Enterol, capsules 250 mg blister 30 pcs

Indications

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.

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 administration.

Children from 1 to 3 years – 1 capsule twice a day.

Children from 3 years and adults – 1-2 capsules twice a day.

In young children and if you have difficulty swallowing, open the capsule and mix the contents with water or another drink, or add to foods or baby food bottles, just before taking.

Do not take with hot, cold, or alcoholic beverages because of the risk of decreased activity and destruction of non-pathogenic yeast.

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

For the prevention of antibiotic-associated diarrhea, the daily course of treatment corresponds to the course of antibiotic administration.

To prevent 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 the treatment of irritable bowel syndrome, the drug should be continued until the symptoms have disappeared.

The treatment of acute diarrhea should always be accompanied by rehydration (drinking plenty of fluids).

Interaction

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 and mechanisms:

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 No. “0” containing a light brown powder with a characteristic yeast odor.

Contraindications

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

It is not possible to overdose on the drug 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.