Expiration date: 10/2025

The composition and form of issue:

Spray for external use 10 mg/g. 100g contains:

terbinafine hydrochloride 0.3 g

isopropyl alcohol 10.5 g

excipients: 1,2-propylene glycol Polysorbate 60 polyethylene oxide 400 purified water 

in the container glass aerosol or aluminum with mechanical pump 30 g in cardboard pack 1 bottle.

Cream for external use 10mg/g. 100g contains:

terbinafine hydrochloride 0.1 g

benzyl alcohol 0.1 g

auxiliary substances: sodium hydroxide cetylpalmitate, cetyl alcohol stearyl alcohol Polysorbate 60 methyl ethyl ketone sorbitana stearate purified water 

the aluminum tube 10 g in a cardboard bundle 1 tuba.

Description pharmaceutical form:

Spray — clear colorless liquid. Allowed weak opalescence.

Cream white or white with a yellowish tint, with low specific smell.

Pharmacokinetics:

When applied topically absorption is less than 5%, it has little systemic effect.

Description pharmacological action:

Antifungal medication for external application, possessing a wide spectrum of antifungal activity. In small concentrations of terbinafine has fungicidal activity against dermatophytes (Trichophyton rubrum, T. mentagrophytes, T. verrucosum, T. violac?um, T. tonsurans, Microsporum canis, Epidermophyton floccosum), mould (mainly C. albicans) and certain dimorphic fungi (Pityrosporum orbiculare). Activity against yeasts, depending on their type, may be fungicidal or fungistatic.

Terbinafine specific changes the early stage of the biosynthesis of sterols occurring in mushrooms. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, which causes cell death of the fungus. The action of terbinafine by inhibiting the enzyme squalene epoxidase, located on the cell membrane of the fungus.

Terbinafine has no influence on the cytochrome P450 system in humans and, consequently, on the metabolism of hormones or other drugs.

Indications:

Both dosage forms

Prevention and treatment of fungal infections of the skin:

mycosis of the feet ("fungus" foot), groin the athlete's (tinea cruris), fungal defeat smooth skin (tinea corporis) 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 called Malassezia furfur).

Cream, optional

yeast infections of the skin, mainly those that are called come from Candida (e.g. C. albicans), in particular diaper rash.

Contraindications:

Hypersensitivity to terbinafine or any to any of the inactive ingredients in the drug.

With caution:

• hepatic and/or renal failure
  
• alcoholism
  
• inhibition of bone marrow hematopoiesis
  
• tumors
  
• of metabolic diseases
  
• occlusive vascular disease of the limbs
  
• children under 12 years of age (no sufficient clinical experience).
  

Application of pregnancy and breast-feeding:

In experimental studies teratogenic properties of terbinafine have been identified. So far not reported any defects in its application. However, as clinical experience with the use of terbinafine in pregnant women is very limited, it should be used only on strict conditions.

Terbinafine is excreted in breast milk, but in the case of a nursing mother of a spray or cream Termix absorbed through the skin a small amount of active substance, therefore, adverse effects on the baby are unlikely.

Side effects:

At the site of application of the drug may appear redness, itching or burning sensation.

Allergic reactions.

Drug interactions:

Any drug interactions for spray or cream Termex not known.

Method of application and dose:

Externally.

Spray adults 1 or 2 times a day depending on readings. Before applying the medication the affected area should be thoroughly cleaned and dry. The drug is sprayed on the affected area in sufficient quantity for their moisturizing, in addition, the drug is applied to adjacent areas of intact skin. The frequency and duration of use in ringworm of the body, legs, feet — 1 time a day for 1 week, with multi-colored lichen — 2 times a day for 1 week.

The dosage regimen in elderly age does not differ from that described above.

Experience with the use of spray in children is limited, therefore the drug is not recommended.

Cream for adults and children from 12 years: 1 or 2 times a day. Before applying the cream the affected area should be thoroughly cleaned and dry. Cream apply a thin layer to the affected areas and surrounding skin, gently RUB. Infections accompanied by diaper rash (under the Breasts, interdigital spaces, between the buttocks, in the inguinal region), place of applying the cream can be covered with gauze, especially at night. The frequency and duration of use in ringworm of the body, legs, feet — 1 time a day for 1 week, candidiasis of the skin — 1-2 times a day for 1-2 weeks, with colored leaves — 1-2 times a day for 2 weeks.

The decrease in the severity of clinical manifestations usually noted in the first days of treatment. In the case of irregular treatment or premature termination there is a risk of renewed infection. If after 1-2 weeks of treatment is not observed signs of improvement, you should verify the diagnosis.

The use of the cream is not recommended in children under 12 years.

Overdose:

The cases of drug overdose were reported. In case of accidental ingestion can be expected to develop side effects: headache, nausea, epigastric pain and dizziness.

Treatment: activated charcoal, if necessary — symptomatic supportive therapy.

Special instructions:

Common

The decrease in the severity of clinical manifestations usually noted in the first days of treatment. In the case of irregular treatment or premature termination there is a risk of recurrence of the infection.

Terbic the spray and the cream is intended for external use only. Avoid falling drug in the eye because it can cause irritation. In case of contact with eyes, immediately wash out with running water, and in the case of persistent phenomena irritation, consult a doctor.

With the development of allergic reactions should stop the drug.

Termix spray additionally

Use caution when applying the spray on damaged areas of skin, because alcohol can cause irritation.

If the drug was accidentally injected into the airway, in case of any symptoms, especially when they are persistent save, you should consult with your doctor.