In this manual :
1. WHAT IS ULTRALEVURE 200 mg, capsule AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ULTRALEVURE 200 mg, capsule?
3. HOW DO I TAKE ULTRALEVURE 200 mg, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE ULTRALEVURE 200 mg, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS ULTRALEVURE 200 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Anti-diarrhoeal microorganisms.
ATC Code: A07F A02 (A: Gastrointestinal tract and metabolism).
It is indicated for the symptomatic treatment of diarrhoea as a supplement to rehydration in adults and children over 6 years of age.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ULTRALEVURE 200 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 ULTRALEVURE 200 mg, capsule:
- If you are allergic to any of its ingredients
- 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
Take care with ULTRALEVURE 200 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).
- 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, very rare cases of fungemia (passage of the yeast into the bloodstream) have been reported in patients with a central venous catheter, even if they were not treated with S. boulardii, most often resulting in fever and Saccharomyces positive blood cultures.
- Children over 6 years of age and adults should consult their doctor immediately 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 decide whether it is necessary to prescribe rehydration, which may be oral or intravenous.
Precautions for use
In children over 6 years of age and in adults, this treatment is a complement to dietary rules:
- rehydrate with abundant drinks, salty or sweet, 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.
As ULTRALEVURE 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
This medicine should not be used during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as only he/she can judge the necessity of continuing it.
Ask your doctor or pharmacist for advice before taking any medication.
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 notable effect:
Lactose monohydrate.
3. HOW TO TAKE ULTRALEVURE 200 mg, capsules
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.
1 capsule at 200 mg per day.
Method and route of administration
Oral route
The capsule 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.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ULTRALEVURE 200 mg, capsule is likely to have undesirable 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 inform your doctor or pharmacist.
5. HOW TO USE ULTRALEVURE 200 mg, capsule
Keep out of the reach and sight of children.
Do not use ULTRALEVURE 200 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 garbage. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does ULTRALEVURE 200 mg, capsule contain?
The active substance is:
Saccharomyces boulardii* ............................................................................................................ 200.00 mg
*Yeast cells
The other components are:
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