SORBENTOMAX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SORBENTOMAX (SORBENTOMAX)

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 in color, odorless.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Antidiarrheal agents, drugs 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 a sorption effect. The drug effectively adsorbs medium-molecular toxic substances of exogenous and endogenous origin, products of incomplete metabolism, incorporated radionuclides, and naturally eliminates them from the body.

The drug eliminates manifestations of intoxication, improves detoxifying 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 an increase in local immunity.

Pharmacokinetics. The drug is not absorbed from the gastrointestinal tract and undergoes no 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, and in alcohol and narcotic intoxication; in allergic and skin diseases (diathesis, neurodermitis); in burn intoxication; in purulent-septic and inflammatory processes accompanied by intoxication; in toxemia of pregnancy during the first half of gestation, and as part of complex therapy for intestinal dysbiosis.

Contraindications. Acute intestinal obstruction.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types 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 as part of combination therapy with other medicinal and prophylactic agents, including prebiotics and probiotics (bifidum-, lactobacteria), phytomedicines, adaptogens, and immunomodulators. Concomitant use with drugs belonging to the class of bile acid sequestrants, such as cholestyramine, is not recommended due to an increased risk of constipation.

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

Instructions for use.

The medication should be taken according to the instructions.

Use during pregnancy or breastfeeding. The medication can be used during pregnancy or breastfeeding. Its use should be limited in pregnant women who are prone to constipation.

Ability to affect reaction rate while driving or operating machinery. Has no effect.

Dosage and Administration.

Take orally 3 times a day, 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 (tablespoon), daily dose is 45 g.

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

Children from birth to 5 years: single dose is 5 g (teaspoon), daily dose is 15 g.

Treatment duration is 7 to 14 days.

In severe cases, double the single dose may be used during the first three days. In chronic conditions (chronic renal insufficiency), the drug may be administered for a longer period (up to 1 month).

Children. The drug may 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 prior to 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. Constipation may develop during the first days of treatment. To prevent constipation, patients prone to this condition are recommended to use a cleansing enema at night or take laxatives (lactulose, sodium picosulfate) during the first two days of treatment. Hypersensitivity reactions are possible.

Reporting of Adverse Reactions

Reporting of adverse reactions following drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf Life: 2 years.

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

Freezing must be avoided. The product loses its properties after freezing.

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

Keep out of reach of children.

Packaging: 135 g in a container, in a box.

Availability: Over-the-counter (without prescription).

Manufacturer: Limited Liability Company "Pharmaceutical Company "Zdorovia".

Manufacturer's Address and Place of Business: 22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.