ENDOFALK

Active material: a mixture of electrolytes
When ATH: A06AD65
CCF: Laxatives osmotic properties, used for intestinal lavage
When CSF: 11.08.03.01
Manufacturer: Dr. FALK PHARMA GmbH (Germany)

Pharmaceutical form, composition and packaging

◊ Powder for oral solution white, crystalline, with aromatic and fruity orange scent.

Excipients: colloidal silicon dioxide, fruity flavor (Firmenih 502.116 AP), orange flavor (Evogran 301768), sodium saccharin.

55.318 g – multilayer laminated bags (6) – packs cardboard.

Pharmacological properties

Endofalk is a mixture of different electrolytes and macrogol for isotonic p-ra for bowel cleansing.
Pharmacodynamic effect is induced diarrhea. The intestine is emptied and cleaned. Electrolytes, contained in the ready-to-use D-p, balanced so, to ensure termination of the reverse process of absorption and secretion of water and electrolytes in the gut and the virtual absence of net flux. The high concentration of macrogol provides isoosmolar, which is characterized by the concentration of particles, comparable with that in the blood plasma. This prevents any significant changes in the fluid between the intestinal lumen and vascular cavity. This type of balancing effect on osmolality and electrolyte balance in the body fluid or virtually absent.
Macrogol 3350 It is an inert compound, little is absorbed while passing through the gastrointestinal tract and metabolized. The minimum number of macrogol 3350 less 1% of the administered dose excreted in urine.

Testimony

Intestinal cleansing prior to colonoscopy.

APPLICATIONS

For a complete bowel cleansing is necessary to drink 3, maximum 4 l r-ra Éndofalʹka. One packet matches ¹/₂ l r-ra.
Pp drink portions of 200-300 ml every 10 m, while rectal washings become transparent.
Pp usually take approximately 4 hours before the study. The total required amount may be consumed in the evening, on the eve of study, or in part and the remainder - the next morning, day study.
Patients should not eat solid food for 2-3 hours before taking Endofalka until the completion of studies.
Endofalk should not be given to children, because the safety of the drug in this age group of patients has not been studied.
Preparation of p-ra
Pp prepared immediately before use. The contents of the two sachets should be dissolved in 500 ml of warm or cool boiled water, and then bring the volume to 1 l of water. Rr is desirable to take chilled.

Contraindications

Ileus or suspected intestinal obstruction, gastrointestinal perforation, the risk of gastrointestinal perforation, expressed colitis, toxic megacolon, violation of gastric emptying, Hypersensitivity to the active substance or to any component of the drug, other macrogols.
Endofalk should not be administered to patients with impaired consciousness or sick, prone to aspiration or belching, general weakness or violation of swallowing reflex.

SIDE EFFECTS

On the side GI
Often (>10%) - Nausea, fullness and bloating.
Often (>1–10%) - Vomiting, abdominal spasms and irritation of the anus. These symptoms often mark due to use relatively large quantities of liquid over a short period of time. If there is gastrointestinal symptoms, reception frequency Endofalka to temporarily slow down or stop until the disappearance of unwanted symptoms.
On the side common disorders
Infrequently (>0,1–1%) - Malaise, and insomnia.
On the side Cardiovascular
Rarely (<0,01%) - Cardiac arrhythmia, tachycardia and pulmonary edema. It is necessary to monitor the electrolyte and fluid balance in patients at risk.
On the side laboratory parameters
Rarely (<0,01%) some patients may mark lowering serum calcium.
On the side immune system
Rarely (<0,01%) - Urticaria, rhinorrhea or dermatitis, probably, allergic origin.
The literature shows the two cases, the syndrome of Mallory - Weiss, notes as a result of vomiting after using p-ing, containing macrogol.

Cautions

Endofalk used in elderly patients and in patients with reflux esophagitis or arrhythmia suspected or confirmed sinoatrial block or sinus node syndrome weakness only under medical supervision.
The drug can be used in patients with chronic inflammatory bowel (exclusion: severe stage of disease and toxic megacolon), but with caution and, if possible, under medical supervision.
Endofalk can 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 these groups of patients studied is not enough.
You can not add any other p-ditch or additives (in particular sugar or flavorings, incompatible with the p-rum Endofalka) to ready for the oral administration of p-py Endofalka, as it can change the osmolality and electrolyte composition or cause increased flatulence.
Pregnancy and breast-feeding. Experience of use during pregnancy is not.
Information concerning the admission of macrogol 3350 breast milk is not. Macrogol 3350 weakly absorbed. Endofalk can be used while breastfeeding, if use of the application exceeds the potential risk.
Effects on ability to drive and use machines. Endofalk does not affect the ability to drive or operate machinery.

INTERACTION

Drugs, applied orally for several hours before or during reception Endofalka, It can be derived from the gastrointestinal tract or their absorption can be reduced or completely discontinued. It belongs, in particular, a modified release formulations. If for health reasons this medication is absolutely necessary, need to replace the use of an oral dosage form of another drug or to find an alternative form of.
They can observe the interaction of macrogol with certain enzymatic tests (eg ELISA) diagnostic tests intestinal fluid, which was devastated.
Ready rr can not be mixed with other p-set or additives.

Overdose

In case of overdose can be severe diarrhea. In the case of a large overdose may develop disorders of water, electrolyte and acid-base balance. It is necessary to conduct adequate fluid replacement and monitoring of serum electrolytes and pH.
Aspiration may develop toxic pulmonary edema, that requires immediate intensive care, including pressurized ventilation.

STORAGE CONDITIONS

At room temperature (to 25 ° C). Ready rr usable for 3 no, if it is stored at room temperature (to 25 ° C) or for 48 no, if it is stored at 2-8 ° C (in a refrigerator).