Ultra-Levura 50 mg hard capsules
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Ultra-Levura 50 mg hard capsules
Saccharomyces boulardii CNCM I-745
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 2 days.
Leaflet contents:
- What Ultra-Levura is and what it is used for
- What you need to know before taking Ultra-Levura
- How to take Ultra-Levura
- Possible adverse effects
- How to store Ultra-Levura
- Contents of the pack and other information
1. What Ultra-Levura is and what it is used for
Ultra-Levura is a medicine containing as its active substance a probiotic yeast called Saccharomyces boulardii.
It is indicated for the symptomatic treatment of nonspecific diarrhea and prevention of diarrhea associated with antibiotic use in adults and adolescents over 12 years of age.
You should consult a doctor if symptoms worsen or do not improve after 2 days of treatment.
2. What you need to know before taking Ultra-Levura
Do not take Ultra-Levura:
- If you are allergic (hypersensitive) to the active substance or to any of the other components of Ultra-Levura (listed in section 6).
- If you are allergic (hypersensitive) to yeasts.
- If you have a central venous catheter.
- Immunocompromised patients or hospitalized patients due to severe illness or immune system impairment/weakness.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Ultra-Levura.
Take special care with Ultra-Levura:
- If diarrhea is accompanied by fever or vomiting.
- If blood is present in the stools.
- If you experience intense thirst or a dry tongue sensation, as these are symptoms of dehydration.
- Do not open the capsules near patients with central venous catheters, to avoid any possible colonization, especially transmission via hands to the catheter.
Children
Children under 12 years of age must not take this medicine.
Taking Ultra-Levura with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Ultra-Levura may interact with medicines such as:
- Antifungal medicines (used to treat fungal infections).
Taking Ultra-Levura with food, drinks, and alcohol
During treatment with Ultra-Levura, you should not consume very hot drinks or food (temperature above 50°C), ice cream, or products 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 become pregnant, consult your doctor or pharmacist before using this medicine.
The benefit-risk balance should be assessed before using this medicine during pregnancy and breastfeeding.
There are no clinical data on the effect on fertility; the potential risk in humans is unknown.
Driving and using machines
Ultra-Levura has no influence on the ability to drive or operate machinery.
Ultra-Levura contains lactose and sucrose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Ultra-Levura
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The dose used should depend on the progression of symptoms, and the lowest effective dose should always be used.
The recommended dose is:
Adults and adolescents aged 12 years and older: 5 to 10 capsules (250 to 500 mg) per day, divided into two doses (morning and evening).
How to take it:
This medicine is taken orally.
Swallow the capsules whole with water.
It is preferable to take them before meals.
Special populations
Patients with central venous catheters, 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 must not be opened in the rooms of these patients. Extreme caution should be taken when opening the capsules near these patients, and hands must be thoroughly washed after handling the medicine.
If you take more Ultra-Levura than you should
If you have taken more Ultra-Levura than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone: 91.562.04.20), indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, Ultra-Levura can produce adverse effects, although not everyone will experience them.
The most likely adverse effect, although rare, is flatulence.
The possible adverse effects are:
Infections and infestations
- Very rare (<1/10,000): penetration of the yeast into the bloodstream (fungemia).
- Frequency not known: severe blood infection (sepsis).
Gastrointestinal disorders
- Rare (>1/10,000 to <1/1,000): flatulence.
- Frequency not known (cannot be estimated from the available data): constipation.
Immune system disorders
- Very rare (<1/10,000): allergic reaction with itching, urticaria, skin rash, redness of the skin, and local or general swelling.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ultra-Levura
Keep this medicine out of the sight and reach of children.
Store in the original container to protect it from moisture.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ultra-Levura
The active substance is Saccharomyces boulardii.
The other components (excipients) are: lactose, magnesium stearate and sucrose.
Appearance of the product and contents of the pack
Ultra-Levura is presented as white hard capsules.
Each pack contains 20 or 50 hard capsules.
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 most recent review of this leaflet: December 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/