Enterol

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Enterol
250 mg, powder for oral suspension
Saccharomyces boulardii CNCM I-745
Please read carefully the entire leaflet 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 you can read it again if needed.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions 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 of the leaflet:

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 substance 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 ensuring important gastrointestinal functions such as:
digestion, protection against 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 medications including antibiotics, and changes in dietary habits. This may lead to various digestive problems resulting in diarrhea.
Enterol is a medicine affecting intestinal flora, a so-called "natural flora substitute," which helps restore balance in case of transient disturbances.
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 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 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")
• in 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.
It is not recommended to open sachets near patients with a central venous catheter in place,
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 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:

• maintain adequate hydration (rehydration) by consuming large amounts of salty or sweetened drinks 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; reduction of milk and dairy products should be considered.

Seek medical advice immediately if:

• there is no improvement after 2 days of treatment
• fever or vomiting occurs
• blood or mucus appears in the stool
• increased thirst or dryness of the tongue occurs: 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
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 simultaneously with oral antifungal medicines (medicines used to treat fungal infections).

Enterol with food, drink and alcohol
Enterol contains live cells. Therefore, do not mix it with excessively hot (above 50°C) or cold liquids, food 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, consult your 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 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 fructose
One sachet of Enterol contains 471.90 mg of fructose.
With frequent use of this medicine or prolonged use (e.g. for two weeks), fructose may have a harmful effect on teeth.
If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or has hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.

Enterol contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

The medicine contains sorbitol (E 420)
One sachet of this medicine contains 0.10 mg of sorbitol (E 420).

Enterol contains glucose

• If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
• May have a harmful effect on teeth.

3. How to use Enterol

This medicine should always be taken exactly as described in this patient 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 sachets per day for up to 1 week
Antibiotic-associated diarrhoea: 1 to 2 sachets per day during and after antibiotic treatment
Diarrhoea caused by C. difficile infection: 4 sachets per day for up to 4 weeks
Diarrhoea related to enteral nutrition: 1 to 2 sachets per day
Travellers' diarrhoea: 1 to 4 sachets per day for up to 1 week
As an adjunct in the treatment of diarrhoea associated with irritable bowel syndrome (IBS): 1 sachet 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.
The contents of the sachet should be added to a small amount of water or sweetened beverage, stirred, and then consumed. The powder from the sachet may also be mixed with food or added to a bottle of infant formula. Do not mix with liquids or foods that are too hot (temperature above 50°C), frozen, or contain alcohol.
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 any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Rarely (occurring no more frequently than in 1 out of 1,000 people): several 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 (urticaria),
yeast fungi entering the bloodstream (fungemia).
Frequency unknown: (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 also 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 continued monitoring of the medicine's safety and helps gather further information on its safe use.

5. How to store Enterol

Do not store above 25°C.
Keep in the original packaging to protect from moisture.
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.
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 in the medicine is freeze-dried yeast Saccharomyces boulardii CNCM I-745; one sachet contains 250 mg of yeast.
• Other ingredients are: monohydrate lactose, fructose, anhydrous colloidal silicon dioxide (Aerosil 200), fruit flavour (containing sorbitol (E 420)).

What Enterol looks like and contents of the pack
The pack contains 10 or 20 sachets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Latvia, country of export:
Biocodex
22 rue des Aqueducs
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:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in Latvia, country of export: 97-0021
Parallel import authorisation number: 131/25