Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Enterol (Enterol), 250 mg, hard capsules
Saccharomyces boulardii CNCM I-745
Enterol and Enterol are the same brand names of the same medicine written in Polish and Bulgarian.
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 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 your condition worsens, consult your doctor.

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 pack and other information

1. What Enterol is and what it is used for

Enterol is an oral anti-diarrheal medicine. Its active substance 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, resistance to 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 affects intestinal flora, a so-called "natural flora substitute", which helps restore temporary imbalances in gut microflora.
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,
supportive treatment of diarrhea associated with irritable bowel syndrome (IBS).

If there is no improvement after 2 days, or if your condition worsens, consult your 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 reduced 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 or pharmacist.
It is not recommended to open the capsules near patients with a central venous catheter
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) 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 sweetened 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 dishes, frozen food, and chilled drinks; grilled meat and rice are recommended; milk and dairy products should be consumed with caution.

Seek medical advice immediately 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 a doctor who will decide whether oral or intravenous rehydration is necessary.

Enterol with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends 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, 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 the patient is pregnant or breastfeeding, suspects she might 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 insufficient data, the benefit-risk ratio should be carefully considered before using Enterol during breastfeeding.

Driving and operating machinery
Enterol has no effect 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
Adjunctive treatment of diarrhoea in 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
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 formula.
In children under 6 years of age, administration of intact capsules is not recommended due to the risk of choking; it is advised to open the capsule and mix its contents with drink or food.

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 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 fungi entering the bloodstream (fungemia).
Frequency not known: (frequency cannot be estimated from available data): constipation, severe blood infection (sepsis).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information on the safety of this medicine can be collected.

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 30ºC. Keep in the original packaging to protect from light and moisture.
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 hard capsule contains 250 mg of yeast.
Other components: monohydrate lactose, magnesium stearate; capsule shell ingredients: gelatin, titanium dioxide.

What Enterol looks like and contents of the pack
White hard capsules containing a light brown powder with a characteristic odour.
Aluminium blisters in a cardboard box containing 10, 12, 18, 20, 48 or 50 hard capsules.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
BIOCODEX, 7 avenue Gallieni, 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
Marketing Authorisation Number in Bulgaria, country of export: 9600192
Parallel Import Authorisation Number: 93/20