Enterol

Package Leaflet: Information for the Patient

Enterol,250 mg, powder for oral suspension
Saccharomyces boulardiiCNCM I-745

Read the package leaflet carefully 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 your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Enterol and what is it 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 is Enterol and what is it used for

Enterol is an oral anti-diarrheal medicine, whose active substance is lyophilized yeast Saccharomyces boulardii, classified as probiotics, i.e. living microorganisms that bring health benefits to the host organism.
The intestinal bacterial flora consists of billions of microorganisms. Maintaining the balance of the intestinal microflora is necessary to ensure the essential functions of the digestive tract, such as:
digestion, resistance to infections, and strengthening the natural immune system.
The balance of the bacterial flora is delicate and can be disrupted by many factors:
gastrointestinal infections, both viral and bacterial, taking certain medications, including antibiotics, changes in dietary habits. This can cause a range of digestive problems leading to diarrhea.
Enterol is a medicine that affects the intestinal flora, a so-called "substitute for natural flora", which allows for the balancing of its temporary disruption.
Enterol is used in:

• treatment of acute infectious diarrhea
• prevention of antibiotic-associated diarrhea
• recurrent diarrhea caused by Clostridium difficileinfection, as an adjunct to treatment with vancomycin or metronidazole
• prevention of diarrhea associated with enteral nutrition
• prevention of traveler's diarrhea
• supportive treatment of diarrhea occurring in irritable bowel syndrome (IBS)

If after 2 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Enterol

When not to take Enterol

Warnings and precautions

Before starting treatment with Enterol, discuss it with your doctor.
It is not recommended to open sachets near patients with a central venous catheter to prevent unwanted fungal colonization of the catheter, especially through contaminated hands. There have been reports of very rare cases of fungemia (fungal penetration into the blood) with accompanying fever and positive blood culture results, even in patients not treated with Saccharomyces boulardii. In all reported cases, fungemia resolved after antifungal treatment or, when necessary, after removal of the central venous catheter.
As a supplement to treatment, it is recommended:
adequate hydration of the body (rehydration) by consuming large amounts of salty or sweet drinks to compensate for fluid loss due to diarrhea (average daily water intake for an adult is 2 liters)
maintenance of an appropriate dietary regimen, excluding certain foods, such as:
fruits, green vegetables, spicy dishes, frozen food, chilled drinks; while recommending the consumption of grilled meat and rice; it is recommended to consider limiting the consumption of milk and dairy products.
You should immediately consult your doctor if:

• there is no improvement after 2 days of treatment
• you have a fever, vomiting
• blood or mucus appears in the stool
• you experience increased thirst, dry mouth: these are symptoms of impending dehydration, i.e. significant fluid loss due to diarrhea. You should contact your doctor, who will decide on the need for oral or intravenous rehydration.

Enterol and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Enterol at the same time as oral antifungal medicines (medicines used to treat fungal infections).

Enterol with food, drink, and alcohol

Enterol contains live cells. For this reason, it should not be mixed with very hot (above 50°C) or cold liquids, foods, or alcohol, as this could destroy the yeast cells.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Due to the lack of data, it is not recommended to use the medicine during pregnancy.
Saccharomycesboulardiiis not absorbed into breast milk. Due to the lack of data, it is recommended to consider the benefit-risk ratio before taking Enterol during breastfeeding.

Driving and using machines

The medicine does not affect driving or using machines.

Enterol contains fructose

One sachet of the medicine contains 471.90 mg of fructose.
In case of frequent use of this medicine or use for a long time (e.g. for two weeks), fructose may damage teeth.
If you or your child have previously been diagnosed with intolerance to some sugars or have a rare genetic disorder, hereditary fructose intolerance, in which the body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.

Enterol contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

The medicine contains sorbitol

One sachet of the medicine contains 0.10 mg of sorbitol.

Enterol contains glucose

• If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
• It may be harmful to teeth.

Enterol contains flavoring substances, which are components of the fruit flavor: linalool, d-limonene, and eugenol.

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 you are unsure, consult your doctor or pharmacist.
Recommended dosage for adults and children
acute infectious diarrhea: 1 to 2 sachets per day for up to 1 week
antibiotic-associated diarrhea: 1 to 2 sachets per day, during and after antibiotic therapy
diarrhea caused by C. difficileinfection: 4 sachets per day for up to 4 weeks
diarrhea associated with enteral nutrition: 1 to 2 sachets per day
traveler's diarrhea: 1 to 4 sachets per day for up to 1 week
supportive treatment of diarrhea occurring in irritable bowel syndrome (IBS): 1 sachet 1 to 2 times a day. Diarrhea treatment should be continued for several days after symptoms resolve.
Method of administration
Take orally.
The contents of the sachet should be added to a small amount of water or a sweetened drink, mixed, and drunk. The powder from the sachet can also be mixed with food or added to a bottle of food for a child. Do not mix with liquids or foods that are too hot (temperature above 50°C), frozen, or contain alcohol.

Missing a dose of Enterol

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (occurring in less than 1 in 1000): a few cases of bloating have been reported.
Very rare (occurring in less than 1 in 10,000): local rash, allergic reactions, hives, itching, anaphylactic reactions, facial swelling, angioedema, rash all over the body (exanthema), fungal penetration into the blood (fungemia).
Frequency not known: (frequency cannot be estimated from the available data): constipation, severe blood infection (sepsis).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Enterol

Store in a temperature below 25°C.
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 month.
Medicines should 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 of the medicine is lyophilized yeast Saccharomyces boulardiiCNCM I-745, one sachet contains 250 mg of yeast.
• The other ingredients are: lactose monohydrate, fructose, colloidal silica anhydrous (Aerosil 200), fruit flavor (containing sorbitol E420, linalool, d-limonene, eugenol, butylated hydroxyanisole E 320).

What Enterol looks like and contents of the pack

The pack contains 10 or 20 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

BIOCODEX
22 rue des Aqueducs
94250 Gentilly, France

Manufacturer

BIOCODEX
1 avenue Blaise Pascal
60 000 Beauvais, France
To obtain more detailed information, please contact the representative of the marketing authorization holder:
BIOCODEX Polska Sp. z o.o.
ul. Krakowiaków 34

• 02 - 255 Warsaw tel. (22) 243-65-00

Date of last revision of the leaflet: September 2024