LAMICTAL

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

Composition:

Active substance: terbinafine;

1 g of cream contains terbinafine hydrochloride equivalent to 100 % anhydrous substance – 0.01 g;

Excipients: phenethyl alcohol, white soft paraffin, mineral oil, cetylstearyl alcohol, polyethylene glycol (macrogol) 20 cetylstearyl ether, propylene glycol, poloxamer 407, sodium hydroxide, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white or almost white cream with a specific odor.

Pharmacotherapeutic group. Antifungal agents for topical use.

ATC code D01AE15.

Pharmacological Properties

Pharmacodynamics

Terbinafine is an allylamine with a broad spectrum of antifungal activity. Terbinafine exerts a fungicidal effect against dermatophytes, molds, and some dimorphic fungi at low concentrations. Activity against yeast fungi may be either fungicidal or fungistatic, depending on the species. The drug has a prolonged effect, enabling therapeutic efficacy to be achieved within a short treatment period.

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 hormonal agents or other medicinal products.

Pharmacokinetics

When applied topically, less than 5% of the dose is absorbed; therefore, systemic absorption of terbinafine into the bloodstream is minimal.

Terbinafine acts rapidly and demonstrates efficacy with short-term treatment (7 days). After 7 days of treatment with Lamicon® cream, concentrations of terbinafine exceeding those required for fungicidal activity remain present in the stratum corneum for at least 7 days following the end of treatment.

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); cutaneous candidiasis caused by Candida species, usually Candida albicans; 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.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Usage Notes

The cream is intended for external use only. Contact with the eyes should be avoided, as the medicinal product may cause irritation. In case of accidental contact with the eyes, they should be thoroughly rinsed with running water. Lamicon®, cream, contains cetostearyl alcohol, which may cause local skin irritation (e.g., contact dermatitis).

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

To prevent re-infection with dermatophytes, the following precautions should be observed: change underwear daily, as fungi may be present on clothing that has been in contact with infected skin areas; avoid wearing clothes that are too tight or poorly breathable; thoroughly dry affected skin areas after washing; use a clean personal towel every day. Walking barefoot is not recommended in case of foot mycosis. In addition to topical treatment once daily, it is recommended to treat socks or footwear internally with Lamicon® spray.

Animal studies did not reveal any effect of terbinafine on fertility.

Use during pregnancy or breastfeeding

Animal studies did not show any embryotoxic effect of terbinafine. Since clinical experience with the use of the drug in pregnant women is limited, Lamicon®, cream, 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; therefore, the drug should not be used by women who are breastfeeding. Contact between infants and treated skin areas, including the mammary glands, should be avoided.

Effect on the ability to drive or operate machinery

No effect.

Method of Administration and Dosage

The cream is intended for external use only.

Adults and children aged 12 years and older.

Apply Lamicon® cream to the skin once or twice daily, depending on the condition. Before application, thoroughly clean and dry the affected areas. Apply a thin layer of the cream to the affected skin and surrounding areas, gently rubbing it in. In infections associated with intertrigo (under the breasts, in the interdigital areas, groin, and between the buttocks), the treated areas may be covered with gauze, especially at night.

Duration and Frequency of Treatment

The duration of treatment depends on the severity of the disease:

• Interdigital tinea pedis, tinea cruris, and tinea corporis: once daily for 1 week;
• Squamous-hyperkeratotic tinea pedis ("moccasin foot"): twice daily for 2 weeks;
• Cutaneous candidiasis: 1–2 times daily for 1 week;
• Pityriasis versicolor: 1–2 times daily for 2 weeks.

Dose adjustment is not required for elderly patients.

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

If there are no signs of improvement after 2 weeks of treatment, consult a physician.

Children

Experience with the use of the drug in children under 12 years of age is limited; therefore, the drug should not be used in this age group.

Overdose

The low systemic absorption of terbinafine with topical application results in an extremely low risk of overdose. Accidental ingestion of the contents of two 30 g tubes (containing 300 mg of terbinafine hydrochloride) is comparable to taking one 250 mg Lamicon® tablet (the oral dosage form). In cases of overdose due to accidental ingestion of a large amount of cream, adverse effects would be expected to be similar to those seen with overdose of Lamicon® tablets (headache, nausea, epigastric pain, and dizziness).

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

Side effects

Local reactions such as itching, peeling or burning of the skin, pain and irritation at the application site, pigmentary changes, erythema, and crusting 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 hydrochloride may cause eye irritation. Rarely, underlying fungal infection may worsen.

Possible side effects:

Immune system disorders

Frequency not known (cannot be estimated from available data): hypersensitivity reactions, including urticaria*. In isolated cases – angioedema and anaphylactic shock.

Eye disorders

Rare (≥ 1/10000, < 1/1000): eye irritation.

Skin and subcutaneous tissue disorders

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

Uncommon (≥ 1/1000, < 1/100): skin injury, crusting, skin lesions, pigmentary changes, erythema, skin burning sensation.

Rare (≥ 1/10000, < 1/1000): skin dryness sensation, contact dermatitis (including bullous dermatitis), eczema.

Frequency not known (cannot be estimated from available data): rash* or blistering.

General disorders and administration site conditions

Uncommon (≥ 1/1000, < 1/100): pain, pain at application site, irritation at application site.

Rare (≥ 1/10000, < 1/1000): worsening of symptoms.

* Data obtained from post-marketing surveillance.

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.

15 g in a tube. 1 tube per carton.

Supply category. Over-the-counter.

Manufacturer.

JSC "Farmak".

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

74, Kyrylivska Street, Kyiv, 04080, Ukraine.