Expiration date: 04/2025

The composition and form of issue: 

Tablets. 1 tablet contains terbinafine 250 mg

other ingredients: microcrystalline collide the CL-M Aerosil collidon 30 benzoic acid magnesium stearinovokisly — a sufficient number to obtain a tablet weight of 0.37 g 

in a contour package 7 or 10 units in the stack cartons 1 or 2 packs.

Cream 1%. 100g contains terbinafine hydrochloride 1 g

excipients: butylhydroxytoluene (dibunol) — 0.1 urea (carbamide) cetostearyl ether macrogol 20 cetosteatil alcohol proxanol-268 (poloxamer 407) imagemachine propylene glycol, medical vaseline oil (liquid paraffin) purified water to 100 g 

in the aluminium tubes to 15 grams in a cardboard bundle 1 tuba.

Spray for external use, 100 g contains terbinafine hydrochloride 1 g

auxiliary substances: urea (carbamide) — 1 g butylhydroxytoluene (dibunol) — 1 g 95% ethyl alcohol (ethanol) medical low-molecular PVP (povidone, kollidon), propylene glycol up to 100 g 

in the vial the polymer 15 or 30 ml in a cardboard pack 1 bottle.

Description pharmaceutical form:

Pills valium forms, white or white with a yellowish tint.

Cream white or almost white, with a subtle scent.

The spray is colorless transparent liquid.

Feature:

An antifungal drug.

Pharmacokinetics:

Pills

Food does not affect bioavailability. After a single dose of terbinafine oral dose of 250 mg Cmax of the drug in the blood plasma is reached after 2 h and is 0.97 µg/ml. the Drug is well absorbed after oral administration (70%), bioavailability is 40%. Terbinafine is intensively bound to blood plasma proteins (99%), quickly penetrates into the dermal layer of the skin and accumulates in the stratum corneum of the skin and nail plates, providing fungicidal effect. Quickly penetrates into the sebum, leading to the creation of high concentrations in hair follicles, hair and in the skin, the subcutaneous tissue. Biotransformiroetsa in the liver to form inactive metabolites, about 70% of the dose is excreted in the urine. T1/2 is about 17 h. T1/2 the terminal phase — 200-400 h. Not koumouliruet in the body. There were no changes in the equilibrium concentrations of terbinafine in according to age in patients with renal insufficiency or in patients with liver cirrhosis, the rate of excretion of the drug may be slowed, leading to higher concentrations of terbinafine in the blood plasma.

Cream and spray

The local application is absorbed less than 5% of the dose, thus, the systemic effect of the drug is minimal.

Description pharmacological action:

Terbinafine is the active ingredient Fungoterbine, is allylamine and has a broad spectrum of antifungal activity.

Active against dermatophytes such as Trichophyton (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum. In low concentrations has fungicidal activity against dermatophytes, mold fungi (Aspergillus, Cladosporium, Scopulariopsis brevicaulis, etc.) and certain dimorphic fungi. Effect on yeast fungi of the genus Candida and filamentous forms may be fungicidal or fungistatic, depending on the species of mushroom. Terbinafine is also active against Pityrosporum is the causative agent colorful (pityriasis) lichen Pityriasis versicolor, caused by Pityrosporum ovale.

Terbinafine violates occurring in fungi the biosynthesis of ergosterol in the early stages. 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. This enzyme does not belong to the cytochrome P450. Terbinafine does not influence the metabolism of hormones or other drugs.

Due to the presence of urea in a cream and spray, the product has a moisturizing effect, promotes deeper penetration of terbinafine in the skin and thus gives it a high concentration.

For spray optional: carbamide (urea) is included in the composition of the spray, has a keratolytic (softening and defiant rejection of the affected fungal infection of the stratum corneum of epidermis). Urea contributes to the rapid restoration of the epidermis. The butylhydroxytoluene - antioxidant, stimulates regeneration processes. When applied topically inhibits free radical reactions.

Indications:

Tablets:

• the onychomycosis
  
• mycosis of the scalp (trichophytosis, microsporia)
  
• candidiasis of the skin and mucous membranes, caused by fungi of the genus Candida in cases where localization or spread of the process determine the feasibility of oral therapy
  
• fungal diseases of smooth leather (common ringworm of the trunk and extremities).
  

Cream and spray:

Treatment and prevention of fungal diseases of the skin:

• fungal infections of the skin, including 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
  
• skin infections caused by yeast fungi of the genus Candida (e.g. Candida albicans)
  
• pityriasis versicolor (Pityrosporum versicolor), called Pityrosporum orbiculare (also called Malassezia furfur).
  

Spray optional: seborrheic dermatitis of the scalp (dandruff).

Contraindications:

For all dosage forms

hypersensitivity to terbinafine or any any other component, which is part of the drug.

With caution:

Pills

• alcoholism
  
• diseases of the blood
  
• tumors
  
• of metabolic diseases
  
• vascular pathology of the extremities
  
• children up to age 2 years.
  

Cream

• hepatic and/or renal failure
  
• alcoholism
  
• of metabolic diseases
  
• vascular pathology of the extremities
  
• children up to age 12 years.
  

No information on use in pregnancy.

The spray is additionally contraindicated in children (under 12 years).

With caution:

• hepatic and/or renal failure
  
• alcoholism
  
• inhibition of bone marrow hematopoiesis
  
• tumors
  
• of metabolic diseases
  
• occlusive vascular disease of the limbs.
  

Application of pregnancy and breast-feeding:

Fungoterbine spray and cream. In experimental studies teratogenic properties of terbinafine have been identified. So far not reported about any defects in the application Fungoterbine in the form of a spray or cream. As the clinical experience of the drug in pregnant women is very limited, apply Fungoterbine spray and cream should be only under strict indications, when the expected benefit for mother exceeds potential risk to the fetus.

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

Side effects:

Pills

Fungoterbine generally well tolerated. Side effects are usually slightly or moderately expressed and are transient in nature.

Ingestion can occur:

• gastrointestinal: dyspepsia, abdominal pain, feeling of fullness, nausea, loss of appetite, diarrhea and sometimes a violation of taste sensations, including their loss (recover a few weeks after cessation of treatment)
  
• from the side of musculoskeletal system: muscle pain, joint pain
  
• with the hematopoietic system: neutropenia, agranulocytosis, thrombocytopenia rarely is lymphopenia
  
• allergic reactions: skin rash as patches, blisters rarely — toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactoid reactions.
  

Cream and spray

In rare cases redness, itching or burning sensation at the site of application of the cream, however, these phenomena have rarely led to the need to stop treatment. The above symptoms must be distinguished from allergic reactions (e.g. urticaria, generalized rash and/or redness, angioedema, re allergic reaction) which occurs rarely, but when they occur, discontinue treatment.

Drug interactions:

Pills

Terbinafine in vitro has very little ability to change the clearance of many drugs that are metabolized with participation of cytochrome P450 (e.g. cyclosporine, terfenadine, tolbutamide, triazolam or oral contraceptives). In women, at the same time taking terbinafine and oral contraceptives may experience irregular menstrual cycle. Total clearance of terbinafine may be accelerated by drugs that cause induction of enzymes of cytochrome P450 (such as rifampicin) and may slow down drugs — inhibitors of the cytochrome system P450 (such as cimetidine), the simultaneous use of these drugs may require dose adjustment. Decreases the clearance of caffeine by 20%. Fungoterbine does not affect the clearance of antipyrine, digoxin, warfarin. Ethanol and other hepatotoxic drugs increase the risk of hepatotoxicity.

Any interactions for the drug Fungoterbine and cream is unknown.

Method of application and dose:

Pills

Inside, after eating.

The duration of treatment and dosage regimen is determined individually and depend on the location and severity of the disease.

Adults — usually 1 table. (250 mg), 1 time per day. Patients with hepatic and renal insufficiency — 1/2 table. (125 mg) 1 times a day.

Fungal infections of the skin. The recommended duration of treatment: ringworm of the feet (interdigital, plantar or the type of "socks") — 2-6 weeks tinea of the trunk and extremities — 2-4 weeks candidiasis of skin and mucous membranes is 2-4 weeks. Complete disappearance of clinical manifestations of the disease there is usually a few weeks after mycological cure.

Fungal infections of the scalp. The recommended duration of treatment: fungal infection of the scalp about 4 weeks. Fungal infections of the scalp occurs predominately in children.

The onychomycosis. The duration of the course of treatment in most patients is 6-12 weeks. Onychomycosis fingers in most cases is 6 weeks, but onychomycosis of the fingers of the stop 12 weeks. Some patients who have a decreased rate of nail growth, may require longer treatment. The optimal clinical effect observed some months after mycological cure and cessation of treatment. It is determined by the period of time necessary for the regrowth of healthy nails.

Children drug designate 2 years. The dose depends on the body weight of the child: children weighing up to 20 kg — 62.5 mg/day (1/4 table). from 20 to 40 kg 125 mg/day (1/2 tab.) more than 40 kg — 250 mg/day (1 table.). Data on the use of the drug in children under 2 years (with body weight <,12 p="">,

Cream

Externally, adults and children from 12 years. 1 or 2 times a day cream applied in a thin layer on the skin (previously cleaned and dried) and adjacent areas of the skin and gently RUB. Infections accompanied by diaper rash (under Breasts, in the interdigital intervals, between the buttocks, in the inguinal region), place of applying the cream can be covered with gauze, especially at night.

Spray

Externally, adults and children from 12 years. 1 or 2 times per day sprayed onto the affected and surrounding areas as the affected, and intact skin in a quantity sufficient for their thorough wetting. Experience with the use of Fungoterbine spray in children is limited, therefore its use in children under 12 years not recommended.

The average duration of treatment for both forms:

ringworm of the body, legs and feet — 1 time a day for 1 week

candidiasis of the skin — 1-2 times a day for 1-2 weeks

pityriasis versicolor — 1-2 times a day for 1 week.

Overdose:

Pills

To date no cases of overdose Fungoterbine when administered in recommended doses is not described.

Symptoms (in acute overdose): nausea, vomiting, pain in the epigastric region.

Treatment: gastric lavage with subsequent appointment activated charcoal, if necessary — symptomatic supportive therapy.

Cream and spray

In case of accidental ingestion you should expect the same symptoms as an overdose of pills.

Spray optional: consider content in the product alcohol.

Precautions:

The irregular treatment or premature termination there is a risk of renewed infection.

Special instructions:

Pills

Irregular use or premature termination of treatment increases the risk of relapse. If after 2 weeks of treatment there has been no improvement, you need to re-determine the causative agent and its sensitivity to the drug. Use caution when assigning Fungoterbine inside patients with impaired liver and/or kidneys. In identifying symptoms, allowing to assume violation of function of a liver (lack of appetite, fatigue, persistent nausea, jaundice, dark urine), you must stop the drug. Patients with chronic disorders of the liver and kidneys should appoint half the usual recommended dose of the drug and to monitor the performance of liver and kidney in the treatment process.

Unlike Fungoterbine for local use, Fungoterbine pills are ineffective in multi-colored lichen. In the process, and at the end of the treatment, it is necessary to produce the antifungal treatment of footwear, socks and stockings.

Data on the effect Fungoterbine on the ability to drive and operate machinery demanding attention, no.

Cream

For external use only. Avoid getting the cream in your eyes. If after 2 weeks of treatment were observed signs of improvement, you should verify that diagnosis.

Elderly no alteration of dosage.

Of drug use by the breastfeeding mother, any negative effects on the baby are unlikely, since systemic absorption through the skin is very small.

Spray

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. Avoid contact of spray with eyes and mucous membranes. If after 2 weeks of treatment were observed signs of improvement, you should verify that diagnosis. In case of contact with eyes, immediately wash out with running water, and in the case of persistent phenomena irritation, consult a doctor.