Enterol, 250 mg 10 pcs.

Indications

The 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;

– traveler’s diarrhea;

– diarrhea caused by Clostridium difficile, in combination with vancomycin or metronidazole therapy.

– adverse gastrointestinal reactions during eradication therapy with Helicobacter pylori.

Composition

Active ingredient: Saccharomyces boulardii CNCM I-745 lyophilizate 250.00 mg.

Auxiliary substances:lactose monohydrate, fructose, colloidal silicon dioxide, tutti-frutti flavoring.

How to take, the dosage

For oral administration.

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

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

The contents of the sachet can be mixed with water or other beverage, or added to food or baby food bottle, just before taking.

Do not take with hot drinks 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 prevention of antibiotic-associated diarrhea the course of treatment by 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 by day corresponds to the duration of the trip.

To treat irritable bowel syndrome, the drug should be continued until symptoms disappear.

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

Interaction

Special Instructions

If after two days of using Enterol® for treatment of acute diarrhea there is no improvement, as well as in case of fever, blood or mucus in stools, you should immediately contact a physician. A feeling of thirst and dry mouth are signs of inadequate rehydration (not drinking enough).

Due to the yeast nature of Enterol®, very rare cases of fungemia have been reported (cultures of Saccharomyces were isolated from the 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.

Influence on driving and operating ability:

Enterol® does not affect the ability to drive or engage in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

High sensitivity to one of the components of the drug, allergy to yeast, especially to Saccharomyces boulardii.

Having a central venous catheter, patients in severe condition or with significant immune disorders due to risk of fungemia.

Lactose intolerance, lactase deficiency, congenital galactosemia,
glucose-galactose malabsorption syndrome.

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

Rarely: flatulence;

Frequent unknown: constipation.

Infectious and parasitic diseases

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

Overdose

Pregnancy use

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

Saccharomyces boulardii is not absorbed from the gastrointestinal tract.

As a precautionary measure, it is preferable to evaluate the benefit ratio of the drug to the possible risk before using the drug during pregnancy and breastfeeding.