ULTRA-LEVURA 250 mg POWDER AND SOLVENT FOR ORAL SUSPENSION

Introduction

Leaflet: information for the patient

Ultra-Levura 250 mg powder and solvent for oral suspension

Saccharomyces boulardiiCNCM I-745?

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

Follow the administration instructions of the medicine 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 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 medicine that contains a probiotic yeast called Saccharomyces boulardiias an active ingredient.

It is indicated for the symptomatic treatment of diarrhea of unspecified origin and prevention of diarrheal processes produced by the administration of antibiotics in adults and children.

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 takeUltra-Levura:

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Ultra-Levura, (listed in section 6).
• If you are allergic (hypersensitive) to yeasts.
• Patients with a central venous catheter (See "Warnings and precautions").
• Immunocompromised or hospitalized patients due to severe illness or alteration/weakening of the immune system.

Warnings and precautions

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

Be particularly careful with Ultra-Levura:

• If the 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 vials should not be opened near patients with a central venous catheter, to avoid any colonization, especially those transmitted by hand to the catheter.

Children and adolescents

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

TakingUltra-Levurawith other medicines

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

Ultra-Levura may interact with medicines such as: Antifungal medicines (to treat fungi).

TakingUltra-Levurawith food, drinks, and alcohol

During treatment with Ultra-Levura, do not take hot drinks or foods (above 50°C), icy 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 medicine.

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

No effect on fertility was detected during animal studies. There are no clinical data, and 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 sodium benzoate

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

This medicine contains 1.520.0 mg of fructose in each vial. 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 medicine.

This medicine contains 8.0 mg of sodium benzoate in each vial. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains less than 23 mg of sodium (1mmol) per vial; it is essentially "sodium-free".

3. How to take Ultra-Levura

Follow the administration instructions of the medicine 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 minimum effective dose should always be used.

The recommended dose is:

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

Use in children

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

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

Method of administration:

This medicine is taken orally. It is recommended to take it before meals.

• Screw the cap to the end, automatically the piston pierces the tab, releasing the powder into the solvent contained in the vial.
• Shake the vial well to mix the powder and the solvent.
• Unscrew and open the vial
• Drink the preparation immediately.

Special populations

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

If you take moreUltra-Levurathan 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, (phone: 91.5620420), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Ultra-Levura can cause side effects, although not everyone gets 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 available data): constipation.

Immune system disorders

• Very rare (<1/10,000): anaphylactic reaction with itching, urticaria, skin rash, 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

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

5. Storage of Ultra-Levura

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

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

Keep the packaging in the outer packaging to protect it from light.

Do not use this medicine if you observe visible signs of deterioration.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofUltra-Levura

The active ingredient is: Saccharomyces boulardiiCNCM I-745: 250 mg

The other components (excipients) are: lactose, fructose, forest fruit flavor, citric acid, potassium sorbate, sodium benzoate, purified water.

Appearance of the product and package contents

Ultra-Levura is a polyethylene terephthalate (PET) vial, equipped with a cap container composed of a polypropylene (PP) blade and a container of low-density polyethylene (LDPE) for the powder (active substance). The vial closure is a low-density polyethylene (LDPE) screw cap (anti-tamper-evident cap). Each vial contains 8 ml of sugary solution.

Each package contains 10 or 14 vials.

Marketing authorization holder and manufacturer

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:April 2022

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