In this manual :
1. WHAT IS ULTRA-LEVURE 50 mg, capsule AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING ULTRA-LEVURE 50 mg, capsule?
3. HOW TO TAKE ULTRA-LEVURE 50 mg, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE ULTRA-LEVURE 50 mg, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS ULTRA-LEVURE 50 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
It is indicated for the symptomatic treatment of diarrhoea, as a complement to rehydration in adults and children over 6 years of age.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ULTRA-LEVURE 50 mg, capsule?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Never take ULTRA-LEVURE 50 mg, capsule:
- If you are allergic to any of its components
- If you have a central venous catheter.
In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Precautions for use; special warnings
Use caution with ULTRA-LEVURE 50 mg, capsule:
Warnings:
- The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
- This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
- It is recommended not to open the capsule in the environment of patients with a central venous catheter, in order to avoid any colonisation of the catheter, in particular by hand.
Indeed, it has been reported that patients with a central venous catheter, even those not treated with S. boulardii,have experienced very rare cases of fungemia (passage of the yeast into the bloodstream), most often resulting in fever and Saccharomyces positive blood cultures.
- For children over 6 years of age and adults, you should consult your doctor as soon as possible in the following cases
o if there is no improvement after 2 days of treatment,
o if fever or vomiting occurs,
o in case of blood or mucus in the stools,
o in case of intense thirst, dry tongue sensation. In fact, these signs indicate the beginning of dehydration, i.e. a significant loss of liquid due to diarrhoea. Your doctor will then judge the need to prescribe rehydration which can be done orally or intravenously.
Precautions for use:
In children over 6 years and adults, this treatment is a complement to dietary rules:
- rehydrate with abundant drinks, salted or sweetened, in order to compensate for fluid losses due to diarrhoea (the average daily water intake is 2 litres) ;
- eat during the diarrhea,
o by excluding certain foods, especially raw vegetables, fruit, green vegetables, spicy dishes, and iced foods or drinks,
o by favouring grilled meats and rice.
ULTRA-LEVURE is made up of living cells: do not mix it with a 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.
Interactions with other medicines
Taking or using other medicines
Do not take this medicine with an antifungal (anti-fungal) drug.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including medication obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
Pregnancy
It is preferable not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can judge whether it is necessary to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a known effect: Sucrose, lactose.
3. HOW TO TAKE ULTRA-LEVURE 50 mg, capsule
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For adults and children over 6 years of age only.
4 capsules per 24 hours in two doses.
Method and route of administration
Take by mouth.
The capsules should be swallowed with a glass of water.
Freeze-drying of the active substance guarantees the stability and vitality of Saccharomyces boulardii.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ULTRA-LEVURE 50 mg, capsule is likely to have side effects, although not everyone is subject to them.
- Very rarely, allergic reactions (including angioedema), redness, itching have been observed.
- Rarely, hives have been observed.
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. HOW TO USE ULTRA-LEVURE 50 mg, capsule
Keep out of the reach and sight of children.
Do not use ULTRA-LEVURE 50 mg, capsule after the expiry date stated on the box.
Store at a temperature not exceeding 25°C and protect from moisture.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does ULTRA-LEVURE 50 mg capsule contain?
The active substance is:
Saccharomyces boulardii* .............................................................................................................. 50.00 mg
For one 150 mg capsule no. 2
*Yeast cells
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