Anusol (Suppositories) Instructions for Use

ATC Code

C05AX03 (Preparations for the treatment of hemorrhoids and anal fissures in combination)

Active Substances

Xeroform (Grouping Name)

Zinc sulfate (BP British Pharmacopoeia)

Belladonna (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Drug for topical treatment of hemorrhoids

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

A combined drug for the treatment of hemorrhoids.

It has antispasmodic, anti-inflammatory, antimicrobial, analgesic, astringent, and drying effects.

Indications

Use this medication exclusively for the symptomatic relief and local treatment of specific anorectal conditions.

• Hemorrhoids, including both internal and external presentations for the reduction of inflammation, swelling, and discomfort.
• Anal fissures to alleviate pain and promote healing of the mucosal tear.

The application is strictly for topical use within the anal canal and is not intended for systemic conditions or other dermatological issues.

ICD codes

Dosage Regimen

Administer rectally, ensuring proper hygiene before application. Insert 1 suppository 1 to 3 times per day, following a spontaneous bowel movement or a cleansing enema to ensure effective contact with the affected area.

Strictly adhere to the maximum daily dose of 7 suppositories to minimize the risk of systemic adverse effects from the belladonna alkaloids. The typical treatment course should not exceed 7 to 10 days unless directed by a physician.

Adverse Reactions

Monitor for localized and systemic adverse effects, primarily attributable to the anticholinergic properties of belladonna.

Local reactions may include allergic reactions, burning, or irritation in the anal area. Systemic absorption can cause dry mouth, thirst, constipation, tachycardia, mydriasis (dilated pupils), accommodation paresis (blurred vision), headache, dizziness, drowsiness, photophobia, and urinary retention.

Drug Interactions

Exercise caution due to potential pharmacodynamic interactions with other drugs. The belladonna component may exhibit additive anticholinergic effects when used concurrently with other anticholinergic agents, including tricyclic antidepressants, antihistamines, and anti-Parkinson drugs, increasing the risk of adverse effects like severe constipation, urinary retention, and tachycardia.

Concomitant use with CNS depressants (alcohol, sedatives) may potentiate drowsiness and impaired coordination. Monitor for enhanced effects when administered with drugs that decrease gastrointestinal motility.

Contraindications

Do not use this medication under any circumstances in patients with known hypersensitivities or specific medical conditions due to the risk of severe adverse reactions.

• Hypersensitivity to xeroform, zinc sulfate, belladonna, or any excipient.
• Decompensated heart failure, tachyarrhythmia, myasthenia gravis, intestinal atony, or paralytic ileus.
• Angle-closure glaucoma due to the risk of acute attack from mydriasis.
• Prostatic hypertrophy with significant impairment of urinary flow, which can be exacerbated.
• Pregnancy and the lactation period are absolute contraindications.

Overdose

Recognize that systemic absorption can lead to anticholinergic toxicity. Symptoms of overdose are an extension of adverse effects and include severe dry mouth, flushed and dry skin, hyperthermia, tachycardia, marked mydriasis, restlessness, confusion, hallucinations, and convulsions.

Immediately discontinue use and initiate symptomatic and supportive care. Treatment may require gastric lavage, administration of activated charcoal, and the use of a physostigmine antidote in severe, life-threatening cases. Manage hyperthermia with external cooling and seizures with benzodiazepines.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Special Precautions

Influence on the ability to drive vehicles and mechanisms

During the treatment period, it is necessary to refrain from 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 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.