Bethiol^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

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

Active Substances

Belladonna (Ph.Eur. European Pharmacopoeia)

Ichthammol (Ph.Eur. European Pharmacopoeia)

Dosage Form

Bethiol®

Rectal suppositories 15 mg+200 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories dark brown in color, torpedo-shaped, with a characteristic odor; the appearance of a coating on the surface of the suppository and the presence of an air core on the cut and a funnel-shaped depression are allowed.

Excipients: purified water, emulsifier T-2, solid fat (witepsol grades H 15, W 35, suppocire grades NA 15, NAS 50).

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

Clinical-Pharmacological Group

A drug with anti-inflammatory, analgesic, and spasmolytic action for topical use in proctology

Pharmacotherapeutic Group

Hemorrhoid treatment agent of natural origin

Pharmacological Action

A combined medicinal product for topical use. It has a spasmolytic (belladonna extract) and anti-inflammatory (ichthammol) effect.

Indications

• Hemorrhoids for the relief of symptoms including inflammation and pain.
• Anal fissures to reduce sphincter spasm and associated discomfort.

ICD codes

Dosage Regimen

Administer rectally after hygiene procedures.

Insert one suppository into the rectum one to three times daily, depending on symptom severity.

Apply after bowel movements for optimal effect.

Do not exceed a maximum daily dose of ten suppositories.

Wash hands thoroughly before and after application.

The duration of treatment is determined by the physician based on clinical response.

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

Adverse Reactions

Adverse reactions are primarily associated with the systemic absorption of belladonna alkaloids.

Reported effects include dry mouth, thirst, constipation, palpitations, mydriasis (dilated pupils), and accommodation paresis (blurred near vision). Discontinue use if severe reactions occur.

Drug Interactions

Concurrent use with other anticholinergic agents may result in additive effects and an increased risk of adverse reactions.

Use with caution with drugs that possess anticholinergic properties, including some antidepressants, antihistamines, and antipsychotics. Monitor for enhanced anticholinergic symptoms.

Contraindications

• Angle-closure glaucoma due to the risk of increased intraocular pressure from anticholinergic effects.
• Prostatic hypertrophy with impaired urine outflow, as anticholinergic action can precipitate acute urinary retention.
• Known hypersensitivity to belladonna extract, ichthammol, or any excipient of the suppository base.

Overdose

Symptoms of overdose are characteristic of anticholinergic poisoning and may include severe dry mouth, difficulty swallowing, flushed and dry skin, tachycardia, restlessness, confusion, and hallucinations.

Treat symptomatically and provide supportive care. In severe cases, consider the administration of physostigmine. Seek immediate medical attention.

Special Precautions

Effect on the ability to drive vehicles and machinery

During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration, speed of psychomotor reactions, and good vision.

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.