Lamictal

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LAMICON® (LAMICON)

Composition:

Active substance: terbinafine;

1 g of the solution contains 10 mg of terbinafine hydrochloride, calculated as 100 % anhydrous substance;

Excipients: benzoic acid (E 210), polyethylene glycol (macrogol) 20 cetostearyl ether, propylene glycol, poloxamer 407, disodium edetate, water for injections.

Pharmaceutical form. Cutaneous spray.

Main physicochemical properties: the preparation is dispensed from the container as an aerosol jet consisting of liquid particles dispersed in air.

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. At appropriate concentrations, terbinafine exerts a fungicidal effect against dermatophytes, molds, and some dimorphic fungi. Activity against yeast fungi may be either fungicidal or fungistatic, depending on the species.

Terbinafine specifically inhibits an early step in the biosynthesis of sterols in the fungal cell membrane. This leads to a deficiency of ergosterol 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 hormone metabolism or the metabolism of other medicinal drugs.

Pharmacokinetics.

When applied topically, the drug is hardly absorbed, acts quickly, and demonstrates efficacy even with short-term treatment (7 days).

With topical application, less than 5% of the applied dose is absorbed, so systemic exposure to terbinafine is negligible.

Clinical characteristics.

Indications.

Fungal infections of the skin 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 other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Unknown. The use of other medicinal products on treated areas is not recommended.

Special precautions for use.

This is a topical preparation. Avoid inhalation. In case of accidental inhalation, medical advice should be sought if any adverse symptoms worsen or persist.

Avoid contact with eyes. Do not apply the spray to the face. In case of accidental contact with eyes or face, immediately rinse thoroughly with running water.

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

To prevent re-infection with skin mycoses, the following rules should be observed: change underwear daily, as fungi may be present on clothing that has been in contact with infected skin surfaces; avoid wearing clothing that is too tight or poorly breathable; thoroughly dry affected skin areas after washing; use a clean personal towel every day. In case of tinea pedis (athlete's foot), walking barefoot should be avoided. In addition to topical treatment once daily, it is recommended to treat socks or the inside of footwear once daily with Lamicon® spray.

Lamicon® topical spray contains propylene glycol, which may cause skin irritation.

Lamicon® topical spray contains benzoic acid, which may mildly irritate the skin, eyes, and mucous membranes.

Animal studies have not revealed any effect of terbinafine on fertility.

Use during pregnancy or breastfeeding.

Pregnancy.

Animal studies have not shown teratogenic or embryotoxic effects of terbinafine. To date, there have been no reports of congenital malformations in humans. Clinical experience with use during pregnancy is limited. Fetal toxicity studies in animals indicate absence of adverse effects. Lamicon® topical spray should be used during pregnancy only if the expected benefit to the woman outweighs the potential risk to the fetus.

Breastfeeding.

Terbinafine passes into breast milk in small amounts; therefore, the product should not be used in women who are breastfeeding.

Contact between infants and any area of skin treated with the product should be avoided.

Ability to influence reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

Lamicon® topical spray is intended for external use only.

Before application, the affected skin areas should be thoroughly cleaned and dried. The medication should be sprayed onto the affected skin areas in sufficient quantity to ensure thorough wetting, and also applied to adjacent areas of healthy skin.

The duration of treatment and frequency of application should be determined according to the indication:

• Tinea pedis (athlete's foot) and tinea corporis (ringworm of the body) – once daily for one week;
• Pityriasis versicolor – twice daily for one week.

Dose adjustment is not required for elderly patients.

Symptom relief is usually expected within a few days.

Irregular use or premature discontinuation of treatment may lead to recurrence of the infection. If there is no sign of improvement after one week of treatment, medical advice should be sought.

Children

Safety and efficacy in children have not been established; therefore, the use of this medication in children is not recommended.

Overdose

Due to the low systemic absorption of terbinafine with topical application, the likelihood of overdose is extremely low. Accidental ingestion of the contents of one 25 g bottle of Lamicon® topical spray (containing 250 mg of terbinafine hydrochloride) is comparable to taking one 250 mg Lamicon® tablet (the oral dosage form). If a larger amount of Lamicon® topical spray is accidentally ingested, adverse effects would be expected to resemble those of an overdose of Lamicon® tablets (e.g. headache, nausea, epigastric pain, and dizziness).

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

Side effects.

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

The adverse reactions listed below are categorized by organ system classes and frequency. Frequency is defined as: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10000 to <1/1000); very rare (<1/10000); or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are listed in order of decreasing severity.

Immune system disorders: not known – hypersensitivity, including urticaria.

Eye disorders: rare – eye irritation.

Skin and subcutaneous tissue disorders: common – skin peeling, itching; uncommon – skin damage, crusting, skin lesions, pigmentary changes, erythema, skin burning sensation; rare – skin dryness, contact dermatitis, eczema; not known – rash.

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

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging. 25 g in a bottle with a pump dispenser. 1 bottle per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "Farmak".

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

74, Kyrylivska Street, Kyiv, 04080, Ukraine.