Sorbex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SORBEX®

Composition:

Active ingredient: activated charcoal;

1 capsule contains 0.25 g of activated charcoal;

Excipients: gelatin, iron oxide black (E 172), diamond black (E 151).

Pharmaceutical form. Capsules.

Main physicochemical properties: capsule body black in color, black cap with yellow/gold marking «SORBEX» printed on it or without such marking. Capsule contents – free-flowing black powder.

Pharmacotherapeutic group.
Enterosorbents. ATC code A07B A01.

Pharmacological Properties.

Pharmacodynamics. The enterosorbent SORBEX® exerts a detoxifying effect.

The active ingredient of the medicinal product SORBEX® is activated charcoal of plant origin with a highly developed active surface, capable of adsorbing gases and liquid toxic compounds formed and accumulated in excess during acute and chronic diseases or entering the body from outside.

Pharmacokinetics. Activated charcoal is a non-toxic inert substance. While in the body, it undergoes no chemical changes or metabolic transformations, is not absorbed from the intestinal lumen, does not enter beyond the gastrointestinal tract, is not detected in any concentrations in biological fluids, and is eliminated from the body through the intestine.

Clinical characteristics.

Indications.

SORBEKS® is used:

• in chronic poisoning with household and industrial toxins (alkaloids, heavy metal salts, and other substances), food products, pharmaceuticals, and in cases of alcohol and food overload, to reduce absorption, prevent further absorption, and accelerate the elimination of toxic substances from the body;
• in living conditions with adverse environmental factors or exposure to harmful occupational factors, as well as during changes in usual diet during vacations, business trips, or travel;

as an adjunctive therapy:

• in gastrointestinal disorders and infectious diseases of the gastrointestinal tract (dyspepsia, meteorism, intestinal infections, acute and chronic viral hepatitis);
• in diseases associated with endogenous intoxication syndrome: acute and chronic liver and kidney damage, allergic, autoimmune and oncological diseases, as well as in cases of elevated cholesterol levels.

Contraindications.

Individual hypersensitivity to the sorbent. Ulcerative and erosive lesions of the gastrointestinal tract in the acute phase, gastrointestinal bleeding, intestinal obstruction.

Interaction with other medicinal products and other forms of interaction.

Due to its adsorbing properties, activated charcoal may reduce the effectiveness of medicinal products taken simultaneously. Therefore, when concomitant pharmacotherapy is required, SORBEKS® should be taken 1–1.5 hours before or after other medicinal products.

Provided the recommended method of administration is followed, the drug may be used in combination with other medicinal products as part of complex therapy.

Special precautions.

Women taking oral contraceptives should use additional contraceptive methods during treatment with SORBEKS®.

Concomitant intake of the drug with food reduces its adsorption capacity; therefore, SORBEKS® should be taken 1–1.5 hours before or after meals.

Prolonged use (more than 15 days) may interfere with nutrient absorption and lead to deficiencies of vitamins, hormones, fats, and proteins in the body, requiring appropriate medical or dietary correction.

Stool may turn black after taking the medicinal product SORBEKS®.

In cases of hypovitaminosis, which may occur during prolonged use of activated charcoal, polyvitamins should be prescribed.

The capsules of the medicinal product SORBEKS® contain the dye diamond black (E 151), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

There are no data on the negative effects of the medicinal product SORBEKS® during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

SORBEKS® is not contraindicated when driving or operating machinery.

Dosage and Administration.

For adults with meteorism and dyspepsia: take 1–3 capsules 3–4 times daily.

For adults with poisonings and intoxications: take 2–6 capsules 3 times daily.

For children aged 7 years and older: take 1–3 capsules 3–4 times daily.

The drug should be taken 1.5–2 hours before or after meals or taking other medications, with water.

The treatment course for acute conditions is up to 3–5 days; for chronic diseases caused by endogenous intoxications – up to 10–15 days.

Children.

It is not recommended to administer this drug in this dosage form to children under 7 years of age.

Overdose.

Significantly exceeding the maximum single doses may cause adverse effects: nausea, vomiting, constipation.

Side effects.

Possible nausea, vomiting, and manifestations of increased sensitivity. Prolonged use may be accompanied by gastrointestinal disorders (diarrhea, constipation), which are easily resolved by discontinuing the drug and initiating symptomatic therapy. Prolonged administration (more than 15 days) may be associated with impaired absorption and may cause deficiency of vitamins, hormones, fats, and proteins in the body, requiring appropriate medicinal or dietary correction.

If any side effects not listed in this instruction occur, immediately inform your doctor!

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Store separately from substances and materials that emit gases and vapors.

Keep out of reach of children.

Packaging. Capsules of 0.25 g;

10 capsules per blister, 1 or 2 blisters per carton;

2 capsules per blister, 100 blisters per carton.

Dispensing category. Over-the-counter.

Manufacturer.

LLC "VALARTIN PHARMA".

Manufacturer's address and place of business.

60, Hrushevskoho St., village Chayky, Kyiv-Sviatoshyn District, Kyiv Region, 08135, Ukraine.

Marketing Authorization Holder.

LLC "VALARTIN PHARMA".

Address of the Marketing Authorization Holder.

60, Hrushevskoho St., village Chayky, Kyiv-Sviatoshyn District, Kyiv Region, 08135, Ukraine.