Enterol

Package Leaflet: Information for the Patient

Enterol,250 mg, capsules
Saccharomyces boulardiiCNCM I-745

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 days there is no improvement or the patient feels worse, contact a doctor.

Table of Contents of the Leaflet:

• 1. What is Enterol and what is it used for
• 2. Important information before taking Enterol
• 3. How to take Enterol
• 4. Possible side effects
• 5. How to store Enterol
• 6. Contents of the pack and other information

1. What is Enterol and what is it used for

Enterol is an oral anti-diarrheal medicine, whose active substance is lyophilized Saccharomyces boulardiiyeast, classified as probiotics, i.e. living microorganisms that provide health benefits to the host organism.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining the balance of the intestinal microflora is necessary to ensure the proper functioning of the digestive tract, such as:
digestion, resistance to infections, and strengthening the natural immune system.
The balance of the bacterial flora is delicate and can be disrupted by many factors:
gastrointestinal infections, both viral and bacterial, taking certain medications, including antibiotics, changes in dietary habits. This can lead to a range of digestive problems leading to diarrhea.
Enterol is a medicine that affects the intestinal flora, a so-called "natural flora substitute", which allows for the temporary imbalance to be balanced.
Enterol is used in:

• treatment of acute infectious diarrhea
• prevention of antibiotic-associated diarrhea
• recurrent diarrhea caused by Clostridium difficileinfection, as an adjunct to vancomycin or metronidazole treatment
• prevention of diarrhea associated with enteral nutrition
• prevention of traveler's diarrhea
• supportive treatment of diarrhea in irritable bowel syndrome (IBS)

If after 2 days there is no improvement or the patient feels worse, consult a doctor.

2. Important information before taking Enterol

When not to take Enterol:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if the patient has a central venous catheter (see section Warnings and precautions)
• Patients with significantly reduced immunity or hospitalized (due to severe illness or immunodeficiency)

Warnings and precautions

Before taking Enterol, discuss it with your doctor or pharmacist.
It is not recommended to open capsules near patients with a central venous catheter to prevent unwanted fungal colonization of the catheter, especially through contaminated hands. There have been reports of very rare cases of fungemia (fungal penetration into the blood) with accompanying fever and positive blood culture results, even in patients not treated with Saccharomyces boulardii. In all reported cases, fungemia resolved after antifungal treatment or, if necessary, after removal of the central venous catheter.
As a supplement to treatment, it is recommended:
adequate hydration of the body (rehydration) by consuming large amounts of salty or sweet drinks, to compensate for fluid loss caused by diarrhea (average daily water intake for an adult is 2 liters)
maintenance of an appropriate dietary regimen, excluding certain foods, such as:
fruits, green vegetables, spicy dishes, frozen food, chilled drinks; however, it is recommended to consume grilled meat and rice; consider limiting the consumption of milk and dairy products.
Seek medical attention immediately if:

• there is no improvement after 2 days of treatment
• fever, vomiting
• blood or mucus appears in the stool
• excessive thirst, dry mouth: these are symptoms of impending dehydration, i.e. significant fluid loss due to diarrhea. Contact a doctor who will decide on the need for oral or intravenous rehydration.

Enterol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Enterol at the same time as oral antifungal medicines (medicines used to treat fungal infections).

Enterol with food, drink, and alcohol

Enterol contains live cells. Therefore, it should not be mixed with very hot (above 50°C) or cold liquids, foods, and alcohol, as this may destroy the yeast cells.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Due to the lack of data, it is not recommended to use the medicine during pregnancy.
Saccharomyces boulardiiis not absorbed into breast milk. Due to the lack of data, it is recommended to consider the benefit-risk ratio before taking Enterol during breastfeeding.

Driving and using machines

The medicine does not affect driving or using machines.

Enterol contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Enterol

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
Recommended dosage for adults and children
acute infectious diarrhea: 1 to 2 capsules per day, for up to 1 week
antibiotic-associated diarrhea: 1 to 2 capsules per day, during and after antibiotic therapy
diarrhea caused by C. difficileinfection: 4 capsules per day, for up to 4 weeks
diarrhea associated with enteral nutrition: 1 to 2 capsules per day
traveler's diarrhea: 1 to 4 capsules per day for up to 1 week
supportive treatment of diarrhea in irritable bowel syndrome (IBS): 1 capsule 1 to 2 times a day. Diarrhea treatment should be continued for several days after symptoms resolve.
Method of administration
Take orally. Swallow the capsule with a glass of water.
The capsule can be opened, and its contents poured into a small amount of sweetened drink, food, or added to a bottle of food for a child.
In children under 6 years of age, it is not recommended to use capsules due to the risk of choking; it is recommended to open the capsules and add their contents to a drink or food.

Missing a dose of Enterol

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (occurring in less than 1 in 1000): a few cases of bloating have been reported.
Very rare (occurring in less than 1 in 10,000): local rash, allergic reactions, hives, itching, anaphylactic reactions, facial swelling, angioedema, rash all over the body (exanthema), penetration of yeast into the blood (fungemia).
Frequency not known: (frequency cannot be estimated from the available data): constipation, severe blood infection (sepsis).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Enterol

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Enterol contains

• The active substance of the medicine is lyophilized Saccharomyces boulardiiyeast, CNCM I-745, one capsule contains 250 mg of yeast
• Other ingredients are: lactose monohydrate, magnesium stearate; ingredients of the gelatin capsule: gelatin, titanium dioxide.

What Enterol looks like and contents of the pack

White capsules containing light brown powder with a characteristic odor.
Glass bottle with LDPE cap, in a cardboard box, containing 10, 20, 30, or 50 capsules.
Aluminum blisters, in a cardboard box, containing 20 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

BIOCODEX
22 rue des Aqueducs
94250 Gentilly, France

Manufacturer

BIOCODEX
1 avenue Blaise Pascal
60 000 Beauvais, France
To obtain more detailed information, contact the representative of the marketing authorization holder:
BIOCODEX Polska Sp. z o.o.
ul. Krakowiaków 34

• 02 - 255 Warsaw tel. (22) 243-65-00

Date of last revision of the leaflet: September 2024