Smektit Canon (Powder) Instructions for Use

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

ATC Code

A07BC05 (Diosmectite)

Active Substance

Diosmectite (Ph.Eur. European Pharmacopoeia)

Dosage Form

Smektit Canon

Powder for oral suspension preparation 3 g

Dosage Form, Packaging, and Composition

Powder for oral suspension preparation

3.76 g – sachets (10 pcs.) – cardboard packs – Over-the-Counter
3.76 g – sachets (12 pcs.) – cardboard packs – Over-the-Counter
3.76 g – sachets (20 pcs.) – cardboard packs – Over-the-Counter
3.76 g – sachets (30 pcs.) – cardboard packs – Over-the-Counter

Clinical-Pharmacological Group

Antidiarrheal drug with adsorbent action

Pharmacotherapeutic Group

Antidiarrheals, intestinal anti-inflammatory/antimicrobial agents; intestinal adsorbents; other intestinal adsorbents

Pharmacological Action

An adsorbent and antidiarrheal agent of natural origin. It has a protective effect on the intestinal mucosa, has a pronounced adsorbing 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 violations and qualitative composition of food), diarrhea of infectious origin – as part of complex therapy.

Treatment of symptoms associated with diseases of the stomach and intestines: heartburn, feeling of heaviness, bloating, abdominal discomfort and other symptoms of dyspepsia.

ICD codes

Dosage Regimen

Administer orally as a suspension.

Prepare the suspension immediately before use by dissolving the entire contents of one sachet in 50 mL (approximately 1/4 cup) of water. For infants and young children, mix the powder with a semi-liquid food such as porridge, puree, or compote.

For acute diarrhea in adults, the typical dose is 3 sachets per day. In severe cases, the initial dosage may be doubled to 6 sachets per day.

For children under one year of age, administer 1 sachet per day. For children aged 1 to 2 years, administer 1-2 sachets per day. For children over 2 years of age, administer 2-3 sachets per day.

For other indications such as heartburn or dyspepsia, the standard adult dose is 3 sachets per day. The dosage for children with these conditions is 2-3 sachets per day.

Divide the total daily dose into two or three separate administrations. Maintain an interval of 1-2 hours between the administration of this drug and any other oral medications or food to prevent adsorption and reduced efficacy.

In cases of acute diarrhea, initiate oral rehydration therapy concurrently to prevent dehydration. The duration of treatment is typically three to seven days.

Adverse Reactions

From the digestive system:often – constipation; infrequently – flatulence, vomiting.

Allergic reactionsfrequency 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

In children, use 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 medicines 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 simultaneously, 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.