Lamisil^® UNO (Solution) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Healthcare, JSC (Russia)

Manufactured By

GSK Consumer Healthcare SARL (Switzerland)

ATC Code

D01AE15 (Terbinafine)

Active Substance

Terbinafine (Rec.INN registered by WHO)

Dosage Form

Lamisil® UNO

Film-forming solution for external use 1%: tube 4 g

Dosage Form, Packaging, and Composition

Film-forming solution for external use 1% transparent or slightly matte, viscous, from colorless to light yellow, with the smell of ethanol.

Excipients : acrylic acid and octylacrylamide copolymer (Dermacryl 79) – 50 mg, medium chain triglycerides – 50 mg, hypromellose – 25 mg, ethanol 96% – 863.75 mg.

4 g – laminated tubes (1) with a first-opening control system – contour cell packaging (1) – cardboard packs with a “window”.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal drug for external use with a broad spectrum of antifungal activity. In low concentrations, Terbinafine has a fungicidal effect against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, depending on the species, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis in fungi. This leads to ergosterol deficiency and intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase, located on the fungal cell membrane.

Squalene epoxidase is not associated with the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other drugs.

Pharmacokinetics

After applying the drug Lamisil^® Uno to the skin, the solution forms a transparent, imperceptible film that remains on the skin for 72 hours. From the film, Terbinafine quickly penetrates into the stratum corneum of the skin: 60 minutes after the procedure, 16-18% of the applied dose is detected in the stratum corneum. The release of terbinafine is progressive; the active substance is present in the stratum corneum after 13 days at a concentration exceeding the minimum inhibitory concentration of terbinafine in vitro against dermatophytes.

Systemic bioavailability is extremely low. With external use, the absorption of the drug is less than 5%. Lamisil^® Uno has a slight systemic effect.

The recurrence rate after 3 months of using the drug is low (not higher than 12.5%).

Indications

• Mycoses (dermatophytoses) of the feet (tinea pedis).

ICD codes

Dosage Regimen

The drug is used externally, once.

For adults and adolescents over 15 years of age, the film-forming solution Lamisil^® Uno is applied once to both feet, even if the fungal infection is observed only on one foot. This guarantees the destruction of fungi (dermatophytes) that may be present on areas of the foot where lesions are not visually noticeable.

Before applying the drug, wash and dry your feet and hands. First, one foot is treated, then the other. Starting the procedure on the interdigital areas, apply a thin layer evenly between the toes and around their entire surface, as well as on the sole and lateral parts of the foot up to a height of 1.5 cm. Use a sufficient amount of the drug to cover the necessary skin surface, usually 1/2 tube for treating each foot.

The other foot should be treated in the same way, even if the skin on it looks healthy. Allow the solution to dry for 1-2 minutes until a film forms. After finishing the foot treatment, wash your hands.

The drug should not be reapplied to the treated skin.

Lamisil^® Uno should not be rubbed into the skin.

Adverse Reactions

Side effects are observed very rarely, are mild and short-lived.

Systemic reactions: very rarely (< 1/10,000) – allergic reactions (rash, redness, bullous dermatitis and urticaria).

Local reactions: rarely (>1/1000, < 1/100) – dryness, skin irritation or burning sensation on the skin area treated with the drug.

Contraindications

• Hypersensitivity to the components of the drug.

With caution: hepatic and/or renal insufficiency, alcoholism, bone marrow depression, tumors, metabolic diseases, occlusive vascular diseases of the extremities, children under 15 years of age (lack of sufficient clinical experience).

Use in Pregnancy and Lactation

Clinical experience with the use of the drug Lamisil^® Uno for external use during pregnancy is very limited; the drug should be used only for strict indications.

Terbinafine is excreted in breast milk, so the drug should not be prescribed to nursing mothers.

In experimental studies, no teratogenic properties of terbinafine were identified. To date, no developmental defects have been reported with the use of Lamisil^® Uno.

Use in Hepatic Impairment

With caution: hepatic insufficiency.

Use in Renal Impairment

With caution: renal insufficiency.

Pediatric Use

The effect of the drug Lamisil^® Uno in pediatric practice has not been studied. Therefore, it is not recommended to use the drug in children under 15 years of age.

Geriatric Use

There is no data indicating that different doses are required or different side effects occur when treating elderly patients compared to younger patients.

Special Precautions

Lamisil^® Uno is not recommended for use in cases of chronic plantar hyperkeratosis caused by Tinea pedis (moccasin type).

Lamisil^® Uno is for external use only. The drug should not be applied to the skin of the face, as it may cause irritation of the mucous membrane of the eyes. If it accidentally gets into the eyes, they should be thoroughly rinsed with running water. The drug should not be taken orally!

If an allergic reaction to the drug develops, the film should be removed using an organic solvent (for example, denatured alcohol) and then the feet should be washed with soap and water.

If allergic reactions develop, the drug should be discontinued.

To achieve the best results, the treated area should not be washed for 24 hours after the procedure. Therefore, it is recommended to apply Lamisil^® Uno after taking a shower or bath and wash your feet again the next day at the same time.

Use the amount of the drug required to apply the film to both feet, performing the procedure according to the method described above. The unused remainder of the drug should be destroyed.

Improvement in clinical symptoms is usually observed within a few days. If there are no signs of improvement after a week, the diagnosis should be verified.

There is no data indicating that dose adjustment is required or different side effects occur when treating elderly patients compared to younger patients.

Use in pediatrics

The effect of the drug Lamisil^® Uno in pediatric practice has not been studied. Therefore, it is not recommended to use the drug in children under 15 years of age.

Effect on ability to drive vehicles and machinery

With external use, Lamisil^® Uno does not affect the ability to drive vehicles or operate machinery.

Overdose

No cases of drug overdose have been reported. Overdose is unlikely since the drug is released in an amount necessary for a single use and is intended for external use.

Symptoms in case of accidental ingestion of the drug may include headache, nausea, epigastric pain and dizziness.

Treatment administration of activated charcoal, if necessary, symptomatic therapy is carried out in a hospital setting.

Drug Interactions

Currently, drug interactions of Lamisil^® Uno are not known.

Storage Conditions

The drug should be stored out of the reach of children, in the original packaging, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.