Lamizil Uno - instructions for use, doses, side effects, contraindications

Terbinafine (an allylamine derivative) is an antifungal agent for topical use, with a wide range of antifungal activity. In small concentrations terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), moldy C. albicans) and certain dimorphic fungi (Pityrosporum orbicular or Malassezia furfur). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.

Terbinafine specifically changes the early stage of biosynthesis of sterols occurring in fungi. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus. Squalene epoxidase is not associated with the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other medications.

Pharmacokinetics:

After applying Lamizil® Uno solution to the skin, the preparation forms a transparent imperceptible film that remains on the skin for 72 hours. From the film terbinafine quickly penetrates into the stratum corneum: 60 min after the procedure 16-18 % The applied dose is found in the stratum corneum. The release of terbinafine is progressive, the active substance is present in the stratum corneum after 13 days at a concentration greater than the minimum inhibitory concentration of terbinafine in vitro in relation to dermatophytes.

Systemic bioavailability is extremely low. With topical application, the absorption of the drug is less than 5%. Lamisil® Uno has a minor systemic effect. The level of relapses after 3 months of the drug is low (not higher than 12.5%).

Indications:

Mycosis (dermatophytosis) stop ("fungus" of the foot, Tinea pedis).

Contraindications:

Hypersensitivity to terbinafine or any of the inactive ingredients that make up the drug.

Carefully:Hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the extremities, children under 15 years of age (lack of sufficient clinical experience).

Pregnancy and lactation:

In experimental studies teratogenic properties of terbinafine were not revealed. To date, no developmental defects have been reported with the use of Lamisil® Uno. However, since the clinical experience of using Lamisil® Uno in pregnant women is very limited, it should be used only on strict indications.

Terbinafine is excreted in breast milk, so the drug should not be given to nursing mothers.

Dosing and Administration:

Outwardly.

Adults and teenagers from the age of 15:

The drug is intended for the treatment of foot fungus with a single use. The film-forming solution of Lamisil® Uno is applied once on both feet, even if the fungal lesion is observed only on one foot. This ensures the destruction of fungi (dermatophytes), which can be located on the foot areas where lesions are visually invisible.

Before applying the product, you should wash and dry your feet and hands. First, one stop is processed, then the other. Starting the procedure on the interdigital patches, it is necessary to apply a thin layer evenly between the fingers and around all over their surface, as well as to the sole and sides of the foot to a height of up to 1.5 cm.Use a sufficient amount of the drug to cover the necessary surface of the skin, usually 1/2 tubes for processing each foot.

In the same way, another foot should be treated, even if the skin on it looks healthy. Dry the solution for 1-2 minutes before film formation. After finishing stop treatment, you should wash your hands.

Do not apply the product again to the treated skin.

Lamisil® Uno should not be rubbed into the skin.

Side effects:

Undesirable effects are extremely rare, mild, and short-lived.

Systemic reactions:

Very rarely (<1/10 000) - allergic reactions, such as rash, redness, bullous dermatitis and urticaria.

Local reactions:

In rare cases (> 1/1 000, <1/100) - dryness, skin irritation or burning sensation on the skin treated area.

Overdose:

No cases of drug overdose have been reported. If you randomly take Lamisil® Uno inwards, you can expect the development of the same side effects as with an overdose of Lamisil® tablets (headache, nausea, epigastric pain and dizziness).

Overdose is unlikely, because the drug is released in quantities,required for single use and intended for outdoor use.

First aid: Activated carbon, if necessary - symptomatic therapy in a hospital.

Interaction:

Drug interactions for Lamisil® Uno are not known.

Special instructions:

Lamisil® Uno is not recommended for chronic plantar hyperkeratosis caused by Tinea pedis (moccassin type/moccasin type).

Lamisil® Uno is for external use only. The drug should not be applied to the skin of the face, it can cause irritation of the mucous membrane of the eyes. In case of accidental contact with eyes, rinse thoroughly with running water. The drug should not be taken inside!

If the allergic reaction to the drug develops, the film should be removed with an organic solvent (eg denatured alcohol) and then rinsed with soap and water.

When developing allergic reactions, it is necessary to cancel the drug.

For best results, the treated area should not be washed within 24 hours after the procedure. Therefore, Lamisil® Uno is recommended to be applied after taking a shower or bath and the next day again to wash your feet at the same time.Use the amount of preparation that will be required to apply the film on both feet by following the procedure described above (see section "Method of use"). Unused residue should be disposed of. Improvement of clinical symptoms is usually observed within a few days. If there is no sign of improvement in a week, you should consult your doctor.

Children:

The effect of Lamisil® Uno in pediatric practice has not been studied. Therefore, it is not recommended to use the drug in children under 15 years of age.

Elderly:

There is no evidence that other doses or other side effects are required in the treatment of elderly patients than in younger patients.

Effect on the ability to drive transp. cf. and fur:

When applied externally, Lamisil® Uno does not affect the ability to drive or operate machinery.

Form release / dosage:

Solution for external application film-forming 1%.

Packaging:4 grams per tube laminated (polyethylene / aluminum / polyethylene) with a lid of polyethylene screwed, equipped with a control system of the first opening. For 1 tube in a plastic contour pack together with instructions for use in a cardboard bundle with"window".

Storage conditions:At temperatures not higher than 30 ° C in the original packaging, out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-003583/07

Date of registration:06.11.2007 / 13.04.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

NOVARTIS CONSUMER HEALTH, S.A. Switzerland

Information update date: & nbsp13.02.2018

Illustrated instructions

Instructions

Lamizil® Uno (Lamisil® Uno)