Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Enterol (ULTRA-LEVURE 250 mg)
250 mg, powder for oral suspension
Saccharomyces boulardii CNCM I-745
Enterol and ULTRA-LEVURE 250 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking 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 physician or pharmacist.

Keep this leaflet for future reference.
If advice or additional information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. 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 a probiotic, i.e. live microorganisms that provide health benefits to the host organism.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining the balance of intestinal microflora is essential for ensuring 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, both viral and bacterial, use of certain medicines 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 balance after its temporary disruption.
Enterol is used:

in the treatment of acute infectious diarrhea
in the prevention of antibiotic-associated diarrhea
in recurrent diarrhea caused by Clostridium difficile infection, as an adjunct to vancomycin or metronidazole therapy
in the prevention of diarrhea associated with enteral nutrition
in the prevention of travelers' diarrhea
as an adjunct in the treatment of diarrhea occurring in irritable bowel syndrome (IBS)

If there is no improvement after 2 days, or if the patient feels worse, consult a doctor.

2. 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")
in patients with severely 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 sachets 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) associated with 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:

maintain 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 considered for restriction.

Seek medical advice immediately if:

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

Enterol with other medicines
Inform your doctor or pharmacist about all medicines currently taken or 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. Therefore, do not mix it with liquids, food or alcohol that are too hot (above 50°C) or too cold, 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, 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 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 or long-term use of this medicine (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 with hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot metabolise 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.

The medicine 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 information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician 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 supportive treatment in 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 have resolved.

Administration method
For oral use.
The contents of the 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 feed. Do not mix with liquids or foods that are too hot (temperature above 50°C), frozen, or contain alcohol.

Missed dose of 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 physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rarely (occurring no more frequently than in 1 out of 1,000 people): several cases of bloating have been reported.
Very rarely (occurring less frequently than in 1 out of 10,000 people): local rash, allergic reactions,
urticaria, pruritus, 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 or pharmacist. 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store Enterol

Store below 25°C. Protect from moisture.
Keep the medicine in a place invisible and out of 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicinal product Enterol contains

The active substance in Enterol is lyophilized Saccharomyces boulardii CNCM I-745 yeast.

One sachet contains 250 mg of yeast.

Other ingredients are: lactose monohydrate, fructose, colloidal anhydrous silica, 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 marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
PETSIAVAS S.A.
Ag. Anargyron 21
14564 Κ.Kifisia, Greece
Manufacturer:
BIOCODEX
1 avenue Blaise Pascal
60 000 Beauvais, France
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Greece, country of export: 67618/22-6-2018
Parallel Import Authorisation Number: 304/25