Sorbentogel

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SORBENTOGEL (SORBENTOGEL)

Composition:

Active substance: methylsilicic acid hydrogel;

1 g of the preparation contains 0.7 g of methylsilicic acid hydrogel;

Excipient: purified water.

Pharmaceutical form. Oral gel.

Main physicochemical properties: homogeneous gel-like mass, white to almost white, odorless.

Pharmacotherapeutic group. Agents affecting the gastrointestinal tract and metabolism. Antidiarrheal agents, agents used for the treatment of infectious and inflammatory intestinal diseases. Enterosorbents. Other enterosorbents.

ATC code A07BC.

Pharmacological Properties.

Pharmacodynamics.

An inert organosilicon compound. When administered, it exerts an adsorption effect. The drug effectively adsorbs toxic substances of exogenous and endogenous origin, products of incomplete metabolism, medium-sized molecules, incorporated radionuclides, and naturally eliminates them from the body.

The medicinal product alleviates symptoms of intoxication, improves detoxification functions of the intestine, liver, and kidneys, normalizes blood and urine parameters.

By coating the mucous membranes of the stomach and intestines, the drug protects them against erosive processes and promotes enhancement of local immunity.

Pharmacokinetics.

The drug is not absorbed from the gastrointestinal tract and undergoes neither metabolic nor 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, and in alcohol and narcotic poisoning; in allergic and skin diseases (diathesis, neurodermatitis); in burn intoxication; in purulent-septic and inflammatory conditions accompanied by intoxication; in toxemias of pregnancy during the first half of gestation, and as part of complex therapy for 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. Provided the recommended administration method is followed (other medicinal products are taken with an interval of 1.5–2 hours), the drug may be prescribed in combination therapy with other medicinal and prophylactic agents, including prebiotics and probiotics (bifidobacteria, lactobacteria), phytomedicines, adaptogens, and immunomodulators. Concurrent use with medicinal products belonging to the class of bile acid sequestrants, for example cholestyramine, is not recommended due to increased risk of constipation development.

The drug should not be used concurrently with silver-containing medicinal products.

Instructions for use.

Use during pregnancy or breastfeeding.

The medicinal product can be used during pregnancy or breastfeeding. Its use should be restricted in pregnant women who are prone to constipation.

Ability to affect reaction speed when driving or operating machinery.

Has no effect.

Dosage and Administration.

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

Adults and children aged 14 years and older: single dose is 15 g (one tablespoon or one 15-g sachet), daily dose is 45 g.

Children aged 5 to 14 years: single dose is 10 g (one dessert spoon), daily dose is 30 g.

Children from birth to 5 years: single dose is 5 g (one teaspoon), daily dose is 15 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 insufficiency), the treatment duration may be extended up to 1 month.

Children. The drug can be used in children from birth. For children under 2 years of age, the single dose may be mixed with a small amount of water before administration. For children under 14 years of age, Sorbentogel Baby oral gel may be used.

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. Constipation may develop during the first days of treatment. To prevent constipation, patients prone to it are recommended to use a cleansing enema at night or take laxatives (lactulose, sodium picosulfate) during the first two days of drug administration.

Shelf life.

2 years from the date of manufacture in bulk packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Do not allow freezing. After freezing, the product loses its properties.

After opening the package, store under the same conditions in tightly closed containers.

Keep out of reach of children.

Packaging. 200 g in a tube in a box; 15 g in sachets № 20 in a box.

Availability category. Over-the-counter.

Manufacturer. Limited Liability Company "Pharmaceutical Company "Vertex".

Manufacturer's address and location of business activity.

33, Astronomichna Street, lit. "V-1", Kharkiv, Kharkiv region, 61085, Ukraine.