Exifin - instructions for use, dose, side effects, contraindications

Auxiliary substances: isopropyl myristate, butylhydroxytoluene, benzyl alcohol, sorbitan laurate, polysorbate 20, carbomer 974P, sodium hydroxide, disodium edetate, ethanol, purified water.

Description:Homogeneous gel from white to almost white without visible foreign particles.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Antifungal drug for external use, which has a wide range of antifungal activity. In small concentrations terbinafine has a fungicidal action against dermatophytes (Trichophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), yeast (mostly 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. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus. Terbinafine does not affect the cytochrome P system₄₅₀ at the person and, accordingly, on a metabolism of hormones or other medical products.

Pharmacokinetics:

At external application absorption - less than 5%, renders insignificant system action.

Indications:

Treatment and prevention 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; Epidermophyton floccosum.

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

If necessary, please consult with your doctor before using the medication.

Contraindications:

- Hypersensitivity to terbinafine or any of the excipients of the drug;

- the period of breastfeeding;

- Children's age (up to 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 studies conducted on animals teratogenic properties of terbinafine were not revealed. To date, no developmental deficiencies have been reported with terbinafine. However, since the clinical experience with the use of terbinafine gel in pregnant women is very limited, its use is possible if the intended benefit to the mother exceeds the potential risk to the fetus.

Terbinafine is excreted in breast milk, so the drug should not be given to nursing mothers. Avoid contact of the baby with the skin surface treated with the drug, incl. with the surface of the skin of the breast.

Dosing and Administration:

Outwardly.

Adults and children over 18 years of age

Terbinafine gel is used once a day for all indications.

Duration of treatment and the frequency of 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;

- multi-colored lichen: 1 week 1 time per day.

Dosing regimen in elderly peopleand does not require changes.

Before the first use, the sealing membrane of the tube should be punctured with a tip on the outside of the cap.

Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The gel is gently rubbed into the areas of both affected and adjacent intact skin. In the case of infections accompanied by intertrigo (under the mammary glands, between the fingers, in the gluteal and groin folds), the gel application area can be covered with gauze, especially at night.

Reducing the severity of clinical manifestations is usually observed in the first days of treatment.

In case of irregular treatment or premature termination, there is a risk of recurrence of the infection. In the event that after 2 weeks of treatment there are no signs of improvement, the diagnosis should be clarified.

Use the drug only according to the method of administration and at the doses specified in the instructions for use.

If necessary, please consult with your doctor before using the medication.

Side effects:

Classification of incidence of adverse reactions: very often (<1/10 appointments), often (1/10 - 1/100 appointments); infrequently (1/100 - 1/1000 appointments); rarely (1/1000 - 1/10 000 prescriptions), very rarely (<1/10 000), the frequency is unknown (the frequency can not be estimated from the available data).

Immune system disorders

Frequency is unknown - hypersensitivity reactions *.

Disturbances on the part of the organ of sight

Rarely - eye irritation.

Disturbances from the skin and subcutaneous tissues

Often - skin peeling, itching; infrequently - skin damage, crusting, skin disorders, pigmentation, erythema, burning sensation of the skin.

Rarely - dry skin sensation, contact dermatitis, eczema; frequency unknown - 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.

* Based on experience of post-marketing application.

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 an overdose of terbinafine for external use have been reported. When using the drug in accordance with the instructions for use, an overdose is unlikely. If you accidentally take more gel inside you can expect the development of the same unwanted reactions as in the overdose of terbinafine in tablet form (headache, nausea, epigastric pain and dizziness).

Treatment: Activated carbon, symptomatic maintenance therapy.

Interaction:

The interaction of terbinafine with external application has not been studied.

Special instructions:

Exifin® is for external use only. Avoid getting the product into the eyes, as it can cause irritation.In case of accidental ingestion of the drug in the eye, they should be washed immediately with running water, and in case of development of persistent irritation phenomena it is necessary to consult a doctor.

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.

Caution should be exercised when using Exxin®, since the alcohol included in the gel may cause skin irritation.

Read the instructions carefully before using the product. Keep the manual, it may be needed again. If you have any questions, contact your doctor. The medicine you are treating is intended for you personally, and it should not be passed on to others, as it can harm them even if you have the same symptoms as you.

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

Does not affect.

Form release / dosage:

Gel for external use, 1%.

Packaging:

For 15 g or 30 g of the drug in an aluminum tube with an aluminum protective membrane and a high-density polyethylene lid provided with a protrusion for perforating the membrane.

A tube with instructions for use is placed in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004077

Date of registration:16.01.2017

Expiration Date:16.01.2022

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.

Information update date: & nbsp29.01.2017

Illustrated instructions

Instructions

Exifin® (Exifine)