Expiration date: 03/2025

Structure and Composition:

Gel for topical application 1%

active ingredient (per 1g):

terbinafine (base form) 10 mg

Other ingredients: water, ethanol isopropyl myristate Polysorbate 20 Carbomer 974P sorbitan monolaurate, benzyl alcohol, sodium hydroxide, butylated gidroksitoluen

in the box for 5, 15 or 30 grams in paper cartons 1 tube.

Characteristic:

Antifungal agent for topical use (synthetic allylamine derivative) with a broad spectrum of activity.

Description of the pharmacological actions:

At low concentrations terbinafine has fungicidal activity against dermatophytes, molds and certain dimorphic fungi. Activity against yeast fungi, depending on their type, may be a fungicidal or fungistatic. Terbinafine specifically alters the early stage of the biosynthesis of sterols, occurring in fungi. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, which causes death of fungal cells. Terbinafine action effected by the enzyme squalene epoxidase inhibiting located on the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450 system. Terbinafine has no influence on the metabolism of hormones or other drugs.

Indications:

fungal skin infections caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

pityriasis versicolor (Pityriasis versicolor), called Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications:

Increased sensitivity to terbinafine or any of the inactive ingredients included in the formulation.

Application of pregnancy and breastfeeding:

In studies conducted in animals, teratogenic properties of terbinafine have been identified. So far no reports about any developmental defects in the application of Lamisil. However, as clinical experience with Lamisil Dermgelya in pregnant women is very limited, it should be used only on strict conditions. Terbinafine is excreted in breast milk, so the drug should not be administered to nursing mothers.

Side effect:

In the field of application of the drug can be redness, itching or a burning sensation, but discontinuation of therapy because of these phenomena is rarely required. These are not as serious adverse events must be distinguished from the rarely occurring allergic reactions (eg generalized rash and / or redness, urticaria, angioedema, re allergic reaction), the development of which requires discontinuation of treatment. The patient should be kept in mind that in the event of an adverse event, not mentioned in the leaflet, you should inform about this phenomenon doctor or pharmacist.

Drug Interactions:

Unknown.

Dosage and administration:

Outwardly. Adult patients

Lamisil Dermgel used 1 time per day for any of the indications. Before using the product, thoroughly clean and dry the affected area. The drug is slightly rubbed into the affected sites as well as the adjacent intact skin. In the case of infections, diaper rash accompanied (under the breasts, between the fingers, in the gluteal and inguinal folds), the area of ??application dermgelya can be covered with gauze, especially at night.

Treatment duration and frequency of use of the drug:

• Ringworm of the body, legs: 1 week 1 time per day
  
• Tinea pedis: 1 week 1 time per day
  
• Pityriasis versicolor: 1 week 1 time per day.
  

Reducing the severity of clinical manifestations are usually noted in the first days of treatment. In the case of irregular or premature treatment termination there is a risk of recurrence of infection. In the event that after a week of treatment shows no sign of improvement, must verify the diagnosis.

Elderly patients

There is no reason to assume that the elderly need to change the dosing of the drug, or that they have marked side effects that differ from those of younger patients.

How to handle drug

Before the first use of the drug should pierce the sealing membrane with a sharp, fitted into the outside to the screw-cap.

Overdose:

No cases of overdose Lamisil Dermgelya were reported. If the drug is accidentally ingested, we can expect the emergence of the same symptoms that occur with an overdose of tablets (eg headache, nausea, epigastric pain and dizziness).

Precautionary measures:

Caution must be exercised when applying Lamisil Dermgelya on damaged skin, because alcohol can cause irritation. Lamisil Dermgel intended for external use only. Avoid getting it in your eyes, because it can cause irritation. In case of accidental contact with the drug in the eyes, they should immediately wash with running water, and in the case of persistent phenomena of irritation consult a doctor.

Experience with Lamisil Dermgelya in children is limited, therefore the use of the drug in these patients can not be recommended.