Patient Information Leaflet

Ultra-Levura 50 mg Hard Capsules

Saccharomyces boulardiiCNCM I-745?

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse 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 adolescents over 12 years old.

Consult a doctor if it worsens or does 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.
• If you are a carrier of a central venous catheter.
• Patients who are immunocompromised or hospitalized due to severe illness or alteration/debilitation 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 capsules near patients with central venous catheters, to avoid any colonization, especially those transmitted by hands to the catheter.

Children

Children under 12 years old cannot take this medication.

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 (temperature above 122°F or 50°C), ice cream or those containing alcohol, asSaccharomyces boulardiicontains live cells.

Fertility, pregnancy, and breastfeeding

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

The benefit-risk relationship should be evaluated before using it in pregnancy and breastfeeding.

No clinical data are available on the effect on fertility, and the possible risk in humans is unknown.

Driving and operating machines

The influence of Ultra-Levura on the ability to drive and operate machines is none.

Ultra-Levura contains lactose and saccharose

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

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

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

The recommended dose is:

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

How to take:

This medication is taken orally.

The capsules are taken whole with water.

Administer preferably before meals.

Special populations

Patients with 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 patient rooms, and special caution should be taken when opening them near these patients, and wash hands 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, or call the Toxicological Information Service (phone: 91.562.04.20), indicating the medication and the amount ingested.

Like all medications, Ultra-Levura may cause 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%
• Unknown frequency: Severe hematological infection (sepsis).

Gastrointestinal alterations

• Rare (>1/10,000 to <1%).
• Unknown frequency (cannot be estimated from unavailable 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 an 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.

Medications should not be disposed of through drains or 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 packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ultra-Levura

The active ingredient isSaccharomyces boulardii.

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

Appearance of the product and content of the packaging

Ultra-Levura is presented in hard white capsules.

Each package contains 20 or 50 hard capsules.

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:December 2020

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