Fukorcin

INSTRUCTIONS for medical use of the medicinal product FUCORCIN (Fucorcin)

Composition:

Active substances: 1 ml of solution contains: basic fuchsin – 4 mg, boric acid – 8 mg, phenol – 39 mg, acetone – 0.049 ml, resorcinol – 78 mg, ethanol 96% – 0.095 ml;

Excipient: purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties: dark red liquid with a characteristic phenol odor.

Pharmacotherapeutic group.
Antiseptics and disinfectants. ATC code D08AX.

Pharmacological properties.

Pharmacodynamics.

The active ingredients contained in the drug provide a broad spectrum of antimicrobial effects in infections affecting the skin and mucous membranes. The drug also exhibits a fungicidal effect against fungal infections of external surfaces.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Treatment of skin diseases caused by pathogens sensitive to the components of the drug: various types of dermatophytes (Trichophyton, Microsporum, Epidermophyton), microbial eczema, seborrhea of greasy and mixed forms.

Contraindications.
Hypersensitivity to the components of the drug. Children under 12 years of age. Pregnancy, lactation period. Chronic allergic dermatoses.

Special precautions.

Treatment with the drug should be carried out under medical supervision and recommended doses must be followed.

The drug should not be applied to large body surface areas, and care must be taken to avoid contact with the eyes.

Treatment with the drug should be administered with caution in patients with impaired renal function.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of topical antifungal antibiotics such as griseofulvin, clotrimazole, and products containing phenol or boric acid, as well as hormonal preparations, should be avoided. Allergic reactions may occur when used concomitantly with topical medicinal products.

When using any other medicinal products simultaneously, inform your doctor.

Instructions for use.

Use during pregnancy or breastfeeding.

Do not use in women during pregnancy or breastfeeding.

Ability to influence reaction rate when driving vehicles or operating machinery.

No effect on the ability to drive vehicles or operate machinery has been observed.

Administration and Dosage

Apply the solution to affected areas of skin and mucous membranes 1–3 times daily until clinical recovery. The treatment duration is determined by the physician.

Children

Do not use in children under 12 years of age.

Overdose. Prolonged use of the drug or application over large skin areas may lead to symptoms characteristic of phenol poisoning (dizziness, weakness, respiratory disturbances, collapse). In case such symptoms occur, ensure access to fresh air for the patient, wash the drug off the skin with water, and administer symptomatic treatment.

Overdose may also lead to an increase in adverse effects and allergic reactions.

Treatment is symptomatic.

Adverse Reactions

Immune system disorders: Hypersensitivity reactions, including anaphylactic shock, urticaria, angioneurotic edema; local allergic reactions (e.g., rash, hyperemia, swelling, itching at the application site).

In some patients, especially with prolonged use, the following may occur:

Nervous system disorders: Dizziness, weakness, seizures, confusion, headache.

Respiratory system disorders: Respiratory disturbances.

Gastrointestinal disorders: Nausea, vomiting, diarrhea.

Renal and urinary system disorders: Oliguria.

Skin and subcutaneous tissue disorders: Epithelial desquamation.

If such symptoms occur, residual drug on the skin surface should be washed off with water; discontinue the drug and initiate symptomatic therapy.

In case of any adverse events, consult a physician immediately!

Reporting of adverse reactions following drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the drug. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf Life

2 years.

Do not use the drug after the expiry date stated on the packaging!

Storage Conditions

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach and sight of children.

Packaging

25 ml in bottles.

Availability Classification

Over-the-counter (without prescription).

Manufacturer

PJSC "FITOPHARM"

Manufacturer's Address and Place of Business

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder

PJSC "FITOPHARM"

Address of the Marketing Authorization Holder

7 Boulevard of the Verkhovna Rada, Premises 18, 3rd Floor, Kyiv, 02100, Ukraine.

In case of adverse reactions or questions regarding the safety, quality, and efficacy of the drug, please contact the Pharmacovigilance Department of PJSC "FITOPHARM" at +38 (044) 390 52 96.

INSTRUCTION

for medical use of the medicinal product

FUCORCIN

(Fucorcin)

Composition:

Active ingredients: 1 ml of solution contains: basic fuchsin – 4 mg, boric acid – 8 mg, phenol – 39 mg, acetone – 0.049 ml, resorcinol – 78 mg, ethanol 96% – 0.095 ml;

Excipient: purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties: dark red liquid with a characteristic phenol odor.

Pharmacotherapeutic group.
Antiseptics and disinfectants. ATC code D08AX.

Pharmacological properties.

Pharmacodynamics.

The active ingredients contained in the preparation provide a broad spectrum of antimicrobial effects in infections affecting the skin and mucous membranes. The preparation also exhibits a fungicidal effect in fungal infections of external surfaces.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Treatment of skin diseases caused by pathogens sensitive to the components of the drug: various types of dermatomycetes (Trichophyton, Microsporum, Epidermophyton), microbial eczema, seborrhea of the greasy and mixed forms.

Contraindications.
Hypersensitivity to the components of the drug. Children under 12 years of age. Pregnancy, breastfeeding. Chronic allergic dermatoses.

Special precautions.

Treatment with the drug should be carried out under medical supervision and in accordance with recommended dosages.

The drug should not be applied to large body surfaces and must not come into contact with the eyes.

Treatment with the drug should be administered with caution in patients with impaired renal function.

Interaction with other medicinal products and other types of interactions.

Concomitant use of topical antifungal antibiotics such as griseofulvin, clotrimazole, and products containing phenol, boric acid, as well as hormonal drugs, should be avoided. Allergic reactions may occur when used simultaneously with topical medicinal products.

When using any other medicinal products concomitantly, inform your doctor.

Usage instructions.

Use during pregnancy or breastfeeding.

Do not use in women during pregnancy or breastfeeding.

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

No effect on the ability to drive vehicles or operate machinery has been observed.

Method of Administration and Dosage

Apply the solution to affected areas of skin and mucous membranes 1–3 times daily until clinical recovery occurs. The treatment duration is determined by the physician.

Children

Do not use in children under 12 years of age.

Overdose
Prolonged use of the drug or application over large areas of skin may lead to symptoms characteristic of phenol poisoning (dizziness, weakness, respiratory disturbances, collapse). If such symptoms occur, ensure access to fresh air for the patient, wash the drug off the skin with water, and administer symptomatic treatment.

In case of overdose, adverse effects and allergic reactions may be intensified.

Treatment is symptomatic.

Side effects.

Immune system disorders: hypersensitivity reactions, including anaphylactic shock, urticaria, angioedema; local allergic reactions (e.g., rash, hyperemia, swelling, itching at the application site).

In some patients, especially with prolonged use, the following may occur:

Nervous system disorders: dizziness, weakness, seizures, confusion, headache.

Respiratory system disorders: breathing difficulties.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

Renal and urinary system disorders: oliguria.

Skin and subcutaneous tissue disorders: epithelial desquamation.

If such symptoms occur, residual product should be washed off the skin surface with water; discontinue the drug and initiate symptomatic therapy.

In case of any adverse events, consult a physician immediately!

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Do not use the medicinal product after the expiry date stated on the packaging!

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

25 ml in bottles.

Availability.

Over-the-counter (without prescription).

Manufacturer: JSC "FITOPHARM" (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of manufacturing site.

17, Chumatska St., Boryspil, Kyiv region, 08303, Ukraine.

Marketing Authorization Holder:

JSC "FITOPHARM".

Address of the Marketing Authorization Holder:

7, Verkhovnoyi Rady Blvd., floor 3, room 18, 02100, Kyiv, Ukraine.

If you experience any adverse reactions or have questions regarding the safety, quality, or efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOPHARM" at +38 (044) 390 52 96.