Endofalk (Powder) Instructions for Use

ATC Code

A06AD65 (Macrogol in combination with other drugs)

Clinical-Pharmacological Group

Laxative drug with osmotic properties, used for bowel lavage

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative.

Macrogol 3350 (polyethylene glycol), due to the creation of an iso-osmolar solution, prevents the absorption of water in the stomach and intestines, promotes accelerated passage and excretion of the gastrointestinal tract contents.

The electrolytes of the salts included in the composition prevent the disruption of the body’s water-salt balance.

Polyethylene glycol with high molecular weight, due to the absence of absorption and metabolism, prevents undesirable gas formation caused by the metabolizing action of bacteria.

Pharmacokinetics

Polyethylene glycol with high molecular weight is not absorbed in the gastrointestinal tract and is not metabolized during passage.

Indications

• Preparation for endoscopic or radiological examination of the lower intestine.
• Preparation for surgical manipulations accompanied by the need for the absence of intestinal contents – chyme.

ICD codes

Dosage Regimen

Administer orally as a solution. For adults and children over 18 years of age, the recommended total volume is 3-4 liters of the prepared solution.

Ingest the solution in portions of 200-300 ml every 10 minutes until the entire volume is consumed or until the rectal effluent is clear. Complete the ingestion according to the prescribed schedule, typically on the day before the procedure.

Powder

Adults and children over 18 years of age are usually prescribed orally in the form of a solution. The recommended dose is 3-4 liters of solution, taken in portions of 200-300 ml every 10 minutes.

Adverse Reactions

Common adverse reactions are related to the gastrointestinal system and include nausea, vomiting, abdominal cramping, pain, flatulence, and anal irritation.

Less frequently, sleep disturbance, general malaise, dizziness, headache, and hypersensitivity reactions such as rash, urticaria, and anaphylaxis may occur. Severe vomiting, electrolyte disturbances, and ileus are rare but serious potential reactions.

Contraindications

• Known hypersensitivity to any component of the formulation.
• Severe impairment of general condition, such as dehydration, cardiac failure, or renal failure.
• Gastrointestinal obstruction, perforation, or ileus.
• Toxic megacolon or toxic colitis.
• Gastric retention or stenosis.
• Severe active inflammatory bowel disease.
• Children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Used during pregnancy and breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus.

Use in Hepatic Impairment

Contraindicated in liver disease.

Use in Renal Impairment

Contraindicated in renal failure, impaired renal excretory function.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Elderly patients with existing concomitant diseases are recommended to use under medical supervision.

Special Precautions

Elderly patients with existing concomitant diseases are recommended to use under medical supervision.

The patient should inform the attending physician about all medications taken concomitantly, as well as about the occurrence of any side effects.

Drug Interactions

The accelerated gastrointestinal transit time can reduce the absorption of concurrently administered oral medications, potentially diminishing their therapeutic effect.

Administer other oral medications at least one hour before starting the bowel preparation. Exercise caution in patients with known or suspected electrolyte abnormalities or those taking medications that affect electrolyte levels.

Overdose

Overdose may lead to severe diarrhea, dehydration, and electrolyte imbalances such as hyponatremia or hypokalemia. Symptoms can include dizziness, syncope, tachycardia, and excessive thirst.

Discontinue use immediately and initiate supportive care, including fluid and electrolyte replacement. Monitor vital signs and correct any electrolyte abnormalities as clinically indicated. There is no specific antidote.

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.