NOTICE
ANSM - Last updated: 02/05/2017
Name of the medicinal product
ULTRA-LEVURE 100 mg powder for oral suspension in sachet
Saccharomyces boulardii
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is ULTRA-LEVURE 100 mg, powder for oral suspension in sachets and in which cases it is used?
2. What should I know before taking ULTRA-LEVURE 100 mg powder for oral suspension in sachets?
3. How to take ULTRA-LEVURE 100 mg powder for oral suspension in sachet?
4. What are the possible side effects?
5. How to store ULTRA-YEVURE 100 mg powder for oral suspension in sachets?
6. Package contents and other information.
1. WHAT IS ULTRA-YEVURE 100 mg powder for oral suspension in sachets AND WHAT IS IT USED FOR?
Pharmacologic class: ANTIDIARRHEAL MICRO-ORGANISMS - ATC code: A07FA02 .
(A: Digestive System and Metabolism).
It is indicated in supportive symptomatic treatment of diarrhea, supplementing rehydration in adults and children over 6 years.
2. BEFORE YOU TAKE ULTRA-YEAST 100 mg powder for oral suspension in a sachet?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Never take ULTRA-LEVURE 100 mg powder for oral suspension in sachets in the following cases:
· If you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6,
· If you are carrying a central venous catheter.
Warnings and Precautions
Talk to your doctor or pharmacist before taking ULTRA-LEVURE 100 mg powder for oral suspension in sachets .
Warnings
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
It is advisable not to open the capsule in the environment of patients carrying a central venous catheter, in order to avoid any colonization, in particular carried out (by hand) of the catheter.
Indeed, very rare cases of fungemia (passage of the yeast in the blood) have been reported in patients carrying a central venous catheter, even if not treated with S. boulardii, which usually results in fever and positive blood cultures at Saccharomyces. In all cases, these incidents have evolved favorably after administration of antifungal treatment and, where appropriate, after removal of the catheter.
For children between 2 and 6 years of age you should consult your doctor in the following cases:
- in case of diarrhea greater than 6 liquid stools per day or which lasts more than 24 hours or which is accompanied by a loss of weight; your doctor will then judge the need to prescribe rehydration by oral rehydration solution.
- in case of fever, vomiting,
- in the presence of blood or mucus in the stools,
For children over 6 years of age and adults, you should consult your doctor promptly in the following cases:
- in the absence of improvement after 2 days of treatment,
- in case of fever, vomiting,
- in the presence of blood or mucus in the stools,
- in case of intense thirst, sensation of dry tongue. Indeed, these signs show an onset of dehydration, that is to say a significant loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done either orally or intravenously.
For infants and children under 6 years of age, it is imperative that you follow the instructions for use and the method of reconstitution of the oral rehydration solution, as prescribed by your doctor, and follow his advice regarding diet .
Precautions for use
In children over 6 years of age and in adults, this treatment is a complement to the dietary rules:
· Rehydrate with abundant, salty or sugary drinks to compensate for fluid losses due to diarrhea (the average daily water intake is 2 liters);
· Feeding time diarrhea,
- Excluding certain intakes and especially raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,
- By favoring grilled meats, rice.
ULTRA-LEVURE is made up of living cells: do not mix with liquid or food that is too hot (over 50 ° C), iced or alcoholic.
In case of doubt, do not hesitate to consult your doctor or pharmacist.
children
Not applicable.
Other medicines and ULTRA-LEVURE 100 mg powder for oral suspension in sachet
Due to its fungal nature, do not combine this medication with an oral or systemic antifungal medication (active against mushrooms).
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ULTRA-YEVURE 100 mg powder for oral suspension in sachets with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
ULTRA-YEVURE 100 mg powder for oral suspension in sachet contains excipients
Fructose, Lactose.
3. HOW TO TAKE ULTRA-YEAST 100 mg powder for oral suspension?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Reserved for adults and children over 2 years of age.
The recommended dose is 2 sachets per day, in two doses.
If you take more ULTRA-YEVURE 100 mg powder for oral suspension in a sachet than you should have
Not applicable.
If you forget to take ULTRA-LEVURE 100 mg powder for oral suspension in sachet
Not applicable.
If you stop taking ULTRA-LEVURE 100 mg powder for oral suspension in sachet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
- Very rarely have been observed allergic reactions (which can go as far as Quincke edema), redness, itching,
- Rarely have been observed cases of urticaria.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ULTRA-YEAST 100 mg powder for oral suspension in sachet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer packaging.
Store at a temperature not exceeding 25 ° C and away from moisture.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ULTRA-LEVURE 100 mg contains, powder for oral suspension in sachet
· The active substance is:
Saccharomyces boulardii ................................................ ........................................... 100.00 mg
for a lyophilisate of 113.00 mg
· The other components are:
Fructose, lactose monohydrate, anhydrous colloidal silica, tutti frutti aroma.
What is ULTRA-LEVURE 100 mg powder for oral suspension in sachet and contents of the pack
Powder for oral suspension. Boxes of 10, 14, 20, 30 or 50 sachets.
Marketing Authorization Holder
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Marketing Authorization Operator
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Maker
BIOCODEX
1, AVENUE BLAISE PASCAL
60000 BEAUVAIS
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
Health education councils:
Ultra-Yeast is a complement to important dietary rules:
· Rehydrate with abundant, salty or sweetened drinks,
· Feeding time diarrhea, preferring grilled meats, rice.
What is a substitute flora?
The intestinal flora is made up of billions of microorganisms. Its balance is necessary to maintain certain essential functions of the digestive tract such as digestion of food, defense against infectious agents, stimulation and strengthening of immune defenses.
But this balance is fragile and can be called into question by many factors: intestinal infections by a virus or a bacterium, taking certain drugs such as antibiotics, changes in eating habits ... which can lead to various digestive disorders including diarrhea. Ultra-Yeast is a drug of the intestinal flora called "substitution flora" which compensates for a transient imbalance of the intestinal flora.