Tambuil (Solution) Instructions for Use

Marketing Authorization Holder

Bivitex LLC (Russia)

ATC Code

D08AX (Other antiseptics and disinfectants)

Dosage Form

Tambuil

Solution for external use oil-based: 50 g, 100 g, or 200 g bottle

Dosage Form, Packaging, and Composition

Solution for external use (oil-based) in the form of a liquid from yellowish-brown to brown in color, with a weak specific odor.

Excipients: sunflower oil – 50 mg.

50 g – dark glass bottles (1) – cardboard packs.
100 g – dark glass bottles (1) – cardboard packs.
200 g – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antiseptic for external use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Therapeutic mud, an antiseptic medicinal product, is produced from the peloids of Lake Tambukan, exerts an antimicrobial action, and stimulates reparative processes in skin lesions.

Indications

• Long-term non-healing wounds and ulcers of various origins.
• Radiation-induced skin lesions.
• Burns.

ICD codes

Dosage Regimen

Apply the solution externally only. Use a thin layer on the affected skin areas once or twice daily.

For long-term non-healing wounds or ulcers, apply under a sterile dressing. Change the dressing every 24 to 48 hours to maintain hygiene and efficacy.

For radiation-induced skin lesions and burns, apply directly to the clean, affected area. The frequency of application may be adjusted based on the severity of the condition.

Duration of treatment depends on the clinical response. Continue use until the skin lesion is fully epithelialized or as directed by a physician.

Do not apply to large areas of damaged skin without medical supervision. Avoid contact with eyes and mucous membranes. If accidental contact occurs, rinse thoroughly with water.

Adverse Reactions

Monitor for local and systemic hypersensitivity responses. Discontinue use immediately if signs of an allergic reaction appear.

Reported adverse effects include urticaria and contact dermatitis. Seek medical attention for any severe or persistent skin reactions.

Drug Interactions

Concurrent use with other topical products on the same area is not recommended. Avoid applying other ointments, creams, or antiseptics simultaneously.

This may alter the product’s effect or increase the risk of local skin reactions. Consult a healthcare professional before combining with any other medicinal product.

Contraindications

• Hypersensitivity to the active substance (Tambukan Mud) or to any of the excipients, including sunflower oil.

Overdose

Overdose from topical application is unlikely. Excessive application may increase the risk of local adverse reactions.

If accidental ingestion occurs, seek immediate medical advice. Provide symptomatic and supportive care as there is no specific antidote.

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.