Enterol

Package leaflet: Information for the patient

Warning! Keep this 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 medicinal product.
Please read the entire 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 leaflet or as directed by a physician or pharmacist.

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

Table of contents of the leaflet:

1. What Enterol is and what it is used for
2. Important information before taking Enterol
3. How to take Enterol
4. Possible side effects
5. How to store Enterol
6. Contents of the package 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 probiotics—live microorganisms that provide health benefits to the host organism.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining the balance of intestinal microbiota is essential for ensuring important gastrointestinal functions such as digestion, protection against infections, and strengthening natural immunity.
However, this bacterial balance is delicate and can be disrupted by many factors: gastrointestinal infections, both viral and bacterial, taking certain medications—including antibiotics—or changes in dietary habits. Such disruptions may lead to various digestive problems resulting in diarrhoea.
Enterol is a medicine that acts on the intestinal flora, a so-called "natural flora substitute," which helps restore temporary imbalances in gut microbiota.
Enterol is indicated for:

• Treatment of acute infectious diarrhoea
• Prevention of antibiotic-associated diarrhoea
• Recurrent diarrhoea caused by Clostridium difficile infection, as an adjunct to treatment with vancomycin or metronidazole
• Prevention of diarrhoea associated with enteral nutrition
• Prevention of traveller's diarrhoea
• Adjunctive treatment of diarrhoea associated with irritable bowel syndrome (IBS)

If there is no improvement within 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)
• Patients with significantly weakened immunity or those hospitalized due to severe diseases or disorders (weakening) of the immune system

Warnings and precautions
Before starting treatment with Enterol, discuss this 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 transmission via contaminated hands. There have been reports of very rare cases of fungaemia (fungal invasion into the bloodstream) associated with 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:

• maintain adequate hydration (rehydration) by drinking large amounts of salty or sweet beverages 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 foods, frozen food, chilled beverages; grilled meat and rice are recommended. Milk and dairy products should be considered for restriction.

Seek immediate medical advice if:

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

Enterol and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Do not take Enterol simultaneously with oral antifungal medicines (medicines used to treat fungal infections).

Enterol, food, drink and alcohol
Enterol contains live cells. Therefore, it should not be mixed with excessively hot (above 50°C) or cold liquids, foods, 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 have a child, she should consult her doctor or pharmacist before using this medicine.
Due to lack of data, the use of Enterol is not recommended during pregnancy.
Saccharomyces boulardii is not absorbed into breast milk. Due to insufficient data, the benefit-risk balance should be carefully considered before using Enterol during breastfeeding.

Driving and operating machinery
Enterol does not affect the ability to drive or operate machinery.

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

3. How to use Enterol

This medicine should always be taken 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 hard capsules per day for up to 1 week
• Antibiotic-associated diarrhoea: 1 to 2 hard capsules per day during and after antibiotic therapy
• Diarrhoea caused by C. difficile infection: 4 hard capsules per day for up to 4 weeks
• Diarrhoea associated with enteral nutrition: 1 to 2 hard capsules per day
• Travellers' diarrhoea: 1 to 4 hard capsules per day for up to 1 week
• As an adjunct in the treatment of diarrhoea associated with irritable bowel syndrome (IBS): 1 hard capsule 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 hard capsule should be swallowed with a glass of water.
The hard capsule may be opened and its contents mixed with a small amount of sweetened drink, food, or added to a bottle of infant feed.
In children under 6 years of age, administration of hard capsules is not recommended due to the risk of choking; it is recommended to open the hard capsules and mix their contents with a drink or food.

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

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everybody experiences them.
Rare (occurring no more frequently than in 1 out of 1,000 people): several cases of bloating have been reported.
Very rare (occurring less frequently than in 1 out of 10,000 people): local rash, allergic reactions,
urticaria, itching, anaphylactic reactions, facial swelling, angioedema, generalized 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 this 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
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Enterol

Keep this medicine 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 stated month.
Store below 25°C. Protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Enterol contains

• The active substance is lyophilized Saccharomyces boulardii CNCM I-745 yeast; one hard capsule contains 250 mg of yeast.
• Other ingredients: monohydrate lactose, magnesium stearate; ingredients of the gelatin capsule: gelatin, titanium dioxide.

What Enterol looks like and contents of the pack
White hard capsules containing light brown powder with a characteristic odour.
Bottle made of colourless glass (type III) with a plastic stopper, in a cardboard box,
containing 10 hard capsules.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Greece, 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
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing authorisation number in Greece, country of export: 54567/23-6-2021
Parallel import authorisation number: 278/24