Enterol, capsules 250 mg 30 pcs

Indications

Intestinal infections, Poisoning, Salmonellosis, Diarrhea, Dysbiosis, Colitis

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

– intestinal dysbacteriosis (dysbiosis);

– acute infectious, viral or bacterial diarrhea;

– diarrhea caused by taking antibiotics (antibiotic-associated diarrhea);

– irritable bowel syndrome, enterocolitis;

– Travelers’ diarrhea;

– Diarrhea caused by Clostridium difficile, in combination with therapy with vancomycin or metronidazole;

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– adverse gastrointestinal reactions during eradication therapy with Helicobacter pylori.

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Composition

Active ingredient: Saccharomyces boulardii CNCM I-745 lyophilizate 250 mg.

Auxiliary substances: lactose monohydrate, magnesium stearate.

Capsule:titanium dioxide, gelatin.

How to take, the dosage

For oral intake.
Children from 1 to 3 years – 1 capsule twice a day.
Children from 3 years and adults – 1-2 capsules twice a day.
When administered to small children and in cases of difficulty in swallowing the capsule should be opened and the content mixed with water or other beverages, and added to food or baby food bottle immediately before intake.
It is not recommended to take the preparation together with hot, cold and alcoholic beverages due to the risk of decrease in activity and destruction of non-pathogenic yeast.
For acute infectious, viral or bacterial diarrhea the course of treatment is 5-10 days.
For prevention of antibiotic-associated diarrhea the treatment course corresponds to the antibiotic course.
For prevention of diarrhea caused by Clostridium difficile in combination with van comicin or metronidazole therapy the course of treatment is 1 month.
For prevention of traveler’s diarrhea the course of treatment by days corresponds to the duration of the trip.
For treatment of irritable bowel syndrome the drug should be continued until symptoms disappear.
Administration of the drug for acute diarrhea treatment should be obligatory accompanied by rehydration (drinking plenty of fluids).

Interaction

Enterol is not taken together with antifungal drugs.
Compatible with antibiotics.

Special Instructions

Diarrhea may be one symptom of a more serious primary disease.

If diarrhea persists after two days of administration, and if fever, blood, or mucus are found in stools, treatment should be reconsidered and oral or parenteral rehydration should be considered. In children under 2 years of age, consultation with the attending physician is recommended.

After stopping diarrhea, treatment with the drug may be continued for several days.

The use of the drug does not replace rehydration when necessary. The dosage for rehydration and the route of administration should be chosen according to the severity of the diarrhea and the patient’s age and condition.

In children from 1 to 2 years of age:Consultation with a physician may be necessary because of the possibility of primary disease. Rehydration may be the primary treatment for acute diarrhea in children and should be systematically reviewed.

In children aged 2 to 6 years:rehydration may be the primary treatment for acute diarrhea in children and should be systematically reviewed. Oral rehydration is given to prevent or treat dehydration. The use of ready-to-use preparations provided for this purpose is recommended.

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

In adults and children over 6 years of age:If diarrhea persists after two days of taking the drug, treatment should be reconsidered and oral or parenteral rehydration should be considered.

Due to the yeast nature of Enterol^®, very rare cases of fungemia have been reported (cultures of Saccharomyces have been isolated from blood), mostly in patients who had a central venous catheter, in patients who were extremely ill or had immunodeficiency states, which was often accompanied by fever (elevated 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.

Particular caution should be exercised when handling the drug in the presence of patients with central and peripheral venous catheters, even if they are not treated with Enterol^®, care should be taken to avoid the risk of contamination by contaminated hands or airborne spread of microorganisms.

Preparations for administration of the drug by patients and opening capsules of Enterol ^® should be done with medical gloves; in case of contact with the contents of the capsules, the gloves must be disposed of immediately after their use; hands must be thoroughly washed.

Influence on the ability to drive vehicles, machinery:

The use of Enterol^® does not affect the ability to drive vehicles and engage in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Smooth, shiny, opaque, white gelatin capsules number “0” containing a light brown powder with a characteristic yeast odor.

Contraindications

Hypersensitivity to one of the components of the drug, allergy to yeast, especially to Saccharomyces boulardii.
Presence of central venous catheter, patients in severe condition or with marked immune disorders due to risk of fungemia.
Lactose intolerance, lactase deficiency, congenital galactosemia,
glucose-galactose malabsorption syndrome.
Childhood under 1 year.

Side effects

Skin and subcutaneous tissue disorders

Very rare: allergic reactions – itching, papular rash (urticaria), skin rash, local or distributed throughout the body (localized or generalized exanthema), facial edema (angioedema).

Disorders of the immune system

Very rare: anaphylactic reactions or anaphylactic shock.

Gastrointestinal tract disorders

Rare: flatulence;

Frequent unknown: constipation.

Infectious and parasitic diseases

Very rare: fungemia (in patients who have a central venous catheter installed, as well as in hospitalized patients, persons with immunodeficiency conditions (see “Special Instructions”).

Overdose

Overdose of the drug is not possible, due to its pharmacokinetic properties.

Pregnancy use

There are no or limited data on the use of Saccharomyces boulardii in pregnant women and during breastfeeding.

Saccharomyces boulardii is not absorbed from the gastrointestinal tract.

As a precautionary measure, it is preferable to evaluate the ratio of the expected benefit to the mother to the potential risk to the fetus and child before using the drug during pregnancy and while breastfeeding.

The physician should be consulted.