Antezoil (Suppositories) Instructions for Use

Marketing Authorization Holder

Pharmregister LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

C05AD03 (Benzocaine)

Dosage Form

Antezoil

Rectal suppositories: 4, 5, 6, 8, 10, or 12 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories yellow or greenish-yellow in color, torpedo-shaped.

Excipients: polyethylene oxide base – sufficient quantity to obtain a suppository weighing 2.6 g: macrogol 1500 (polyethylene oxide 1500) – 95%, macrogol 400 (polyethylene oxide 400) – 5%.

4 pcs. – contour cell packaging (1) – cardboard packs.
4 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – 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; local anesthetics

Pharmacological Action

A combined drug that has a local anesthetic, antiseptic, astringent, and drying effect.

Pharmacokinetics

Benzocaine, Zinc oxide are practically not absorbed.

Bismuth subgallate – absorption is insignificant. Elimination of the absorbed portion is mainly by the kidneys, but some amount may be retained in the bones and tissues (capable of accumulating, causing an intoxication syndrome).

Bismuth penetrates the placental barrier.

Indications

• For the symptomatic relief of discomfort associated with hemorrhoids.
• For the management of pain and irritation from anal fissures.

Use only for the conditions listed.

ICD codes

Dosage Regimen

Administer rectally.

Ensure bowel evacuation prior to administration, either via spontaneous defecation or a cleansing enema.

Wash the anal area thoroughly with mild soap and water; dry with a clean towel.

Remove one suppository from its protective foil wrapper immediately before use.

Assume a comfortable position lying on your side with the lower leg straightened and the upper leg bent toward the stomach.

Gently insert the suppository, pointed end first, completely into the rectum past the anal sphincter.

Apply the recommended dosage of one suppository up to twice daily.

Maintain the maximum duration of therapy for seven to ten days unless otherwise directed by a physician.

Discontinue use and consult a doctor if symptoms persist or worsen after the recommended treatment period.

Avoid exceeding the stated maximum daily dose to minimize the risk of systemic absorption and adverse effects.

Wash hands thoroughly both before and after the administration procedure.

Adverse Reactions

Local reactions: burning sensation in the anus, laxative effect.

Systemic reactions: allergic reactions, including skin rash and itching.

Discontinue use immediately if severe local irritation or signs of a systemic allergic response occur.

Drug Interactions

Avoid concurrent use with other local anesthetic products, as this increases the risk of systemic adverse effects.

The potential for interactions with sulfonamides exists due to the presence of benzocaine, which may antagonize their antibacterial action.

Inform your physician about all concomitant medications.

Contraindications

• Hypersensitivity to benzocaine, bismuth subgallate, levomenthol, zinc oxide, or any excipient of the suppository base.
• Known allergy to other local anesthetics of the ester type (e.g., procaine, tetracaine).

Do not use if any of these conditions are present.

Overdose

Excessive use or accidental ingestion may lead to systemic absorption of active ingredients.

Symptoms of bismuth toxicity include encephalopathy, nephropathy, and osteoarthropathy with long-term use.

Benzocaine overdose can cause methemoglobinemia, presenting with cyanosis, headache, dizziness, and tachycardia.

In case of suspected overdose, discontinue use immediately and seek medical attention.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is possible if the potential benefit to the mother outweighs the risk to the child and fetus.

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.