Neofungin (Solution) Instructions for Use

Marketing Authorization Holder

Ivax-CR, A.S. (Czech Republic)

ATC Code

D01AE04 (Undecylenic acid)

Active Substance

Undecylenic acid (USP United States Pharmacopeia)

Dosage Form

Neofungin

Solution for external use 0.44%: bottle 25 ml

Dosage Form, Packaging, and Composition

25 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent. It has a fungistatic effect.

It shows activity against dermatophytes: Epidermophyton, Trichophyton and Microsporum.

When combined with zinc or copper salts (zinc undecylenate, copper undecylenate), the activity of undecylenic acid increases.

Indications

• Treatment and prevention of fungal skin diseases, primarily fungal foot infections (tinea pedis).

ICD codes

Dosage Regimen

Apply the solution externally to the affected skin areas twice daily.

The typical treatment duration is 15 to 20 days; continue therapy based on clinical response and confirmatory microscopic examination results.

For prevention of recurrence after the main treatment course, apply the solution once or twice per week.

Adverse Reactions

Local allergic reactions, such as contact dermatitis, itching, or erythema, may occur rarely at the application site.

Discontinue use immediately and consult a physician if any signs of hypersensitivity or severe skin irritation develop.

Drug Interactions

No specific drug interactions are currently known.

Avoid concurrent use with other topical medications on the same area unless directed by a physician to prevent potential incompatibility or skin irritation.

Contraindications

• Hypersensitivity to undecylenic acid or any other component of the formulation.
• Do not use on skin with signs of severe inflammation, ulceration, or broken skin barriers unless specifically advised by a healthcare professional.

Overdose

Topical application makes systemic overdose unlikely.

Excessive application may lead to intensified local adverse effects, such as severe skin irritation; treat symptomatically and discontinue the product.

Special Precautions

Use with caution in extensive skin lesions, especially in acute dyshidrotic form or eczematous epidermophytosis (to avoid exacerbation).

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

Rx Only

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.