Enterol

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

ENTEROL(ULTRA LEVURE)

250 mg, hard capsules

Saccharomyces boulardii CNCM I-745
ENTEROL and ULTRA LEVURE are different trade names for the same drug.

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

This medicine should always be taken exactly as described in the patient leaflet, 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, 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 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. However, 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 disruption of its balance 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 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:

• 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 immune system disorders)

Warnings and precautions

Before starting to take Enterol, the patient should discuss it with their 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 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 foods, and chilled drinks; on the other hand, it is recommended to consume grilled meat and rice; consideration should be given to limiting the consumption of milk and dairy products.

The patient should immediately consult their doctor if:

• there is no improvement after 2 days of treatment
• they have a fever, vomiting
• there is blood or mucus in the stool
• they experience increased thirst, dry tongue: these are symptoms of impending dehydration, i.e., significant fluid loss due to diarrhea. The patient should contact their doctor, who will decide on the need for oral or intravenous rehydration.

Enterol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Enterol should not be taken 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 very hot (above 50°C) or cold liquids, foods, and alcohol, as this could destroy the yeast cells.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Due to the lack of data, it is not recommended to take 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 monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

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 in doubt, the patient should consult their 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 occurring 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. The capsule should be swallowed 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 baby's bottle.
In children under 6 years of age, it is not recommended to take 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

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their 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 patients): a few cases of bloating have been reported.
Very rare (occurring in less than 1 in 10,000 patients): local rash, allergic reactions, urticaria, itching, anaphylactic reactions, facial edema, angioedema, rash on the whole 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Enterol

The medicine should be stored 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 stated.
Store in a temperature below 25°C. Protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 boulardiiCNCM I-745 yeast; one hard capsule contains 250 mg of yeast.
• The other ingredients are: lactose monohydrate, magnesium stearate; capsule shell: gelatin, titanium dioxide (E 171).

What Enterol looks like and what the package contains

White hard capsules containing light brown powder with a characteristic odor.
A glass bottle (type III) with a plastic cap, in a cardboard box, containing 10 hard capsules.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

PETSIAVAS S.A.
AG Anargyron 21
145 64 Kifissia
Greece

Manufacturer:

BIOCODEX
1 avenue Blaise Pascal
60 000 Beauvais
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Greece, the country of export: 67617/ 22-06-2018

Parallel import authorization number: 116/24

Date of leaflet approval: 18.03.2024

[Information about the trademark]