Neo-Anusol (Suppositories) Instructions for Use

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

ATC Code

C05AX02 (Bismuth preparations in combination with other drugs)

Active Substances

Iodine (Ph.Eur.)

Zinc oxide (Ph.Eur.)

Bismuth subnitrate (USAN)

Dosage Form

Neo-Anusol

Rectal suppositories 75 mg+5 mg+200 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories of a grayish-green or bluish-green color, torpedo-shaped; the appearance of a white coating on the surface of the suppository is allowed.

Excipients: tannin – 50 mg, resorcinol (resorcin) – 5 mg, methylthioninium chloride (methylene blue) – 3 mg, suppository base: hard fat, type A – sufficient quantity to obtain a suppository weighing 2.38 g, emulsifier T-2 – up to 2% of the base mass.

5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Drug with astringent, drying, and antimicrobial action for topical use in proctology

Pharmacotherapeutic Group

Hemorrhoid treatment agent

Pharmacological Action

Antihemorrhoidal agent. It has antimicrobial and astringent action.

Indications

• Hemorrhoids;
• Anal fissures.

ICD codes

Dosage Regimen

Administer rectally after thorough cleansing of the anal area.

Use one suppository once or twice daily, depending on the severity of symptoms.

For acute symptoms, apply the suppository morning and evening, preferably after a bowel movement.

For maintenance therapy, a single daily application may be sufficient.

Adhere strictly to the recommended duration of treatment prescribed by a healthcare professional.

Do not exceed the maximum daily dose of two suppositories unless directed by a physician.

Discontinue use and consult a doctor if symptoms persist or worsen after 7 days of treatment.

Adverse Reactions

Monitor for allergic reactions, including skin rash, itching, or localized irritation.

Discontinue use immediately and seek medical attention if signs of a severe hypersensitivity reaction occur.

Report any unexpected local or systemic effects to a physician.

Drug Interactions

Avoid concurrent use with other rectally administered products to prevent potential physical or chemical incompatibilities.

Inform your physician about all concomitant medications, including prescription, over-the-counter, and herbal products.

The potential for systemic interactions is considered low due to topical application.

Contraindications

• hypersensitivity to the drug components, including iodine, zinc oxide, bismuth subnitrate, or any of the excipients.

Overdose

Overdose from topical rectal use is unlikely.

In case of suspected accidental ingestion of multiple suppositories, seek immediate medical advice.

Symptoms of systemic absorption of components, particularly iodine or bismuth, would require symptomatic and supportive care.

Storage Conditions

Store in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 15°C (59°F).

Shelf Life

Shelf life is 2 years. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.