Natalsidum^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM Group of Companies (Russia)

ATC Code

B02BC (Local hemostatics)

Active Substance

Sodium alginate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Natalsidum®

Rectal suppositories 250 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories white with a brownish tint, or light brown, or light gray with a brownish tint, torpedo-shaped; the appearance of a coating on the surface of the suppository and the presence of an air core and a funnel-shaped depression on the cut are allowed.

Excipients : hard fat.

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

Clinical-Pharmacological Group

Drug with hemostatic, anti-inflammatory, and wound-healing action for topical use in proctology

Pharmacotherapeutic Group

Hemostatic agents; vitamin K and other hemostatic agents; topical hemostatic agents

Pharmacological Action

The active substance of the drug – Sodium alginate – is a natural polysaccharide obtained from brown seaweed. It has a pronounced hemostatic, anti-inflammatory, and reparative effect.

Pharmacokinetics

Not described.

Indications

• Chronic anal fissures in the epithelialization stage;
• Chronic bleeding hemorrhoids;
• Proctosigmoiditis;
• Inflammation of the rectum in the postoperative period.

ICD codes

Dosage Regimen

Administer rectally.

Free the suppository from its contour packaging immediately before use.

Ensure bowel evacuation occurs naturally or via a cleansing enema prior to administration.

For adults and children over 14 years, insert one suppository twice daily: in the morning and at night.

Adhere to a treatment course duration of 7 to 14 days.

Continue the full course even if symptoms improve earlier to ensure complete therapeutic effect.

Wash hands thoroughly both before and after the administration procedure.

Assume a comfortable position on your side for easier and correct insertion of the suppository.

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

Remain lying down for several minutes after insertion to prevent expulsion.

Consult a physician if no improvement is observed upon completion of the recommended 14-day course.

Adverse Reactions

Possible allergic reactions.

If any of the above side effects worsen or the patient notices any other side effects, they should inform their doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Children under 14 years of age.

Use in Pregnancy and Lactation

Natalsidum^® is not contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 14 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to drive vehicles or work with mechanisms.

Overdose

Cases of overdose are unknown.

Overdose is unlikely when the drug is used in accordance with the recommended dosage regimen.

Drug Interactions

No clinically significant drug interactions have been noted.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

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.