Enterol

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Enterol (UL-250),250 mg, powder for oral suspension
Saccharomyces boulardiiCNCM I-745
Enterol and UL-250 are different trade names for the same drug.

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 days or if you feel worse, contact your 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. Package contents 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 essential for ensuring 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, including gastrointestinal infections, both viral and bacterial, taking certain medications, including antibiotics, and changes in dietary habits. This can lead to a range of digestive problems, resulting in diarrhea.
Enterol is a medicine that affects the intestinal flora, a so-called "natural flora substitute," which allows for the temporary disruption of its balance to be restored.
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 occurring in irritable bowel syndrome (IBS).

If there is no improvement after 2 days or if you feel worse, consult your doctor.

2. Important information before taking Enterol

When not to take Enterol

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you have a central venous catheter (see section Warnings and precautions)
• in patients with significantly reduced immunity or hospitalized (due to severe illness or immune system disorders).

Warnings and precautions

Before taking Enterol, discuss it with your doctor.
It is not recommended to open sachets 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, when 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 due to diarrhea (the average daily water requirement for an adult is 2 liters)
• maintenance of an appropriate dietary regimen, excluding certain foods such as fruits, green vegetables, spicy dishes, frozen food, and chilled drinks; however, it is recommended to consume grilled meat and rice; consider limiting the consumption of milk and dairy products.

Consult your doctor immediately if:

• there is no improvement after 2 days of treatment
• you have a fever, vomiting
• blood or mucus appears in the stool
• you experience increased thirst, dry tongue: these are symptoms of beginning dehydration, i.e., significant fluid loss due to diarrhea. Consult your 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 currently taking or have recently taken, as well as any medicines you 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 could 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 fructose

One sachet of the medicine contains 471.90 mg of fructose.
If this medicine is used frequently or for a long time (e.g., for two weeks), fructose may harm teeth.
If you or your child have previously been diagnosed with intolerance to some sugars or have a rare genetic disorder, hereditary fructose intolerance, where the body does not break down fructose, consult your doctor before taking the medicine or giving it to your child.

Enterol contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
Enterol contains sorbitol (E 420), which is a component of the fruit flavor.

3. How to take Enterol

Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Recommended dosage for adults and children:
acute infectious diarrhea: 1 to 2 sachets per day for up to 1 week
antibiotic-associated diarrhea: 1 to 2 sachets per day, during and after antibiotic therapy
diarrhea caused by C. difficileinfection: 4 sachets per day for up to 4 weeks
diarrhea associated with enteral nutrition: 1 to 2 sachets per day
traveler's diarrhea: 1 to 4 sachets per day for up to 1 week
supportive treatment of diarrhea occurring in irritable bowel syndrome (IBS): 1 sachet 1 to 2 times a day. Diarrhea treatment should be continued for several days after symptoms resolve.
Method of administration:
Take orally.
The contents of the sachet should be added to a small amount of water or a sweetened drink, mixed, and consumed. The powder from the sachet can also be mixed with food or added to a bottle of food for a child. Do not mix with liquids or foods that are too hot (above 50°C), frozen, or contain alcohol.

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 your 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), fungal penetration 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 possible side effects not listed in the leaflet, tell your doctor, 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Enterol

Do not store above 25°C.
Store in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. Package contents and other information

What Enterol contains

• The active substance of the medicine is lyophilized Saccharomyces boulardiiyeast CNCM I-745. One sachet contains 250 mg of yeast.
• The other ingredients are: lactose monohydrate, fructose, colloidal silica anhydrous, fruit flavor (containing sorbitol (E 420)).

What Enterol looks like and what the package contains

A cardboard box contains 10 or 20 sachets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

Biocodex
7 Avenue Galliéni
94250 Gentilly
France

Manufacturer:

Biocodex
1 avenue Blaise Pascal
60000 Beauvais
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number, the country of export:8615211

Parallel import authorization number: 103/25

Date of leaflet approval: 24.03.2025

[Information about the trademark]