Diosmectite

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

Composition:

Active substance: diosmectite;

One sachet contains smectite (in the form of dioctahedral smectite), calculated as dry substance — 3 g;

Excipients: glucose monohydrate, sodium saccharin, vanillin.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: powder from greyish-white to ochre colour with a slight vanilla odour.

Pharmacotherapeutic group.

Antidiarrheal agents used in infectious and inflammatory intestinal diseases. Enterosorbents. ATC code A07BC05.

Pharmacological properties.

Pharmacodynamics.

In clinical pharmacology studies, diosmectite has demonstrated the ability to:

• adsorb intestinal gas in adults;
• restore normal mucosal permeability (in a clinical study conducted in children with gastroenteritis).

Due to its lamellar structure and high plastic viscosity, diosmectite has a high coating capacity on the mucosa of the gastrointestinal tract.

Combined results from comparative efficacy studies of diosmectite versus placebo in patients suffering from acute diarrhea showed a significant reduction in defecation frequency during the first 72 hours in the group treated with diosmectite in combination with oral rehydration therapy.

Pharmacokinetics.

Due to the structure of the active substance, diosmectite, the powder for oral suspension remains on the luminal side of the epithelium, is neither absorbed nor metabolized. Diosmectite is excreted in feces through normal intestinal transit.

Clinical characteristics.

Indications.

For the treatment of acute diarrhea in children from 2 years of age (in addition to oral rehydration) and in adults.

For symptomatic treatment of chronic functional diarrhea in adults.

For symptomatic treatment of pain associated with functional intestinal disorders in adults.

Contraindications.

Hypersensitivity to diosmectite or to any of the excipients listed in the section "Composition".

Interaction with other medicinal products and other forms of interaction.

Due to the adsorptive properties of the medicinal product Diosmectite, powder for oral suspension, the extent and/or rate of absorption of other substances may be affected. Therefore, it is recommended not to administer other medicinal products simultaneously (an interval of more than 2 hours should be ensured whenever possible).

Special precautions for use.

Diosmectite should be used with caution in patients with a history of severe chronic constipation.

The use of Diosmectite powder for oral suspension should be avoided in infants and children under 2 years of age. Oral rehydration solution (ORS) is the standard treatment for acute diarrhea.

In children aged 2 years and older, acute diarrhea should be treated in combination with early use of oral rehydration solution (ORS) to prevent dehydration. Chronic use of Diosmectite powder for oral suspension should be avoided.

In adults, treatment does not exclude rehydration when necessary.

The volume of rehydration, either with oral rehydration solution or intravenous fluids, depends on the severity of diarrhea, patient's age, and individual disease course.

Patients should be advised about the necessity of:

• rehydration using a sufficient amount of salty or sweet liquids to compensate for fluid loss due to diarrhea (the average daily fluid requirement for an adult is 2 liters);
• maintaining food intake during diarrhea:
  • excluding certain foods, particularly raw vegetables and fruits, leafy greens, spicy dishes, as well as frozen foods or beverages;
  • preferring baked meat and rice.

This medicinal product contains glucose. It is not recommended for patients with glucose or galactose malabsorption syndromes.

This medicinal product contains ethanol (alcohol) in small amounts: less than 100 mg per daily dose.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of Diosmectite powder for oral suspension in pregnant women are lacking or limited (fewer than 300 pregnancy cases reported).

Animal studies are insufficient to draw conclusions on reproductive toxicity.

Diosmectite powder for oral suspension is not recommended during pregnancy.

Breastfeeding

Data on the use of Diosmectite powder for oral suspension during breastfeeding are limited.

Diosmectite powder for oral suspension is not recommended during breastfeeding.

Fertility

The effect of this medicinal product on human fertility has not been studied.

Ability to affect reaction speed when driving or operating machinery.

No studies have been conducted on the ability to drive or operate machinery under the influence of this medicinal product. However, its effect is expected to be negligible or absent.

Dosage and Administration.

Dosage

Treatment of acute diarrhea

Children from 2 years of age: 4 sachets per day for 3 days, followed by 2 sachets per day for 4 days.

Adults: 3 sachets per day for 7 days. If necessary, the dose may be doubled at the beginning of treatment.

Other indications

Adults: on average 9 g (3 sachets) per day.

Administration

For oral use.

The contents of the sachet should be mixed with water or liquid food to form a suspension immediately before administration.

For children, the contents of the sachet may be mixed in a bottle with 50 ml of water for administration at intervals throughout the day, or thoroughly mixed with semi-liquid food such as broth, compote, puree, baby food, etc.

For adults, the contents of the sachet may be mixed with half a glass of water.

Children.

To be used for treatment of children aged 2 years and older.

Overdose.

Overdose may lead to severe constipation or formation of a bezoar.

Adverse reactions.

The most commonly reported adverse reaction during treatment is constipation, occurring in approximately 7% of adults and approximately 1% of children. If constipation occurs, treatment with diosmectite should be discontinued and, if necessary, resumed at a lower dose. The table below lists adverse reactions to the medicinal product reported during clinical trials and in the post-marketing period.

The frequency of adverse reactions is classified as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Adverse reactions to the medicinal product identified during clinical trials and in the post-marketing period

*Frequency determined from clinical trial data.

Reporting suspected adverse reactions

It is important to report suspected adverse reactions after marketing authorization of the medicinal product. This enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions in accordance with applicable legislation.

Reporting of adverse reactions following marketing authorization of the medicinal product is of significant importance.

It allows continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical personnel, 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.

Keep out of reach and sight of children.

Packaging.

3.76 g of powder in a sachet, 10 or 30 sachets per carton.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and location of operations.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, Ukraine, 61115.