicochemical characteristics: white or almost white cream with a mild almond odor, easily washed off with water.

Pharmacotherapeutic group.

Antifungal agents for dermatological use. Other topical antifungal agents. ATC code D01AE15.

Pharmacological properties.

Pharmacodynamics.

Mechanism of action

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

At low concentrations, terbinafine exhibits fungicidal activity against dermatophytes, molds, and some dimorphic fungi. Its activity against yeasts may be either fungicidal or fungistatic, depending on the fungal species. The drug has a prolonged effect, allowing therapeutic efficacy to be achieved within a short treatment period.

Terbinafine specifically affects the early stage of sterol biosynthesis. This leads to ergosterol deficiency and intracellular accumulation of squalene, resulting in fungal cell death.

Terbinafine inhibits the enzyme squalene epoxidase located in the fungal cell membrane. Squalene epoxidase is not part of the cytochrome P450 system.

Terbinafine does not affect hormone metabolism or the metabolism of other medicinal products.

Pharmacokinetics.

When applied topically in humans, absorption is less than 5%, resulting in minimal systemic exposure.

With 7-day application of Terbisil cream, concentrations in the stratum corneum exceed the fungicidal concentration and remain detectable for at least 7 days after discontinuation of treatment.

Clinical characteristics.

Indications.

Fungal infections of the skin caused by dermatophytes of the genus Trichophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum, such as tinea pedis (athlete's foot), tinea pedis affecting the soles and edges of the feet; tinea cruris (jock itch); tinea corporis (ringworm). Yeast infections of the skin caused primarily by fungi of the genus Candida, usually Candida albicans; pityriasis versicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare, also known as Malassezia furfur.

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.

Drug interactions with topical terbinafine are unknown.

Special precautions for use

Terbizil cream is intended for topical use only.

Avoid contact with the eyes, as the cream may cause irritation. If accidental contact occurs, rinse the eyes thoroughly with running water.

Scratching the affected areas of skin is not recommended, even if itching occurs, as this may lead to further skin damage, delay the healing process, or spread infection.

These infections may be transmitted to other people; therefore, patients should use only individual towels and clothing. To prevent reinfection, patients are advised to frequently wash their clothes and towels.

Keep out of reach of children.

Avoid contact of infants with skin areas treated with the cream, including the breasts.

The cream contains cetyl alcohol and cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

This medicinal product contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause mild local irritation.

Use during pregnancy or breastfeeding

Pregnancy

Animal studies have not shown embryotoxic or fetotoxic effects of terbinafine. However, due to the lack of clinical experience with terbinafine use in pregnant women, Terbizil cream should not be used during pregnancy unless clearly necessary.

Breastfeeding period

Terbinafine passes into breast milk; therefore, Terbizil cream should not be administered to breastfeeding mothers unless the expected benefit to the mother outweighs the potential risk to the infant. In addition, contact between infants and treated skin areas, including the mammary glands, should be avoided.

Effect on fertility

Animal studies have shown no effect on fertility.

Ability to affect reaction rate while driving or operating machinery

Terbizil cream does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

For skin treatment. Before the first use, the membrane sealing the tube should be pierced with the spike located on the cap.

Before applying the cream, hands and affected areas of the skin must be thoroughly cleaned and dried by gently patting—do not rub. Apply the cream in a thin layer to the affected skin and surrounding areas, gently rubbing in. In infections associated with intertrigo (under the breasts, in the interdigital areas, groin, and between the buttocks), the treated areas may be covered with gauze, especially at night. Hands should always be washed after applying the cream to prevent the spread of infection to other parts of the body or to other people.

For use in adults and children aged 12 years and older.

Terbysil cream may be applied once or twice daily, depending on the indication.

Elderly Patients

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

Duration and Frequency of Treatment

The duration and frequency of treatment depend on the severity of the condition:

• Tinea pedis: once daily for 1 week;
• Tinea pedis affecting soles and lateral edges of the feet: twice daily for 2 weeks;
• Tinea cruris and tinea corporis: once daily for 1 week;
• Cutaneous candidiasis: once or twice daily for 1 week;
• Pityriasis versicolor: once or twice daily for 2 weeks.

Symptom improvement is usually observed within a few days after starting treatment. Irregular use or premature discontinuation of treatment increases the risk of infection recurrence. If there is no sign of improvement after two weeks of treatment, consult a physician.

The therapeutic effect of Terbysil cream persists after discontinuation of treatment. Skin improvement continues even after stopping the cream.

Children

Experience with topical use of terbinafine in children under 12 years of age is limited; therefore, the use of this medication is not recommended in this age group.

Overdose

Terbysil cream is intended for topical use only. The low systemic absorption of terbinafine in cream form results in an extremely low risk of overdose. Accidental ingestion of two 15 g tubes (total 300 mg terbinafine) is comparable to the intake of the active ingredient in one 250 mg Terbysil tablet (a single oral dose for adults).

In case of accidental ingestion of a larger amount of cream, symptoms similar to those observed after oral overdose may occur, including headache, nausea, epigastric pain, and dizziness.

Recommended management in case of overdose includes measures to remove the drug, primarily by administering activated charcoal, and if necessary, symptomatic and supportive therapy.

Adverse reactions.

At the site of application, the following symptoms may occur: itching, skin peeling, pain at the application site, irritation at the application site, pigment disturbances, skin burning sensation, skin redness, and crust formation. These benign symptoms should be differentiated from symptoms of hypersensitivity reactions such as rash, widespread itching, bullous eruptions, and urticaria, which are observed rarely; if such reactions occur, the use of the drug should be discontinued.

In case of accidental contact with eyes, terbinafine hydrochloride may cause eye irritation.

Adverse reactions are classified by organ system classes and frequency of occurrence as follows: very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated based on available data).

Within each group, adverse reactions are listed in order of decreasing severity.

* Data obtained from post-marketing surveillance.

In a therapeutic equivalence study of Terbizil cream 10 mg/g and 1% terbinafine cream (EQUATE), a total of 733 patients received either Terbizil (n = 366) or terbinafine (n = 367) for 1 week, with at least one adverse reaction occurring in 10.1% of patients (74 patients). Overall, 20 adverse reactions occurred during the study.

* These adverse reactions were not observed during the "Equate" study.

Reporting of suspected adverse reactions

Reporting of suspected medicinal adverse reactions should be carried out even after marketing authorization has been granted. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions.

Shelf life.

5 years.

Storage conditions.

Keep out of reach and sight of children.

Store at a temperature not exceeding 30 °C.

Packaging.

15 g of cream in a white aluminum tube with a white polyethylene cap with a perforated spike; 1 tube in a cardboard box.

Classification.

Over-the-counter (without prescription).

Manufacturer.

JSC "Gedeon Richter", Hungary.

Manufacturer's address and address of the place of business.

H-1103 Budapest, Demrédi street 19-21, Hungary.