Endofalk powder for oral solution 55.318 g, package of 6 pcs.

Pharmacodynamics. Endofalk is a mixture of various electrolytes and macrogol to obtain a physiological solution for bowel cleansing.

The pharmacodynamic effect is to induce diarrhea. The intestine is emptied and cleansed. The electrolytes contained in the ready-to-use solution are balanced to ensure that the reverse process of absorption and secretion of water and electrolytes in the digestive tract is stopped and there is virtually no net flow. The high molecular weight macrogol provides an isoosmolar concentration, which is characterized by a particle concentration comparable to that in blood plasma. This prevents any significant changes in the fluid between the intestinal lumen and the vascular cavity. With this type of balancing and osmolarity, there is practically no effect on the electrolyte or fluid balance in the body.

Pharmacokinetics. Macrogol 3350 is an inert compound that undergoes only minimal absorption in the gastrointestinal tract and is not metabolized. A minimal amount of macrogol 3350, 1% of the administered dose, is excreted in the urine.

Colon cleansing before colonoscopy.

To completely cleanse the intestines, you need to drink up to 3 liters, maximum up to 4 liters of Endofalk solution. One sachet corresponds to 500 ml of solution.

The solution is drunk in portions of 200-300 ml every 10 minutes until the rectal wash water becomes clear.

The solution is usually taken about 4 hours before the start of the study. The total required amount can be drunk the evening before the study, or part of it and the rest the next morning, on the day of the study.

Patients should not eat solid food 2-3 hours before taking Endofalk and until the study is completed.

Solution preparation

The solution is prepared immediately before use. The contents of two sachets should be dissolved in 500 ml of warm or cooled boiled water and then the volume should be made up to 1 l with water. The solution should be taken chilled.

Hypersensitivity to the active substances, other Macrogol or one of the ingredients included in the medicinal product, established or suspected intestinal obstruction, gastrointestinal obstruction, gastrointestinal perforation, risk of gastrointestinal perforation, carcinoma and other severe inflammatory bowel diseases (including ulcerative colitis, Crohn’s disease), toxic megacolon, impaired gastric emptying.

Endofalk should not be administered to patients with impaired consciousness or to patients prone to aspiration or regurgitation, with general weakness or impaired swallowing reflex.

On the part of the digestive system: often (≥1/100, 1/10) – vomiting, cramping pain, abdominal pain and irritation of the anus; very often (≥1/10) – nausea, feeling of fullness and bloating.

These symptoms are more likely to occur after drinking a relatively large amount of fluid over a short period of time. If gastrointestinal symptoms occur, the frequency of Endofalk administration should be temporarily reduced or the use discontinued until the undesirable symptoms disappear.

General disorders: rarely (≥1/1000, 1/100) – general malaise and insomnia.

Cardiovascular system: very rarely (1/10,000) – cardiac arrhythmia, tachycardia and pulmonary edema.

From the laboratory parameters: very rarely (1/10,000) some patients may have persistent decreases in the levels of calcium, potassium, and sodium in the blood plasma.

From the side of the central nervous system: very rarely (1/10,000) – neurological disorders as a result of fluctuations in electrolyte balance may lead to mild disorientation or generalized seizures.

On the part of the immune system: very rarely (1/10,000) – urticaria, rhinorrhea; itching or dermatitis, probably of allergic origin; rash, Quincke’s syndrome, anaphylactic shock.

The literature provides data on two cases of Mallory-Weiss syndrome, which was noted as a result of vomiting after the use of solutions containing macrogol.

Endofalk is used in elderly patients and in individuals with reflux esophagitis or arrhythmia with suspected or confirmed sinoatrial block or sick sinus syndrome only under medical supervision.

The drug can be used in patients with chronic inflammatory bowel diseases (exception: severe stages of the disease and toxic megacolon), but with caution and, if possible, under medical supervision.

Endofalk should not be used in patients with heart failure (NYHA class III and IV), renal failure, liver disease or in people with severe dehydration, since the safety of use in these groups of patients has not been sufficiently studied. The drug should be taken with caution in patients at risk of water and electrolyte balance disorders (for example, patients with impaired liver or kidney function, while taking diuretics). Isolated cases of water and electrolyte balance disorders in patients at risk have been recorded. In patients with heart or renal failure, acute pulmonary edema may develop due to excessive intake of sodium hydroxide.

No other solutions or additives (including sugar or flavorings incompatible with Endofalk solution) should be added to the ready-to-use Endofalk solution, as this may change the osmolarity and electrolyte composition or cause increased gas formation in the intestines.

It is necessary to monitor fluid and electrolyte balance in patients at risk, including elderly and debilitated patients.

Pregnancy and breastfeeding. Pregnancy. There is no experience of using the drug during pregnancy.

Breastfeeding. There is no data on the passage of macrogol 3350 into breast milk. Macrogol 3350 is poorly absorbed. Endofalk can be used during breastfeeding if the benefit of use outweighs the potential risk.

Children: Endofalk should not be used in children because the safety of the drug in this age group of patients has not been adequately studied.

Effects on ability to drive and use machines Endofalk does not affect the ability to drive or use machines.

Medicinal products taken orally within a few hours before or during the administration of Endofalk may be excreted from the gastrointestinal tract or their absorption may be reduced or completely stopped. This applies in particular to modified-release preparations. If this medicine is absolutely necessary for life, the oral form of the medicine should be replaced by another dosage form or an alternative should be found.

Macrogol may interact with certain enzymatic tests (e.g. ELISA) in diagnostic studies of intestinal fluid that has been removed.

The finished solution cannot be mixed with other solutions or additives.

In case of overdose, severe diarrhea is possible. In case of significant overdose, disturbances of water, electrolyte and acid-base balance may develop. Adequate fluid replacement and monitoring of electrolytes in blood plasma and pH values ​​are necessary.

If fluid, electrolyte, or acid-base imbalance occurs, electrolytes should also be restored and measures taken to restore acid-base balance.

Aspiration may cause toxic pulmonary edema, requiring immediate intensive care, including mechanical ventilation under increased pressure.

Does not require special storage conditions. The prepared solution is suitable for use within 3 hours when stored at a temperature not exceeding 25 °C or within 48 hours at a temperature of 2-8 °C (in a refrigerator).