Endofalc, 55, 318 g 8 pcs

Endofalc is a mixture of different salts and macrogoal 3350 to produce an isotonic solution for colon cleansing.

The pharmacodynamic action is the initiation of diarrhea. The intestines are emptied and cleansed. In the prepared solution the electrolytes are in a balanced form, so absorption and secretion of water and electrolytes in the gastrointestinal tract are mostly neutral and the flux of substances is almost zero.

The addition of high molecular weight macrogoal 3350 conditions the isoosmolarity of the solution, the concentration of particles in which is comparable with blood plasma. This prevents any significant shift in the balance of fluids between the lumen of the gastrointestinal tract and the vascular bed. Due to this equilibrium and osmolarity, there is virtually no effect on the body’s water-electrolyte balance.

Pharmacokinetics

. Macrogol 3350 itself is an inert compound that is only minimally absorbed during passage through the gastrointestinal tract and is not metabolized. A minimal amount of Macrogol 3350 (< 1% of the dose taken) is excreted in the urine.

Indications

For colon cleansing before colonoscopy.

Composition

1 sachet contains:

acting ingredients:

Macrogol 3350 52.5 g,

Sodium chloride 1.4 g,

sodium bicarbonate 0.715 g,

Potassium chloride 0.185 g;

excipients:

colloidal silicon dioxide 0.00046 g,

Fruit flavoring 0.4 g,

orange flavoring 0.1 g,

sodium saccharinate 0.018 g.

How to take, the dosage

Intravenously.

Preparation of the solution

The solution should be prepared immediately before use.

In order to prepare the solution, the contents of 1 sachet are dissolved in 1/2 liter of cooled boiled water. For complete colon cleansing it is recommended to prepare and take 3-4 liters of Endofalk solution.

The recommended dose

3-4 liters of the solution is taken in portions of 200-300 ml every 10 minutes until the discharge from the rectum becomes clear.

The solution should be drunk within about 4 hours, usually on the day of the study. The total amount needed can be taken the evening before the day of the study, or part the night before and the rest the morning of the day of the study.

You should refrain from eating solid foods 2-3 hours before taking Endofolk and until the end of the study.

Interaction

Medicinal products administered orally several hours before or during administration of Endofolk may be eliminated from the gastrointestinal tract or their absorption may be reduced or completely stopped. This applies in particular to modified-release drugs. If this medication is absolutely necessary for vital signs, the oral form of the drug must be replaced by another dosage form or an alternative must be found.

In diagnostic studies of separated intestinal fluid using enzyme-linked assays (e.g., ELISA), there may be an interaction between MacroGol 3350 and enzyme-linked assays.

Prepared Endofolk solution should not be mixed with other solutions or additives (particularly sugar or flavorings that are not compatible with Endofolk solution), as this may alter osmolarity or electrolyte composition and produce an explosive gas when the additives are broken down by intestinal flora bacteria.

Special Instructions

Consult your doctor if you experience any side effects.

It is not recommended for use in children.

Patients who are elderly and have comorbidities are advised to use the drug under medical supervision.

The patient should tell the attending physician about all medications taken at the same time as Endofolk.

Influence on the ability to drive vehicles and moving machinery. Not detected.

Contraindications

Side effects

The following undesirable adverse reactions noted during use of the drug are categorized according to the following frequency of occurrence: very frequent (> 10%), frequent (≥ 1/00 to 1/10000 to ≥ 1/100%), frequent (≥ 1/00 to 1/10000 to ≥ 1/100%).

If these symptoms occur, particularly nausea and vomiting, Endofolk administration should be slowed or temporarily stopped until the symptoms disappear.

Unwanted adverse reactions according to organ and system involvement (MedDRA)

Immune system disorders
Very rare ( Nervous system disorders
Very rare ( Cardiac disorders
Very rare ( Gastrointestinal disorders
Very common (≥1/10) Nausea, feeling of full stomach, flatulence
Frequent (≥1/100 to General disorders and disorders at the site of administration
Infrequent (≥1/1000 to Laboratory and instrumental findings
Very rare (

Please note:
Two cases of Mallory-Weiss syndrome have been reported in the literature as a result of vomiting after ingestion of macrogol-containing bowel cleansing solutions.

If any of the side effects listed in the instructions worsen or if you notice other side effects not listed in the instructions, tell your doctor.

Overdose

In case of overdose, pronounced diarrhea occurs. Only in severe overdose one can expect disorders of water-electrolyte and acid-base balance. In this case it is necessary to carry out sufficient fluid replenishment and monitoring of serum electrolytes and pH. If water-electrolyte or acid-base balance is impaired, electrolytes should be replenished and acid-base balance corrected.

In case of aspiration, toxic pulmonary edema may develop. If toxic pulmonary edema occurs, emergency intensive care, including positive pressure breathing, should be given.