Enterol

Package leaflet: information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Enterol (ULTRA LEVURE), 250 mg, hard capsules
Saccharomyces boulardii CNCM I-745
Enterol and ULTRA LEVURE are different trade names of the same medicine.
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 the patient leaflet or as advised by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 days, or if you feel worse, contact your 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 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 probiotics—live microorganisms that provide
health benefits to the host organism.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining microbial
balance in the gut is essential for 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, and changes
in dietary habits. This may lead to various digestive problems resulting in diarrhea.
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 used for:

• treatment of acute infectious diarrhea,
• prevention of antibiotic-associated diarrhea,
• recurrent diarrhea caused by Clostridium difficile infection, 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 associated with irritable bowel syndrome (IBS).

If there is no improvement after 2 days, or if you feel worse, consult your doctor.
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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 who are hospitalised (due to severe diseases or disorders (weakening) of the immune system).

Warnings and precautions
Before starting treatment with Enterol, consult a doctor or pharmacist.
It is not recommended to open capsules near patients with a central venous catheter in place,
to prevent unwanted fungal colonisation of the catheter, especially transmission via
contaminated hands. There have been reports of very rare cases of fungaemia (fungal penetration into the blood) accompanied by fever and positive blood culture, 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 drinking large amounts of salty or sweet beverages to compensate for fluid loss caused by diarrhoea (the average daily water 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; milk and dairy products should be limited.

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 are experienced: 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 with other medicines
Inform the 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 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 have a child, 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 carefully considered before using Enterol during breastfeeding.

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

Enterol contains lactose monohydrate
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 capsules per day, for up to 1 week
• Antibiotic-associated diarrhoea: 1 to 2 capsules per day, during and after antibiotic treatment
• Diarrhoea caused by C. difficile infection: 4 capsules per day, for up to 4 weeks
• Diarrhoea associated with enteral nutrition: 1 to 2 capsules per day
• Travellers' diarrhoea: 1 to 4 capsules per day for up to 1 week
• As supportive treatment in managing diarrhoea associated with irritable bowel syndrome (IBS): 1 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. Swallow the capsule with a glass of water.
The 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 capsules is not recommended due to the risk of choking; it is advised to open the capsule and mix its contents with a drink or food.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare (occurring no more frequently than in 1 out of 1,000): 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 skin rash (exanthema),
yeast invasion into the blood (fungemia).
Frequency not known: (frequency cannot be estimated from available data): constipation, severe blood infection (sepsis).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse effects helps to provide more information on the safety of the medicine.
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5. How to store the medicine Enterol

Keep the medicine out of the 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.
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; capsule shell: gelatin, titanium dioxide.

What Enterol looks like and contents of the pack
White hard capsules containing a light brown powder with a characteristic odour.
The medicine is packed in a colourless glass bottle (type III) with a plastic stopper, placed in a cardboard box containing 10 hard capsules. Each package contains 1, 2, 3 or 5 bottles.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Petsiavas A.E., Ag. Anargyron 21, 145 64 K. Kifissia, Greece
Manufacturer:
BIOCODEX, 1 avenue Blaise Pascal, 60000 Beauvais, France
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Greece, country of export: 67617/22-6-2018
Parallel Import Licence Number: 270/23
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