ULTRA-LEVURA 50 mg HARD CAPSULES

Introduction

Leaflet: information for the patient

Ultra-Levura 50 mg hard capsules

Saccharomyces boulardiiCNCM I-745?

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the leaflet:

1. What is Ultra-Levura and what is it used for.
2. What you need to know before taking Ultra-Levura
3. How to take Ultra-Levura
4. Possible side effects
5. Storage of Ultra-Levura
6. Package contents and additional information

1. What is Ultra-Levura and what is it used for

Ultra-Levura is a medication that contains the probiotic yeast Saccharomyces boulardiias its active ingredient.

It is indicated for the symptomatic treatment of diarrhea of unspecified origin and prevention of diarrhea processes produced by the administration of antibiotics in adults and adolescents over 12 years old.

You should consult a doctor if it worsens or does not improve after 2 days of treatment.

2. What you need to know before taking Ultra-Levura

Do not take Ultra-Levura:

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Ultra-Levura (included in section 6)
• If you are allergic (hypersensitive) to yeasts.
• If you have a central venous catheter.
• Immunocompromised or hospitalized patients due to severe illness or immune system impairment/debilitation.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ultra-Levura.

Be especially careful with Ultra-Levura:

• If diarrhea is accompanied by fever or vomiting.
• In case of blood in the stool.
• In case of very intense thirst or dry mouth sensation, as these are symptoms of dehydration.
• The capsules should not be opened near patients with a central venous catheter to avoid any colonization, especially those transmitted by hands to the catheter.

Children

Children under 12 years old cannot take this medication.

Taking Ultra-Levura with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Ultra-Levura may interact with medications such as:

• Antifungal medications (to treat fungi).

Taking Ultra-Levura with food, beverages, and alcohol

During treatment with Ultra-Levura, do not take hot beverages or foods (temperature above 50°C), ice cream, or those containing alcohol, as Saccharomyces boulardiicontains live cells.

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The benefit/risk ratio should be evaluated before using it in pregnancy and breastfeeding.

There are no clinical data on the effect on fertility; the possible risk in humans is unknown.

Driving and using machines

Ultra-Levura has no influence on the ability to drive and use machines.

Ultra-Levura contains lactose and sucrose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ultra-Levura

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The dose to be used will depend on the evolution of the symptoms and the minimum effective dose should always be used.

The recommended dose is:

Adults and adolescents from 12 years old: 5 to 10 capsules (250 to 500 mg) per day, divided into two doses (morning and evening).

How to take:

This medication is taken orally.

The capsules are taken whole with water.

Administer preferably before meals.

Special populations

Patients with a central venous catheter, immunocompromised, or in critical condition: This medication is contraindicated in these patients (see section 2). Additionally, due to the risk of airborne contamination, the capsules should not be opened in the rooms of these patients; special precautions should be taken when opening them near the patients, and hands should be washed well after handling the medication.

If you take more Ultra-Levura than you should

If you have taken more Ultra-Levura than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone: 91.562.04.20), indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, Ultra-Levura can cause side effects, although not everyone will experience them.

The most common side effect, although rare, is flatulence.

The side effects that can occur are:

Infections and infestations

• Very rare (<1/10,000): penetration of the yeast into the blood (fungemia).
• Frequency not known: severe hematological infection (sepsis).

Gastrointestinal disorders

• Rare (>1/10,000 to <1/1,000): flatulence.
• Frequency not known (cannot be estimated from the available data): constipation.

Immune system disorders

• Very rare (<1/10,000): allergic reaction with itching, hives, skin rash, redness, and local or general swelling.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ultra-Levura

Keep this medication out of the sight and reach of children.

Store in the original package to protect it from moisture.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ultra-Levura

The active ingredient is Saccharomyces boulardii.

The other components (excipients) are: lactose, magnesium stearate, and sucrose.

Appearance of the product and package contents

Ultra-Levura is presented in white hard capsules.

Each package contains 20 or 50 hard capsules.

Marketing authorization holder:

BIOCODEX

22 rue des Aqueducs

94250 Gentilly (France)

Manufacturer:

BIOCODEX

1 Avenue Blaise Pascal

60000 Beauvais (France)

Local representative

Zambon S.A.U.

Maresme 5, Pol. Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda – Barcelona (Spain)

Date of the last revision of this leaflet:December 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/