Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Enterol (UL-250), 250 mg, powder for oral suspension
Saccharomyces boulardii CNCM I-745
Enterol and UL-250 are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by a physician or pharmacist.

Keep this leaflet for future reference.
If advice or additional information is needed, consult a pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 2 days or if the patient feels worse, consult a doctor.

Table of contents:

What Enterol is and what it is used for
Important information before taking Enterol
How to take Enterol
Possible side effects
How to store Enterol
Contents of the pack and other information

1. What Enterol is and what it is used for

Enterol is an oral anti-diarrheal medicine whose active substance consists of lyophilized yeast Saccharomyces boulardii, classified as a probiotic, i.e. live microorganisms that provide health benefits to the host organism.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining the balance of intestinal microflora is essential for ensuring important gastrointestinal functions such as digestion, resistance to infections, and strengthening natural immunity.
However, the balance of bacterial flora is delicate and can be disrupted by many factors: gastrointestinal infections, both viral and bacterial, taking certain medicines, including antibiotics, and changes in dietary habits. This may lead to various digestive problems resulting in diarrhea.
Enterol is a medicine that acts on intestinal flora, a so-called "natural flora substitute," which helps restore temporary imbalances in the intestinal flora.
Enterol is indicated for:

treatment of acute infectious diarrhea
prevention of antibiotic-associated diarrhea
recurrent diarrhea caused by Clostridium difficile infection, as an adjunct to vancomycin or metronidazole therapy
prevention of diarrhea associated with enteral nutrition
prevention of traveler's diarrhea
adjunctive treatment of diarrhea occurring in irritable bowel syndrome (IBS).

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

2. Important information before using Enterol

When not to use Enterol

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if the patient has a central venous catheter in place (see section Warnings and precautions)
in patients with significantly weakened immunity or who are hospitalized due to severe diseases or disorders (weakening) of the immune system.

Warnings and precautions
Before starting treatment with Enterol, discuss it with your doctor.
It is not recommended to open sachets near patients with a central venous catheter in place, to prevent unwanted fungal colonization of the catheter, especially transmission via contaminated hands. There have been reports of very rare cases of fungaemia (fungal invasion into the bloodstream) accompanied by fever and positive blood cultures, even in patients not treated with Saccharomyces boulardii. In all reported cases, fungaemia resolved after antifungal treatment or, when necessary, after removal of the central venous catheter.
As an adjunct to treatment, it is recommended to:

ensure adequate hydration (rehydration) by consuming large amounts of salty or sweet drinks to compensate for fluid loss caused by diarrhoea (the average daily fluid requirement for an adult is 2 litres)
maintain an appropriate diet, excluding certain foods such as: fruits, green vegetables, spicy dishes, frozen food, chilled drinks; grilled meat and rice are recommended; consumption of milk and dairy products should be considered for limitation.

Seek immediate medical advice if:

there is no improvement after 2 days of treatment
fever or vomiting occur
blood or mucus appears in the stool
increased thirst or dry mouth occurs: these are symptoms of developing dehydration, meaning significant fluid loss due to diarrhoea. Contact a doctor who will decide whether oral or intravenous rehydration is necessary.

Enterol and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Enterol simultaneously with 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 excessively hot (above 50°C) or cold liquids, food, or alcohol, as this could destroy the yeast cells.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Due to lack of data, use of Enterol during pregnancy is not recommended.
Saccharomyces boulardii is not absorbed into breast milk. Due to lack of data, the benefit-risk balance should be considered before using Enterol during breastfeeding.

Driving and operating machinery
Enterol has no influence on the ability to drive or operate machinery.

Enterol contains fructose
One sachet of the medicine contains 471.90 mg of fructose.
With frequent use of this medicine or prolonged use (e.g. for two weeks), fructose may have a harmful effect on teeth.
If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or has a rare hereditary fructose intolerance—a genetic disorder in which the patient's body cannot metabolize fructose—the patient should consult a doctor before taking the medicine or giving it to a child.

Enterol contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

Enterol contains sorbitol (E 420), which is a component of the fruit flavouring.

3. How to use Enterol

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dosage for adults and children
Infectious acute diarrhoea: 1 to 2 sachets per day for up to 1 week
Antibiotic-associated diarrhoea: 1 to 2 sachets per day, during and after antibiotic treatment
Diarrhoea caused by C. difficile infection: 4 sachets per day for up to 4 weeks
Diarrhoea associated with enteral nutrition: 1 to 2 sachets per day
Travellers' diarrhoea: 1 to 4 sachets per day for up to 1 week
As supportive treatment in diarrhoea associated with irritable bowel syndrome (IBS): 1 sachet 1 to 2 times per day. Treatment of diarrhoea should be continued for several days after symptoms have resolved.

Method of administration
For oral use.
The contents of a sachet should be mixed with a small amount of water or sweetened beverage, stirred, and then taken orally. The powder from the sachet may also be mixed with food or added to a bottle of infant formula. Do not mix with liquids or foods that are too hot (temperature above 50°C), frozen, or containing alcohol.

If you forget to take Enterol
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rarely (occurring no more frequently than in 1 out of 1,000 people): several cases of bloating have been reported.
Very rarely (occurring less frequently than in 1 out of 10,000 people): local rash, allergic reactions,
urticaria, pruritus, anaphylactic reactions, facial swelling, angioedema, generalized skin rash (urticaria),
yeast invasion into the bloodstream (fungemia).
Frequency not known: (frequency cannot be estimated from the available data): constipation,
severe blood infection (sepsis).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Enterol

Do not store above 25°C.
Keep 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Enterol contains

The active substance in Enterol is lyophilized Saccharomyces boulardii CNCM I-745 yeast. Each sachet contains 250 mg of yeast.
Other ingredients are: monohydrate lactose, fructose, anhydrous colloidal silicon dioxide, fruit flavour (containing sorbitol (E 420)).

What Enterol looks like and contents of the pack
The cardboard package contains 10 or 20 sachets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Portugal, 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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Portugal, country of export: 8615211
Parallel Import Licence Number: 103/25