Enterol 250

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENTEROL 250 (ENTEROL® 250)

Composition:

Active substance: 1 capsule contains lyophilized cells of Saccharomyces boulardii CNCM I-745 250 mg;

Excipients: lactose monohydrate, magnesium stearate.

Pharmaceutical form. Capsules.

Main physicochemical properties: opaque white gelatin capsules containing a light brown powder with a specific odor.

Pharmacotherapeutic group. Antidiarrheal microbial agents. Saccharomyces boulardii.

ATC code A07FA02.

Pharmacological Properties

Pharmacodynamics

Enterol 250 normalizes intestinal microflora and has a pronounced etiopathogenic antidiarrheal effect. While passing through the gastrointestinal tract, Saccharomyces boulardii CNCM I-745 exert a biological protective effect on the normal intestinal microflora.

Main mechanisms of action of Saccharomyces boulardii CNCM I-745:

• Direct antagonism (antimicrobial activity) due to the ability of Saccharomyces boulardii CNCM I-745 to inhibit the growth of pathogenic and opportunistic microorganisms and fungi that disrupt intestinal biocenosis, such as: Clostridium difficile, Clostridium pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Candida krusei, Candida pseudotropical, Candida albicans, Salmonella typhi, Salmonella enteritidis, Escherichia coli, Shigella dysenteriae, Shigella flexneri, Klebsiella, Proteus, Vibrio cholerae, as well as Entamoeba histolytica, Lamblia; Enterovirus, Rotavirus;
• Antitoxic activity due to the production of proteases that degrade toxins and act on the enterocyte receptor to which the toxin binds (particularly with respect to toxin A of Clostridium difficile);
• Antisecretory activity due to reduction of cAMP in enterocytes, leading to decreased secretion of water and sodium into the intestinal lumen;
• Enhancement of nonspecific immune defense by increasing the production of IgA and secretory components of other immunoglobulins;
• Enzymatic activity due to increased disaccharidase activity in the small intestine (lactase, sucrase, maltase);
• Trophic effect on the mucosa of the small intestine due to the release of spermine and spermidine.

Genetically determined resistance of Saccharomyces boulardii CNCM I-745 to antibiotics justifies the possibility of their concomitant use with antibiotics to protect the normal biocenosis of the gastrointestinal tract.

Pharmacokinetics

After administration, a high concentration of Saccharomyces boulardii CNCM I-745 is rapidly achieved in the colon and maintained for 24 hours. Saccharomyces boulardii CNCM I-745 do not penetrate into the systemic circulation or mesenteric lymph nodes. After completion of treatment, Saccharomyces boulardii CNCM I-745 are completely eliminated in feces within 3–5 days.

Clinical characteristics.

Indications.

Prevention and treatment of colitis and diarrhea associated with antibiotic use.

Intestinal dysbiosis.

Acute and chronic bacterial diarrhea.

Acute viral diarrhea.

Irritable bowel syndrome.

Traveler's diarrhea.

Pseudomembranous colitis and diseases caused by Clostridium difficile.

Diarrhea associated with long-term enteral nutrition.

Contraindications.

Hypersensitivity to any component of the drug. The drug is contraindicated in patients with established central or peripheral venous catheters; critically ill patients; and patients with weakened immunity due to the risk of fungemia (see section "Special precautions"); patients treated in intensive care units; immunocompromised patients, such as: HIV-infected individuals, oncology patients, organ transplant recipients, and those receiving chemotherapy and/or radiation therapy and/or prolonged high-dose corticosteroids.

Special precautions.

If symptoms persist for more than 2 days during treatment at the usual dosage, medical consultation is required and dosage adjustment should be considered.

Enterol 250 contains a live culture. Therefore, the drug should not be mixed with very hot (above 50 °C) or cold beverages, liquids containing alcohol, or very hot or cold food.

Treatment does not replace rehydration when needed. The volume and route of fluid administration (oral/intravenous) should be based on the severity of diarrhea, age, and the patient's overall condition.

Very rare cases of fungemia (and positive blood cultures for Saccharomyces strains), as well as sepsis, have been reported, primarily in patients with central venous catheters, critically ill patients, or immunocompromised patients. Most reported cases presented with fever. In most cases, outcomes were favorable after discontinuation of Saccharomyces boulardii, administration of antifungal therapy, and, if necessary, catheter removal. In some critically ill patients, fungemia resulted in fatal outcomes. (See sections "Contraindications" and "Adverse reactions").

As with all medicinal products containing live microorganisms, careful attention must be paid to handling Saccharomyces boulardii CNCM I-745 in the presence of patients—especially those with central venous catheters, but also those with peripheral catheters—even for individuals not receiving Saccharomyces boulardii CNCM I-745 treatment—to prevent contamination via hands and/or airborne spread of microorganisms.

The drug contains lactose; therefore, it should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Interaction with other medicinal products and other forms of interaction.

Do not take simultaneously with antifungal agents when administered orally or systemically.

Usage features.

Use during pregnancy or breastfeeding.

Currently, no clinically significant malformative or fetotoxic effects have been identified.

Monitoring of pregnancy in women taking this drug is not sufficient to exclude any risk. Therefore, as a precautionary measure, it is advisable to avoid using the drug during pregnancy.

During breastfeeding, the drug can be used under medical supervision.

Ability to affect reaction speed when driving or operating machinery. Does not affect.

Dosage and Administration

For adults and children aged 6 years and older: 1–2 capsules 1–2 times daily. Maximum daily dose: 4 capsules.

Recommended treatment duration:

• Acute diarrhea: 3–5 days;
• Treatment of dysbiosis, chronic diarrhea syndrome, irritable bowel syndrome:
  10–14 days;
• Prevention and treatment of antibiotic-associated diarrhea and pseudomembranous colitis:
  Enterol 250 should be administered concomitantly with antibiotics, starting on the first day of antibiotic therapy and continuing until the end of antibiotic treatment;
• Traveler’s diarrhea:
  Initiate treatment 5 days before travel, 1 capsule daily, continuing throughout the entire trip; discontinue on the day of return from the travel destination. The product should be taken every morning on an empty stomach. Maximum duration of use: 30 days.

Capsules should be taken with water.

Due to the risk of environmental contamination, capsules should not be opened in patient care areas. Healthcare workers should wear disposable gloves when preparing probiotics for administration, remove them promptly afterwards, and thoroughly wash their hands (see section "Special Precautions").

Children.
For use in children aged 6 years and older. For children under 6 years of age, Enterol 250 in the form of lyophilized powder for oral administration is recommended.

Overdose.
Not reported.

Side effects.

In individuals with individual intolerance to any component of the medicine, hypersensitivity reactions are possible, including skin rashes, pruritus, exanthema, urticaria, anaphylactic reactions, angioneurotic edema, anaphylactic shock, constipation with undefined frequency, flatulence, epigastric discomfort. Very rarely, there is a risk of fungemia or sepsis with unknown frequency in hospitalized patients with central or peripheral venous catheters, in critically ill patients or patients with weakened immune systems (see section "Special precautions").

Shelf life. 3 years.

Storage conditions. Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 10, 20, 30, or 50 capsules in a glass bottle with a polyethylene cap and a PVC seal for first opening control; 1 glass bottle in a cardboard box;

5 capsules in a blister pack; 2, 4, or 6 blisters in a cardboard box;

6 capsules in a blister pack; 5 blisters in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

BIODEX.

Manufacturer's location and address of its business activity.

Manufacturing address: 1 Avenue Blaise Pascal, 60000 Beauvais, France / 1 avenue Blaise Pascal, 60000 Beauvais, France.