Exifine

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EXIFINE (EXIFINE)

Composition:

Active substance: terbinafine;

1 g of gel contains terbinafine 10 mg;

Excipients: isopropyl myristate, butylhydroxytoluene (E 321), benzyl alcohol, sorbitan laurate, polysorbate 20, carbomer 974P, sodium hydroxide, disodium edetate, anhydrous ethanol, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: homogeneous gel, white to almost white, without visible foreign inclusions.

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. Terbinafine exerts a fungicidal effect against dermatophytes and molds at low concentrations. Activity against yeasts is either fungicidal (e.g., Pityrosporum orbiculare or Malassezia furfur) 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. The action of terbinafine is mediated by inhibition of squalene epoxidase, an enzyme located in the fungal cell membrane. This enzyme is not part of the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other medicinal products.

Terbinafine provides prolonged activity in the treatment of tinea pedis. In most patients, no recurrences or reinfections were observed within 2 months after discontinuation of treatment.

Pharmacokinetics. When applied topically, less than 5% of the dose is absorbed, so systemic absorption of terbinafine into the bloodstream is negligible.

Fungicidal concentrations of terbinafine are present in the stratum corneum of the epidermis after 7 days of treatment and persist for up to 7 days after treatment cessation. No effects of terbinafine on fertility were observed in animal studies.

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, interdigital 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 to any of the components of the medicinal product.

Safety precautions.

Exifin gel should be used with caution in skin lesions where alcohol may cause an irritant effect.

Exifin gel is intended for topical use only. It may cause irritation upon contact with the eyes. In case of accidental contact with eyes, they should be thoroughly rinsed with running water; if irritation persists, medical advice should be sought.

Do not apply to the face.

To prevent skin mycoses, the following measures should be observed: change underwear daily, as microorganisms may be present on clothing parts that have been in contact with infected skin surfaces; avoid wearing tight or poorly ventilated clothing; dry affected skin areas thoroughly after washing; use a clean personal towel daily. In case of foot mycosis, walking barefoot should be avoided. In addition to topical treatment once daily, it is recommended to spray the inside of socks or footwear with an antifungal spray or to apply antifungal powder inside them.

Exifin gel contains butylated hydroxytoluene, which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

Interaction with other medicinal products and other forms of interaction.

Interaction is unknown; however, as a precaution, other medicinal products should not be applied to treated areas.

Use during pregnancy or breastfeeding.

Animal studies have not shown terbinafine to have embryotoxic effects. However, since clinical experience with the use of the drug in pregnant women is limited, Exifin gel should not be used during pregnancy except when, in the opinion of the physician, the expected benefit to the pregnant woman outweighs the potential risk to the fetus.

Terbinafine passes into breast milk in small amounts; therefore, the drug should not be used during breastfeeding. In addition, direct contact between infants and any area of skin to which the medicinal product has been applied should be avoided.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage

Exifine gel is applied once daily. Before application, the affected areas should be thoroughly cleaned and dried. Apply a thin layer of the gel to the affected skin and surrounding areas and gently rub in. In infections accompanied by intertrigo in skin folds (under the breasts, between fingers, between buttocks, in the groin area), the areas treated with the gel may be covered with gauze, especially at night.

If the tube is sealed with a protective membrane, the membrane should be punctured before first use, for example, with a sharp piercing device that may be present on the screw cap.

Duration and Frequency of Use.

Tinea corporis, tinea cruris: once daily for 1 week.

Tinea pedis (interdigital): once daily for 1 week.

Clinical improvement usually occurs within a few days. Irregular use or premature discontinuation of treatment may lead to recurrence. If no improvement is observed after completion of treatment, consult a physician.

Dose adjustment is not required for elderly patients.

Children.

Due to insufficient experience, the medicinal product is not recommended for use in children.

Overdose.

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

In case of accidental ingestion of the contents of one Exifine gel tube (containing 300 mg of terbinafine), the effect of the medicinal product can be compared to that of one terbinafine tablet (250 mg – single oral dose for adults).

If a larger amount of the product is accidentally ingested, adverse effects would be similar to those observed after an overdose of terbinafine tablets, i.e., headache, nausea, epigastric pain, and dizziness.

Treatment of overdose in case of accidental ingestion consists of elimination of the active substance, primarily by administration of activated charcoal, and symptomatic supportive therapy as needed.

Adverse Reactions

Local reactions such as itching, skin peeling, pain at the application site, irritation at the application site, pigmentation changes, burning sensation, erythema, and crusting may occur at the site of application. These mild reactions should be differentiated from hypersensitivity reactions such as generalized itching, rash, bullous eruptions, and urticaria, which have been reported in isolated cases and require discontinuation of treatment. Accidental contact with eyes may cause eye irritation. Rarely, underlying fungal infection may be exacerbated.

Immune system disorders: Frequency unknown — hypersensitivity reactions.

Eye disorders: Rare — eye irritation.

Skin and subcutaneous tissue disorders: Common — skin peeling, itching; uncommon — skin injury, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of skin; rare — skin dryness, contact dermatitis, eczema; frequency unknown — rash.

General disorders and administration site conditions: Uncommon — pain, pain at application site, irritation at application site; rare — worsening of symptoms.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy to the State Expert Center of the Ministry of Health of Ukraine via the following link: https://aisf.dec.gov.ua/

Shelf life. 2 years.

Storage conditions. Keep out of reach of children at a temperature not exceeding 25 °C.

Packaging. 15 g or 30 g of gel in a tube. 1 tube per cardboard box.

Availability. Over-the-counter.

Manufacturer. Dr. Reddy’s Laboratories Limited

Manufacturer's address and location of operations.

Production unit - VI Mile, Khol, Nalagarh Road, Baddi, Solan District, Himachal Pradesh, 173205, India

To report an adverse reaction or lack of efficacy during use of the medicinal product, please call:

+380 44 207 51 97 or +380 50 414 39 39; or email: [email protected] (available 24/7).