Ultra - yeast 50 Mg 50 Capsules

Ultra-Levura is a medicine that contains as its active ingredient a probiotic yeast called Saccharomyces boulardii.

It is indicated for the symptomatic treatment of diarrhea of nonspecific origin and prevention of diarrheal processes caused by the administration of antibiotics in adults and adolescents over 12 years of age.

You should consult a doctor if your condition 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 any of the other ingredients of Ultra-Levura, (listed in section 6)
• If you are allergic (hypersensitive) to yeast.
• If you have a central venous catheter.
• Immunocompromised patients or those hospitalized due to severe illness or impaired/weakened immune system.

Warnings and precautions

Consult your doctor or pharmacist before you start taking Ultra-Levura.

Take special care 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 a sensation of dry tongue, as these are symptoms of dehydration.
• The capsules should not be opened in the vicinity of patients with central venous catheters, to avoid any colonization, especially those transmitted by hands to the catheter.

Children

Children under 12 years of age cannot take this medicine.

Taking Ultra-Levura with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ultra-Levura may interact with medications such as:

• Antifungal medications (to treat fungi).

Take Ultra-Levura with food, drinks and alcohol

During treatment with Ultra-Levura, you should not consume very hot drinks or foods (temperature above 50ºC), ice cream or foods containing alcohol, as Saccharomyces boulardii contains live cells.

Fertility, pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

The benefit/risk ratio should be assessed before using it during pregnancy and breastfeeding.

There is no clinical data on the effect on fertility, and the potential risk to humans is unknown.

Driving and operating machinery

Ultra-Levura has no influence on the ability to drive and operate machinery.

Ultra-Levura contains lactose and sucrose

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Follow the instructions for administering this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult 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 of age : 5 to 10 capsules (250 to 500 mg) per day divided into two doses (morning and evening).

How to take:

This medication is taken orally.

The capsules are taken whole with water.

Administer preferably before meals.

Special populations

Patients with a central venous catheter, immunocompromised patients, or critically ill patients : This medicine is contraindicated in these patients (see section 2). Additionally, due to the risk of airborne contamination, the capsules should not be opened in these patients' rooms; special care should be taken when opening them in their immediate vicinity, and hands should be washed thoroughly after handling the medicine.

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 National Poison Control Center (telephone: 91.562.04.20), indicating the medicine and the amount ingested.

Like all medicines, Ultra-Levura can cause side 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 (<1/10,000): 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 unavailable data): constipation.

Immunological alterations

• Very rare (<1/10,000): allergic reaction with itching, hives, rash, skin reddening and local or general swelling.

Reporting of adverse effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es.

By reporting side effects you can help provide more information on the safety of this medicine.

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

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of down the drain or in the trash. Take any unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of unused medicines and their packaging. By doing so, you will help protect the environment.

Ultra-Yeast Composition

The active ingredient is Saccharomyces boulardii .

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

Product appearance and package contents

Ultra-Levura comes in white hard capsules.

Each package contains 20 or 50 hard capsules.

Marketing Authorisation Holder:

BIOCODEX

7 avenue Gallieni

94250 Gentilly (France)

Responsible for manufacturing:

BIOCODEX

1 Avenue Blaise Pascal

60000 Beauvais (France)

Local Representative

Zambon SAU

Maresme 5, Pol. Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda - Barcelona

Date of last revision of this leaflet: December 2020

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