ULTRA-LEVURA 250 mg HARD CAPSULES
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Introduction
Package Leaflet: Information for the Patient
Ultra Levura 250 mg Hard Capsules
Saccharomyces boulardiiCNCM I-745
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.
- Keep this package leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 2 days.
Contents of the Package Leaflet:
- What is Ultra Levura and what is it used for.
- What you need to know before taking Ultra Levura
- How to take Ultra Levura
- Possible side effects
- Storage of Ultra Levura
- Package Contents and Additional Information
1. What is Ultra Levura and what is it used for
Ultra-Levura is a medication that contains the probiotic yeast Saccharomyces boulardiias its active ingredient.
It is indicated for the symptomatic treatment of diarrhea of unspecified origin and prevention of diarrhea caused by antibiotic administration 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 ingredient or any of the other components of Ultra Levura (listed in section 6)
- If you are allergic (hypersensitive) to yeasts.
- Patients with a central venous catheter (see "Warnings and Precautions").
- Immunocompromised or hospitalized patients due to severe illness or immune system impairment.
Warnings and Precautions
Consult your doctor or pharmacist before starting to take Ultra Levura.
Be particularly careful with Ultra Levura:
- If diarrhea is accompanied by fever or vomiting.
- In case of blood in the stool
- In case of very intense thirst or dry mouth sensation, as these are symptoms of dehydration.
- The capsules should not be opened near patients with a central venous catheter to avoid any colonization, especially those transmitted by hands to the catheter.
Children and Adolescents
Administration in children under 2 years of age will require medical advice.
Taking Ultra Levura with Other Medications
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
Ultra Levura may interact with medications such as:
- Antifungal medications (to treat fungi)
Taking Ultra Levura with Food, Beverages, and Alcohol
During treatment with Ultra Levura, do not consume hot beverages or foods (above 50°C), cold foods, or those containing alcohol, as Saccharomyces boulardiicontains 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 medication.
The benefit-risk ratio should be evaluated before using it during pregnancy and breastfeeding.
No effect on fertility was detected during animal studies. There are no clinical data; the possible risk to humans is unknown.
Driving and Using Machines
Ultra Levura has no influence on the ability to drive and use machines.
Ultra Levura Contains Lactose
This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
3. How to Take Ultra Levura
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask 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: 1 to 2 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, or in critical condition: This medication is contraindicated in these patients (see section 2). Additionally, due to the risk of airborne contamination, the capsules should not be opened in the rooms of these patients; special precautions should be taken when opening them near the patients, and hands should be washed well after handling the medication.
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 medication and the amount ingested.
4. Possible Side Effects
Like all medications, Ultra Levura can cause side effects, although not everyone will experience them.
The most common side effect, although rare, is flatulence.
The side effects that can 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 the available data): constipation.
Immune System Disorders
- Very rare (<1/10,000): anaphylactic reaction with itching, urticaria, skin rash, redness, and local or general swelling.
Reporting Side Effects
If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.
By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Ultra Levura
Keep this medication out of sight and reach of children.
Store in the original package to protect it from moisture.
Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Ultra Levura
The active ingredient of Ultra Levura is Saccharomyces boulardii.
The other components (excipients) are: lactose and magnesium stearate
Appearance of the Product and Package Contents
Ultra Levura is presented in a transparent glass bottle with a white safety cap and in a thermoformed blister pack composed of an aluminum sheet and aluminum/PVC.
Each package 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 Last Revision of this Package Leaflet: December 2020
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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