Lamisil

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LAMISIL

Composition:

Active ingredient: terbinafine hydrochloride;

1 g of cream contains 10 mg of terbinafine hydrochloride, equivalent to 8.8 mg of terbinafine;

Excipients: benzyl alcohol, sodium hydroxide, sorbitan stearate, cetyl palmitate, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: white, homogeneous or almost homogeneous, glossy cream with a weak characteristic 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 fungicidal activity against dermatophytes, molds, and some dimorphic fungi at low concentrations. Activity against yeasts 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 depletion 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 does not belong to the cytochrome P450 system. Terbinafine does not affect the metabolism of hormonal agents or other medicinal drugs.

Pharmacokinetics. When applied topically, less than 5% of the dose is absorbed, so systemic absorption of terbinafine is negligible.

After 7 days of treatment with Lamisil cream, concentrations of terbinafine exceeding those required for fungicidal activity remain in the stratum corneum of the epidermis for at least 7 days after discontinuation of treatment.

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: tinea pedis; 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 excipients of the product.

Interaction with other medicinal products and other forms of interaction. Unknown.

Special precautions for use

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. Lamisil cream contains cetyl alcohol and stearyl alcohol, which may cause local skin irritation (e.g. contact dermatitis).

Contact between infants and skin areas treated with the medicinal product should be avoided, including contact with the mammary glands.

In animal studies, terbinafine did not show any effect on fertility.

Use during pregnancy or breastfeeding

In animal studies, terbinafine did not show embryotoxic effects. However, because clinical experience with the use of the product in pregnant women is limited, Lamisil cream should not be used during pregnancy except when, in the opinion of the physician, the expected benefit to the woman outweighs the potential risk to the fetus.

Terbinafine passes into breast milk; therefore, the product must not be used by women who are breastfeeding. Contact between infants and skin areas treated with the medicinal product should be avoided, including contact with the mammary glands.

Effects on ability to drive and use machines
Topical application of terbinafine does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

The cream is intended for topical use only.

Adults and children aged 12 years and older

Lamisil cream should be applied to the skin once or twice daily, depending on the condition being treated. Before application, the affected areas must be thoroughly cleaned and dried. The cream should be applied in a thin layer to the affected skin and surrounding areas, gently rubbed in. For infections associated with maceration (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 condition:

• Athlete’s foot (interdigital tinea pedis), tinea cruris (jock itch), and tinea corporis: once daily for 1 week;
• Squamous-hyperkeratotic tinea pedis ("moccasin foot"): twice daily for 2 weeks;
• Cutaneous candidiasis: once or twice daily for 1–2 weeks;
• Pityriasis versicolor: once or twice 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 recurrence.

If there are no signs of improvement after two weeks of treatment, medical advice should be sought.

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. 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 30 g tube (containing 300 mg of terbinafine hydrochloride) is comparable to taking one 250 mg Lamisil tablet (an oral dosage form). In cases of overdose due to accidental ingestion of a large amount of cream, adverse effects would be similar to those seen with an overdose of Lamisil 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.

Adverse Reactions

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 hydrochloride may cause irritation. Rarely, an underlying fungal infection may worsen.

Possible adverse effects:

Immune system disorders

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

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): dry skin sensation, contact dermatitis, eczema.

Frequency unknown (cannot be estimated from available data): rash or blistering.

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.

Note: data obtained from post-marketing experience are reported voluntarily, therefore their frequency cannot be determined and is labeled as "unknown"; however, these cases are most likely rare (≥1/10,000, <1/1,000) or very rare (<1/10,000).

Shelf life. 3 years.

Storage conditions. Keep out of reach and sight of children. Store at temperatures not exceeding 30 °C.

Packaging. 15 g or 30 g in a tube; 1 tube per cardboard box.

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

Manufacturer.

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

Manufacturer's address and place of business.

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