Instructions Endofalk powder for oral solution 55.318 g sachet No. 6
Composition
active ingredients: 1 packet (55.318 g of powder) contains: macrogol 3350 – 52.500 g, sodium chloride – 1.400 g, sodium bicarbonate – 0.715 g, potassium chloride – 0.185 g;
excipients: sodium saccharin, colloidal anhydrous silicon dioxide, passion fruit flavor, orange flavor.
Dosage form
Powder for oral solution.
Main physicochemical properties: white powdery mixture of various crystalline substances.
Pharmacotherapeutic group
Osmotic laxatives. Macrogol, combinations.
ATX code A06A D65.
Pharmacological properties
Pharmacodynamics.
Endofalk is a mixture of various electrolytes and macrogol to produce an isotonic 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. The addition of 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 change in fluid between the intestinal lumen and the vascular cavity. Due to 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.
Indication
To cleanse the intestines before colonoscopy.
Contraindication
Hypersensitivity to the active substances, other macrogols or to one of the ingredients included in the medicinal product.
Intestinal obstruction 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 used in patients who are unconscious or semi-conscious, or in patients prone to aspiration or regurgitation, with general weakness or impaired swallowing reflex.
Interaction with other drugs and other types of interactions.
Drugs taken orally within a few hours before or during the administration of Endofalk may be eliminated from the gastrointestinal tract or their absorption may be reduced or completely stopped. This applies in particular to drugs with delayed release. If these drugs are absolutely necessary for life, their oral administration should be avoided and the drug(s) should be used in a different dosage form or an alternative should be found.
There is a possible interaction between macrogol and certain enzyme tests (e.g. ELISA) in the diagnostic examination of excreted intestinal fluid.
The finished solution cannot be mixed with other solutions or additives.
Application features
Endofalk should only be used under medical supervision in elderly patients, patients with reflux esophagitis or existing cardiac arrhythmia with suspected or confirmed sinoatrial block or sick sinus syndrome.
Patients with chronic inflammatory bowel diseases (except severe cases and toxic megacolon) should use the drug with caution, under the supervision of a physician.
Endofalk should not be used in patients with heart failure (NYHA III and IV degrees), renal failure, liver disease or patients with severe dehydration, since the safety of the drug in such patients has not been sufficiently studied. The drug should be used 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 alter the osmolarity and electrolyte composition or cause the formation of gas mixtures in the intestine.
It is necessary to monitor fluid and electrolyte balance in patients at risk, including elderly and debilitated patients.
Use during pregnancy or breastfeeding
Pregnancy
There is no experience with the use of the drug during pregnancy.
Breastfeeding period
Macrogol 3350 is poorly absorbed. Endofalk can be used during breastfeeding if the benefit to the mother outweighs the potential risk to the child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Endofalk does not affect the ability to drive or operate machinery.
Method of administration and doses
To completely cleanse the intestines, you need to drink up to 3, maximum 4 liters of Endofalk solution. One packet corresponds to ½ liter of solution.
Drink the solution in portions of 200-300 ml every 10 minutes until the rectal wash water becomes clear.
Typically, the drug should be taken 4 hours before the start of the test. The total required amount of solution can also be taken the evening before the test, or partially the evening before and the remainder the next morning, on the day of the test.
Patients should not consume any solid food 2-3 hours before taking Endofalk and until the study is completed.
Solution preparation
Prepare the solution before use by dissolving the contents of 2 sachets in 500 ml of warm or cooled boiled water, and then bring the volume to 1 liter by adding water. The freshly prepared ready-to-use solution can be placed in the refrigerator, as it is preferable to use it chilled.
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.
Overdose
Severe diarrhea may occur in case of overdose. In case of significant overdose, disturbances of fluid, electrolyte and acid-base balance may be expected. Adequate fluid replacement and monitoring of serum electrolytes and pH values should be carried out.
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, which requires immediate intensive treatment, including positive pressure ventilation.
Side effects
| Organ system | Frequency according to MedDRA | |
Very often (≥ 1/10) | Often (≥ 1/100 to < 1/10) | |
| Gastrointestinal disorders | Nausea, feeling of fullness and bloating | Vomiting, stomach cramps, and anal irritation |
These symptoms are usually caused by 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 drug should be discontinued until the symptoms resolve.
| Organ system | Frequency according to MedDRA | | |
Infrequently (≥ 1/1,000 to < 1/100) | Very rare (< 1/10000) | Not known (frequency cannot be estimated from the available data) | |
| Immune system disorders | | Anaphylactic shock | |
| Metabolic and digestive disorders | | | Dehydration, electrolyte imbalance (hypocalcemia, hypokalemia, hyponatremia) |
| Mental disorders | Insomnia | | |
| Central nervous system disorders | | Neurological effects, ranging from mild disorientation to generalized seizures, due to electrolyte imbalance (see "Metabolic and digestive disorders") | |
| Cardiac disorders | | Cardiac arrhythmia, tachycardia | |
| Respiratory, thoracic and mediastinal disorders | | Pulmonary edema, rhinorrhea, probably of allergic origin | |
| General disorders and administration site conditions | General malaise | | |
| Skin and subcutaneous tissue disorders | Urticaria, dermatitis (presumably of allergic origin) | | |
Note
Two cases of Mallory-Weiss syndrome have been documented in the medical literature, which were the result of vomiting after administration of macrolide-containing colonic lavage solutions.
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit-risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua/.
Expiration date
5 years. Do not use after the expiry date stated on the packaging.
Storage conditions
No special storage conditions required. Keep out of reach of children. The reconstituted solution is suitable for use within 3 hours if stored at a temperature not exceeding 25°C, or within 48 hours if stored at 2–8°C (in a refrigerator).
Packaging
55.318 g of powder per bag; 6 bags per cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Falk Pharma GmbH, Germany.
Location of the manufacturer and address of its place of business.
Leinenweberstrasse 5, 79108 Freiburg, Germany.
