Package leaflet: Information for the user

Enterol Forte, 500 mg, powder for oral suspension in sachet
Saccharomyces boulardii CNCM I-745
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
your doctor or pharmacist.

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

Contents of the leaflet

What Enterol Forte is and what it is used for
Important information before taking Enterol Forte
How to take Enterol Forte
Possible side effects
How to store Enterol Forte
Contents of the pack and other information

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

Enterol Forte is an oral medicine whose active ingredient consists of lyophilized yeast
Saccharomyces boulardii, classified as probiotics—live microorganisms that provide health benefits to the host.
The intestinal microbiota (flora) consists of billions of microorganisms. Maintaining the balance of the gut microbiota is essential for important gastrointestinal functions such as digestion, protection against infections, and strengthening natural immunity.
However, the balance of bacterial microbiota 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 diarrhoea.
Enterol Forte is a medicine that affects the intestinal microbiota, a so-called "natural microbiota substitute," which helps restore its temporary imbalance.
Enterol Forte is used in adults for the prevention and treatment of diarrhoea of various origins, such as:

acute infectious diarrhoea (bacterial or viral),
antibiotic-associated diarrhoea and inflammatory bowel diseases,
gastrointestinal side effects during Helicobacter pylori eradication therapy,
recurrent diarrhoea caused by Clostridium difficile infection, as an adjunct to vancomycin or metronidazole treatment.

If there is no improvement after 2 days, or if you feel worse, consult your doctor.
Enterol Forte is intended for adults. This medicine is not intended for use in children and adolescents. For children and adolescents, use Enterol 250 mg.

2. Important information before using Enterol Forte

When not to use Enterol Forte:

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 is allergic to yeast, particularly Saccharomyces boulardii
if the patient has a central venous catheter in place (see section Warnings and precautions)
patients with severely weakened immunity or who are hospitalized due to serious illnesses or disorders (weakening) of the immune system.

Warnings and precautions
It is not recommended to open sachets 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 fungemia (fungal penetration
into the bloodstream) associated with fever and positive blood culture, 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 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 diarrhea (the average daily fluid requirement for an adult is 2 liters)
maintain an appropriate diet, excluding certain foods such as: fruits, green vegetables, spicy foods, frozen food, chilled 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 dry mouth occur: these are symptoms of developing dehydration, meaning significant fluid loss due to diarrhea. A doctor should be contacted to determine whether oral or intravenous rehydration is necessary.

Enterol Forte and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.
Do not take Enterol Forte simultaneously with oral antifungal medicines (medicines used to treat fungal infections).
Use of Enterol Forte with food and drink
Enterol Forte contains live cells. Therefore, it should not be mixed with liquids or foods that are too hot (over 50°C) or too cold, or with alcohol, as this could destroy the yeast cells.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
As a precaution, the use of Enterol Forte during pregnancy is not recommended.
Saccharomyces boulardii is not excreted into breast milk. Due to lack of data, the benefit-risk balance should be carefully considered before using Enterol Forte during breastfeeding.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Enterol Forte contains fructose and lactose
This medicine contains 943.8 mg of fructose in each sachet.
If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking this medicine.
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 Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. In case of doubt, consult your doctor or pharmacist.
Recommended dosage
Acute infectious diarrhoea (bacterial or viral): 1 to 2 sachets per day for up to
1 week.
Diarrhoea associated with antibiotic use and inflammatory bowel diseases: 1 to 2 sachets per day,
during and after antibiotic therapy.
Adverse effects during H. pylori eradication: 1 to 2 sachets per day.
Diarrhoea caused by C. difficile infection: 2 sachets per day for up to 4 weeks.
Method of administration
The product is for oral use.
The contents of a sachet should be poured into a small amount of water or sweetened beverage, mixed,
and taken immediately. The powder from the sachet may also be mixed with food. It is important that the water
or food is not too hot.
Missed dose of Enterol Forte
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 effects

Like all medicines, this medicinal product may cause adverse effects, although not everyone experiences them.
Rare (occurring in fewer than 1 in 1,000 but more than 1 in 10,000 people): flatulence.
Very rare (occurring in fewer than 1 in 10,000 people): allergic reactions: itching, blistering (urticaria), rash, localised or generalised exanthema, facial connective tissue swelling (angioedema), anaphylactic reaction and even shock, translocation of yeast into the bloodstream (fungaemia).
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 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Enterol Forte

Keep this 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.
There are no special precautions for storage of this medicine.
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 help protect the environment.

6. Contents of the pack and other information

What Enterol Forte contains

The active substance is lyophilized Saccharomyces boulardii CNCM I-745; one sachet contains 500 mg of yeast.
Other ingredients are: monohydrate lactose, fructose, anhydrous colloidal silicon dioxide, tutti-frutti flavour.

What Enterol Forte looks like and contents of the pack
Sachets containing light brown powder.
Carton box containing 10, 14 or 20 PET/Aluminium/PE sachets.
Marketing Authorisation Holder
BIOCODEX
7 avenue Gallieni
94250 Gentilly
France
Manufacturer
BIOCODEX
1 avenue Blaise Pascal
60000 Beauvais
France
For further information, please contact the local representative of the Marketing Authorisation Holder:
BIOCODEX Polska Sp. z o.o.
ul. Krakowiaków 34
02-255 Warsaw
tel. (22) 243-65-00