Lamisil uno

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LAMISIL UNO (LAMISIL UNO)

Composition:

Active substance: terbinafine;

1 g of solution contains 11.25 mg of terbinafine hydrochloride, corresponding to 10 mg of terbinafine;

Excipients: acrylate/octylacrylamide copolymer, medium-chain triglycerides, hydroxypropylcellulose, ethanol 96 %.

Pharmaceutical form. 1 % topical film-forming solution.

Main physicochemical properties: transparent or slightly opalescent viscous solution, colorless or pale yellow, with an ethanol odor.

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, used for the treatment of fungal infections caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum. At low concentrations, terbinafine exhibits fungicidal activity against dermatophytes and mold fungi. The activity of terbinafine against yeast fungi may be either fungicidal (e.g., Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine specifically interferes with the early stage of sterol biosynthesis in fungal cells. 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. Squalene epoxidase does not belong to the cytochrome P450 system. Terbinafine does not affect hormone metabolism or the metabolism of other medicinal agents.

After a single application of Lamisil Uno to both feet, a therapeutic effect was observed in patients with tinea pedis (athlete's foot) involving interdigital areas spreading to both sides of the feet and the soles.

Terbinafine has a prolonged effect. Less than 12.5% of patients with athlete's foot experienced recurrences/reinfections within 3 months after treatment with Lamisil Uno.

Pharmacokinetics.

After a single topical application, Lamisil Uno forms a film on the skin, in which terbinafine remains present for up to 72 hours. From this film, terbinafine rapidly penetrates into the stratum corneum: 16–18% of the applied dose is present in the stratum corneum within 60 minutes after application. Release of terbinafine from the film is progressive and continues until the film disappears. Terbinafine remains detectable in the stratum corneum for up to 13 days at concentrations exceeding the minimum inhibitory concentration (MIC) of terbinafine in vitro against dermatophytes.

Systemic bioavailability is extremely low. After application of Lamisil Uno to a back area three times larger than the combined surface area of both feet, the systemic bioavailability of terbinafine is only 0.5% of that observed after oral administration of a 250 mg tablet.

In vitro and in vivo genotoxicity studies revealed no mutagenic or clastogenic properties of the medicinal product. No effects on fertility or other reproductive functions were observed in animal studies.

Clinical characteristics

Indications.

Fungal infections of the feet (athlete's foot).

Contraindications.

Hypersensitivity to terbinafine or to any of the inactive ingredients contained in the medicinal product. Do not use during breastfeeding.

Interaction with other medicinal products and other forms of interaction.

There are no reports of any drug interactions associated with topical use of the medicinal product.

Special precautions for use

Consult your doctor before starting treatment.

Do not use Lamisil Uno if the patient has hypersensitivity to any of the components of the product.

Since fungal infections can be transmitted to other people, use only individual towels and clothing, which should not be shared with others.

Lamisil Uno is intended for topical use only. Avoid contact with skin, eyes, or other damaged skin areas not intended for treatment, as the product may cause irritation. Use with caution on affected areas where alcohol may cause irritation (e.g., after sun exposure or in cases of severe skin desquamation). In case of accidental contact with eyes, rinse thoroughly with running water. If discomfort persists, consult a doctor. Avoid contact with the mouth (do not swallow!). In very rare cases of allergic reactions to the product, remove the film using an organic solvent such as denatured alcohol, wash the feet with warm soapy water, and then rinse thoroughly. Afterwards, apply a moisturizing cream to the feet. If symptoms persist, consult a doctor.

The use of Lamisil Uno is not recommended in cases of chronic hyperkeratotic tinea pedis.

Do not apply to the face.

Contains alcohol; therefore, keep away from open flames.

Avoid contact of infants with skin areas treated with the medicinal product, including the mammary glands.

Keep out of reach and sight of children.

Use during pregnancy or breastfeeding

There is no clinical experience with the use of Lamisil Uno in pregnant women. Animal studies have shown no teratogenic or embryotoxic effects of terbinafine, nor any effects on fertility or other reproductive functions. The product should be used only if absolutely necessary and only if, in the physician's opinion, the expected benefit outweighs the potential risk to the fetus.

Systemic exposure following topical application is expected to be low.

Terbinafine passes into breast milk; therefore, the product should be prescribed to breastfeeding women only if the expected benefit to the mother outweighs the potential risk to the infant. Avoid contact of infants with skin areas treated with the medicinal product, including the mammary glands.

Ability to influence reaction rate while driving or operating machinery

Topical application of Lamisil Uno does not affect the ability to drive a vehicle or operate machinery.

Method of Administration and Dosage.

Treatment of adults and children aged 15 years and older: single application.

For external use only.

Lamisil One is applied once to both feet, even if fungal lesions are visible on only one foot. This ensures elimination of fungi (dermatophytes) that may be present on areas of the foot where infection is not visually apparent.

After application to the skin of the feet, the product dries quickly and forms a colorless film. The tube contains sufficient medication for treatment of both feet. Depending on foot size, not the entire contents of the tube may be required for treatment.

Before applying Lamisil One solution, the following steps should be taken:

• Wash both feet and thoroughly dry the skin;
• Wash and dry hands;
• Remove the cap from the tube.

Procedure for applying Lamisil One solution:

• Treatment consists of a single procedure;
• The product must be applied to both feet. The second foot should not be treated until the first foot has been completely covered;
• Approximately ½ of the tube should be used for each foot, but the amount applied should be sufficient to cover the required skin surface;
• Apply the product to each foot manually, as shown in the image: begin with the interdigital areas, applying a thin, even layer between the toes and around their entire surface, as well as to the soles and sides of the feet up to a height of 1.5 cm;
• The other foot must be treated in the same manner, even if its skin appears healthy;
• Do not reapply the product to treated skin. Do not rub the product into the skin;
• After application, allow the solution to dry for 1–2 minutes until a film forms;
• Recap the tube and dispose of any remaining product. Leftover medication must not be stored or shared with others;
• Wash hands after completing the procedure.

Lamisil One begins acting immediately against fungi. After application, the barely noticeable, imperceptible film remaining on the skin continues to work, killing fungal microorganisms over several days following the single treatment. Relief of clinical symptoms typically occurs within several days, but complete skin recovery may take up to 4 weeks.

If there is no sign of improvement within 2 weeks, consult a physician to confirm the diagnosis. There is no data on repeat treatment with this product; therefore, further treatment is not recommended within the same episode of fungal foot infection ("athlete's foot").

For optimal results, avoid washing the treated area for 24 hours after application of Lamisil One. It is recommended to apply the product after a shower or bath and to wash the feet again at the same time the following day. Dry the skin thoroughly without rubbing. Avoid injuring the affected area, even if itching is present, as this may cause further skin damage, delay healing, and promote infection spread.

There are no data indicating the need for different dosing in elderly patients. No differences in the incidence of adverse effects compared to younger patients have been observed in elderly individuals.

Children.

The efficacy of Lamisil One has not been studied in pediatric practice; therefore, the product is not recommended for use in children under 15 years of age.

Overdose.

Overdose is unlikely, as the product is supplied as a single-dose formulation intended for topical use, and one tube contains only enough medication for one treatment. Accidental ingestion of the tube contents (40 mg terbinafine) would result in significantly less systemic effect compared to ingestion of a 250 mg Lamisil tablet (oral dose). However, accidental ingestion of multiple tubes may lead to adverse effects similar to those observed with overdose of oral Lamisil tablets (including headache, nausea, epigastric pain, and dizziness).

In case of accidental ingestion, consider the ethanol content of the product (81.05% w/w).

Recommended treatment for accidental ingestion includes removal of the active substance, primarily by administration of activated charcoal, and symptomatic therapy as needed.

Adverse Effects.

Mild and transient reactions at the application site may occur. Allergic reactions are very rare.

Disorders of the skin and subcutaneous tissues:

Rare (<1/10,000, including isolated cases): allergic reactions such as rash, pruritus, bullous dermatitis, or urticaria.

Frequency not known: skin desquamation, skin fissures, pigmentary disturbances, erythema.

General disorders:

Uncommon (>1/1,000, <1/100): local reactions at the application site, such as dryness, irritation, or burning sensation.

Frequency not known: pain at the application site.

Eye disorders:

Frequency not known: eye irritation.

Note: Data obtained from post-marketing experience are reported voluntarily; therefore, their frequency cannot be determined and is labeled as "not known." However, these cases are most likely either isolated (≥1/10,000, <1/1,000) or rare (<1/1,000).

Shelf Life. 3 years.

Storage Conditions. Store at temperatures not exceeding 30°C, in a place inaccessible and out of sight of children. Keep in the original packaging.

Packaging. 4 g in tubes. One tube in a plastic holder, packed in a cardboard box.

Availability. Over-the-counter (without prescription).

Name and Address of Manufacturer.

Haleon CH S.a.r.l. / Haleon CH S.a.r.l.

Route de l’Etraz 2, Nyon, 1260, Switzerland / Route de l’Etraz 2, Nyon, 1260, Switzerland