Mykoseptin^® (Ointment) Instructions for Use

Marketing Authorization Holder

Opella Healthcare, LLC (Russia)

Manufactured By

Sanofi Winthrop Industrie (France)

ATC Code

D01AE54 (Undecylenic acid in combination with other drugs)

Active Substances

Undecylenic acid (USP United States Pharmacopeia)

Zinc undecylenate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Mykoseptin®

Ointment for external use 50 mg+200 mg/1 g: tube 30 g

Dosage Form, Packaging, and Composition

Ointment for external use from almost white to white with a light yellowish tint, with a characteristic odor and with small fatty granules.

Excipients: stearic acid, white beeswax, hard paraffin (melting point 64-68°C (147.2-154.4°F)), hard paraffin, liquid paraffin, methylparaben, macrogol oleate, distilled monoglycerides, white soft paraffin, purified water.

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

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Undecylenic acid and its salts have a pronounced fungistatic effect against dermatophytes of the genera Trichophyton, Epidermophyton, Microsporum.

Zinc, which is part of the drug, has an astringent effect, thereby reducing the manifestations of skin irritation and promoting faster healing.

Indications

• Treatment and prevention of fungal skin diseases caused by fungi sensitive to the drug.

ICD codes

Dosage Regimen

For external use.

Apply to a clean, dry surface of the affected skin 2 times/day. The duration of the treatment course is 4-6 weeks.

After the disappearance of clinical manifestations of the disease, to prevent relapse, it is recommended to apply the ointment 1 time/day for a week and then, every other day or 2 times a week for one month; shortening the course of treatment increases the risk of disease relapse.

Adverse Reactions

Hypersensitivity reactions to the components of the drug are possible in the form of redness, itching of the skin, swelling, burning sensation, skin rash.

If signs of hypersensitivity appear, the use of the drug should be discontinued and the doctor should be informed.

Contraindications

• Children’s age (under 2 years);
• Hypersensitivity to undecylenic acid and its derivatives, parabens, and other components of the drug.

Use in Pregnancy and Lactation

The possibility of using Mykoseptin^® during pregnancy and breastfeeding is determined by the doctor individually.

Pediatric Use

The drug is contraindicated in children under 2 years of age.

Special Precautions

Mykoseptin^® should not be applied to an open wound surface, damaged skin surface, or the periorbital area; avoid getting the ointment into the eyes.

Overdose

Cases of overdose have not been described. In case of accidental ingestion of the drug, nausea and vomiting may occur. It is necessary to perform gastric lavage and consult a doctor; if necessary, symptomatic treatment is carried out.

Drug Interactions

No data on the interaction of Mykoseptin^® with other drugs have been obtained. The possibility of simultaneous use of other drugs for external use is determined by the doctor.

Storage Conditions

Store in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

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.