ENTEROMECTITE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENTEROSMEKTIT (ENTEROSMEKTIT)

Composition:

Active ingredient: diosmectite;

1 sachet (3.76 g of powder) contains diosmectite (dihexagonal smectite) 3 g;

Excipients: glucose monohydrate, sodium saccharin, orange flavor (orange oil, tangerine oil, aldehyde C10, α-terpineol, maltodextrin, starch sodium octenyl succinate, glucose, ascorbyl palmitate, butylated hydroxyanisole).

Pharmaceutical form. Powder for oral suspension.

Main physicochemical characteristics: powder ranging from greyish-white to beige, in which white specks may be present, with an orange odor when preparing the suspension.

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

Pharmacological Properties

Pharmacodynamics

Smecta is a double silicate of aluminum and magnesium.

Due to its stereometric structure and high plastic viscosity, the drug has a pronounced coating ability on the gastrointestinal mucosa.

By interacting with mucosal glycoproteins, it increases mucus resistance to irritants. By influencing the barrier function of the gastrointestinal mucosa and due to its high capacity for binding to the mucosa, it protects the gastrointestinal mucosa. Smecta is radiolucent, does not color the stool, and does not affect the physiological intestinal transit time when used at recommended doses.

Pharmacokinetics

Due to the structure of diosmectite, the drug remains localized on the inner side of the epithelium, is neither absorbed nor metabolized. Diosmectite is excreted in the feces through normal intestinal transit.

Clinical Characteristics

Indications

• Symptomatic treatment of acute diarrhoea in children from 2 years of age (in addition to oral rehydration) and in adults.
• Symptomatic treatment of chronic diarrhoea in adults.
• Symptomatic treatment of pain associated with functional intestinal disorders in adults.

Contraindications

• Hypersensitivity to diosmectite or to any of the excipients of the medicinal product.
• Intestinal obstruction.

Interaction with other medicinal products and other forms of interaction

Due to the adsorbing 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 Enterofarm (an interval of at least 2 hours should be ensured if possible).

Special precautions for use

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

The use of Enterofectin 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. Prolonged use of Enterofectin should be avoided.

In adults, treatment does not exclude rehydration when necessary.

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

Patients should be informed about the necessity of:

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

The medicinal product contains glucose. If the patient has been diagnosed with carbohydrate intolerance, medical advice should be sought before taking this medicinal product.

This medicinal product contains 0.05 mmol (or 1.23 mg)/dose of sodium. Caution is advised when administering to patients on a sodium-controlled diet.

Use during pregnancy or breastfeeding

Pregnancy

Data on the use of diosmectite in pregnant women are absent or limited (fewer than 300 pregnancy cases).

Animal studies are insufficient to draw conclusions regarding reproductive toxicity.

The use of Enterofectin is not recommended during pregnancy.

Breastfeeding

Data on the use of diosmectite during breastfeeding are limited.

The use of Enterofectin 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

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.

Dosage and Administration

Dosages

Treatment of acute diarrhea

Children aged 2 years and older: 4 sachets per day for 3 days, followed by 2 sachets per day for the next 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 method

For oral use.

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

For children, the contents of the sachet can 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 can be mixed with half a glass of water.

Children

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

Overdose

Overdose may lead to severe constipation or formation of bezoars.

Adverse Reactions

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

Adverse reactions are classified according to the following frequency categories: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated based on available data).

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

Reporting of suspected adverse reactions

Reporting adverse reactions after the medicinal product has been registered is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 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 sachets; 10 or 30 sachets in a cardboard box.

Supply classification. Over-the-counter.

Manufacturer/Marketing Authorization Holder. LLC "Ternofarm".

Address of manufacturer and location of its business activities / address of marketing authorization holder

4 Fabrychna Street, Ternopil, 46010, Ukraine.