Patient Information Leaflet

Ultra Levura 250 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 of 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.
• Patients with central venous catheter (See "Warnings and precautions").
• Immunocompromised patients 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 dry mouth sensation, as they are symptoms of dehydration.
• Do not open the capsules near patients with central venous catheter, to avoid any colonization, especially those transmitted by hands to the catheter.

Children and adolescents

Administration in children under 2 years will require medical advice.

Taking Ultra Levura with other medicines

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

Ultra Levura may interact with medicines such as:

• Antifungal medications (to treat fungi)

Taking Ultra Levura with food, drinks, and alcohol

During treatment with Ultra Levura, do not take hot drinks 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 medicine.

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

No effect on fertility was detected during animal studies. No clinical data, unknown possible risk for humans

Driving and operating machines

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

Ultra Levura contains lactose

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

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 of age and older: 1 to 2 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 the rooms of these patients. Special caution should be exercised when opening them near these patients, 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, go to your doctor immediately 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%
• 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 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 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 of Ultra Levura isSaccharomyces boulardii.

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

Appearance of the product and contents of the packaging

Ultralevura is presented in a transparent glass bottle with a white safety cap and in a thermoformed blister composed of an aluminum and aluminum/PVC laminate

Each package contains 10 or 20 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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.