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, hard capsules
Saccharomyces boulardiiCNCM I-745
Enterol and Ultra Levure are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

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

• You should keep this leaflet, so that you can read it again if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform 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 drug, whose active substance is lyophilized Saccharomyces boulardiiyeast, which belongs to 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 the intestinal microflora is necessary to ensure the essential functions 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 cause a range of digestive problems leading to diarrhea.
Enterol is a drug that affects the intestinal flora, a so-called "substitute for natural flora", which allows for the balancing of its temporary disorder.
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 contact 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 or pharmacist.
It is not recommended to open the hard 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 (penetration of fungi into the blood) with accompanying fever and a positive blood culture result, even in patients not treated with Saccharomyces boulardii. In all described cases, fungemia resolved after the use of antifungal treatment or, when necessary, after the 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)
• maintenance of an appropriate dietary regimen, excluding certain foods, such as: fruits, green vegetables, spicy dishes, frozen foods, chilled drinks; on the other hand, it is recommended to consume grilled meat and rice; it is advisable 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 a 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 impending 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 drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
You should not take Enterol at the same time as oral antifungal drugs (drugs used to treat fungal infections).

Enterol with food, drink, and alcohol

Enterol contains live cells. For this reason, 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, you should consult your doctor or pharmacist before taking this drug.
Due to the lack of data, it is not recommended to use the drug 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 operating machinery

The drug does not affect driving or operating machinery.

Enterol contains lactose monohydrate.

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the drug.

3. How to take Enterol

This drug 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 hard capsules per day, for up to 1 week
antibiotic-associated diarrhea: 1 to 2 hard capsules per day, during and after antibiotic therapy
diarrhea caused by C. difficileinfection: 4 hard capsules per day, for up to 4 weeks
diarrhea associated with enteral nutrition: 1 to 2 hard capsules per day
traveler's diarrhea: 1 to 4 hard capsules per day, for up to 1 week
supportive treatment of diarrhea occurring in irritable bowel syndrome (IBS): 1 hard capsule, 1 to 2 times a day. Diarrhea treatment should be continued for several days after the symptoms have resolved.
Method of administration
Take orally. The hard capsule should be swallowed with a glass of water.
The hard 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 hard capsules due to the risk of choking; it is recommended to open the hard capsules and add their contents to a drink or food.

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 drug, you should consult your doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everybody gets them.
Rare (occurring in less than 1 in 1000 people): a few cases of bloating have been reported.
Very rare (occurring in less than 1 in 10,000 people): local rash, allergic reactions, urticaria, itching, anaphylactic reactions, facial edema, angioedema, rash on the whole 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, you should inform 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 drug.

5. How to store Enterol

The drug should be stored out of sight and reach of children.
Do not use this drug after the expiry date stated on the carton. The expiry date refers to the last day of the given month.
Store in a temperature below 25°C. Protect from moisture.
Drugs should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of drugs 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 drug is lyophilized Saccharomyces boulardiiyeast CNCM I-745, one hard capsule contains 250 mg of yeast.
• The other ingredients are: lactose monohydrate, magnesium stearate; ingredients of the gelatin capsule: gelatin, titanium dioxide.

What Enterol looks like and what the package contains

White hard capsules containing a light brown powder with a characteristic odor.
A glass bottle (type III) with a plastic cap, in a cardboard box, containing 10 hard capsules.
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
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Marketing authorization number in Greece, the country of export:54567/23-6-2021

Parallel import authorization number: 278/24

Date of leaflet approval: 05.07.2024

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