Enterol

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Enterol (Ultra Levure)
250 mg, hard capsules
Saccharomyces boulardii CNCM I-745
Enterol and Ultra Levure are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the physician or pharmacist.

• Keep this leaflet for possible future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 2 days, or if the patient feels worse, consult a 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-diarrhoeal medicine. Its 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 important gastrointestinal functions such as digestion, protection against infections, and strengthening natural immunity.
However, this bacterial flora balance is delicate and can be disrupted by many factors: gastrointestinal infections (viral or bacterial), use of certain medicines—especially antibiotics—or changes in dietary habits. Such disturbances may lead to various digestive problems resulting in diarrhoea.
Enterol is a medicine that acts on intestinal flora, a so-called "natural flora substitute", which helps restore temporary imbalances in the intestinal microflora.
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 treatment with vancomycin or metronidazole;
• prevention of diarrhoea associated with enteral nutrition;
• prevention of travellers' diarrhoea;
• adjunctive treatment of diarrhoea associated with irritable bowel syndrome (IBS).

If there is no improvement after 2 days, or if the patient feels worse, consult a 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 components of this medicine (listed in section 6)
• if the patient has a central venous catheter in place (see Warnings and precautions)
• patients with significantly weakened immunity or those 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 in place,
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 bloodstream) associated with 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, the following are recommended:

• adequate hydration (rehydration) by drinking large amounts of salty or sweet beverages to compensate for fluid loss caused by diarrhoea (the average daily fluid requirement for an adult is 2 litres)
• maintaining an appropriate diet, excluding certain foods such as: fruits, green vegetables, spicy dishes, frozen food, chilled beverages; 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 dryness of the mouth occur: 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 used or recently taken, as well as any medicines the patient intends 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, it should not be mixed with liquids, food, or alcohol that are too hot (above 50°C) or too cold, 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 a 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
This medicine 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
• 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 supportive treatment in 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
Take 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 feed.

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 its contents with a drink or food.

Missed dose of 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 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 fungi entering the bloodstream (fungaemia).
Frequency not known (frequency cannot be estimated from available data): constipation, severe blood infection (septicaemia).

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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables the collection of further information on the safety of using 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.
Store below 25°C. 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 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.
Bottle made of colourless glass (type III) with a plastic cap, in a cardboard box,
containing 10 hard capsules.
For more detailed information, please contact the responsible entity or the parallel importer.
Responsible entity in Greece, country of export:
Petsiavas A.E.
Ag. Anargyron 21
145 64 K. Kifissia
Greece
Manufacturer:
BIOCODEX
1 avenue Blaise Pascal
60000 BEAUVAIS
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Greece, country of export: 67617/22-6-2018
54567/23-06-2021
Parallel import authorisation number: 15/24