Anuzoprokt (Suppositories) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (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

Anuzoprokt

Rectal suppositories: from 1 to 100 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 is allowed.

Excipients: tannin – 0.05 g, resorcinol – 0.005 g, methylthioninium chloride – 0.003 g, hard fat type A – 2.001 g, emulsifier T-2 – 0.041 g.

From 1 to 10 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory, astringent, drying, and local anesthetic action for topical use in proctology

Pharmacotherapeutic Group

Angioprotectors; agents for the treatment of hemorrhoids and anal fissures for topical use; other agents for the treatment of hemorrhoids and anal fissures for topical use

Pharmacological Action

Antihemorrhoidal agent. It has antiseptic and astringent action.

Indications

• Hemorrhoids for the relief of symptoms including inflammation, swelling, and discomfort.
• Anal fissures to promote healing and provide symptomatic relief from pain and irritation.

Use specifically for conditions where an astringent, antiseptic, and local anti-inflammatory effect is required in the anorectal area.

ICD codes

Dosage Regimen

Administer rectally. Use one suppository inserted into the rectum, typically one to two times per day, or as directed by a physician.

The frequency and duration of therapy depend on the severity of symptoms. Cleanse the anal area before insertion. If symptoms persist beyond 7-10 days, discontinue use and consult a doctor.

Adverse Reactions

Localized allergic reactions are possible, manifesting as skin rash, itching, redness, or irritation at the application site.

Discontinue use immediately if any signs of hypersensitivity appear. The incidence of these reactions is generally low but monitor for any unusual local symptoms during treatment.

Contraindications

• Hypersensitivity to any of the active substances (iodine, zinc oxide, bismuth subnitrate) or to any of the excipients.
• Known iodine intolerance, due to the potential for severe allergic reactions.

Do not use in patients with a history of allergic contact dermatitis to any component of the suppository formulation.

Drug Interactions

Formal interaction studies have not been conducted. Due to the local action and low systemic absorption, clinically significant drug interactions are not anticipated.

Concurrent use with other topical anorectal preparations is not recommended to avoid potential local irritation or incompatibility. Inform your physician about all medications you are using.

Overdose

Overdose with rectal suppositories is unlikely due to the local route of administration. Excessive use could potentially lead to intensified local adverse effects such as severe irritation.

In case of suspected overdose, discontinue treatment and manage symptoms supportively. There is no specific antidote. Seek medical attention if severe local reactions occur.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is only possible if the intended benefit to the mother outweighs the potential risk to the fetus or child.

If it is necessary to use the product during pregnancy or while breastfeeding, a doctor should be consulted beforehand.

Special Precautions

If after 7-10 days of treatment there is no improvement in the condition, or the symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°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.