Patient Information Leaflet

Ultra-Levura 250 mg Oral Suspension Powder

Saccharomyces boulardiiCNCMI-745?

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, consult your pharmacist.
• Report any side effects to your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.
• You should see a doctor if your symptoms worsen or do not improve after 2 days.

1. What is Ultra-Levura 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. Contents of the pack and additional information

Ultra-Levura is a medication that contains as its active ingredient a probiotic yeast calledSaccharomyces boulardii.

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

Consult a doctor if symptoms worsen or do not improve after 2 days of treatment.

Do not take Ultra-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 yeast.
• Patients with central venous catheter (See "Warnings and precautions").
• Immunocompromised patients or hospitalized due to severe illness or alteration/depletion of the immune system.

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 intense thirst or sensation of dry tongue, as they are symptoms of dehydration.
• Do not open the packets near patients with central venous catheter, to avoid any colonization, especially those transmitted by hand to the catheter.

Children and adolescents

Administration in children under 2 years will require medical advice.

Ultra-Levura with other medications

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

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

Ultra-Levura with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Evaluate the benefit-risk relationship before using it in pregnancy and breastfeeding.

No effects on fertility were detected in animal studies. There are no clinical data, the possible risk for humans is unknown.

Driving and operating machines

The influence of Ultra-Levura on the ability to drive and operate machines is nil.

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 him before taking this medication.

This medication contains 471.9 mg of fructose in each packet. 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 (HF), 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 packet.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

The recommended dose is:

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

Use in children

Children 2 years and older: 1 packet (250 mg) per day.

Administration in children under 2 years will require medical advice.

How to take:

This medication is taken orally.

The packets are taken dissolved in a glass of water.

Administer preferably before meals.

Special populations

Patients 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 packets should not be opened in the rooms of these patients, special caution should be taken when opening them in their vicinity, and hands should be washed thoroughly 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, seek immediate medical attention or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

Like all medications, Ultra-Levura may produce adverse effects, although not everyone will experience them.

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

The adverse effects that may occur are:

Infections and infestations

• Very rare (<1%
• Frequency not known: Severe hematological infection (sepsis)

Gastrointestinal alterations

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

Immunological alterations

• Very rare (<1%

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.

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

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

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ultra-Levura

The active principle isSaccharomyces boulardii.

The other components (excipients) are: fructosa, lactosa, anhydrous colloidal silica, tuttifrutti flavor (contains sorbitol).

Appearance of the product and contents of the packaging

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

Each package contains 10 or 20 sachets of powder.

Holder of the marketing authorization:

BIOCODEX

22 rue des Aqueducs

94250 Gentilly (France)

Responsible for manufacturing:

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 review of this leaflet:July 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.