Lamisil Dermgel gel 1%, 15 g

• Prevention and treatment of fungal skin infections, incl. mycoses of the feet (tinea pedis), inguinal epidermophytosis (tinea cruris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes), Trichophyrichophyton verrucosum, violin canis and Epidermophyton floccosum;

• versicolor versicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).

Outwardly.

Before using the drug LamisilЃ Dermgel for the first time, pierce the sealing membrane with the tip on the outside of the cap.

LamisilЃ Dermgel is used in adults 1 time / day for any of the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is lightly rubbed into the areas of both the affected and adjacent intact skin. In the case of infections accompanied by diaper rash (under the mammary glands, between the fingers, in the gluteal and inguinal folds), the area of ??application of the gel can be covered with gauze, especially at night.

The duration and frequency of application of the drug LamisilЃ Dermgel for dermatomycosis of the trunk, legs - 1 week, 1 time / day; with dermatomycosis of the feet - 1 week, 1 time / day; with multi-colored lichen - 1 week, 1 time / day.

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In the case of irregular treatment or premature termination of it, there is a risk of recurrence of the infection. In the event that after a week of treatment there are no signs of improvement, the diagnosis should be verified.

For elderly patients, no dosage adjustment is required.

Gel for external use 1% glossy, from white to off-white.

100 g

terbinafine 1 g

Excipients: benzyl alcohol - 0.5 g, carbomer - 1 g, isopropyl myristate - 10 g, butyl hydroxytoluene - 0.02 g, sorbitan laurate - 1 g, polysorbate 20 - 5 g, sodium hydroxide (in the form of sodium hydroxide solution 30% m / m) - 0.1 g, ethanol 96% (vol.) - 10 g, water - 71.38 g.

• Hypersensitivity to terbinafine or to any component of the drug.

• breastfeeding period; children under 18 years of age.

• With caution: care should be taken when applying the drug to damaged areas of the skin, because the alcohol contained in the preparation may cause irritation.

pharmachologic effect

Antifungal drug for external use with a broad spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly some Candida albicans) and molds (mainly some Candida albicans) and fungi. Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis in fungi. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell. Terbinafine works by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.

Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other drugs.

Pharmacokinetics

When applied externally, the absorption of terbinafine is less than 5%. The systemic effect is insignificant.

Side effect

From the immune system: isolated messages - hypersensitivity reactions (rash).

From the side of the organ of vision: rarely - eye irritation.

On the part of the skin: often - peeling of the skin, itching; infrequently - skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rarely - a feeling of dry skin, contact dermatitis, eczema; isolated messages - rash.

Local reactions: infrequently - pain, pain at the site of application, irritation at the site of application; rarely - exacerbation of symptoms of the disease. In places where the drug is applied, itching, peeling of the skin, pain, irritation, changes in skin pigmentation, burning, erythema, crusting are possible. These minor symptoms should be distinguished from hypersensitivity reactions such as rashes, which occur in rare cases and require discontinuation of therapy. In rare cases, the course of a fungal infection may worsen.

Application during pregnancy and lactation

Clinical experience with the drug LamisilЃ Dermgel for external use during pregnancy is very limited, its use is possible if the intended benefit to the mother outweighs the potential risk to the fetus.

Terbinafine is excreted in breast milk and should not be given to nursing mothers.

In experimental studies, the teratogenic properties of terbinafine have not been identified. So far, no malformations have been reported with the use of LamisilЃ Dermgel.

Use in elderly patients

For elderly patients, no dosage adjustment is required.

special instructions

LamisilЃ Dermgel is intended for external use only.

The drug should not be applied to the face.

Avoid getting the drug in the eyes. it can be irritating. In case of accidental contact with eyes, rinse immediately with running water, and in case of persistent irritation, consult a doctor.

The drug contains butylhydroxytoluene, which can cause local allergic reactions (contact dermatitis) at the application sites, as well as irritation of the eyes and mucous membranes.

It should be borne in mind that the drug contains ethanol 96%.

Care should be taken when applying LamisilЃ Dermgel to damaged skin areas, because the alcohol it contains can cause irritation.

Influence on the ability to drive vehicles and mechanisms

Does not affect.

Overdose

No cases of overdose of LamisilЃ Dermgel have been reported.

Symptoms: Accidental ingestion of a 30 g tube containing 300 mg of terbinafine base is comparable to taking 1 tablet of LamisilЃ with a dosage of 250 mg (single dose for an adult). If you accidentally take a larger amount of LamisilЃ Dermgel inside, you can expect the development of the same side effects as with an overdose of LamisilЃ tablets (headache, nausea, epigastric pain and dizziness). It should also be borne in mind that the spray contains ethyl alcohol (9.4% (v / v).

Treatment: activated carbon, if necessary, symptomatic therapy is performed.

Drug interactions

Currently, the drug interaction of the drug LamisilЃ Dermgel is not described.