Package leaflet: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Enterol, 250 mg, hard capsules
Saccharomyces boulardii CNCM I-745
Enterol (Enterol), 250 mg, hard capsules
Saccharomyces boulardii CNCM I-745
Enterol and Enterol are the same trade names of the same medicinal product written in Polish and Bulgarian.
Please read carefully the contents of this leaflet 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 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 or pharmacist. See section 4.
If there is no improvement within 2 days or if your condition worsens, contact 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 pack 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—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 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 intestinal flora, a so-called "natural flora substitute," which helps restore temporary imbalances in the gut microbiota.
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 adjunctive treatment in diarrhea associated with irritable bowel syndrome (IBS)

If there is no improvement within 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 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 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 penetration 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 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, excluding 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 reduction.

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 a doctor who will decide on the need for oral or intravenous rehydration.

Enterol and other medicines
Inform your doctor or pharmacist about all medicines currently taken 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, foods, 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, use of Enterol during pregnancy is not recommended.
Saccharomyces boulardii is not absorbed into breast milk. Due to lack of data, consideration of the benefit-risk balance is recommended before using Enterol during breastfeeding.

Driving and operating machinery
Enterol does not affect the ability to drive or operate machinery.

Enterol contains monohydrate lactose
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
*C.\ difficile-associated diarrhoea: 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 an adjunct in the treatment of diarrhoea occurring 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
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 recommended 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 missed dose.
If you have any further doubts concerning 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 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, pruritus, 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 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 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 reactions enables further information on the safety of the medicine to be collected.

5. How to store 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 30°C. 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. This will help protect the environment.

6. Contents of the pack and other information

What Enterol contains

The active substance is lyophilized yeast Saccharomyces boulardii CNCM I-745; one hard capsule contains 250 mg of yeast.
Other ingredients: 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.
Glass bottle with PE cap, in a cardboard box, containing 10, 20 or 50 hard capsules.
Al/Al blisters in a cardboard box, containing 6, 12, 18, 24, 30, 36, 42 or 48 hard capsules.
For more detailed 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Bulgaria, country of export: 9600192
Parallel Import Licence Number: 255/19