Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Enterol (Ultra Levure)
250 mg, powder for oral suspension
Saccharomyces boulardii CNCM I-745
Enterol and Ultra Levure are different trade names for the same medicinal product.
Please read this 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 the doctor or pharmacist.
Keep this leaflet for future reference.
If advice or additional information is needed, consult the pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 2 days, or if the patient feels worse, consult a doctor.

Table of contents:

What Enterol is and what it is used for
Important information before taking Enterol
How to take Enterol
Possible side effects
How to store Enterol
Contents of the pack and other information

1. What Enterol is and what it is used for

Enterol is an oral anti-diarrheal medicine. Its active ingredient consists of lyophilized yeast Saccharomyces boulardii, classified as probiotics—live microorganisms that provide health benefits to the host.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining the balance of intestinal microflora is essential for important gastrointestinal functions such as digestion, protection against infections, and strengthening natural immunity.
However, the balance of bacterial flora is delicate and can be disrupted by many factors: gastrointestinal infections (viral or bacterial), taking certain medicines—especially antibiotics—as well as changes in dietary habits. This may lead to various digestive problems resulting in diarrhea.
Enterol is a medicine that acts on intestinal flora, a so-called "natural flora substitute," which helps restore balance during temporary disturbances.
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 vancomycin or metronidazole treatment
Prevention of diarrhea associated with enteral nutrition
Prevention of traveler's diarrhea
Adjunctive treatment of diarrhea associated with irritable bowel syndrome (IBS)

If there is no improvement after 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 who are hospitalised (due to severe diseases or disorders (weakening) of the immune system)

Warnings and precautions
Before starting treatment with Enterol, discuss this with your doctor.
It is not recommended to open the sachets near patients with a central venous catheter in place, in order to prevent unwanted fungal colonisation 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, avoiding certain foods such as: fruits, green vegetables, spicy dishes, frozen food, chilled drinks; grilled meat and rice are recommended; consumption of milk and dairy products should be considered for reduction. Seek medical advice immediately if:
no improvement after 2 days of treatment
fever, vomiting occur
blood or mucus appears in the stool
increased thirst or dry mouth occur: these are symptoms of developing dehydration, meaning significant fluid loss due to diarrhoea. Contact your doctor, who will decide whether oral or intravenous rehydration is necessary.

Enterol with other medicines
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.
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. For this reason, it should not be mixed with liquids, foods or alcohol that are too hot (above 50°C) or too cold, as this could destroy the yeast cells.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Due to lack of data, use of Enterol during pregnancy is not recommended.
Saccharomyces boulardii is not excreted into breast milk. Due to lack of data, the benefit-risk ratio should be carefully considered before using Enterol during breastfeeding.

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

Enterol contains fructose
One sachet of Enterol contains 471.90 mg of fructose.
With frequent use or prolonged use (e.g. for two weeks), fructose may damage teeth.
If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to a child.

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

Enterol contains sorbitol
One sachet of this 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
physician or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosage for adults and children:
infectious acute diarrhoea: 1 to 2 sachets per day for up to 1 week
antibiotic-associated diarrhoea: 1 to 2 sachets per day, during and after antibiotic treatment
diarrhoea caused by C. difficile infection: 4 sachets per day for up to 4 weeks
diarrhoea associated with enteral nutrition: 1 to 2 sachets per day
travellers' diarrhoea: 1 to 4 sachets per day for up to 1 week
as an adjunct in the treatment of diarrhoea associated with irritable bowel syndrome (IBS): 1 sachet 1
to 2 times per day. Treatment of diarrhoea should be continued for several days after symptoms resolve.
Method of administration
For oral use.
The contents of a sachet should be added to a small amount of water or sweetened beverage, stirred
and then consumed. The powder from the sachet may also be mixed with food or added to a bottle of
infant formula. Do not mix with liquids or foods that are too hot (temperature above 50°C), frozen, or
containing alcohol.
Missed dose of Enterol
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

5. How to store Enterol

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

6. Contents of the pack and other information

What Enterol contains

The active substance is lyophilized Saccharomyces boulardii CNCM I-745 yeast; one sachet contains 250 mg of yeast.
Other ingredients: monohydrate lactose, fructose, anhydrous colloidal silicon dioxide, tutti frutti flavour (containing sorbitol).

What Enterol looks like and contents of the pack
The pack contains 10 or 20 sachets.
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. Shiraz Productions Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37 ul. Tymiankowa 24/28
02-234 Warsaw 87-100 Toruń 95-054 Ksawerów
Marketing authorization number in Greece, country of export: 67618/22-06-2018
Parallel import authorization number: 182/25