Enterol

Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Enterol, 250 mg, hard capsules
Saccharomyces boulardii CNCM I-745
Please read all of this leaflet carefully before taking this medicine, because 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 possible future reference.
• 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 you feel worse, consult your doctor.

Table of contents:

1. What Enterol is and what it is used for
2. Important information before taking Enterol
3. How to take Enterol
4. Possible side effects
5. How to store Enterol
6. 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 microbiota is essential for important gastrointestinal functions such as digestion, protection against infections, and strengthening natural immunity.
However, this microbial balance is delicate and can be disrupted by various factors: gastrointestinal infections (both viral and bacterial), taking certain medications—including antibiotics—or changes in dietary habits. Such disruptions may lead to various digestive problems resulting in diarrhea.
Enterol is a medicine that acts on intestinal flora, a so-called "natural flora substitute," helping to restore temporary imbalances in gut microbiota.
Enterol is indicated for:

• Treatment of acute infectious diarrhea;
• Prevention of antibiotic-associated diarrhea;
• Recurrent diarrhea caused by Clostridium difficile infection, as an adjunct to treatment with vancomycin or metronidazole;
• 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 you feel worse, 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 hospitalized (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 capsules near patients with a central venous catheter
to prevent unwanted fungal colonization of the catheter, especially transmission via
contaminated hands. There have been reports of very rare cases of fungaemia (fungal penetration
into the blood) 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 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 foods, frozen food, chilled beverages; grilled meat and rice are recommended; milk and dairy products should be limited.

Seek immediate medical advice 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 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 or recently taken,
as well as any medicines the patient intends to use.
Do not take Enterol simultaneously with other 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, food, or alcohol, 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 lack of data, the benefit-risk balance should be considered 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 contact the doctor before taking this medicine.

3. How to use 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 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 related to 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 associated with 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, the use 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 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 everybody will experience them.
Rarely (occurring no more frequently than in 1 out of 1,000 people): a few cases of bloating have been reported.
Very rarely (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 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 of 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 helps to provide more information on the safety of the medicine.

5. How to store Enterol

Keep the medicine out of 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.
Do not store above 25°C. Store in the original packaging to protect from moisture.
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 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 in a cardboard box, containing 20 hard capsules.
For more detailed information, please contact the Marketing Authorisation Holder or the 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
Marketing Authorisation number in Latvia, country of export: 97-0022
Parallel Import Authorisation number: 240/25