ULTRA-LEVURA 250 mg POWDER FOR ORAL SUSPENSION

Introduction

Patient Information Leaflet

Ultra-Levura 250 mg powder for oral suspension

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 for 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 not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 days.

Contents of the leaflet:

1. What Ultra-Levura is and what it is 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 Ultra-Levura is and what it is 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 non-specific origin diarrhea and prevention of diarrhea processes produced by antibiotic administration in adults and children.

You should consult a doctor if your condition 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 any of the other components of Ultra-Levura (listed in section 6)
• If you are allergic (hypersensitive) to yeasts.
• Patient with central venous catheter (see "Warnings and precautions").
• Immunocompromised or hospitalized patients due to severe illness or immune system alteration/impairment.

Warnings and precautions

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

Be particularly 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 sachets should not be opened near patients with a central venous catheter to avoid any colonization, especially those transmitted by hands to the catheter.

Children and adolescents

Administration in children under 2 years of age will require medical advice.

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 consume hot beverages or foods (above 50°C), cold foods, or those containing alcohol, as Saccharomyces boulardiicontains live cells.

Pregnancy, breastfeeding, and fertility

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.

No effects on fertility were detected during animal studies. There are no clinical data; the possible risk to humans is unknown.

Driving and using machines

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

Ultra-Levura contains lactose, fructose, and sorbitol (E-420)

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 471.9 mg of fructose in each sachet. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult with your doctor before taking this medication.

This medication contains 0.1 mg of sorbitol in each sachet.

3. How to take Ultra-Levura

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

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

The recommended dose is:

Adults and adolescents from 12 years: 1 to 2 sachets (250 mg to 500 mg) per day, divided into two doses (morning and evening).

Use in children

Children from 2 years: 1 sachet (250 mg) per day.

Administration in children under 2 years of age will require medical advice.

How to take:

This medication is taken orally.

The sachets are taken dissolved in a glass of water.

Administer preferably before meals.

Special populations

Patient with central venous catheter, immunocompromised, or critically ill: This medication is contraindicated in these patients (see section 2). Additionally, due to the risk of airborne contamination, the sachets 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.

In case of overdose or accidental ingestion, go immediately to your doctor or call the Toxicology Information Service (telephone: 91.5620420), 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): yeast penetration 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 available data): constipation.

Immune system disorders

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed 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 sight and reach of children.

Store in the original package to protect it from moisture.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This 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: fructose, lactose, anhydrous colloidal silica, tuttifrutti flavor (contains sorbitol).

Appearance of the product and package contents

Ultra-Levura is presented in sachets with powder for oral suspension.

Each package contains 10 or 20 sachets of powder.

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:July 2021

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/.