Griseofulvin-Farcos (Liniment) Instructions for Use

Marketing Authorization Holder

Farkos NPF, LLC (Russia)

ATC Code

D01BA01 (Griseofulvin)

Active Substances

Salicylic acid (USP)

Griseofulvin (INN)

Dosage Form

Griseofulvin-Farcos

Liniment 25 mg+10 mg/1 g: jar 10 g, 15 g, 20 g, or 30 g.

Dosage Form, Packaging, and Composition

10 g – polymer jars (1) – cardboard packs.
15 g – polymer jars (1) – cardboard packs.
20 g – polymer jars (1) – cardboard packs.
30 g – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antifungal and antiproliferative action for external use

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Combined antifungal agent for external use.

Griseofulvin has a fungistatic effect on various types of dermatophytes (Trichophyton, Microsporum, Epidermophyton). By disrupting the structure of the mitotic spindle, it suppresses the division of fungal cells in metaphase. It accumulates to varying degrees in the cells of the skin, hair, and nails, which are precursors of keratin, making keratin resistant to fungal invasion. As the infected keratin is shed, it is replaced by healthy tissue.

Due to the presence of salicylic acid in the preparation, it penetrates into the deep layers of the affected skin and nail plate. It also has antiseptic and keratolytic effects, reduces itching, and has an analgesic effect.

It does not cause local irritation.

When applied topically, the active components are not absorbed and do not enter the bloodstream, which determines the practical absence of side effects characteristic of the oral use of griseofulvin.

Indications

• Dermatophytosis of the skin, hair, and nails caused by susceptible dermatophytes.
• Fungal infections of the scalp (tinea capitis) and beard area (tinea barbae).
• Onychomycosis affecting the fingernails and toenails.
• Superficial skin mycoses including tinea pedis (athlete’s foot), tinea corporis (ringworm), tinea cruris (jock itch), and tinea manuum (hand fungus).

ICD codes

Dosage Regimen

Apply a thin layer of the liniment to the affected skin areas and gently rub in. Use the preparation twice daily, in the morning and evening.

Before applying to nails, remove the affected parts of the nail plate as much as possible. The maximum daily dose for liniment application should not exceed 20 grams.

Continue treatment for a minimum of 2 weeks after the complete disappearance of clinical symptoms to prevent relapse. The total duration of therapy is determined by the rate of healthy tissue regeneration.

Adverse Reactions

Adverse reactions are infrequent and primarily localized. Allergic reactions may occur, manifesting as skin rash, urticaria, or erythematous rashes at the application site.

In cases of individual hypersensitivity to the components, localized skin irritation, such as redness, peeling, or a burning sensation, may develop. Discontinue use if any adverse reactions occur.

Contraindications

• Hypersensitivity or known allergy to griseofulvin, salicylic acid, or any other component of the formulation.
• Pregnancy at any trimester due to potential teratogenic risks associated with griseofulvin.
• Breastfeeding, as the safety of topical griseofulvin and salicylic acid for the infant has not been established.
• Children under the age of 14 years, as safety and efficacy in this pediatric population have not been confirmed.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Use is contraindicated in children under 14 years of age.

Special Precautions

It is not recommended for prophylactic use.

Ethanol intake should be avoided during treatment.

Treatment should continue for at least 2 weeks after the disappearance of clinical symptoms.

If systematic use is necessary, medical supervision is required.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.