Lamifen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LAMIFEN®

Composition:

Active substance: terbinafine;

1 g of gel contains terbinafine hydrochloride (calculated as 100 % anhydrous terbinafine) 10 mg;

Excipients: phenoxyethanol and ethylhexylglycerin (calculated as phenoxyethanol) 10 mg, propylene glycol, isopropyl myristate, dimethicone, polysorbate 60, sorbitan stearate, hydroxypropyl starch phosphate, sodium hydroxide, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: white or almost white gel with a weak specific odor. The gel should be homogeneous in appearance.

Pharmacotherapeutic group.

Antifungal agents for topical use. Terbinafine. 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 at low concentrations 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 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 through inhibition of the enzyme squalene epoxidase 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 drugs.

When applied topically, the drug acts rapidly, and effective results can be achieved with short-term treatment (7–14 days).

Pharmacokinetics.

With topical application, less than 5% of the terbinafine dose is absorbed, resulting in very low systemic exposure. Fungicidal concentrations of terbinafine in the stratum corneum are maintained for up to 7 days after discontinuation of treatment, following 7 days of application.

In animal studies, terbinafine was not found to affect fertility.

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, 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 other component of the product.

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.

Special precautions for use.

The drug should be prescribed with caution to patients with facial lesions. The gel is intended for topical application to the skin only. Contact with the eyes should be avoided. In case of accidental contact with the eyes, they should be rinsed thoroughly with running water.

Symptom relief usually occurs within a few days. Irregular use of the drug or premature discontinuation of treatment may lead to disease relapse.

To prevent skin mycosis, the following rules should be observed: change underwear daily, since microorganisms may be present on clothing parts that have been in contact with infected skin areas; avoid wearing tight or poorly ventilated clothing; thoroughly dry affected skin areas after washing; change personal towels daily. Barefoot walking is not recommended in case of foot mycosis. In addition to topical treatment, it is recommended to treat the inside of socks or footwear once daily with an appropriate antifungal agent.

Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding.

As clinical experience with the use of the drug in pregnant women is limited, it should not be used during pregnancy unless, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus.

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

Ability to influence reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

The duration of treatment depends on the disease and the severity of its course.

Apply the gel to the skin once daily. Before applying the gel, the affected areas must be cleaned and dried thoroughly. Apply a thin layer of gel to the affected skin areas and surrounding tissue, and gently rub in. In infections associated with intertrigo of skin folds (under the breasts, interdigital, intergluteal, or in the groin area), the treated areas may be covered with gauze, especially at night.

Duration and Frequency of Treatment

Fungal skin infections caused by dermatophytes, namely:

• Tinea pedis (interdigital): once daily for 1 week;
• Tinea cruris and tinea corporis: once daily for 1 week;
• Pityriasis versicolor: once daily for 1 week.

Dosage adjustment is not required for elderly patients.

Children

Due to insufficient experience with use, Lamifen**®** gel 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. Accidental ingestion of the contents of one 30 g tube of Lamifen**®** gel (containing 300 mg of terbinafine) is comparable to taking one 250 mg Lamifen**®** tablet (an oral dosage form). In cases of accidental ingestion of a larger amount of the product, adverse effects are expected to be similar to those seen with overdose of Lamifen**®** tablets (headache, nausea, epigastric pain, and dizziness).

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

Side effects.

Local reactions such as itching, peeling, or burning of the skin, pain and irritation at the application site, pigmentation disorders, erythema, crusting, and others may occur at the site of application. These mild reactions should be differentiated from hypersensitivity reactions, including rash, which have been reported in isolated cases and require discontinuation of treatment. In case of accidental contact with eyes, terbinafine may cause eye irritation. In rare cases, underlying fungal infection may worsen.

Possible adverse effects:

Immune system disorders:

Frequency unknown (cannot be estimated from available data): hypersensitivity reactions*.

Eye disorders:

Rare (≥1/10,000, <1/1,000): eye irritation.

Skin and subcutaneous tissue disorders:

Common (≥1/100, <1/10): skin peeling, itching.

Uncommon (≥1/1,000, <1/100): skin injury, crusting, skin lesions, pigmentation disorders, erythema, skin burning sensation.

Rare (≥1/10,000, <1/1,000): skin dryness sensation, contact dermatitis, eczema.

Frequency unknown: rash*.

General disorders and administration site conditions:

Uncommon (≥1/1,000, <1/100): pain, pain at application site, irritation at application site.

Rare (≥1/10,000, <1/1,000): worsening of symptoms.

*Data obtained from post-marketing surveillance of the active substance.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging. 15 g or 30 g in tubes; 1 tube per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "FITOPHARM".

Manufacturer's address and place of business.

2 Sybirtseva St., Bakhmut, Donetsk Oblast, 84500, Ukraine.

Marketing authorization holder. JSC "FITOPHARM".

Address of the marketing authorization holder.

7 Verkhovnoyi Rady Ave., Kyiv, 02100, Ukraine, Building 7, Floor 3, Premises 18.

Date of last review.

INSTRUCTION

for medical use of medicinal product

LAMIFEN®

Composition:

Active ingredient: terbinafine;

1 g of gel contains terbinafine hydrochloride (calculated as 100% anhydrous terbinafine) 10 mg;

Excipients: phenoxyethanol and ethylhexylglycerin (calculated as phenoxyethanol) 10 mg, propylene glycol, isopropyl myristate, dimethicone, polysorbate 60, sorbitan stearate, hydroxypropyl starch phosphate, sodium hydroxide, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: white or almost white gel with a weak specific odor. The gel should be homogeneous in appearance.

Pharmacotherapeutic group.

Antifungal agents for topical use. Terbinafine. 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 at low concentrations 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 stage of 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 the metabolism of hormones or other medicinal agents.

When applied topically, the drug acts rapidly, and effective treatment can be achieved with short-term therapy (7–14 days).

Pharmacokinetics.

With topical application, less than 5% of the terbinafine dose is absorbed, so systemic exposure is very low. Fungicidal concentrations of terbinafine in the stratum corneum are maintained for up to 7 days after discontinuation of treatment, following 7 days of application.

In animal studies, terbinafine was not found to affect fertility.

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, 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 other component of the product.

Interaction with other medicinal products and other forms of interaction.

Interaction is unknown; however, as a precautionary measure, other medicinal products should not be used on the treated areas.

Special precautions for use.

The drug should be prescribed with caution to patients with facial lesions. The gel is intended for topical application to the skin only. Contact with the eyes should be avoided. If the gel comes into contact with the eyes, they should be thoroughly rinsed with running water.

Clinical symptom relief usually occurs within a few days. Irregular use of the drug or premature discontinuation of treatment may lead to recurrence of the disease.

To prevent skin fungal infections, the following rules should be observed: change underwear daily, as microorganisms may be present on clothing parts that have been in contact with infected skin areas; avoid wearing tight-fitting or poorly ventilated clothing; thoroughly dry affected skin areas after washing; change personal towels daily. When treating foot fungal infections, walking barefoot should be avoided. In addition to topical treatment, it is recommended to treat the inside of socks or footwear once daily with an appropriate antifungal agent.

Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding.

As clinical experience with use of this drug in pregnant women is limited, the drug should not be used during pregnancy except when, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus.

Terbinafine passes into breast milk in small amounts; therefore, the drug should not be used by breastfeeding mothers. Additionally, direct contact between infants and any area of skin treated with the drug should be avoided.

Ability to affect reaction rate while driving or operating machinery.

No effect.

Method of Administration and Dosage

The duration of treatment depends on the disease and the severity of its course.

Apply the gel to the skin once daily. Before applying the gel, the affected areas must be cleaned and dried thoroughly. Apply a thin layer of gel to the affected skin and adjacent areas and gently rub in. For infections associated with intertrigo of skin folds (under the breasts, interdigital, buttock, groin), the areas treated with gel may be covered with gauze, especially at night.

Duration and frequency of treatment.

Fungal skin infections caused by dermatophytes, namely:

• tinea pedis (interdigital): once daily for 1 week;
• tinea cruris and tinea corporis: once daily for 1 week;
• pityriasis versicolor: once daily for 1 week.

Dosage adjustment is not required for elderly patients.

Children.

Due to insufficient experience of use, Lamifen**®** gel is not recommended for use in children.

Overdose.

Low systemic absorption of terbinafine with topical application results in an extremely low risk of overdose. Accidental ingestion of the contents of one 30 g tube of Lamifen**®** gel (containing 300 mg of terbinafine) is comparable to taking one 250 mg Lamifen**®** tablet (an oral dosage form). It is expected that accidental ingestion of a larger amount of the product would result in adverse effects similar to those seen with an overdose of Lamifen**®** tablets (headache, nausea, epigastric pain, and dizziness).

Treatment of overdose following accidental ingestion consists of removing the active substance, primarily by administering activated charcoal, and providing symptomatic therapy as necessary.

Side effects.

Local reactions 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 reactions should be differentiated from hypersensitivity reactions, including rash, which have been reported in isolated cases and require discontinuation of treatment. In case of accidental contact with eyes, terbinafine may cause eye irritation. In rare cases, an underlying fungal infection may worsen.

Possible side effects:

Immune system disorders:

Frequency unknown (cannot be estimated from available data): hypersensitivity reactions*.

Eye disorders:

Rare (≥1/10,000, <1/1,000): eye irritation.

Skin and subcutaneous tissue disorders:

Common (≥1/100, <1/10): skin peeling, itching.

Uncommon (≥1/1,000, <1/100): skin injury, crusting, skin lesions, pigmentary disturbances, erythema, skin burning sensation.

Rare (≥1/10,000, <1/1,000): skin dryness sensation, contact dermatitis, eczema.

Frequency unknown: rash*.

General disorders and administration site conditions:

Uncommon (≥1/1,000, <1/100): pain, pain at application site, irritation at application site.

Rare (≥1/10,000, <1/1,000): worsening of symptoms.

*Data obtained from post-marketing surveillance of the active substance.

Shelf life. 2 years.

Storage conditions. Store in original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging. 15 g or 30 g in tubes; 1 tube per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC «FITOPHARM» (responsible for batch release, excluding batch control/testing).

Manufacturer's address.

17 Chumatska Street, Boryspil, Kyiv Oblast, Ukraine, 08303.

Marketing Authorization Holder. JSC «FITOPHARM».

Address of the Marketing Authorization Holder.

7, Verkhovnoi Rady Avenue, 3rd floor, room 18, Kyiv, Ukraine, 02100.