NOTICE
ANSM - Updated: 20/08/2018
Name of the drug
ULTRA-YEAST 200 mg capsule
Saccharomyces boulardii CNCM I-745
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is ULTRA-YEAST 200 mg capsule and in what cases is it used?
2. What information do you need to know before taking ULTRA-YEAST 200 mg capsule?
3. How to take ULTRA-YEAST 200 mg, capsule?
4. What are the possible side effects?
5. How to store ULTRA-YEAST 200 mg capsule?
6. Contents of the package and other information.
1. WHAT IS ULTRA-YEAST 200 mg capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: ANTIDIARRHEIC MICROORGANISMS - ATC code: A07FA02
It is indicated for adjunctive symptomatic treatment of diarrhea, in addition to rehydration in adults and children over 6 years of age.
2. BEFORE YOU TAKE ULTRA-YEAST 200 mg capsule?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Never take ULTRA-YEAST 200 mg, capsule:
· If you are allergic to the active substance or to any of the other ingredients of this medicine, listed in section 6.
· If you have a central venous catheter that is immunocompromised or hospitalized (because of a serious illness or if your immune system is weakened).
Warnings and precautions
Talk to your doctor or pharmacist before taking ULTRA-YEAST 200 mg capsule
warnings
It is recommended not to open the capsules in the environment of patients with a central venous catheter, to avoid colonization, particularly hand-held, of the catheter.
It is recommended not to open the capsules in the presence of a patient in critical or immunocompromised state because of the risk of contamination by air .
In fact, it has been reported in patients with a central venous catheter and in critically ill or immunocompromised patients, even those not treated with S. boulardii , very rare cases of fungi (passage of the yeast into the blood). most often expressed by fever and blood cultures positive to Saccharomyces.
For children over 6 years old 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;
- If there is blood or mucus in the stool;
- In case of intense thirst, feeling of dry tongue. Indeed, these signs show a beginning of dehydration, ie a significant loss of liquid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done orally or intravenously.
Precautions
In children over 6 years of age and adults, this treatment complements dietary rules:
· Rehydrate with abundant, salty or sugary drinks to compensate for fluid loss due to diarrhea (the average daily water intake of adults is 2 liters);
· Feed the time of diarrhea,
- excluding certain inputs and particularly raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,
- by focusing on grilled meats, rice.
If in doubt, do not hesitate to consult your doctor or pharmacist.
children
Not applicable.
Other medicines and ULTRA-YEAST 200 mg capsule
Due to its fungal nature, do not combine this medicine with an oral or systemic antifungal (active medicine against fungi).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ULTRA-YEAST 200 mg capsule with food and drink
ULTRA-YEAST is made of live cells, do not mix with a liquid or a food too hot (over 50 ° C), iced or alcoholic.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice or pharmacist before taking this medicine.
It is best not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
ULTRA-YEAST 200 mg capsule contains lactose monohydrate.
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
3. HOW TO TAKE ULTRA-YEAST 200 mg, capsule?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 capsule per day.
Swallow the capsules with a large glass of water.
Reserved for adults and children over 6 years old.
Lyophilization of the active ingredient ensures the stability and vitality of Saccharomyces boulardii CNCM I-745 .
If you take more ULTRA-YEAST 200 mg capsule than you should
Not applicable.
If you forget to take ULTRA-YEAST 200 mg capsule
Not applicable.
If you stop taking ULTRA-YEAST 200 mg capsule
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects:
- Allergic reactions (up to Quincke's edema), redness, itching.
- Passage of yeast into the blood (fungemia)
Rare side effects:
- Urticaria.
Undesirable effects of undetermined frequency :
- Constipation
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the National Agency for Drug and Health Product Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE ULTRA-YEAST 200 mg, capsule?
Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25 ° C, away from moisture.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of this month.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What ULTRA-YEAST contains 200 mg capsule
· The active substance is:
Saccharomyces boulardii CNCM I-745 * ........................................... .................................. 200 mg
* yeast cells
· The other ingredients are: Lactose monohydrate, magnesium stearate.
Composition of the capsule shell:
Body: gelatin, titanium dioxide (E171),
Headdress: gelatin, titanium dioxide (E171), red iron oxide (E172), indigotin (E132).
What is ULTRA-YEAST 200 mg, capsule and contents of the pack
This medicine is in the form of a capsule (200 mg in vials of 6, 10, 20, 30 or 40 or in wafers of 6, 10, 20 or 30).
Marketing Authorization Holder
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Operator of the marketing authorization
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Maker
BIOCODEX
1, AVENUE BLAISE PASCAL
60000 BEAUVAIS
LA FRANCE
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date 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 Council:
ULTRA-YEAST is a complement of important dietary rules:
· Rehydrate with abundant, salty or sweet drinks,
· Feed the time of diarrhea, focusing on grilled meats, rice.
What is a surrogate flora?
The intestinal flora consists of billions of microorganisms. Its balance is necessary to maintain certain essential functions of the digestive tract such as food digestion, defense against infectious agents, stimulation and strengthening of immune defenses.But this balance is fragile and can be challenged by many factors: intestinal infections with a virus or bacteria, taking certain medications such as antibiotics, changes in eating habits ... can lead to various digestive disorders including diarrhea. ULTRA-YEAST is a medicine of the intestinal flora known as "surrogate flora" that compensates for a transient imbalance of the intestinal flora.