Tolmicen (Cream) Instructions for Use

Marketing Authorization Holder

Pharmacia & Upjohn, S.p.A. (Italy)

ATC Code

D01AE19 (Tolciclate)

Active Substance

Tolciclate (Rec.INN registered by WHO)

Dosage Form

Tolmicen

Cream 1%: tube 30 g

Dosage Form, Packaging, and Composition

30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent for external use. It has a fungicidal or fungistatic effect.

Tolciclate is active against dermatophytes (Epidermophyton, Microsporum, Trichophyton); the causative agent of pityriasis versicolor (Malassezia furfur); as well as the causative agent of erythrasma (Corynebacterium minutissimum).

Indications

• Apply for the treatment of fungal skin infections caused by susceptible organisms.
• Use specifically for tinea pedis (athlete’s foot), tinea cruris (jock itch), and other dermatophytoses of skin folds.
• Indicated for pityriasis versicolor and for erythrasma.

Ensure the causative organism is one against which the drug is known to be active before initiating therapy.

ICD codes

Dosage Regimen

Apply a thin layer of the cream to the affected skin areas and gently rub in. Use this medication for external application only.

Administer twice daily, in the morning and evening. The duration of treatment is set individually by the physician based on the infection’s severity and clinical response.

Continue application for several days after clinical symptoms have completely resolved to prevent recurrence.

Adverse Reactions

Local skin reactions may occur at the application site. These include redness, itching, burning sensation, and erythematous rashes.

Dyshidrosis has been reported rarely. These local effects are usually mild and resolve spontaneously without requiring discontinuation of treatment.

In some cases, allergic reactions may develop. Discontinue use immediately if signs of hypersensitivity appear.

Contraindications

• Do not use in patients with known hypersensitivity to tolmicen (tolciclate) or to any of the excipients in the cream formulation.
• Avoid application on skin areas with known allergic contact dermatitis to any component of the product.

Confirm absence of hypersensitivity before initiating treatment to prevent severe allergic responses.

Special Precautions

In some cases, at the beginning of treatment, a slight increase in the severity of the clinical symptoms of the disease may be observed.

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.