Ultra-Levura 250 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ultra Levura 250 mg hard capsules
Saccharomyces boulardii CNCM I-745?
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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 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.
Contents of the 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 containing as its active substance a probiotic yeast called Saccharomyces boulardii.
It is indicated for the symptomatic treatment of nonspecific diarrhoea and for the prevention of diarrhoeal episodes associated with antibiotic use 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.
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.
- Capsules must not be opened near patients with central venous catheters to avoid any risk of colonization, 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 medicines (used to treat fungal infections)
Taking Ultra Levura with food, drinks, and alcohol
During treatment with Ultra Levura, avoid consuming very hot drinks or food (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. Clinical data are lacking, and the potential risk in humans is unknown.
Driving and using machines
The influence of Ultra Levura on the ability to drive and operate machinery is negligible.
Ultra Levura contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Ultra Levura
Follow exactly the instructions for use provided in this leaflet or those indicated 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.
Recommended dose:
Adults and adolescents aged 12 years and older: 1 to 2 capsules (250 to 500 mg) daily, divided into two doses (morning and night).
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, capsules must not be opened in the rooms of these patients. Extreme caution should be exercised when opening 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, 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), stating 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 common 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 blood (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): anaphylactic reaction with itching, urticaria, skin rash, skin redness, 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 through 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.
Store in the original packaging to protect from moisture.
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.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are 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 in Ultra Levura is Saccharomyces boulardii.
The other components (excipients) are: lactose and magnesium stearate.
Appearance of the product and contents of the pack
Ultralevura is presented in a transparent glass bottle with a white safety cap, and in thermoformed blisters composed of an aluminum/aluminum-PVC foil.
Each pack contains 10 or 20 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 revision of this leaflet: December 2020
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/.