ENTEROSGEL

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENTEROSGEL (ENTEROSGELUM)

Composition:

Active substance: 100 g of paste contains 70 g of methylsilicic acid hydrogel;

Excipients: purified water.

Pharmaceutical form. Oral paste.

Main physicochemical properties: homogeneous white, odorless, paste-like mass.

Pharmacotherapeutic group.

Enterosorbents. ATC code A07BC.

Pharmacological properties.

Pharmacodynamics.

Enterosgel is an inert silicon-organic compound. When administered, it exhibits sorption activity. The drug effectively adsorbs medium-molecular toxic substances of exo- and endogenous origin, products of incomplete metabolism, incorporated radionuclides, and naturally eliminates them from the body.

Enterosgel alleviates manifestations of intoxication, improves intestinal, liver, and kidney function, and normalizes blood and urine parameters.

Pharmacokinetics.

By coating the mucous membrane of the stomach and intestine, Enterosgel protects it from erosive processes and promotes enhancement of local immunity.

Enterosgel is not absorbed from the gastrointestinal tract and does not undergo metabolic or chemical transformations.

Clinical characteristics.

Indications.

As part of complex detoxification therapy in chronic renal failure; in toxic hepatitis, viral hepatitis A and B, liver cirrhosis, and cholestasis of various etiologies; in enterocolitis, colitis, diarrhea, gastritis with reduced acidity, alcohol and drug intoxication; in allergic and skin diseases (diathesis, neurodermatitis); in burn intoxication; in purulent-septic and inflammatory processes accompanied by intoxication; in first-trimester pregnancy toxemia; in complex treatment of intestinal dysbiosis.

Contraindications.

Acute intestinal obstruction.

Interaction with other medicinal products and other forms of interactions.

The drug may reduce the effect of other medicinal products taken concurrently. Concomitant use with medicinal products belonging to the class of bile acid sequestrants, such as cholestyramine, is not recommended due to increased risk of constipation.

The drug should not be used together with silver-containing preparations.

Special precautions.

When following the recommended administration method (Enterosgel and medicinal products are taken with an interval of 1.5–2 hours), the drug can be used in complex therapy with other medicinal and prophylactic agents, including prebiotics and probiotics (bifidobacteria, lactobacilli), phytopharmaceuticals, adaptogens, and immunomodulators.

Use during pregnancy or breastfeeding.

The drug can be used during pregnancy or breastfeeding. However, its use should be limited in pregnant women who are prone to constipation.

Ability to affect reaction rate while driving or operating machinery.

Does not affect.

Dosage and Administration.

Take orally 3 times daily, 1.5–2 hours before or 2 hours after meals or taking medications, with sufficient amount of water.

For adults and children aged 14 years and older: single dose is 15 g (tablespoon), daily dose is 45 g.

For children from birth to 5 years: single dose is 5 g (teaspoon), daily dose is 15 g; for children from 5 to 14 years: single dose is 10 g (dessert spoon), daily dose is 30 g.

Treatment duration: 7 to 14 days.

In severe cases, double the single dose may be used during the first three days. In chronic conditions (e.g., chronic renal failure), the treatment duration may be extended up to 1 month.

Children.

The drug can be administered to children from birth. For children under 2 years of age, the single dose may be mixed with a small amount of water before administration.

Overdose.

Cases of overdose have not been reported. In case of overdose, adverse effects may be intensified.

Adverse reactions.

Dyspeptic symptoms may occur during administration of the drug. In the first days of treatment, constipation may develop. To prevent constipation, patients prone to this condition are recommended to use a cleansing enema at night or laxatives (lactulose, sodium picosulfate) during the first two days of treatment.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C; do not freeze. The product loses its properties after freezing. After opening the package, store under the same conditions in tightly closed container.

Keep out of reach of children.

Packaging.

135 g, 270 g, or 405 g in a container; 1 container per cardboard box; 15 g in a sachet; 15 or 30 sachets per cardboard box; 90 g or 225 g in a tube; 1 tube per cardboard box.

Dispensing category. Over-the-counter.

Manufacturer.

JSC "EOP "KREOMA-PHARM".

Manufacturer's name and address.

3 Radysheva Street, Kyiv, Ukraine.