Fonzhial (Cream, Lacquer) Instructions for Use

ATC Code

D01AE14 (Ciclopirox)

Active Substance

Ciclopirox (Rec.INN registered by WHO)

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Broad-spectrum antifungal agent. It has a bacteriostatic effect.

It is active against dermatophytes, yeast-like, mold and other types of fungi, as well as against some strains of gram-negative and gram-positive bacteria.

Indications

• Treat fungal nail infections (onychomycosis) caused by susceptible pathogens.
• Treat fungal skin infections, including tinea pedis, tinea corporis, and tinea manuum, caused by susceptible pathogens.
• Treat vulvovaginal candidiasis caused by susceptible yeast-like fungi.
• Use for the prevention of fungal infections in at-risk individuals.

ICD codes

Dosage Regimen

Apply the cream to the affected and surrounding skin areas twice daily, in the morning and evening. Gently rub in until absorbed.

For onychomycosis, apply the lacquer to the entire surface of the affected nails once daily, preferably at bedtime. Before the first application, remove the affected nail areas with the file provided. Remove the applied lacquer with alcohol once weekly.

The treatment duration is set individually; continue treatment for several weeks after clinical cure to prevent relapse.

Adverse Reactions

At the application site, local reactions such as redness, itching, burning sensation, and skin peeling may occur. These are usually mild and transient.

Allergic contact dermatitis is possible. When treating onychomycosis, periungual erythema and transient nail discoloration may be observed.

Discontinue use if severe irritation or signs of a significant allergic reaction develop.

Contraindications

• Do not use in patients with a known hypersensitivity to ciclopirox or any of the excipients in the formulation.
• Contraindicated during pregnancy and breastfeeding due to potential risks to the fetus or infant.
• Do not use certain dosage forms in specific pediatric age groups; refer to the specific product labeling for age restrictions.

Drug Interactions

No specific drug interactions are known. The systemic absorption after topical application is minimal.

Avoid concurrent use of other topical preparations on the same area unless directed by a physician, as this may alter the efficacy or increase local irritation.

When using the nail lacquer, do not apply cosmetic nail polish over the medicated lacquer, as it may impede therapeutic efficacy.

Overdose

Acute overdose from topical application is unlikely due to minimal systemic absorption. Accidental ingestion may cause gastrointestinal irritation.

In case of accidental ingestion, perform gastric lavage and administer activated charcoal if a large amount was consumed. Provide symptomatic and supportive care.

For topical over-application, wash the affected area thoroughly with soap and water. Treatment is not typically required for topical overdose.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

It can be used in children of the appropriate age categories strictly according to indications, in recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the ciclopirox drug labels regarding contraindications for the use of specific ciclopirox dosage forms in children of different ages.

Special Precautions

For fungal infections of the vagina, simultaneous treatment of sexual partners is recommended.

During the treatment of onychomycosis, the use of cosmetic nail polishes is not recommended.

Avoid contact of the product with the eyes.

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.