Lakcid Entero

Package Leaflet: Information for the Patient

Lakcid ENTERO, 250 mg, Hard Capsules

Saccharomyces cerevisiae var. boulardii

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 2 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Lakcid Entero and what is it used for
• 2. Important information before taking Lakcid Entero
• 3. How to take Lakcid Entero
• 4. Possible side effects
• 5. How to store Lakcid Entero
• 6. Contents of the pack and other information

1. What is Lakcid Entero and what is it used for

Lakcid Entero is an oral anti-diarrheal medicine, whose active substance is lyophilized yeast Saccharomyces cerevisiae var. boulardii(synonym Saccharomyces boulardii) belonging to probiotics. These yeasts are a component of the natural intestinal flora, the disruption of which can cause a number of digestive problems leading to diarrhea.

Lakcid Entero is used in:

• treatment of acute infectious diarrhea (occurring after consuming food or drinks containing pathogenic bacteria or after contact with rotaviruses)
• treatment of diarrhea occurring in irritable bowel syndrome (IBS)
• prevention of diarrhea associated with antibiotic use (diarrhea occurring during or after antibiotic use)
• recurrent diarrhea caused by Clostridium difficileinfection, as an adjunct to vancomycin or metronidazole treatment
• prevention of diarrhea associated with enteral nutrition
• prevention of traveler's diarrhea
• supportive treatment of Helicobacter pyloriinfection.

Lakcid Entero restores and helps maintain the proper composition of the intestinal bacterial flora, which is a natural barrier to the development of unfavorable microflora. The balance of the bacterial flora is delicate and can be disrupted by many factors, such as:

viruses transmitted through the airborne route

viruses in food, contaminated water, dirty hands (e.g., rotaviruses, noroviruses)

protozoa, such as Giardia lambliaor intestinal parasites

bacteria present in food or water (e.g., Salmonellarods)

products of bacterial metabolism, so-called enterotoxins, such as staphylococcal toxin present in contaminated dairy products, e.g., ice cream.

Consuming food or fluids containing bacteria or their metabolic products can lead to bacterial food poisoning.

Maintaining the balance of the intestinal microflora is essential for ensuring the proper functioning of the digestive tract, such as digestion, immunity to infections, and strengthening natural immunity.

2. Important information before taking Lakcid Entero

When not to take Lakcid Entero

• If the patient is allergic to yeast or any of the other ingredients of this medicine (listed in section 6).
• If the patient has a central venous catheter.
• If the patient has impaired immunity or is hospitalized due to severe illness or immune system disorders.

Warnings and precautions

Before starting treatment with Lakcid Entero, the patient should discuss it with their doctor or pharmacist.

As a supplement to treatment, it is recommended:

• proper hydration of the body (rehydration) through the consumption of glucose-electrolyte fluids (ORS) to compensate for fluid loss due to diarrhea (the average daily water requirement for an adult is 2 liters). Children should be given fluids very frequently, i.e., every 15 minutes. In the case of diarrheal diseases, especially in children, fluids and electrolytes should be used as the most important therapeutic measure. There are many ready-made ORS on the market, but you can also prepare such a solution at home by adding 1 teaspoon of kitchen salt and 8 teaspoons of sugar to 1 liter of boiled and cooled water.
• maintenance of an appropriate dietary regimen, excluding certain foods, such as fruits, green vegetables, spicy dishes, frozen foods, and chilled drinks; however, it is recommended to consume rice, pasta, salted crackers, potatoes, groats, bananas, soups, and cooked meat; it is also recommended to consider limiting the consumption of milk and dairy products.

The patient should immediately consult their doctor in the event of:

• no improvement after 2 days of treatment
• fever
• appearance of blood or mucus in the stool
• excessive thirst, dryness of the tongue, as these are symptoms of impending dehydration, i.e., significant fluid loss due to diarrhea. The doctor will decide on the need for hydration (oral or intravenous) depending on the severity of symptoms, age, and overall health of the patient.

Patients with immune system disorders

Similarly, as with all medicines containing live microorganisms, special attention should be paid to the handling of the product in the presence of patients with immune system disorders, especially those with a central venous catheter, but also peripheral, including those who do not take Saccharomyces cerevisiae var. boulardii. 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 results, even in patients not treated with Saccharomyces cerevisiae var. boulardii. In all reported cases, fungemia resolved after antifungal treatment or, when necessary, after removal of the central venous catheter.

Laboratory tests

If microbiological stool tests are performed during or shortly after treatment with this medicine, the laboratory should be informed about the use of this medicine, as otherwise, false-positive results may be obtained.

Children and adolescents

This medicine should not be used in infants under 6 months of age, as there are no appropriate doses and safety studies available.

Treatment of diarrhea in children aged 6 months to 2 years should be carried out under medical supervision.

Lakcid Entero and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Concomitant use of this medicine and antifungal medicines may interfere with the action of Lakcid Entero.

Concomitant use with monoamine oxidase inhibitors may increase blood pressure.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Given the widespread use of yeast as a food ingredient, there is no indication of risk during pregnancy and breastfeeding. However, due to the lack of data, it is not recommended to use during pregnancy and breastfeeding.

There is no data on the effect on fertility.

Driving and using machines

Lakcid Entero does not affect the ability to drive and use machines.

Lakcid Entero contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Lakcid Entero

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Children over 6 months, adolescents, and adults:

Treatment of acute diarrhea and diarrhea occurring in irritable bowel syndrome

1 capsule 1 to 2 times a day. Diarrhea treatment should be continued for several days after symptoms have resolved.

Prevention of diarrhea associated with antibiotic use

1 capsule 1 to 2 times a day, during and after antibiotic therapy. The product should be taken for several days after antibiotic use.

Recurrent diarrhea caused by Clostridium difficileinfection

4 capsules per day for up to 4 weeks.

Prevention of diarrhea associated with enteral nutrition

3 capsules corresponding to 750 mg of lyophilized Saccharomyces cerevisiae var. boulardiiin 1.5 liters of enteral nutrition solution per day.

Prevention of traveler's diarrhea

1 capsule 1 to 2 times a day. The product should be started 5 days before travel and continued throughout the trip.

Supportive treatment of Helicobacter pyloriinfection.

1 capsule 2 times a day.

In children aged 6 months to 2 years, treatment should be carried out under medical supervision.

Method of administration

Oral administration.

The capsule should be swallowed with a sufficient amount of liquid (preferably a glass of water). The medicine should be taken before a meal.

For patients who have difficulty swallowing and for children under 6 years of age, as well as for tube feeding, the capsule should be opened and its contents mixed with food or liquid (room temperature) or enteral nutrition solution.

Duration of treatment

There are no known time limits for the use of probiotics.

Overdose of Lakcid Entero

No cases of poisoning with products containing lyophilized yeast have been reported so far.

In the event of an overdose, no special action is required.

Missed dose of Lakcid Entero

A double dose should not be taken to make up for a missed dose.

Treatment with the medicine should be continued as directed by the doctor or according to the dosage schedule described in the package leaflet for the patient.

Stopping treatment with Lakcid Entero

The patient can stop taking Lakcid Entero at any time, as stopping treatment is generally considered harmless.

If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following symptoms occur, the patient should stop taking the medicine and contact their doctor immediately:

• allergic reactions, including severe anaphylactic reactions (symptoms may include pale skin, itching, low blood pressure, wheezing, and even loss of consciousness),
• swelling of the face, lips, tongue, or throat which may cause difficulty breathing (angioedema),
• shortness of breath (dyspnea).

Other side effects:

Very rare (occurring in less than 1 in 10,000 people):

• fungal infection of the blood (fungemia).

Frequency not known (frequency cannot be estimated from the available data):

• bloating, constipation,
• severe blood infection (sepsis),
• facial swelling,
• local rash, rash all over the body (exanthema),
• hives, itching.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.

Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Lakcid Entero

The medicine should be stored 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 month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lakcid Entero contains

• The active substance of the medicine is Saccharomyces cerevisiae var. boulardii. Each hard capsule contains 250 mg of lyophilized (221.25 mg of active substance) yeast Saccharomyces cerevisiae var. boulardii(synonym Saccharomyces boulardii), which corresponds to at least 10 billion live cells/1 g of lyophilizate.
• The other ingredients are: lactose, magnesium stearate, gelatin, titanium dioxide (E171), copper complex of chlorophyll (E141), yellow iron oxide (E172), water, sodium dodecyl sulfate.

What Lakcid Entero looks like and contents of the pack

Long, shiny, opaque hard gelatin capsules with a light green body and a yellow cap, filled with a granular powder of ochre to beige-gray color with a characteristic odor.

PVC/PE/PVDC/Aluminum blister pack in a cardboard box.

Package sizes:

10, 20, 50, or 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Ardeypharm GmbH

Loerfeldstr. 20

58313 Herdecke, Germany

Date of last revision of the package leaflet: