Enterol Forte

Package Leaflet: Information for the Patient

Enterol Forte, 500 mg, Powder for Oral Suspension, in Sachet

Saccharomyces boulardiiCNCM I-745

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

This Medicinal Product Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Directed by the Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Ask Your Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Package 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 Package Leaflet

• 1. What is Enterol Forte and What is it Used for
• 2. Important Information Before Using Enterol Forte
• 3. How to Use Enterol Forte
• 4. Possible Side Effects
• 5. How to Store Enterol Forte
• 6. Contents of the Package and Other Information

1. What is Enterol Forte and What is it Used for

Enterol Forte is an Oral Medicinal Product, Whose Active Substance is Lyophilized Yeast Saccharomyces boulardii, Classified as Probiotics, i.e. Living Microorganisms that Provide Health Benefits to the Host Organism.
The Intestinal Microbiota (Flora) is Composed of Billions of Microorganisms. Maintaining the Balance of the Intestinal Microbiota is Essential for Ensuring the Proper Functions of the Digestive Tract, Such as: Digestion, Resistance to Infections, and Strengthening the Natural Immunity.
The Balance of the Intestinal Microbiota is Delicate and can be Disrupted by Many Factors: Infections of the Digestive Tract, Both Viral and Bacterial, Taking Certain Medications, Including Antibiotics, Changes in Dietary Habits. This can Cause a Series of Digestive Problems Leading to Diarrhea.
Enterol Forte is a Medicinal Product that Affects the Intestinal Microbiota, a so-called "Substitute for Natural Microbiota", which Allows for the Restoration of its Temporary Imbalance.
Enterol Forte is Used in Adults for the Prevention and Treatment of Diarrhea of Various Origins, Such as:

• Acute Infectious Diarrhea (Bacterial or Viral),
• Diarrhea Associated with Antibiotic Use and Inflammatory Bowel Diseases,
• Adverse Reactions During Eradication Therapy of Helicobacter pylori,
• Recurring Diarrhea Caused by Clostridium difficileInfection, as an Addition to Treatment with Vancomycin or Metronidazole.

If After 2 Days There is no Improvement or You Feel Worse, Contact Your Doctor.
Enterol Forte is Intended for Adults. This Medicinal Product is not Intended for Use in Children and Adolescents. For Children and Adolescents, the Medicinal Product Enterol 250 mg Should be Used.

2. Important Information Before Using Enterol Forte

When not to Use Enterol Forte:

• If You are Allergic to the Active Substance or any of the Other Ingredients of this Medicinal Product (Listed in Section 6)
• If You are Allergic to Yeast, in Particular Saccharomyces boulardii
• If You Have a Central Venous Catheter (See Section Warnings and Precautions)
• Patients with Significantly Reduced Immunity or Hospitalized (Due to Severe Diseases or Disorders (Impairment) of the Immune System).

Warnings and Precautions

It is not Recommended to Open Sachets Near Patients with a Central Venous Catheter, to Prevent Unwanted Colonization of Fungi on the Catheter, Especially Through Contaminated Hands. There are Reports of Very Rare Cases of Fungemia (Penetration of Fungi into the Blood) with Accompanying Fever and Positive Blood Culture, Even in Patients not Treated with Saccharomyces boulardii. In all Described Cases, Fungemia Resolved After Antifungal Treatment or, if Necessary, After Removal of the Catheter from the Central Vein.
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 Losses Caused by Diarrhea (Average Daily Water Requirement for an Adult is 2 Liters)
• Maintenance of an Appropriate Dietary Regimen, Excluding Certain Foods, Such as: Fruits, Green Vegetables, Spicy Dishes, Frozen Foods, Chilled Drinks; on the Other Hand, it is Recommended to Consume Grilled Meat and Rice; it is Advisable to Consider Reducing the Consumption of Milk and Dairy Products.

You Should Immediately Contact Your Doctor if:

• There is no Improvement After 2 Days of Treatment
• You Have a Fever, Vomiting
• There is Blood or Mucus in the Stool
• You Feel Excessive Thirst, Dryness of the Tongue: These are Symptoms of Beginning Dehydration, i.e. Loss of a Significant Amount of Fluids Due to Diarrhea. You Should Contact Your Doctor, who will Decide on the Need for Oral or Intravenous Rehydration.

Enterol Forte and Other Medicinal Products

Tell Your Doctor or Pharmacist About all Medicinal Products You are Currently Taking or Have Recently Taken, as well as Those You Plan to Take.
Do not Use Enterol Forte at the Same Time as Oral Antifungal Medicinal Products (Medicinal Products Used to Treat Fungal Infections).

Using Enterol Forte with Food and Drink

Enterol Forte Contains Live Cells. For this Reason, it Should not be Mixed with Too Hot (Above 50°C) or Cold Liquids, Foods, and Alcohol, as this Could Destroy the Yeast Cells.

Pregnancy, Breast-feeding, and Fertility

If You are Pregnant or Breast-feeding, Think You May be Pregnant or are Planning to Have a Child, Consult Your Doctor or Pharmacist Before Using this Medicinal Product.
As a Precaution, it is not Recommended to Use Enterol Forte During Pregnancy.
Saccharomyces boulardiiis not Absorbed into Breast Milk. Due to the Lack of Data, it is Recommended to Consider the Benefit-Risk Ratio Before Using Enterol Forte During Breast-feeding.

Driving and Using Machines

The Medicinal Product Does not Affect the Ability to Drive and Use Machines.

Enterol Forte Contains Fruktose and Lactose

The Medicinal Product Contains 943.8 mg of Fruktose in Each Sachet.
If You Have Previously been Diagnosed with Intolerance to Some Sugars or Have Previously been Diagnosed with Hereditary Fruktose Intolerance, a Rare Genetic Disorder in which the Body Does not Break Down Fruktose, You Should Consult Your Doctor Before Taking the Medicinal Product.
If You Have Previously been Diagnosed with Intolerance to Some Sugars, You Should Consult Your Doctor Before Taking the Medicinal Product.

3. How to Use Enterol Forte

This Medicinal Product Should Always be Used Exactly as Described in the Package Leaflet for the Patient or as Directed by the Doctor or Pharmacist. If You are in Doubt, Consult Your Doctor or Pharmacist.
Recommended Dosage
Acute Infectious Diarrhea (Bacterial or Viral): 1 to 2 Sachets per Day for up to 1 Week.
Diarrhea Associated with Antibiotic Use and Inflammatory Bowel Diseases: 1 to 2 Sachets per Day, During and After Antibiotic Therapy.
Adverse Reactions During Eradication Therapy of H. pylori: 1 to 2 Sachets per Day.
Diarrhea Caused by C. difficileInfection: 2 Sachets per Day for up to 4 Weeks.
Method of Administration
The Product Should be Used Orally.
The Contents of the Sachet Should be Poured into a Small Amount of Water or a Sweetened Drink, Mixed and Swallowed Immediately. The Powder from the Sachet can also be Mixed with Food. Remember that the Water or Food Should not be Too Hot.

Missing a Dose of Enterol Forte

Do not Take a Double Dose to Make up for a Missed Dose.
If You Have any Further Doubts About Using this Medicinal Product, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicinal Products, this Medicinal Product can Cause Side Effects, Although not Everybody gets them.
Rare (Occurring in Less than 1 in 1000, but More than 1 in 10,000 People): Abdominal Distension.
Very Rare (Occurring in Less than 1 in 10,000 People): Allergic Reactions: Itching, Blistering (Urticaria), Rash, Localized or Generalized Erythema, Swelling of the Connective Tissue of the Face (Angioedema), Anaphylactic Reaction and Even Anaphylactic Shock, Penetration of Yeast into the Blood (Fungemia).
Frequency not Known (Frequency cannot be Estimated from the Available Data): Constipation, Severe Blood Infection (Septicaemia).

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Package 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.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, You can Help Provide more Information on the Safety of this Medicinal Product.

5. How to Store Enterol Forte

Keep this Medicinal Product out of the Sight and Reach of Children.
Do not Use this Medicinal Product After the Expiry Date Stated on the Carton. The Expiry Date is the Last Day of the Specified Month.
There are no Special Precautions for Storage of the Medicinal Product.
Medicinal Products Should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicinal Products that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Enterol Forte Contains

• The Active Substance of the Medicinal Product is Lyophilized Yeast Saccharomyces boulardiiCNCM I-745, One Sachet Contains 500 mg of Yeast.
• The Other Ingredients are: Lactose Monohydrate, Fruktose, Colloidal Silica Anhydrous, Tutti-frutti Flavor.

What Enterol Forte Looks Like and What the Package Contains

Sachets Containing Light Brown Powder.
Paperboard Box Containing 10, 14 or 20 Sachets PET/Aluminum/PE.

Marketing Authorization Holder

BIOCODEX
7 avenue Gallieni
94250 Gentilly
France

Manufacturer

BIOCODEX
1 avenue Blaise Pascal
60000 Beauvais
France
To Obtain more Detailed Information, 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 Package Leaflet: