Enterol

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the outer 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 taking 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 for future reference.
• If you need advice or further information, 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:

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. Its active ingredient 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 microflora 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 many factors: gastrointestinal infections (viral or
bacterial), use of certain medicines, including antibiotics, and changes in dietary habits. Such
disruptions 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 gut microflora.
Enterol is indicated 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 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 those who are hospitalized (due to severe illnesses 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 the capsules near patients with a central venous catheter in place, in order 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, 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 fluid requirement for an adult is 2 litres)
• maintain an appropriate diet, avoiding certain foods such as: fruits, green vegetables, spicy dishes, frozen food, and cold beverages; grilled meat and rice are recommended. Milk and dairy products should be considered for restriction.

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 your doctor, who will decide whether oral or intravenous rehydration is necessary.

Enterol and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for 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 (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 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
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, he or she 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:

• Acute infectious diarrhoea: 1 to 2 capsules per day, for up to 1 week during diarrhoea
• Antibiotic-associated diarrhoea: 1 to 2 capsules per day, during and after antibiotic therapy
• 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
• Adjunctive treatment of diarrhoea occurring in 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 formula.
In children under 6 years of age, administration of intact capsules is not recommended due to the risk of choking; it is advised to open the capsules 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 missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody 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 the available data): constipation,
severe blood infection (septicaemia).

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 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 effects helps to provide more information on the safety of the medicine.

5. How to store Enterol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the package. 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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: gelatin, titanium dioxide (E 171).

What Enterol looks like and contents of the pack
White hard capsules containing light brown powder with a characteristic odour.
Bottle made of colourless glass (type III) with a plastic stopper, packed in a cardboard box containing 10 hard capsules.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Greece, country of export:
PETSIAVAS S.A.
AG Anargyron 21
145 64 Kifissia
Greece
Manufacturer:
BIOCODEX
1 avenue Blaise Pascal
60 000 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 Greece, country of export: 67617/22-06-2018
Parallel Import Authorisation number: 116/24