Lamisil - instructions for use, doses, side effects, contraindications

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

Description:White homogeneous or almost homogeneous smooth cream with a weak characteristic odor.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

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, I verrucosum, T. violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), moldy (mainly C. albicans) and certain dimorphic fungi (Pityrosporum orbiculare). 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. Act terbinafine is carried out by inhibition of the enzyme of squalene epoxidase located on cell membrane of the fungus.

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

Pharmacokinetics:

At the local application of absorption - less than 5%, has a minor systemic act.

Indications:

Prevention and treatment of fungal infections of the skin, including foot mycoses (foot fungus), hornfels, cracks, itching and flaky skin,caused by foot fungus; 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.

Yeast infections of the skin, mainly those that are caused by the genus Candida (eg, Candida albicans), in particular, diaper rash.

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 (up to 12 years).

Carefully:

Hepatic and / or renal insufficiency, alcoholism, oppression bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

Pregnancy and lactation:

In experimental studies Teratogenic properties of terbinafine it was not revealed. Until now no vices were reported development with the use of Lamisil® cream. However, since clinical experience application of Lamisil® cream in pregnant women women is very limited, it should not be apply, except in cases of extreme necessity.In pregnancy apply only if prospective benefit to the mother exceeds the potential risk to the fetus. It is necessary to consult with doctor.

Terbinafine is excreted in breast milk, so the drug should not be given to nursing mothers. Do not allow the baby to contact any skin surface treated with Lamisil® cream.

Dosing and Administration:

Outwardly.

Adults and children from the age of 12:

Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied once or twice a day with a thin layer on the affected skin and adjacent areas and lightly rubbed. In infections accompanied by intertrigo (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night. With extensive fungal lesions of the body, it is recommended to apply a cream in tubes of 30 g.

Average duration of treatment:

Dermatomycosis of trunk, drumsticks: 1 week 1 time per day

Dermatomycosis of the feet: 1 week 1 time per day; keratinitis, cracks, itching and flaking of the skin caused by foot fungus - 2 weeks 1 - 2 times a day Candidiasis of the skin: 1-2 weeks 1 or 2 times a day. Multicolored lichen: 2 weeks 1 or 2 times a day.

Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection. In the event that after one or two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Dosage regimen Lamizila cream in elderly people does not differ from the above.

Use of the drug in children. The use of this drug in children under 12 years is not recommended.

Side effects:

Frequency classification side effects (WHO): very 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.

From the immune system:

Individual reports: hypersensitivity reactions (rash).

From the side of the organ of vision:

Rarely: eye irritation.

From the skin:

Often: skin peeling, itching.

Infrequent: skin damage, crusting, skin damage, impairment pigmentation, erythema, burning sensation of the skin.

Rarely: dry skin sensation, contact dermatitis, eczema.

Some messages: rash

Local Reactions:

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

Rarely: exacerbation of the symptoms of the disease.

In places where the product is applied, itching, skin flaking, pain, irritation, skin pigmentation change, burning, erythema, and cortex 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.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

No cases of drug overdose have been reported. If, by chance, Lamizil cream is taken orally, it is possible to expect the development of the same side effects as in the case of an overdose of Lamizil tablets (headache, nausea, epigastric pain and dizziness).

Treatment: Activated carbon, if necessary, symptomatic maintenance therapy.

Interaction:

Any drug interactions for Lamizil cream are not known.

Special instructions:Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or premature termination, there is a risk of recurrence of the infection.

Lamisil® cream is only for external application. 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. When developing allergic reactions, it is necessary to cancel the drug.

The drug contains cetyl and stearic alcohols, which can cause local allergic reactions (contact dermatitis) at the sites of application.

Form release / dosage:

Cream for external use 1%.

Packaging:

For 15 g or 30 g of the preparation in an aluminum tube with a protective membrane of aluminum or without a protective membrane of aluminum, with a lid of polypropylene provided with a projection for perforating the membrane or without a protrusion for perforating the membrane or in a laminated tube (low density polyethylene, aluminum, polyethylene low density) with a shoulder made of high-density polyethylene and with a protective membrane of multilayeran aluminum / 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:

Store at a temperature not exceeding 30 ° C, in places inaccessible to children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N008851

Date of registration:10.06.2010 / 11.09.2017

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: & nbsp12.03.2018

Illustrated instructions

Instructions

Lamisil® (Lamisil®)