ENTEROSGEL EXTRACAPS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENTEROSGELUM EXTRACAPS

Composition:

Active substance: polymethylsiloxane xerogel;

1 capsule contains 0.32 g of polymethylsiloxane xerogel;

Excipients: gelatin, titanium dioxide (E 171).

Pharmaceutical form. Capsules for oral administration.

Main physicochemical properties: hard gelatin capsules, white-colored body and cap. The capsule contents are a white or almost white odorless powder.

Pharmacotherapeutic group.

Enter sorbents. ATC code A07BC

Pharmacological properties.

Pharmacodynamics.

When administered orally, exerts a detoxifying effect. The drug effectively adsorbs medium-sized toxic substances and products of incomplete metabolism from the intestinal contents and blood (through capillary membranes of intestinal mucosal villi), and promotes the elimination of incorporated radionuclides. Enterosgel ExtraCaps eliminates manifestations of intoxication, improves intestinal, liver, and kidney function, normalizes blood and urine parameters. As an effective detoxifying agent, Enterosgel ExtraCaps contributes to enhanced immunity.

Pharmacokinetics.

The drug coats the mucous membrane of the stomach and intestine, protecting it from erosive processes. It is not absorbed from the gastrointestinal tract.

Clinical characteristics.

Indications.

As part of complex detoxification therapy in chronic renal failure caused by pyelonephritis, polycystic kidney disease, nephrolithiasis; in toxic hepatitis, viral hepatitis A and B, hepatoholycystitis, liver cirrhosis and cholestasis of various etiologies, gastritis with reduced acidity, enterocolitis, colitis, diarrhea; in alcohol and drug intoxication; allergic reactions, skin diseases (diatheses, neurodermatitis); in burn intoxication; purulent-septic processes accompanied by intoxication; toxemias of pregnancy in the first half of gestation; in the complex treatment of intestinal dysbiosis.

Contraindications.

Acute intestinal obstruction.

Individual intolerance to the components of the drug.

Interaction with other medicinal products and other types of interactions.

Provided the recommended administration method is followed (Enterosgel Extrakaps and medicinal products are taken separately), the drug can be used in complex therapy with other medicinal and prophylactic agents, including bacterial preparations (bifidobacteria, lactobacilli), phytopreparations, adaptogens, immunomodulators. Simultaneous intake with drugs belonging to the class of bile acid sequestrants, for example cholestyramine, is not recommended due to increased risk of constipation.

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

Special precautions for use.

The drug should be taken according to the recommendations provided in this instruction.

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 speed when driving or operating machinery.

No effect.

Dosage and Administration.

Take orally, 1-2 capsules 2-3 times daily, 1.5–2 hours before or 2 hours after meals or taking other medications, with plenty of water.

For adults and children aged 14 years and older, the single dose is 1–2 capsules, and the daily dose is up to 6 capsules.

For children aged 6 to 14 years, the single dose is 1 capsule, and the daily dose is 3 capsules.

Treatment duration: 7 to 14 days.

In severe cases, a double single dose may be used during the first 3 days. In chronic conditions (chronic renal insufficiency, liver cirrhosis), prolonged use of the drug is possible.

Children.

The drug can be administered to children aged 6 years and older. To facilitate swallowing, the capsule (single dose) may be opened before administration and mixed with a small amount of liquid.

Overdose.

Exceeding the maximum single doses does not cause adverse reactions.

Side effects.

Short-term constipation may occur with initial use of the product. To prevent this, individuals prone to constipation are advised to use a cleansing enema at night or take laxatives (lactulose, sodium picosulfate) during the first two days of treatment.

Individual intolerance to components of the product may also occur.

Shelf life. 3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

7 capsules per blister. 1, 2 or 4 blisters are packed into a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

JSC "EOF "KREOMA-PHARM".

Manufacturer's location and address of operations.

03680, Ukraine, Kyiv, Radysheva St., 3.

Marketing Authorization Holder.

JSC "EOF "KREOMA-PHARM".

Address of the Marketing Authorization Holder.

03680, Ukraine, Kyiv, Radysheva St., 3.