Bifonal-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BIFONAL-ZDOROV'YA (BIFONAL-ZDOROVYE)

Composition:

Active substance: bifonazole;

1 g of gel contains bifonazole 10 mg;

Excipients: carbomer, glycerol, concentrated ammonia solution, ethanol 96%, methylparaben (E 218), propylparaben (E 216), purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: white homogeneous gel with a slightly specific odor.

Pharmacotherapeutic group. Antifungal agents for dermatological use. Topically applied antifungal agents. Bifonazole. ATC code D01AC10.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the drug, bifonazole, is an imidazole derivative with a broad spectrum of antifungal activity. The drug is active against dermatophytes, yeasts, molds, and other fungi (Malassezia furfur, Corynebacterium minutissimum). Bifonazole, unlike other azoles and fungicidal agents, inhibits ergosterol biosynthesis at two different levels. Inhibition of ergosterol synthesis leads to structural and functional disturbances of the cytoplasmic membrane of pathogens. Bifonazole remains effective even under conditions of pathogen resistance to other antifungal drugs. Primary resistance to bifonazole in susceptible fungal species is very rare. To date, no development of secondary resistance in initially susceptible strains has been observed during studies.

Pharmacokinetics.

Bifonazole penetrates well into the affected layers of the skin. Six hours after application, concentrations range from 1000 µg/cm³ in the upper epidermal layer to 5 µg/cm³ in the papillary layer. All concentrations thus determined fall within the range of confirmed antifungal activity.

Clinical characteristics.

Indications. Treatment of fungal skin infections caused by bifonazole-susceptible pathogens (dermatophytes; yeasts, molds, and other fungal infections; Malassezia furfur and Corynebacterium minutissimum):

• superficial candidiasis and cutaneous mycoses (including tinea pedis and interdigital mycoses, tinea manuum, mycoses of smooth skin and skin folds);
• pityriasis versicolor;
• erythrasma.

Contraindications. Known hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to imidazole antifungal agents. Diaper rash in children. Do not use vaginally. Scalp infections. Do not apply to the area after removal of the affected portion of the nail plate for the treatment of fungal nail infections.

Interaction with other medicinal products and other forms of interaction. Data are available indicating a potential interaction between topically applied bifonazole and warfarin, leading to an increased international normalized ratio (elevated risk of bleeding). If bifonazole is administered to patients receiving warfarin therapy, appropriate monitoring should be performed.

Special precautions for use

Avoid contact with the eyes. Do not swallow.

Patients with allergic reactions to other imidazole antifungal agents (e.g., econazole, clotrimazole, miconazole) should use with caution.

If symptoms persist, consult a physician.

Antifungal treatment of the nail fold skin using this medicinal product as part of therapy for onychomycosis should only be performed after prior keratolytic removal of the infected nail portion.

Methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

Pregnancy. Available preclinical and human pharmacokinetic data do not indicate harmful effects of bifonazole on the mother or fetus when used during pregnancy. However, clinical data are lacking. Use of bifonazole is not recommended during the first trimester of pregnancy.

Breastfeeding. It is unknown whether bifonazole passes into human breast milk. Pharmacodynamic and toxicological studies in animals indicate excretion of bifonazole and its metabolites into breast milk. Therefore, breastfeeding should be discontinued during treatment with bifonazole. During lactation, bifonazole should not be applied to the area of the chest.

Fertility. There is no evidence that bifonazole may impair male or female fertility.

Ability to influence reaction speed when driving or operating machinery. Unknown.

Method of Administration and Dosage

Apply once daily, preferably in the evening before bedtime.

Apply the medication in a thin layer to the affected area of skin and rub in thoroughly. A small amount of the medication is usually sufficient to treat a skin area the size of the palm.

To ensure sustained therapeutic effect, treatment with the medication should be continued for the recommended duration, even after symptoms have disappeared. The usual treatment duration is: for tinea pedis and interdigital tinea – 3 weeks; for tinea of the hands, smooth skin, and skin folds – 2–3 weeks; for pityriasis versicolor and erythrasma – 2 weeks; for superficial cutaneous candidiasis – 2–4 weeks.

Children. Based on available clinical data, there are no grounds to expect toxic effects in children. However, the medication should be used in children only under medical supervision.

Overdose. There have been no reports of overdose cases associated with the use of this medication.

After a single topical application, there is no risk of acute intoxication. Overdose is possible when applied to large areas of skin or in case of accidental oral ingestion.

Adverse reactions.

General disorders and application site conditions. May cause local skin reactions (e.g., contact dermatitis), pain and swelling of the skin at the application site.

Immune system disorders. Rarely, systemic hypersensitivity reactions may occur.

Skin and subcutaneous tissue disorders. Contact dermatitis, allergic dermatitis, erythema, eczema, pruritus, rash, urticaria, blisters, desquamation, dryness, irritation, maceration, and sensation of warmth on the skin.

All adverse effects resolve after discontinuation of the product.

Shelf life. 5 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 15 g in a tube per box.

Category of release. Over-the-counter (without prescription).

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's location and address of business activity. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, 22.