Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Enterol
250 mg, hard capsules
Saccharomyces boulardii CNCM I-745
Please read the entire leaflet carefully before using this 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
your 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 you feel worse, 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 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 microbiota 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, use of certain medications, including
antibiotics, and changes in dietary habits. This may lead to various digestive problems resulting in diarrhoea.
Enterol is a medicine that affects intestinal flora, a so-called "natural flora substitute", which
helps restore temporary imbalances in the gut microbiota.
Enterol is used for:

treatment of acute infectious diarrhoea
prevention of antibiotic-associated diarrhoea
recurrent diarrhoea caused by Clostridium difficile infection, as an adjunct to vancomycin or metronidazole therapy
prevention of diarrhoea associated with enteral nutrition
prevention of traveller's diarrhoea
adjunctive treatment of diarrhoea in 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 severely weakened immunity or those who are hospitalised (due to severe diseases or disorders (weakening) of the immune system)

Warnings and precautions
Before starting treatment with Enterol, discuss it with your doctor or pharmacist. It is not recommended to open 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) 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:

ensure adequate hydration (rehydration) by drinking large amounts of salty or sweet fluids 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, and 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 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 your doctor, who will decide whether oral or intravenous rehydration is necessary.

Enterol and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future 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 very hot (over 50°C) or cold liquids, food, or alcohol, as this could destroy the yeast cells.

Pregnancy and breastfeeding
If the patient is pregnant, 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 excreted into breast milk. However, due to insufficient data, the benefit-risk balance should be carefully considered before using Enterol during breastfeeding.

Driving and operating machinery
Enterol has no influence on 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 their doctor before taking this medicine.

3. How to take Enterol

This medicine should always be taken exactly as described in this patient information 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
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
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.

Instructions for use

Administer orally. 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 capsules is not recommended due to the risk of choking; it is advised to open the capsule and mix the contents with a drink or food.

If you forget to take Enterol

Do not take a double dose to make up for a forgotten dose.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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, 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department for 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 effects helps to provide more information on the safety of the medicine.

5. How to store the Enterol medicinal product

Keep this medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging in order to protect from moisture.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine Enterol contains

The active substance is lyophilized Saccharomyces boulardii CNCM I-745; one hard capsule contains 250 mg of the yeast.
Other ingredients: monohydrate lactose, magnesium stearate; capsule shell: gelatin, titanium dioxide (E 171).

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 10, 20 or 30 hard capsules.
For further information, please contact the responsible party 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Latvia, country of export: 97-0022
Parallel import authorisation number: 59/26