Diosmektit-zdorovya

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

Composition:

Active ingredient: diosmectite;

1 sachet contains diosmectite (in the form of dioctahedral smectite) 3 g;

Excipients: glucose, sodium saccharin, vanillin.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: contents of the sachet – powder from greyish-white to greyish-yellow in color, with a slight vanilla odor when preparing the suspension.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Antidiarrheal agents: agents used for the treatment of infectious and inflammatory intestinal diseases. Other enterosorbents. Diosmectite.

ATC code A07BC05.

Pharmacological properties.

Pharmacodynamics.

Diosmectite-Zdorovia is a double silicate of aluminium and magnesium.

Due to its stereometric structure and high plastic viscosity, the drug has a high coating capacity towards the mucous membrane of the gastrointestinal tract.

By interacting with glycoproteins of the mucous membrane, it increases mucus resistance to irritants. By affecting the barrier function of the gastrointestinal mucosa and due to its high capacity for binding to the mucous membrane, it protects the mucous membrane of the gastrointestinal tract. Diosmectite-Zdorovia is radiolucent, does not color the stool, and at usual doses does not affect the physiological intestinal transit time.

Combined results of two double-blind randomized studies on the efficacy of diosmectite versus placebo involving 602 patients aged 1 to 36 months suffering from acute diarrhea showed a significant reduction in defecation frequency during the first 72 hours in the diosmectite treatment group combined with oral rehydration.

Pharmacokinetics.

Due to its structure, diosmectite is neither absorbed nor metabolized.

Clinical characteristics.

Indications.

• Treatment of acute diarrhea in children aged 2 years and older (in addition to oral rehydration) and in adults.
• Symptomatic treatment of chronic functional diarrhea in adults.
• 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 this medicinal product, it may affect the extent and/or rate of absorption of other substances; therefore, it is recommended not to administer other medicinal products simultaneously with Diosmectite-Zdorovya.

Special precautions for use.

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

The medicinal product should not be used 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 the medicinal product should be avoided.

For adults, treatment does not exclude rehydration when necessary.

The volume of rehydration using oral or intravenous rehydration solutions depends on the severity of diarrhea, patient's age, and individual disease course characteristics.

Patients should be advised about the necessity of:

• rehydration using a significant volume of salty or sweet liquids to compensate fluid loss caused by diarrhea (average daily fluid requirement in adults is 2 liters);
• maintaining food intake during diarrhea:
  • excluding certain foods, particularly raw vegetables and fruits, leafy vegetables, spicy dishes, as well as frozen foods or beverages;
  • preferring baked meat and rice.

The medicinal product contains glucose. If the patient has known sugar intolerance, medical advice should be sought before taking this medicinal product.

If symptoms do not resolve within 7 days, consult a physician.

If pain is associated with high fever or vomiting, seek medical advice immediately.

Use during pregnancy or breastfeeding.

Pregnancy.

Data on use of the medicinal product in pregnant women are lacking or limited (less than 300 pregnancy cases reported).

Animal studies are insufficient to draw conclusions on reproductive toxicity.

The medicinal product is not recommended during pregnancy.

Breastfeeding.

Data on use of the medicinal product during breastfeeding are limited.

The medicinal product is not recommended during breastfeeding.

Fertility.

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

Ability to affect reaction speed while driving or operating machinery.

Studies on the ability to drive vehicles or operate machinery under the influence of this medicinal product have not been conducted. However, its effect is expected to be negligible or absent.

Method of Administration and Dosage

Treatment of acute diarrhea

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

Adults: on average 3 sachets per day for 7 days. The dose of the medicinal product may be doubled at the beginning of treatment.

Other indications

Adults: on average 3 sachets per day.

Method of administration

For oral use.

The contents of the sachet should be mixed to form a suspension immediately before administration.

It is recommended to take:

• after meals in case of esophagitis;
• between meals for other indications.

Children from 2 years of age

The contents of the sachet may be mixed in a bottle with 50 ml of water for administration throughout the day or thoroughly mixed with semi-liquid food such as broth, compote, puree, or infant food.

Adults

The contents of the sachet may be mixed with half a glass of water.

Children

To be used for treatment of children from 2 years of age.

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. Listed below are adverse reactions reported during clinical trials and the post-marketing period.

Adverse reactions are classified according to the following frequency categories: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000), not known (cannot be estimated from available data).

Gastrointestinal disorders

Common: constipation, which usually resolves after dose reduction but may require discontinuation of treatment in some cases.

Uncommon: flatulence, vomiting.

Skin and subcutaneous tissue disorders

Uncommon: rash.

Rare: urticaria.

Not known: angioedema, pruritus.

Immune system disorders

Not known: hypersensitivity reactions.

Reporting of adverse reactions

Reporting suspected adverse reactions after drug registration is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, or their legal representatives are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: 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 the drug per sachet; 10 or 30 sachets per box.

Supply classification

Over-the-counter (without prescription).

Manufacturer

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Manufacturer's address and place of business

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, Ukraine, 61013.