Enterol

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Enterol, 250 mg, Hard Capsules

Saccharomyces boulardiiCNCM I-745

Enterol (Ентерол), 250 mg, Hard Capsules

Saccharomyces boulardiiCNCM I-745
Enterol and Ентерол are the same trade names of the same drug written in Polish and Bulgarian.

It is Necessary to Carefully Read the Contents of the Leaflet Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet, or According to the Doctor's or Pharmacist's Recommendations.

• The Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, the Pharmacist Should be Consulted.
• If the Patient Experiences any Undesirable Symptoms, Including any Undesirable Symptoms not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If There is no Improvement After 2 Days or the Patient Feels Worse, the Doctor Should be Contacted.

Table of Contents of the Leaflet:

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

1. What is Enterol and What is it Used for

Enterol is an Oral Anti-Diarrheal Medication, whose Active Substance is Lyophilized Saccharomyces boulardiiYeast, Classified as Probiotics, i.e., Living Microorganisms that Provide Health Benefits to the Host Organism.
The Intestinal Bacterial Flora Consists of Billions of Microorganisms. Maintaining the Balance of the Intestinal Microflora is Necessary to Ensure the Proper Functions of the Digestive Tract, such as:
Digestion, Resistance to Infections, and Strengthening the Natural Immunity.
The Balance of the Bacterial Flora is Delicate and can be Disrupted by Many Factors:
Gastrointestinal Infections, both Viral and Bacterial, Taking Certain Medications, including Antibiotics, Changes in Dietary Habits. This can Cause a Range of Digestive Problems Leading to Diarrhea.
Enterol is a Medication that Affects the Intestinal Flora, a so-called "Substitute for Natural Flora", which Allows for the Balance of its Temporary Disorder.
Enterol is Used in:

• Treatment of Acute Infectious Diarrhea
• Prevention of Antibiotic-Associated Diarrhea
• Recurrent Diarrhea Caused by Clostridium difficileInfection, 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 the Patient Feels Worse, the Doctor Should be Consulted.

2. Important Information Before Using Enterol

When Not to Use Enterol:

• If the Patient is Allergic to the Active Substance or any of the Other Ingredients of this Medication (Listed in Section 6)
• If the Patient has 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

Before Starting to Use Enterol, the Doctor or Pharmacist Should be Consulted.
It is Not Recommended to Open Capsules Near Patients with a Central Venous Catheter to Prevent Unwanted Fungal Colonization of the Catheter, Especially Through Contaminated Hands. There have been Reports of Very Rare Cases of Fungemia (Fungal Penetration 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 Central Venous Catheter.
As a Supplement to Treatment, it is Recommended:

• Proper Hydration of the Body (Rehydration) by Consuming Large Amounts of Salty or Sweet Drinks to Compensate for Fluid Loss Due to Diarrhea (Average Daily Water Requirement for an Adult is 2 Liters)
• Maintaining 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 Limiting the Consumption of Milk and Dairy Products.

The Doctor Should be Consulted Immediately in Case of:

• Lack of Improvement After 2 Days of Treatment
• Fever, Vomiting
• Appearance of Blood or Mucus in the Stool
• Feeling of Increased Thirst, Dryness of the Tongue: These are Symptoms of Beginning Dehydration, i.e., Loss of a Significant Amount of Fluids Due to Diarrhea. The Doctor Should be Consulted, who will Decide on the Need for Oral or Intravenous Rehydration.

Enterol and Other Medications

The Doctor or Pharmacist Should be Informed About all Medications Currently or Recently Taken by the Patient, as well as Medications that the Patient Plans to Take.
Enterol Should not be Used Simultaneously with Oral Antifungal Medications (Medications Used to Treat Fungal Infections).

Enterol with Food, Drinks, and Alcohol

Enterol 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 and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Suspects that she may be Pregnant, or Plans to Have a Child, she Should Consult a Doctor or Pharmacist Before Using this Medication.
Due to the Lack of Data, it is Not Recommended to Use the Medication 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 During Breastfeeding.

Driving and Operating Machines

The Medication Does not Affect Driving and Operating Machines.

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 Medication.

3. How to Use Enterol

This Medication Should Always be Used Exactly as Described in this Patient Leaflet, or According to the Doctor's or Pharmacist's Recommendations. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
Recommended Dosage for Adults and Children
Acute Infectious Diarrhea: 1 to 2 Capsules per Day, for a Period of up to 1 Week
Antibiotic-Associated Diarrhea: 1 to 2 Capsules per Day, During and After Antibiotic Therapy
Diarrhea Caused by C. difficileInfection: 4 Capsules per Day, for a Period of up to 4 Weeks
Diarrhea Associated with Enteral Nutrition: 1 to 2 Capsules per Day
Traveler's Diarrhea: 1 to 4 Capsules per Day for a Period of up to 1 Week
Supportive Treatment of Diarrhea Occurring in Irritable Bowel Syndrome (IBS): 1 Capsule 1 to 2 Times a Day. Diarrhea Treatment Should be Continued for Several Days After the Symptoms Have Resolved.
Method of Administration
Oral Use. The Capsule Should be Swallowed with a Glass of Water.
The Capsule can be Opened, and its Contents can be Added to a Small Amount of Sweetened Drink, Food, or Added to a Baby's Bottle.
In Children Under 6 Years of Age, it is Not Recommended to Use Capsules Due to the Risk of Choking; it is Recommended to Open the Capsules and Add their Contents to a Drink or Food.

Missing a Dose of Enterol

A Double Dose Should not be Used to Make up for a Missed Dose.
In Case of any Further Doubts Related to the Use of this Medication, the Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like any Medication, this Medication can Cause Side Effects, although they do not Occur in Everyone.
Rare (Occurring in Less than 1 in 1000): a Few Cases of Bloating have been Reported.
Very Rare (Occurring in Less than 1 in 10,000 People): Local Rash, Allergic Reactions, Urticaria, Itching, Anaphylactic Reactions, Facial Edema, Angioedema, Rash on the Entire Body (Erythema), Fungal Penetration into the Blood (Fungemia).
Frequency Not Known (Frequency Cannot be Determined from Available Data): Constipation, Severe Blood Infection (Septicemia).

Reporting Side Effects

If any Undesirable Symptoms Occur, Including any Undesirable Symptoms not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. Side Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By Reporting Side Effects, More Information can be Collected on the Safety of the Medication.

5. How to Store Enterol

The Medication Should be Stored in a Place Invisible and Inaccessible to Children.
This Medication Should not be Used After the Expiration Date Stated on the Packaging. The Expiration Date Indicates the Last Day of the Specified Month.
Store at a Temperature Below 30°C. Store in the Original Packaging to Protect from Light and Moisture.
Medications Should not be Disposed of in the Drain or Household Waste Containers. The Pharmacist Should be Asked how to Dispose of Medications that are no Longer Used. This will Help Protect the Environment.

6. Package Contents and Other Information

What Enterol Contains

• The Active Substance of the Medication is Lyophilized Saccharomyces boulardiiYeast CNCM I-745, one Hard Capsule Contains 250 mg of Yeast
• Other Ingredients are: Lactose Monohydrate, Magnesium Stearate; Capsule Shell Ingredients: Gelatin, Titanium Dioxide.

What Enterol Looks Like and What the Packaging Contains

White Hard Capsules Containing a Light Brown Powder with a Characteristic Odor.
A Glass Bottle with a PE Cap, in a Cardboard Box, Containing 10, 20, or 50 Hard Capsules.
Al/Al Blister Packs in a Cardboard Box, Containing 6, 12, 18, 24, 30, 36, 42, or 48 Hard Capsules.
For More Detailed Information, the Marketing Authorization Holder or Parallel Importer Should be Contacted.

Marketing Authorization Holder in Bulgaria, the Country of Export:

BIOCODEX
7 Avenue Gallieni
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

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Bulgaria, the Country of Export:9600192
Parallel Import Authorization Number:255/19

Date of Approval of the Leaflet: 08.07.2024

[Information about the Trademark]