Slabiprokt (Solution) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

A06AG11 (Lauryl sulfate, including combination preparations)

Active Substances

Sorbitol (BP British Pharmacopoeia)

Sodium citrate (Ph.Eur. European Pharmacopoeia)

Sodium lauryl sulfoacetate (Grouping name)

Dosage Form

Slabiprokt

Rectal solution 9 mg+90 mg+625 mg/1 ml: microclysters 5 ml 4 or 12 pcs.

Dosage Form, Packaging, and Composition

Rectal solution from white to almost white or white with a yellowish, or yellowish-brownish, or brownish tint, viscous.

Excipients: purified water, glycerol, sorbic acid.

5 ml – microclysters (4) – carton packs.
5 ml – microclysters (12) – carton packs.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Laxative

Pharmacological Action

A combined medicinal product that has a laxative effect.

Sodium lauryl sulfoacetate liquefies 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 the amount of water due to peptization and liquefaction helps to soften the feces and facilitates bowel movement.

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 rectally as a microclyster.

For constipation in adults and adolescents over 12 years of age, use the contents of one 5 ml microclyster once daily.

For children aged 3 to 12 years, use the contents of one 5 ml microclyster once daily under adult supervision.

For preparation for diagnostic procedures (rectoscopy, radiological examination), administer one 5 ml microclyster the evening before the examination and a second microclyster on the morning of the procedure.

Use the lowest effective dose for the shortest duration necessary to achieve a result.

Avoid long-term use; if constipation persists after several days of use, discontinue the drug and consult a physician.

To administer, wash hands thoroughly. Remove the protective cap from the applicator tip. Gently insert the entire tip into the rectum. Squeeze the container to expel the entire contents. Withdraw the tip while maintaining pressure on the container. Discard the used unit.

The laxative effect typically occurs within 5 to 15 minutes after administration.

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 in 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 in accordance with the recommendations 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 necrosis of the large intestine 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.