Enterol^® (Capsules, Powder) Instructions for Use

ATC Code

A07FA02 (Saccharomyces boulardii)

Active Substance

Saccharomyces boulardii (Grouping name)

Clinical-Pharmacological Group

Antidiarrheal drug

Pharmacotherapeutic Group

Antidiarrheal agent

Pharmacological Action

Saccharomyces boulardii CNCM I-745 is a live non-pathogenic yeast (deposited in the National Collection of Cultures and Microorganisms (CNCM), International Depository, Institut Pasteur, Paris). Saccharomyces boulardii is a probiotic and acts in the gastrointestinal tract as an antidiarrheal microorganism.

The pharmacodynamics of Saccharomyces boulardii have been studied on various models during in vitro and in vivo studies, as well as during preclinical and clinical studies, which have shown that the drug

• Has an antimicrobial effect due to an antagonistic effect against pathogenic and opportunistic microorganisms: Clostridium difficile, Candida albicans, Candida krusei, Candida pseudotropicalis, Klebsiella pneumoniae, Pseudomonas aeruginosa, Salmonella typhimurium, Yersinia enterocolitica, Escherichia coli, Shigella dysenteriae, Staphylococcus aureus and others, as well as Entamoeba histolytica and Lamblia;
• Has an antitoxin effect against bacterial cyto- and enterotoxins;
• Improves the enzymatic function of the intestine;
• The component of the Saccharomyces boulardii cell wall, mannitol, is a substrate for pathogenic strains of Escherichia coli and Salmonella typhimurium, which causes their adhesion (attachment) to the surface of Saccharomyces boulardii and subsequent elimination from the body;
• Has natural resistance to antibiotics.

Pharmacokinetics

Saccharomyces boulardii is not a eubiotic and is not part of the microflora of a healthy human body.

Saccharomyces boulardii is not absorbed, passes through the digestive tract unchanged, without colonization.

The concentration of Saccharomyces boulardii in the intestine is maintained at a constant level during the period of drug use. Saccharomyces boulardii is completely eliminated from the body within 2-5 days after discontinuation of the drug.

Indications

Treatment and prevention of diarrhea of any etiology in adults and children from 1 year of age, including

• Intestinal dysbiosis (dysbacteriosis);
• Acute infectious, viral or bacterial diarrhea;
• Antibiotic-associated diarrhea;
• Irritable bowel syndrome, enterocolitis;
• Traveler’s diarrhea;
• Diarrhea caused by Clostridium difficile, in combination with vancomycin or metronidazole therapy;
• Adverse gastrointestinal reactions during Helicobacter pylori eradication therapy.

ICD codes

Dosage Regimen

Capsules

For oral administration.

Children aged from 1 year to 3 years – 1 capsule 2 times a day.

Children aged from 3 years to 18 years and adults – 1-2 capsules 2 times a day.

When used in young children, as well as in cases of difficulty swallowing, the capsule should be opened and its contents mixed with water or another drink, or added to food or a baby bottle, immediately before administration.

The drug should not be taken with hot, cold, or alcoholic beverages due to the risk of reduced activity and destruction of non-pathogenic yeasts.

For treatment of acute infectious, viral, or bacterial diarrhea, the course of treatment is 5-10 days.

For prevention of antibiotic-associated diarrhea, the course of treatment in days corresponds to the course of antibiotic use.

For prevention of diarrhea caused by Clostridium difficile, in combination with vancomycin or metronidazole therapy, the course of treatment is 1 month.

For prevention of traveler’s diarrhea, the course of treatment in days corresponds to the duration of the trip.

For treatment of irritable bowel syndrome, the use of the drug should be continued until the symptoms disappear.

Taking the drug for the treatment of acute diarrhea must be accompanied by rehydration (plenty of fluids).

Powder

The drug for oral administration.

Children aged from 1 year to 3 years – 1 sachet 2 times a day.

Children aged from 3 years and adults – 1-2 sachets 2 times a day.

Method of administration

The contents of the sachet can be mixed with water or another drink, or added to food or a baby bottle, immediately before administration.

The drug should not be taken with hot and alcoholic beverages due to the risk of reduced activity and destruction of non-pathogenic yeasts.

For treatment of acute infectious, viral, or bacterial diarrhea, the course of treatment is 5-10 days.

For prevention of antibiotic-associated diarrhea, the course of treatment in days corresponds to the course of antibiotic use.

For prevention of diarrhea caused by Clostridium difficile, in combination with vancomycin or metronidazole therapy, the course of treatment is 1 month.

For prevention of traveler’s diarrhea, the course of treatment in days corresponds to the duration of the trip.

For treatment of irritable bowel syndrome, the use of the drug should be continued until the symptoms disappear.

Taking the drug for the treatment of acute diarrhea must be accompanied by rehydration (plenty of fluids).

Adverse Reactions

Skin and subcutaneous tissue disorders very rarely – allergic reactions such as pruritus, papular rash (urticaria), skin rash, localized or widespread throughout the body (localized or generalized exanthema), facial edema (angioedema).

Immune system disorders very rarely – anaphylactic reactions or anaphylactic shock.

Gastrointestinal disorders rarely – flatulence; frequency unknown – constipation.

Infections and infestations very rarely – fungemia (in patients with a central venous catheter, as well as in hospitalized patients, persons with immunodeficiency states (see section “Special Precautions”)).

Contraindications

• Hypersensitivity to any of the components of the drug;
• Allergy to yeast, primarily to Saccharomyces boulardii;
• Presence of a central venous catheter;
• Patients in a serious condition or with severe immune disorders due to the risk of fungemia;
• Lactose intolerance, lactase deficiency, congenital galactosemia, glucose-galactose malabsorption syndrome.

Use in Pregnancy and Lactation

Data on the use of Saccharomyces boulardii in pregnant women and during breastfeeding are absent or limited.

Saccharomyces boulardii is not absorbed from the gastrointestinal tract.

As a precautionary measure, it is preferable to assess the benefit-risk ratio of the drug before starting its use during pregnancy and breastfeeding.

Pediatric Use

The drug is prescribed for children over 1 year of age.

Special Precautions

Diarrhea can be a symptom of a more serious underlying disease.

In adults and children over 6 years of age if diarrhea persists after 2 days of taking the drug, as well as in case of fever, detection of blood or mucus in the stool, treatment should be reviewed and the possibility of oral or parenteral rehydration should be considered. For children under 2 years of age, consultation with the attending physician is recommended. After diarrhea stops, treatment with the drug can be continued for several days. The use of the drug does not replace rehydration if necessary. Rehydration doses and route of administration should be chosen depending on the severity of the diarrhea, as well as the age and condition of the patient.

In children under 2 years of age a doctor’s consultation may be required due to the likelihood of an underlying disease. Rehydration may be the main treatment for acute diarrhea in children, which should be systematically reviewed.

In children aged from 2 to 6 years rehydration may be the main treatment for acute diarrhea in children, which should be systematically reviewed. For the prevention or treatment of dehydration, oral rehydration is carried out. It is recommended to use ready-made preparations intended for this purpose and observe the following conditions

• The Na+ concentration should be in the range from 30 to 60 mmol/l. For moderate dehydration, solutions with a lower sodium content are used.
• It is necessary to replenish the losses of Cl^– and K⁺.
• The recommended glucose concentration is from 74 to 110 mmol/l.
• Adding hydrolyzed proteins or amino acids does not improve the rehydration process and nutritional status.
• It is necessary to offer the child to drink very often, approximately every 15 minutes. The volume of oral rehydration solution offered should be equivalent to the weight loss (for example, from 50 to 100 ml/kg with a loss of 5 to 10% of body weight).

In case of severe or prolonged diarrhea, severe vomiting, or refusal of oral rehydration, the possibility of parenteral rehydration should be considered.

However, in the absence of the need to prescribe rehydration, the following should be taken into account

• It is necessary to give the child salted or sweet drinks to replenish fluid loss during diarrhea (the average daily fluid intake is 2 liters);
• During diarrhea, the following diet should be followed: exclude unprocessed foods, vegetables, fruits, spicy dishes, as well as frozen foods and drinks, giving preference to rice dishes and baked meat.

The exclusion of milk and dairy products from the diet should be considered separately in each specific case.

Due to the yeast nature of the drug Enterol^®, cases of fungemia (Saccharomyces cultures were isolated from the blood) have been very rarely reported, mainly in patients who had a central venous catheter, in patients in extremely serious condition or with immunodeficiency states, which was often accompanied by fever (increased body temperature). In most cases, the outcome was satisfactory after discontinuation of treatment, administration of antifungal therapy and removal of the catheter, if necessary. However, in some patients whose condition was severe, the outcome was unfavorable.

Special care must be taken when working with the drug in the presence of patients with an installed central and peripheral venous catheter, even if they are not receiving treatment with Enterol^®, measures must be taken to exclude the risk of contamination with the drug upon contact with hands or the spread of microorganisms by airborne droplets.

Effect on ability to drive vehicles and mechanisms

Enterol^® does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Overdose of the drug is impossible, which is due to its pharmacokinetic properties.

Drug Interactions

Enterol^® is not taken together with antifungal drugs.

The drug is compatible with antibiotics.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed without a prescription.

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.