Symptomatic treatment of diarrhea of non-specific origin and prevention of diarrheal diseases caused by antibiotic administration in adults and children
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1. What is Ultra-Levura and what it is used
Ultra-Levura is a medicine that contains the active substance called a probiotic yeast Saccharomyces boulardii.
It is indicated for the symptomatic treatment of diarrhea of non-specific origin and prevention of diarrheal diseases caused by antibiotic administration in adults and children
You should consult a doctor if 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:
- If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Ultra-Levura.
- If you are allergic (hypersensitive) to yeast.
- Patients with central venous catheter (see "Warnings and Precautions").
Warnings and Precautions
Consult your doctor or pharmacist before you start taking Ultra-Levura.
Take special care with Ultra-Levura
- If diarrhea is accompanied by fever or vomiting.
- If blood is present in the stool.
- In case of very intense feeling of thirst or dry tongue, as they are symptoms of dehydration.
- No need to open the capsules around patients with central venous catheter to avoid any colonization, especially those transmitted by hands to the catheter.
Ultra-Levura Taking with other medicines
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Ultra-Levura can interact with medications such as antifungal medicines (to treat fungal infections).
Ultra-making Levura with food, drink and alcohol
During treatment with Ultra-Levura should not take drinks or hot food (temperature above 50 ° C), ice cream or containing alcohol, as Saccharomyces boulardii contains living cells.
Pregnancy and lactation
If you are pregnant or breastfeeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.
the benefit / risk relationship before use in pregnancy and lactation should be evaluated.
There are no clinical data on the effect on fertility, the potential risk is unknown in humans.
Driving and using machines
The Ultra-Levura influence on the ability to drive and use machines.
Ultra-Levura contains lactose and sucrose
This medicine contains lactose. If your doctor has told you have an intolerance to milk or its products, contact your doctor before taking this medicine.
This medicine contains sucrose. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Ultra-Levura
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The recommended dose is:
- Symptomatic treatment of acute diarrhea of unspecified origin and produced by antibiotics:
Adults and adolescents over 12 years old: 1 capsule (50 mg), administered several times a day depending on the evolution of symptoms, maximum dose 10 capsules (500 mg / day).
Children between 6 and 12 years old: 1 capsule (50 mg), administered several times a day depending on the evolution of symptoms, maximum dose 5 capsules (250 mg / day).
Children up to 6 years old: 1 capsule (50 mg), 1-3 times a day, maximum dose 3 capsules (150 mg / day).
- Prevention of diarrheal diseases by administering antibiotics:
Adults and adolescents over 12 years: 1 capsule (50 mg), administered several times a day depending on the evolution of symptoms, maximum dose 5 capsules (250 mg / day).
Children between 6 and 12 years old: 1 capsule (50 mg), 1-2 times a day, maximum dose 4 capsules (100 mg / day).
Children up to 6 years old: 1 capsule (50 mg), 1 time a day, maximum dose 1 capsule (50 mg / day).
How to take:
This medicine is taken orally. The capsules are swallowed whole with water administered preferably before meals.
If you take more Ultra-Levura than you should
If you take more Ultra-Levura than you should, immediately consult your doctor or pharmacist or call the Toxicology Information Service (telephone: (+034) 91.562.04.20), indicating the medicine and the amount taken.
4. Possible side effects
Like all medicines, Ultra-Levura can cause side effects, although not everybody gets them.
The most common adverse effect can occur, albeit rarely, it is flatulence. Side effects that may occur are:
- Rare (≥1 / 10,000 to <1 / 1,000): flatulence
- Very rare (<1 / 10,000): allergic reaction with itching, hives, rash, skin redness and swelling local or general.
Communication adverse effects
If you experience any side effects, talk to your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet. You can also communicate directly through the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es.
By communicating adverse effects you can help provide more information on the safety of this medicine.
5. Conservation Ultra-Levura
Keep this medicine out of the sight and reach of children. Store in the original package to protect from moisture.
Do not use this medicine after the expiry date on the carton after EXP. The expiry date is the last day of that month
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required at the point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.
6. Contents of the pack and other information
The active substance is saccharomyces boulardii.
The other ingredients (excipients) are lactose, magnesium stearate and sucrose.
Looks like and contents of the pack
Ultra-Levura hard capsules white. Each pack contains 20 or 50 hard capsules.
Holder of the marketing authorization:
Maresme 5. Polygon Can Bernades-Subirà
08130 Santa Perpetua de Mogoda - Barcelona
Responsible for manufacturing:
1 Avenue Blaise Pascal
60000 Beauvais (France)
* All prices indicated are tax included