Olestesin^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Altayvitamins, JSC (Russia)

ATC Code

C05AX (Other preparations for the treatment of hemorrhoids and anal fissures for topical application)

Dosage Form

Olestesin®

Rectal suppositories 330 mg+50 mg+100 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from dark orange to reddish-brown in color, torpedo-shaped.

* containing carotenoids calculated as β-carotene not less than 300 mg/%.

Excipients: polysorbate 80 (tween 80) – 40 mg, macrogol 400 (polyethylene oxide 400) – 60 mg, macrogol 1500 (polyethylene oxide 1500) – 980 mg, macrogol 4000 (polyethylene oxide 4000) – sufficient quantity to obtain a suppository weighing 2.35 g.

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

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Hemorrhoid treatment agent

Pharmacological Action

Combined drug.

It has a local anesthetic, anti-inflammatory, and antimicrobial action. It stimulates reparative processes and accelerates the healing of damaged tissues.

Indications

• hemorrhoids for symptomatic relief and reduction of inflammation;
• anal fissures to alleviate pain and promote tissue repair;
• anal itching (pruritus ani) of various etiologies for soothing relief.

ICD codes

Dosage Regimen

Administer rectally after hygiene procedures. The standard dosage is 1 suppository twice daily.

For severe symptoms, the dosage may be increased to 2-3 suppositories twice daily as needed. Limit the treatment course to 5-7 days; do not exceed 10 days of continuous use without medical consultation.

Adverse Reactions

Possible adverse reactions include allergic reactions such as skin rash, itching, or localized irritation at the application site.

Loose stools (diarrhea) may also occur. Discontinue use and consult a physician if any adverse reactions persist or worsen.

Contraindications

• Hypersensitivity to any component of the drug, including sulfaethidole, benzocaine, sea buckthorn oil, or any of the suppository base excipients.
• Known allergy to sulfonamides or local anesthetics of the ester type due to the risk of cross-sensitivity reactions.

Drug Interactions

Sulfaethidole may potentiate the effects of oral anticoagulants like warfarin, increasing the risk of bleeding; monitor prothrombin time closely.

Concurrent use with other methemoglobin-inducing agents, such as certain local anesthetics or nitrates, may increase the risk of methemoglobinemia. Inform your physician about all concomitant medications.

Overdose

Excessive use may lead to systemic absorption of benzocaine, potentially causing central nervous system effects such as dizziness or convulsions, and cardiovascular effects.

Symptoms of sulfaethidole overdose may include nausea, vomiting, and crystalluria. In case of suspected overdose, discontinue use immediately and initiate symptomatic and supportive treatment; there is no specific antidote.

Storage Conditions

Store in a dry, cool place out of the reach of children.

Shelf Life

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

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.