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Instructions for use TERBISIL®

Terbizil® cream is for external use only. It should not be applied to the mucous membrane of the eyes. If the cream gets into your eyes, rinse them with plenty of water and, if necessary, consult an ophthalmologist.

Terbizil® cream 10 mg/g is not recommended for the treatment of hyperkeratotic, chronic, plantar (moccasin type) dermatophytosis of the feet.

If an allergic reaction occurs, wash off the cream and stop treatment.

The cream contains cetostearyl alcohol and cetyl alcohol, which may cause local skin reactions (eg contact dermatitis).

Impact on the ability to drive vehicles and operate machinery

Terbizil® in the form of a cream does not affect the ability to drive vehicles or operate complex machinery.

Experimental results

In long-term studies (up to 1 year) in rats and dogs, no significant toxic effects were observed in any animal species when terbinafine was administered orally at a dose of about 10 mg/kg/day. When administered orally in high doses, possible target organs include the liver and kidneys.

In a two-year carcinogenicity study in mice, no neoplasms or other pathological changes associated with the drug were found at doses up to 130 mg/kg/day (males) and 156 mg/kg/day (females). In a 2-year oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose of 69 mg/kg/day. At this dose, systemic exposure is similar to that observed in clinical settings. The mechanism of tumor development and its clinical significance are unknown. Changes possibly related to peroxisome proliferation appeared to be species specific because they were not detected in carcinogenicity studies in mice, dogs, or monkeys.

In studies in monkeys using high doses, refractive inhomogeneities were found in the retina (non-toxic level 50 mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in the eyeball tissue and disappeared after discontinuation of the drug. There were no changes at the histological level.

Using a standard battery of in vitro and in vivo genotoxic tests, there was no evidence of mutagenic or clastogenic potential.

Terbizil cream for external use 1% 15g

Compound

Active substance: terbinafine hydrochloride 10 mg, which corresponds to the content of terbinafine 8.8 mg.
Excipients: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, cetostearyl alcohol, polysorbate-60, isopropyl myristate, purified water.

Pharmacokinetics

When used externally, absorption is less than 5%. Has little systemic effect.

Indications for use

Prevention and treatment of fungal skin infections caused by sensitive pathogens, including mycosis of the feet (“fungus” of the foot), inguinal athlete’s foot (tinea cruris), fungal infections of the smooth skin of the body (tinea cruris), fungal infections of the smooth skin of the body (tinea corporus) caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;
yeast infections of the skin, mainly those caused by the genus Candida (for example, Candida albicans), in particular diaper rash;
Versicolor versicolor (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications

Hypersensitivity to terbinafine or to any component of the drug;
children under 12 years of age (lack of sufficient clinical experience of use).

With caution: renal and/or liver failure, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

Directions for use and doses

For external use.

Adults and children over 12 years of age: Before applying the cream, the affected areas must be cleaned and dried. The cream is applied 1 or 2 times a day in a thin layer to the affected skin and adjacent areas and rubbed in lightly. For infections accompanied by diaper rash (under the mammary glands, in the spaces between the fingers, between the buttocks, in the groin area), the places where the cream is applied can be covered with gauze, especially at night.

Duration of treatment and frequency of use of the drug

Dermatomycosis of smooth skin and inguinal dermatomycosis (including dermatomycosis of the trunk, dermatomycosis of the legs): 1 week 2 times a day (morning and evening).

Ringworm of the feet: 1 week 2 times a day between the toes (morning and evening), 2 weeks 1 time a day (upper and lateral parts of the foot).

Fungal skin infections caused by yeast (cutaneous candidiasis): 1 week, 1 time per day.

Tinea versicolor: 2 weeks, 1 time per day.

If after 1-2 weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Elderly patients (over 65 years old)

In elderly people, no dose adjustment is required.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 15° to 30°C.

Best before date

5 years. Do not use after the expiration date stated on the packaging.

special instructions

Terbizil® cream is for external use only.

A decrease in the severity of clinical manifestations is usually observed in the first days of using Terbizil® cream. In case of irregular use or premature cessation, there may be a risk of recurrence of infection.

During the period of use of the drug Terbizil® cream, it is necessary to follow general hygiene rules to prevent reinfection (through underwear, shoes).

If the drug accidentally gets into your eyes, you should immediately rinse them with running water, and if persistent irritation develops, you should consult a doctor.

If allergic reactions develop, use of the drug must be discontinued.

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

Description

Antifungal agent.

Use in children

With caution: children's age (due to lack of sufficient clinical experience).

Pharmacodynamics

An antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinfine has a fungicidal effect on dermatophytes (Trychophyton Rubrum, Trichophyton Mentagrophytes, Trichophyton Verrucosum, Trichophyton Violaceum, Trichophyton Tonsuras, Micross Porum Canis, Epidermophyton Floccosum), mold (for example, Scopulariopsis Breviculis) and certain dimorphous mushrooms (Pityrosporum Orbiculare). Activity against yeast fungi, mainly Candida albicans, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and intracellular accumulation of squalene, which causes the death of the fungal cell. Terbinafine acts by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.

Terbinafine does not affect the isoenzymes of the cytochrome P450 system in humans and, accordingly, the metabolism of hormones or other drugs.

Side effects

Local reactions: redness, itching or a burning sensation may appear at the sites where the cream is applied. Allergic reactions may occur.

If any of these adverse reactions worsen, or the patient notices any other adverse reactions, he should inform the attending physician.

Use during pregnancy and breastfeeding

In experimental studies on animals, teratogenic properties of terbinafine were not identified. To date, no malformations have been reported with the use of Terbizil® cream.

The use of Terbizil® cream during pregnancy is possible if the potential benefit to the mother outweighs the possible risk to the fetus/child.

Terbinafine passes into breast milk in very small quantities.

The cream should not be applied to the mammary glands during breastfeeding.

Interaction

When used externally, terbinafine has not been reported to interact with other drugs.

Overdose

Symptoms: no cases of overdose of Terbizil® cream have been reported. If the drug is accidentally taken orally (despite the dosage form), the following symptoms are possible: headache, nausea, abdominal pain, dizziness.

Treatment: activated carbon, if necessary - symptomatic and supportive therapy.

Impact on the ability to drive vehicles and operate machinery

Terbizil® cream does not affect the ability to drive vehicles and other technical devices that require increased concentration and speed of psychomotor reactions.

Pharmacological properties of the drug Terbizil cream

Terbinafine ((E)-N-(6,6-dimethyl-2-hepten-4-inyl)-N-methyl-1-naphthalenemethylamine hydrochloride) is a broad-spectrum allylamine antifungal drug. Suppresses the biosynthesis of fungal membrane sterols by inhibiting the enzyme squalene epoxidase, which leads to intracellular accumulation of squalene and death of the fungal cell. Terbinafine, even in low concentrations, has a fungicidal effect against dermatophytes, dimorphic and some molds. The effect on yeast fungi (for example, the genus Candida ) can be fungicidal or fungistatic depending on the strain of the fungus. When applied topically, ≤5% of terbinafine is absorbed, so its systemic effect is negligible.

Terbizil tablets 250 mg No. 14x2

Name

Terbizil tablet 250 mg in blister pack. in pack No. 14x2

Main active ingredient

Terbinafine

Release form

pills

Compound

Active ingredient: 250 mg of terbinafine (as 281.25 mg of terbinafine hydrochloride) in each tablet. Excipients: colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose, microcrystalline cellulose, sodium carboxymethyl starch (type A).

Description

White or off-white, round, biconvex tablets, about 11 mm in diameter, scored on one side and engraved “250” on the other.

Dosage

250 mg

Indications for use

The active ingredient of Terbizil tablets is terbinafine. It belongs to the group of antifungal drugs. Terbisil tablets are used to treat fungal infections of the fingernails and toenails, some fungal infections of the skin of the legs (athlete's foot), trunk and groin area, as well as infections caused by yeast, and some fungal infections of the scalp (called lichen). . When taken orally, a significant portion of the terbinafine dose reaches the affected area, killing fungi or inhibiting their spread. What you need to know before you start taking Terbizil tablets are available only with a doctor's prescription. Follow your doctor's instructions exactly, even if they differ from what is written in this leaflet.

Contraindications

If you are allergic (hypersensitive) to terbinafine or any other part of this drug (listed in section 6). If you think you may have an allergic reaction, talk to your doctor and don't take the pills until then!

Use during pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this drug. Your doctor will discuss the risks of terbinafine therapy with you during pregnancy. If you think you are pregnant, tell your doctor. During pregnancy, you can take terbinafine only on the recommendation of a doctor. When taking Terbizil tablets, the active substance passes into breast milk, so this drug should not be taken during breastfeeding. If necessary, a woman should stop breastfeeding. Animal studies have not demonstrated any negative effects on fertility.

Directions for use and doses

How to take Always use the drug strictly in accordance with your doctor's recommendations. If in doubt, consult your doctor or pharmacist. Do not exceed the recommended dose! If you think that the effect of Terbizil is too strong or too weak, tell your doctor or pharmacist. Recommended dose: Adults are recommended to take one tablet per day (250 mg). Duration of treatment The duration of treatment depends on the type and severity of the infection, as well as the location of the affected areas. It is recommended to take the drug for the entire treatment period prescribed by the doctor, since premature cessation of treatment may lead to relapse of the disease. Unless otherwise prescribed by a doctor, the duration of treatment is usually: In the case of a fungal infection of the skin - for the treatment of a fungal infection of the foot (athlete's foot), usually from 2 to 6 weeks - for the treatment of ringworm or candidiasis of the skin of the trunk and groin area, usually from 2 to 4 weeks. In case of infection of the scalp, the duration of treatment is about 4 weeks. In case of fungal nail infection - the duration of treatment is usually longer than for other fungal infections, usually it is from 6 to 12 weeks - in case of fungal infection of fingernails, in most cases the duration of treatment should be 6 weeks - in case of involvement of fingernails feet, the duration of treatment should be 12 weeks - in case of damage to the toenails with slow regrowth of a healthy nail, longer treatment may be required. The specific duration of treatment will be determined by your attending physician. Directions for use The tablets are swallowed without chewing and washed down with a small amount of water. The tablets can be taken regardless of meals. Taking Terbizil at the same time every day will help you adhere to your treatment regimen. Other Treatment Considerations Talk to your doctor about how to avoid re-infection. In addition to taking the tablets, you can help cure or prevent re-infection by keeping the infected area clean, changing bandages covering the infected area daily, disinfecting shoes, and wearing appropriate socks/stockings and underwear. It is also important to keep the infected area from getting wet. Use in children There are no data on the use of Terbizil tablets in children under 2 years of age (usually weighing less than 12 kg), therefore the use of Terbizil tablets in children under 2 years of age is not recommended. Unless the doctor prescribes a different dose, the standard dose for children over 2 years of age is: Children weighing less than 20 kg (usually under 5 years): since there is insufficient experience with this category of patients, use is possible only in cases where there is no other therapeutic alternative, and the benefits of using the drug outweigh the possible risks. For body weight from 20 to 40 kg (from 5 to 12 years): 1/2 tablet of Terbizil (125 mg) once a day. For body weight over 40 kg (usually over 12 years): 1 tablet of Terbizil (250 mg) once a day. Terbizil tablets can be divided into equal doses. Elderly patients (65 years and older) The dose of Terbizil for people aged 65 years and older is the same as for younger adult patients. If you take more than the prescribed amount If you take more Terbizil tablets than prescribed, contact your doctor immediately. In case of overdose, seek medical attention at your nearest hospital emergency room. Take your medication package with you. The same should be done if someone else besides you accidentally took your pills. Symptoms of overdose: headache, nausea, stomach pain and dizziness. If you forget to take it It is most practical to take the tablet at the same time every day. If you forget to take a pill and there are more than 4 hours left before taking the next pill, you can take the missed pill. If you have less than 4 hours until your next tablet is taken, take the next tablet at your usual time. Do not take a double dose to make up for a missed tablet! If you stop taking it, it is recommended to take the drug for the entire treatment period prescribed by your doctor. Premature cessation of treatment may lead to relapse of the disease. If you have any further questions about using this drug, ask your doctor or pharmacist.

Side effect

Like all medicines, Terbizil tablets can cause side effects, although not all patients get them. The following are serious side effects that are very rare or their frequency is unknown. Terbizil tablets may rarely cause liver dysfunction. In very rare cases, this disorder can be serious. Terbizil may cause severe allergic reactions (hypersensitivity), changes in the number of certain blood cells, systemic lupus erythematosus (an autoimmune disease), severe skin reactions (such as erythema multiforme and Stevens-Johnson syndrome), inflammation of the blood vessels and pancreas, and degeneration muscle tissue. Tell your doctor right away if you have any of the following symptoms: - unexplained persistent cough, stomach problems, loss of appetite, unusual tiredness and weakness (you may have liver problems); yellow skin or whites of the eyes (jaundice); sometimes dark urine or light-colored stools (you may have liver dysfunction); - current presence of infectious diseases with fever, chills, sore throat or ulcers on the oral mucosa, or an increase in the frequency of infectious diseases (you may have a disease associated with a change in the number of blood cells); - any skin reactions, for example, rash, redness of the skin, blisters on the lips, mucous membranes of the eyes or mouth, possibly fever (severe skin reactions); - unusual bruising, bleeding in the mucous membranes of the eyes or bleeding (this may be a sign of a disease associated with changes in the number of certain types of blood cells); - difficulty breathing, dizziness, swelling (mainly of the face or throat), redness of the skin, stomach cramps or loss of consciousness (can be signs of severe allergic reactions), as well as joint pain, joint stiffness, skin rash, fever and swollen lymph nodes ; - rash, fever, itching, fatigue or red spots on the skin (this may be a symptom of inflammation of the blood vessels) - severe pain in the stomach or back (this may be a symptom of inflammation of the pancreas); unexplained muscle weakness or muscle pain, or dark (red-brown) urine (symptoms of muscle degeneration). The following side effects have been reported while taking this drug: Very common side effects (occurring in more than 1 in 10 people taking the drug): Headache, nausea, mild abdominal pain, abdominal discomfort after eating, diarrhea, bloating abdominal pain (feeling of fullness), loss of appetite, skin rash, hives (including itching), joint pain and muscle pain. Common side effects (occurring in approximately 1 in 10 patients taking the drug): Mood changes (depression), distortion or loss of taste, dizziness, blurred vision and fatigue. Uncommon side effects (occurring in approximately 1 in 100 patients taking the drug): Unusual paleness of the skin, mucous membranes, or nails, unusual fatigue, weakness, or difficulty breathing during exercise (symptoms of low red blood cell count), restlessness, trembling, or numbness in the extremities with decreased skin sensitivity, increased skin sensitivity to sunlight (with skin inflammation and mild rashes), ringing in the ears, fever and weight loss. Rare side effects (occurred in approximately 1 in 1000 patients taking the drug): Yellowing of the skin and mucous membranes of the eyes (which may be symptoms of liver dysfunction), changes in biochemical indicators of liver function, inflammation of the liver, yellowing of the skin, bile stagnation, malaise. Very rare side effects (occurring in about 1 in 10,000 patients taking the drug): Decreased number of some types of blood cells, dizziness, systemic lupus erythematosus (an autoimmune disease), severe skin reactions, swelling of the face, neck and upper chest, rash , resembling a psoriasis rash (silver rash), worsening of psoriasis, rash with peeling and baldness. Side effects, the frequency of which is unknown (the frequency of their development cannot be estimated from the available data): Severe allergic reactions, inflammation of the blood vessels, impaired sense of smell, loss of smell, decreased sense of smell, blurred vision, blurred vision, impaired hearing, inflammation of the pancreas, drug rash with an increase in the content of certain types of white blood cells, degeneration of muscle tissue, flu-like symptoms (for example, fatigue, chills, sore throat, joint or muscle pain), an increase in the level of certain isoenzymes (creatine phosphokinase) in the blood.

Overdose

headache, nausea, stomach pain and dizziness.

Interaction with other drugs

If you have recently taken, are taking, or will take any other medications, including herbal products, contraceptives, and over-the-counter medications, tell your doctor or pharmacist. When taking Terbizil tablets and certain other medicines at the same time, their effects may interfere with each other, especially when taking the following medicines: - some antibiotics prescribed to treat certain infections (for example, rifampicin), - some medicines taken to treat stomach ulcers ( for example, cimetidine), - some drugs prescribed to treat fungal infections (for example, fluconazole, ketoconazole), - caffeine, - drugs that normalize heart rhythm (antiarrhythmics of groups IA, 1B and 1C, for example, propafenone and amiodarone), - drugs, those that lower blood pressure (some beta blockers, such as metoprolol), certain antitussives (such as dextromethorphan), certain drugs used to treat mental disorders (such as antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase type B, desipramine), cyclosporine and other drugs that act on the immune system (for example, used to prevent the development of transplant rejection). Food and liquid intake Terbizil can be taken on an empty stomach or after meals.

Precautionary measures

Check with your doctor or pharmacist before taking Terbizil tablets: -If you are taking other drugs (see “Interactions with other drugs”) Call your doctor if you have one of the conditions listed below before or during treatment with Terbizil: - If you suffer from any liver disease or have had it previously. - If you suffer from kidney disease. - Please note that if symptoms such as itching, recurring nausea, loss of appetite, weakness, vomiting, yellowing of the skin or whites of the eyes (jaundice), dark urine or light-colored stool, pain in the upper abdomen on the right, appear during treatment, contact your doctor immediately. If these symptoms appear, you should immediately stop taking the drug. Your doctor may order tests to evaluate your liver function tests. - If you experience skin symptoms such as a rash, redness around the eyes or swollen lips, peeling skin, fever (this may be a sign of a serious skin reaction), rash combined with an increase in the number of a certain type of white blood cell. - If you have psoriasis (thick red/silver patches on the skin), cutaneous or generalized systemic lupus erythematosus (face rash, joint and muscle pain, fever), or have similar symptoms. - If you are worried about weakness, unusual bleeding, bruising or frequent infections (these may be symptoms of a blood disorder). — If you are taking any other drugs that are listed in the “Interactions with other drugs” section. Before and during treatment with Terbizil tablets, your doctor may order regular blood tests to monitor your liver function. Deviations of results from the norm may cause discontinuation of the drug Terbizil. Children and adolescents (aged 2 to 17 years): Terbizil tablets can be prescribed to adolescents and children aged 2 years and older. There are no data on the use of Terbizil tablets in children under 2 years of age, so the use of the drug in this age group is not recommended.

Storage conditions

At temperatures from +15 °C to + 30 °C, in a place protected from light. Keep out of the reach of children.