Endosorb^® (Powder) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

Manufactured By

Aliym, JSC (Russia)

Or

Pharmproekt, JSC (Russia)

Packaging and Quality Control Release

ALIUM, JSC (Russia)

Or

PHARMPROEKT, JSC (Russia)

ATC Code

A07BC05 (Diosmectite)

Active Substance

Diosmectite (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Endosorb®	Powder for oral suspension (orange) 3 g/1 sachet: 3.76 g sachet 10 or 30 pcs.
		Powder for oral suspension (vanilla) 3 g/1 sachet: 3.76 g sachet 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Powder for oral suspension (orange) from almost white or white-gray or white-yellow to yellow-gray or yellow-brown in color, with an odor ranging from weak nonspecific to weak vanilla.

Excipients: dextrose monohydrate – 0.679 g, sodium saccharin dihydrate – 0.021 g, orange flavor – 0.01 g, vanilla flavor – 0.05 g.

3.76 g – sachets made of combined multilayer material (10) – cardboard packs.
3.76 g – sachets made of combined multilayer material (30) – cardboard packs.

Powder for oral suspension (vanilla) from almost white or white-gray or white-yellow to yellow-gray or yellow-brown in color, with an odor ranging from weak nonspecific to weak vanilla.

Excipients: dextrose monohydrate – 0.749 g, sodium saccharin dihydrate – 0.007 g, vanillin – 0.004 g.

3.76 g – sachets made of combined multilayer material (10) – cardboard packs.
3.76 g – sachets made of combined multilayer material (30) – cardboard packs.

Clinical-Pharmacological Group

Antidiarrheal drug with adsorbent action

Pharmacotherapeutic Group

Antidiarrheal agent

Pharmacological Action

An adsorbent and antidiarrheal agent of natural origin. It has a protective effect on the intestinal mucosa, has a pronounced adsorbent and a mild enveloping effect.

It is a stabilizer of the mucous barrier, penetrates into the mucus and increases its lifespan, forming a physical barrier that protects the mucous membrane of the digestive tract from the negative effects of H⁺ ions, intestinal microorganisms and their toxins.

Pharmacokinetics

Not absorbed, excreted unchanged.

Indications

Acute and chronic diarrhea (of allergic, drug-induced origin; due to dietary regimen violations and qualitative composition of food), diarrhea of infectious origin – as part of complex therapy.

Treatment of symptoms associated with gastric and intestinal diseases: heartburn, feeling of heaviness, bloating, abdominal discomfort and other dyspepsia symptoms.

ICD codes

Dosage Regimen

Administer orally. Determine the dose and frequency individually based on indication and patient age.

For acute diarrhea in adults, use 3 sachets daily. For other indications in adults, use 2-3 sachets daily.

For children under one year of age, administer 1 sachet daily.

For children aged 1 to 2 years, administer 1-2 sachets daily.

For children aged 2 years and older, administer 2-3 sachets daily.

Divide the total daily dose into two or three separate administrations.

Prepare the suspension immediately before use. Pour the powder from one sachet into a glass. Add approximately 100 ml (half a glass) of warm water. Stir thoroughly until a uniform suspension is formed.

For children under 12 years, the prepared suspension can be mixed with a semi-liquid food such as porridge, puree, or baby food.

In cases of acute diarrhea, initiate rehydration therapy simultaneously with the first dose to correct fluid and electrolyte losses.

Maintain a time interval of 1 to 2 hours between the administration of diosmectite and any other medicinal products.

Adverse Reactions

From the digestive system: common – constipation; uncommon – flatulence, vomiting.

Allergic reactions frequency unknown – urticaria, rash, itching and angioedema.

Contraindications

Hypersensitivity to diosmectite; intestinal obstruction.

With caution in patients with severe chronic constipation.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding according to indications, in recommended doses.

Pediatric Use

Used in children according to indications, in recommended doses, in appropriate dosage forms.

When used in children under 12 years of age, the drug in the appropriate dosage form can be dissolved in liquid or mixed with any semi-liquid product (porridge, puree, baby food).

Special Precautions

The interval between taking diosmectite and other medicinal products should be 1-2 hours.

In children with acute diarrhea, Diosmectite should be used in combination with rehydration measures. If necessary, adults may also be prescribed diosmectite therapy in combination with rehydration measures. A set of rehydration measures is prescribed depending on the course of the disease, age and characteristics of the patient.

Drug Interactions

When taken orally concomitantly, Diosmectite reduces the rate and/or extent of absorption of other drugs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.