Smektiktin (Powder) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A07BC05 (Diosmectite)

Active Substance

Diosmectite (Ph.Eur.)

Dosage Forms

	Smektiktin	Powder for oral suspension with orange flavor 3 g: sachet 1, 3, 5, 10, 15, 20, 25, 30, 35, 40, 45 or 50 pcs.
		Powder for oral suspension (with vanilla flavor) 3 g: sachet 1, 3, 5, 10, 15, 20, 25, 30, 35, 40, 45 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for oral suspension with orange flavor from yellowish- or grayish-white to brownish-white in color, with an odor ranging from weak nonspecific to weak orange.

Excipients: orange flavor* – 0.05 g, dextrose monohydrate – 0.703 g, sodium saccharin – 0.007 g.

* Composition of orange flavor flavoring substances – 18.49%, maltodextrin – 57%, gum arabic – 24.5%, butylated hydroxyanisole – 0.01%.

3.76 g – sachets made of combined material (1) – cardboard packs.
3.76 g – sachets made of combined material (3) – cardboard packs.
3.76 g – sachets made of combined material (5) – cardboard packs.
3.76 g – sachets made of combined material (10) – cardboard packs.
3.76 g – sachets made of combined material (15) – cardboard packs.
3.76 g – sachets made of combined material (20) – cardboard packs.
3.76 g – sachets made of combined material (25) – cardboard packs.
3.76 g – sachets made of combined material (30) – cardboard packs.
3.76 g – sachets made of combined material (35) – cardboard packs.
3.76 g – sachets made of combined material (40) – cardboard packs.
3.76 g – sachets made of combined material (45) – cardboard packs.
3.76 g – sachets made of combined material (50) – cardboard packs.

Powder for oral suspension with vanilla flavor from yellowish- or grayish-white to brownish-white in color, with an odor ranging from weak nonspecific to weak vanilla.

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

3.76 g – sachets made of combined material (1) – cardboard packs.
3.76 g – sachets made of combined material (3) – cardboard packs.
3.76 g – sachets made of combined material (5) – cardboard packs.
3.76 g – sachets made of combined material (10) – cardboard packs.
3.76 g – sachets made of combined material (15) – cardboard packs.
3.76 g – sachets made of combined material (20) – cardboard packs.
3.76 g – sachets made of combined material (25) – cardboard packs.
3.76 g – sachets made of combined material (30) – cardboard packs.
3.76 g – sachets made of combined material (35) – cardboard packs.
3.76 g – sachets made of combined material (40) – cardboard packs.
3.76 g – sachets made of combined material (45) – cardboard packs.
3.76 g – sachets made of combined material (50) – cardboard packs.

Clinical-Pharmacological Group

Antidiarrheal drug with adsorbent action

Pharmacotherapeutic Group

Intestinal adsorbents; other intestinal adsorbents

Pharmacological Action

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

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 combination 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. The contents of one sachet constitute a single dose.

For preparation, gradually pour the powder into 100 mL of warm, clean water in a glass. Stir thoroughly until a uniform suspension is formed.

For adults, the standard dosage is three sachets per day. In acute diarrhea, initiate therapy with a loading dose of six sachets on the first day.

For children over 12 years of age, administer three sachets per day.

For children aged 6 to 12 years, administer two sachets per day.

For children aged 2 to 6 years, administer one to two sachets per day.

For children aged 1 to 2 years, administer one sachet per day.

For infants under 1 year of age, administer one sachet per day.

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

For infants and young children, mix the powder from a single opened sachet with 50 mL of water or incorporate it into a semi-liquid food product such as porridge, puree, or infant formula.

In all cases of acute diarrhea, combine therapy with oral rehydration to prevent dehydration.

The typical course of treatment for acute diarrhea is three days. For other indications, the duration of use is determined by the physician.

Maintain an interval of 1-2 hours between the administration of diosmectite and any other oral medications.

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

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 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. The complex 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 medicinal products.

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.