Enterol

Leaflet attached to the packaging: patient information

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

Enterol (Ultra Levure)

250 mg, powder for oral suspension
Saccharomyces boulardiiCNCM I-745
Enterol and Ultra Levure are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 a doctor or pharmacist.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 days or the patient feels worse, they should contact their 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 yeast Saccharomyces boulardii, which are classified as probiotics, i.e., living
microorganisms that bring health benefits to the host organism.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining the balance
of intestinal microflora is necessary to ensure essential functions of the digestive tract, such as: digestion, immunity to infections, and strengthening natural immunity.
The balance of the bacterial flora is, however, 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 cause a range of digestive problems leading to diarrhea.
Enterol is a medicine that affects the intestinal flora, a so-called "substitute for natural flora", which allows for the balancing of its temporary disruption.
Enterol is used in:

• treatment of acute infectious diarrhea
• prevention of antibiotic-associated diarrhea
• recurrent diarrhea caused by Clostridium difficileinfection, as an adjunct to treatment with vancomycin or metronidazole
• 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 the patient feels worse, they should consult their doctor.

2. Important information before taking Enterol

When not to take Enterol

• Patients with significantly reduced immunity or hospitalized (due to severe diseases or disorders (weakening) of the immune system)

Warnings and precautions

Before starting to take Enterol, you should discuss it with your doctor.
It is not recommended to open sachets near patients with a central venous catheter,
to prevent unwanted colonization of fungi on the catheter, especially transmission through
contaminated hands. There have been reports of very rare cases of fungemia (penetration of
fungi into the blood) with accompanying fever and positive blood culture results, even in
patients not treated with Saccharomyces boulardii. In all described 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 caused by diarrhea (the average daily water requirement for an adult is 2 liters)
• maintaining an appropriate dietary regimen, excluding certain foods, such as: fruits, green vegetables, spicy dishes, frozen food, chilled drinks; while recommending the consumption of grilled meat and rice; it is recommended to consider limiting the consumption of milk and dairy products. You should immediately consult a doctor if:
• there is no improvement after 2 days of treatment
• there is fever, vomiting
• there is blood or mucus in the stool
• there is a feeling of increased thirst, dryness of the tongue: these are symptoms of beginning dehydration, i.e., loss of a significant amount of fluid due to diarrhea. You should contact a doctor, who will decide on the need for oral or intravenous rehydration.

Enterol and other medicines

You should 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.
You should 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. For this reason, it should not be mixed with too 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, you should 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.
In case of frequent use of this medicine or use for a long time (e.g., for two
weeks), fructose may damage teeth.
If you or your child have previously been diagnosed with intolerance to some sugars or
have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the
body does not break down fructose, you should 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, you should consult your doctor before taking the medicine.

The medicine contains sorbitol

One sachet of the medicine contains 0.10 mg of sorbitol.

3. How to take Enterol

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, you should 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 drunk. 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 (temperature above 50°C), frozen, or contain alcohol.

Missing a dose of Enterol

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

4. Possible side effects

Like all medicines, Enterol 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 people): 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 possible side effects not listed in this leaflet, you should 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.: 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 or parallel importer.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Enterol

Store in a temperature below 25°C. Protect from moisture.
The medicine should be stored in a place 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should 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 yeast Saccharomyces boulardiiCNCM I-745, one sachet contains 250 mg of yeast.
• The other ingredients are: lactose monohydrate, fructose, colloidal anhydrous silica, tutti frutti flavor (containing sorbitol).

What Enterol looks like and what the package contains

The package contains 10 or 20 sachets.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Petsiavas A.E.
Ag. Anargyron 21
14564 K. Kifisia
Greece

Manufacturer:

Biocodex
1 avenue Blaise Pascal
60 000 Beauvais
France

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Greece, the country of export:67618/22-06-2018

Parallel import authorization number: 182/25

Date of leaflet approval: 23.05.2025

[Information about the trademark]
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń