Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Enterol, 250 mg, powder for oral suspension
Saccharomyces boulardii CNCM I-745
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 a 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 possible adverse reactions 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, consult your doctor.

Table of contents of the leaflet:

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 packaging and other information

1. What Enterol is and what it is used for

Enterol is an oral anti-diarrheal medicine whose active ingredient consists of lyophilized yeast Saccharomyces boulardii, classified as probiotics, 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, resistance to 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, 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 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 treatment with vancomycin or metronidazole
in the prevention of diarrhea associated with enteral nutrition
in the prevention of traveler's diarrhea
as an adjunct in the 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.

2. Information before using Enterol

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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 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,
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 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, avoiding certain foods such as: fruits, green vegetables, spicy foods, frozen food, chilled drinks; grilled meat and rice are recommended; consumption of milk and dairy products should be considered for restriction.

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 is experienced: 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
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to 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, do not mix it with very hot (above 50°C) or very 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 her doctor or pharmacist before using this medicine.
Due to lack of data, the use of Enterol during pregnancy is not recommended.
Saccharomyces boulardii is not absorbed into breast milk. Due to lack of data, the benefit-risk ratio should be considered before using Enterol during breastfeeding.
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Driving and using machines
Enterol does not affect 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 has hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should contact 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 contact a doctor before taking the medicine.
Enterol contains sorbitol
One sachet of this medicine contains 0.10 mg of sorbitol.
Enterol contains glucose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.
May be harmful to teeth.

3. How to take Enterol

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor 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. Diarrhoea treatment 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, mixed well, and 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.
If you forget to take 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 will experience them.
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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 skin 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 also 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, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Enterol

Do not store above 25°C. Keep in the original packaging to 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 carton. 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. Such measures 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; one sachet contains 250 mg of yeast.
Other ingredients: monohydrate lactose, fructose, anhydrous colloidal silicon dioxide (Aerosil 200), fruit flavour (containing sorbitol (E 420)).

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 parallel importer.
Marketing authorisation holder in Latvia, country of export:
BIOCODEX, 22 rue des Aqueducs, 94250 Gentilly, France
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
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Marketing authorisation number in Latvia, country of export: 97-0021
Parallel import authorisation number: 241/25
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