Lamizil Dermgel - instructions for use, dose, side effects, contraindications

Excipients: gasoline alcohol 0.5 g, carbomer 1.0 g, isopropyl myristate 10.0 g, butyl hydroxytoluene 0.02 g, sorbitan laurate 1.0 g, polysorbate-20 5.0 g, sodium hydroxide (as sodium hydroxide solution 30% m / m) 0.1 g, ethanol 96% (v / v) 10.0 g, water 71.38 g

Description:

Brilliant gel, color from white to almost white.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Antifungal preparation for topical use, with a wide range of activities. In the smallwconcentrations terbinafine has a fungicidal action against dermatophytes, molds and certain dimorphic fungi. 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.

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

Pharmacokinetics:With topical application, absorption - less than 5%, has a minor systemic effect.

Indications:

Prevention and treatment of fungal infections of the skin, including mycosis of the feet ("fungus" of the foot), inguinal epidermophyte (tinea cruris), fungal lesions of smooth skin of the body (tinea corporis), caused by such dermatophytes as Trichophyton (including, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

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

Contraindications:

Hypersensitivity to terbinafine or to any component drug, the period of breastfeeding, children's age (under 18 years).

Carefully:Care should be taken when applying the product to damaged areas of the skin, since alcohol contained in the preparation may cause irritation.

Pregnancy and lactation:

In experimental studies, carried out on animals teratogenic the properties of terbinafine were not revealed. Before At the present time,or malformations in the application drug Lamisil® Dermgel. But, because clinical experience in pregnant women is very It is limited, its application is possible if prospective benefit to the mother exceeds the potential risk to the fetus.

Terbinafine excreted with pectoral milk, so the drug should not be prescribed to nursing mothers.Do not allow the infant to contact the skin surface treated with Lamisil® Dermgel.

Dosing and Administration:

Outwardly. Before first use drug should be pierced sealing membrane of the tube at point help on the outside cap.

Adults and children over 18 years of age:

Lamisil® Dermgel is used once in day for any of the indications. Before use of the drug is necessary thoroughly clean and dry affected areas. Lamisil® Dermgel lightly rub in the areas as affected, and the adjacent intact skin. AT cases 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 preparation

Lamisil® Dermgel can be covered gauze, especially at night.

Duration of treatment and multiplicity application of the drug:

Dermatomycosis of the trunk, legs: 1 week; 1 time per day.

Dermatomycosis of the feet: 1 week; 1 time per day.

Multicolored lichen: 1 week; 1 time in day.

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

The dosage regimen of Lamisil® Dermgel in elderly people does not differ from the above.

Side effects:

Frequency classification adverse reactions:

Often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including individual messages.

Immune system disorders:

Some messages: reactions hypersensitivity.

Disorders from the side of the organ of vision:

Rarely: eye irritation.

Disturbances from the skin and subcutaneous fabrics:

Often: skin peeling, itching.

Infrequent: skin damage, education crusts, skin lesions, pigmentation disorders, erythema, burning sensation of the skin.

Rarely: dry skin sensation, contact dermatitis, eczema.

Separate messages: rash.

General disorders and disorders at the site of application:

Infrequent: pain, pain in the application site, irritation in the application site.

Rarely: exacerbation of symptoms.

In places where the product is applied, itching, skin flaking, pain, irritation, skin pigmentation change, burning, erythema, crusting can be observed.These minor symptoms should be distinguished from hypersensitivity reactions such as rashes that occur in rare cases and require the withdrawal of therapy. In rare cases, the course of the fungal infection may worsen.

Overdose:No cases of drug overdose have been reported. The occasional ingestion of a 30 g drug containing 300 mg of terbinafine base into the tube is comparable to taking one Lamisil® tablet at a dosage of 250 mg (single dose for an adult). If you randomly take more Lamizil® Dermgel inside, you can expect the development of the same side effects as with an overdose of Lamisil® tablets (headache, nausea, epigastric pain and dizziness). It should also be considered the content in the preparation of ethyl alcohol (9.4% (v / v).

Treatment: Activated carbon, symptomatic maintenance therapy.

Interaction:

Any drug interactions for Lamisil® Dermgel are not described.

Special instructions:

Lamisil® Dermgel is for external use only. The drug should not be applied to the face. Avoid contact with eyes, as it can cause irritation.In case of accidental ingestion of the drug into the eyes, they should be washed immediately with running water, and in case of persistent irritation, consult a physician.

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

It should be taken into account that the preparation contains ethanol 96 %.

Care should be taken when applying Lamisil® Dermgel to damaged areas of the skin, since alcohol can cause irritation.

Effect on the ability to drive transp. cf. and fur:Does not affect.

Form release / dosage:

Gel for external use 1%.

Packaging:

For a 5 g package:

For 5 g of the preparation in an aluminum tube with an epoxy-phenolic resin inner coating, with an aluminum protective membrane and a polypropylene cover provided with a protrusion for perforating the membrane. The tube with instruction for use is placed in a cardboard box.

For packing 15 g and 30 g:

For 15 g or 30 g of the preparation in an aluminum tube with an epoxy-phenolic resin inner coating, with a protective aluminum membrane, with a lid of polypropylene,(with a low density polyethylene, aluminum, low density polyethylene) with a high density polyethylene shoulder and an aluminum protective membrane / multi-layer ethylene copolymer, with a polypropylene cover provided with a protrusion for perforating the membrane. The tube with instruction for use is placed in a cardboard box.

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

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

Terms of leave from pharmacies:Without recipe

Registration number:П N013364 / 01

Date of registration:06.08.2010 / 01.04.2016

Expiration Date:Unlimited

The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland

Manufacturer: & nbsp

NOVARTIS CONSUMER HEALTH, S.A. Switzerland

Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland

Information update date: & nbsp13.02.2018

Illustrated instructions

Instructions

Lamisil® Dermgel (Lamisil® Dermagel)