Ultra-Levura 250 mg powder and solvent for oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ultra-Levura 250 mg powder and solvent for oral suspension
Saccharomyces boulardii CNCM I-745?
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for use of this medicine as described in this leaflet or as given 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 side effects not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve after 2 days.
Contents of this leaflet:
- 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 Ultra-Levura is and what it is 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 diarrhoea of unspecified origin and for the prevention of diarrhoeal episodes caused by 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 impairment/weakening of the immune system.
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 vials near patients with central venous catheters, to avoid any possible colonization, especially that transmitted 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 medicines (used to treat fungal infections).
Taking Ultra-Levura with food, beverages, and alcohol
During treatment with Ultra-Levura, do not consume very hot drinks or foods (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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The benefit-risk balance should be evaluated before using this medicine during pregnancy and breastfeeding.
No effect on fertility was detected in animal studies. There are no clinical data available, and 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, fructose, and sodium benzoate
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
This medicine contains 1,520.0 mg of fructose in each vial. 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 break down fructose, consult your doctor before taking this medicine.
This medicine contains 8.0 mg of sodium benzoate in each vial. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains less than 23 mg of sodium (1 mmol) per vial; thus, it is essentially "sodium-free".
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 course of symptoms, and the lowest effective dose should always be used.
Recommended dose:
Adults and adolescents aged 12 years and older: 1 to 2 vials (250 mg to 500 mg) per day, divided into two doses (morning and evening).
Use in children
Children from 2 years of age: 1 vial (250 mg) per day.
Administration in children under 2 years of age requires medical advice.
Method of administration:
This medicine is taken orally. It is preferable to take it before meals.
- Screw the cap fully on until the plunger automatically pierces the partition, releasing the powder into the solvent contained in the vial.
- Shake the vial well to mix the powder and solvent.
- Unscrew and open the vial.
- Drink the preparation immediately.
Special populations
Patients with central venous catheters, immunocompromised patients, or those in critical condition: This medicine is contraindicated in these patients (see section 2). Additionally, due to the risk of airborne contamination, vials should not be opened in the rooms of these patients. Special caution must be taken when opening them near these 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 recommended, 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 may produce adverse effects, although not everyone experiences them.
The most commonly occurring 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 available data): constipation.
Immune system disorders
- Very rare (<1/10,000): anaphylactic 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 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Store the container in the outer packaging to protect it from light.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers 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 CNCM I-745: 250 mg
The other components (excipients) are: lactose, fructose, forest fruit flavour, citric acid, potassium sorbate, sodium benzoate, purified water.
Appearance of the product and contents of the container
Ultra-Levura is a polyethylene terephthalate (PET) bottle, equipped with a spoon-shaped cap composed of a polypropylene (PP) blade and a low-density polyethylene (LDPE) container for the powder (active substance). The bottle is sealed with a low-density polyethylene (LDPE) screw cap (tamper-evident cap). Each bottle contains 8 ml of sweetened solution.
Each pack contains 10 or 14 bottles.
Marketing Authorization Holder and Manufacturer
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 latest revision of this leaflet: April 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.