Ultra-Levura 250 mg powder for oral suspension
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Ultra-Levura 250 mg powder for oral suspension
Saccharomyces boulardii CNCM I-745
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Always follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve within 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 side effects
- How to store Ultra-Levura
- Contents of the pack and other information
1. What is Ultra-Levura and what is it used for
Ultra-Levura is a medicine that contains as its active substance a probiotic yeast called Saccharomyces boulardii.
It is indicated for the symptomatic treatment of nonspecific diarrhea and for the prevention of diarrheal episodes associated with antibiotic use in adults and children.
You should consult a doctor if your condition worsens or does 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.
- Patients with central venous catheters (see "Warnings and precautions").
- Immunocompromised patients or those hospitalized due to severe illness or immune system impairment.
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 appears in the stools.
- If you experience intense thirst or a dry tongue sensation, as these are symptoms of dehydration.
- Do not open the sachets near patients with central venous catheters, to avoid any risk of contamination, especially transmission via hands to the catheter.
Children and adolescents
Administration in children under 2 years of age requires medical advice.
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 drugs (used to treat fungal infections).
Taking Ultra-Levura with food, drinks, and alcohol
During treatment with Ultra-Levura, do not consume very hot food or drinks (above 50°C), ice cream, or products containing alcohol, as Saccharomyces boulardii contains live cells.
Pregnancy, breastfeeding, and fertility
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.
No effect on fertility was detected in animal studies. There are no clinical data available; the potential risk in humans is unknown.
Driving and using machines
Ultra-Levura has no influence on the ability to drive or use machinery.
Ultra-Levura contains lactose, fructose, and sorbitol (E-420)
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 471.9 mg of fructose per sachet. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.
This medicine contains 0.1 mg of sorbitol per sachet.
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 to be used will depend on the progression of symptoms, and the lowest effective dose should always be used.
The recommended dose is:
Adults and adolescents from 12 years of age: 1 to 2 sachets (250 mg to 500 mg) per day, divided into two doses (morning and evening).
Use in children
Children from 2 years of age: 1 sachet (250 mg) per day.
Administration in children under 2 years of age requires medical advice.
How to take:
This medicine is taken orally.
The sachets should be dissolved in a glass of water.
Administer preferably 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 sachets must not be opened in the rooms of these patients. Special caution should be taken when opening them near such patients, and hands should 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, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, go immediately to your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, Ultra-Levura can cause adverse effects, although not everyone will experience them.
The most commonly occurring 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 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 available data): constipation.
Immune system disorders
- Very rare (<1/10,000): anaphylactic reaction with itching, hives, 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 a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 sight and reach of children.
Store in the original packaging 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging 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: fructose, lactose, anhydrous colloidal silica, tutti-frutti flavour (contains sorbitol).
Appearance of the product and pack contents
Ultra-Levura is presented in sachets containing powder for oral suspension.
Each pack contains 10 or 20 sachets of powder.
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: July 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.