Sodium citrate + Sodium laurylsulfoacetate + Sorbitol (Solution) Instructions for Use

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

ATC Code

A06AG11 (Lauryl sulfate, including combination preparations)

Active Substances

Sorbitol (BP British Pharmacopoeia)

Sodium citrate (Ph.Eur. European Pharmacopoeia)

Sodium lauryl sulfoacetate (Group Group name)

Dosage Form

Sodium citrate + Sodium lauryl sulfoacetate + Sorbitol

Rectal solution: tubes 5 ml 1, 4 or 12 pcs.

Dosage Form, Packaging, and Composition

Rectal solution colorless or slightly opalescent, practically odorless, containing small air bubbles.

Excipients : glycerol, sorbic acid, purified water.

5 ml – polyethylene tubes (1) – cardboard packs with an insert.
5 ml – polyethylene tubes (4) – cardboard packs with an insert.
5 ml – polyethylene tubes (12) – cardboard packs with an insert.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Laxative

Pharmacological Action

A combined medicinal product that has a laxative effect.

Sodium lauryl sulfoacetate thins the intestinal contents.

Sodium citrate is a peptizing agent that displaces bound water contained in the feces.

Sorbitol enhances the laxative effect by stimulating the influx of water into the intestine.

The increase in water volume due to peptization and thinning helps to soften the feces and facilitates bowel evacuation.

The effect occurs within 5-15 minutes.

Indications

Constipation (including with encopresis); preparation for endoscopic (rectoscopy) and radiological examination of the gastrointestinal tract.

ICD codes

Dosage Regimen

Administer the solution rectally as a microenema.

For adults and adolescents, use a single 5 ml tube (one full tube).

For children aged 7 to 14 years, use a single 5 ml tube (one full tube).

For children aged 3 to 6 years, use a single 2.5 ml dose (one-half of a 5 ml tube).

For children under 3 years of age, use only as directed by a physician.

Remove the protective cap from the tip of the tube.

Gently squeeze the tube to release a small amount of solution to lubricate the tip.

Insert the entire tip of the tube into the rectum.

Squeeze the tube firmly to expel the entire contents.

Withdraw the tube while it is still compressed.

Discard the used tube after a single application.

The laxative effect typically occurs within 5 to 15 minutes.

For preparation for diagnostic procedures (e.g., rectoscopy), administer one or two microenemas as directed, following the specific instructions provided by the healthcare facility.

Avoid long-term use.

If constipation persists after use, consult a physician.

Adverse Reactions

From the digestive system very rarely – pain in the abdominal area (including abdominal discomfort, pain in the upper abdomen), discomfort in the anorectal area, loose stools.

From the immune system very rarely – hypersensitivity reactions (e.g., urticaria).

Contraindications

Increased individual sensitivity to the components of the combination; intestinal obstruction and abdominal pain of unknown etiology; simultaneous oral/rectal use of sodium/calcium polystyrene sulfonate.

With caution

It is recommended to avoid the use of this medicinal product in case of exacerbation of hemorrhoids, anal fissures, or hemorrhagic rectocolitis.

Special precautions should be observed when used in patients with inflammatory or ulcerative diseases of the colon or with acute gastrointestinal diseases.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies involving pregnant women have not been conducted. Since the components of the combination are probably absorbed into the systemic circulation to an insignificant extent, no adverse effects on the fetus or breastfed infant are expected when used as recommended during pregnancy or lactation.

Special Precautions

Long-term use should be avoided; if symptoms persist, the patient should consult a doctor.

Drug Interactions

There is a risk of developing colon necrosis with simultaneous oral/rectal use of sodium polystyrene sulfonate and sorbitol, which is part of this combination.

If it is necessary to use other rectal drugs, an interval between their applications should be observed.

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.