Full Prescribing Info
Saccharomyces boulardii CNCM l-745.
Each capsule contains lyophilized yeast cells Saccharomyces boulardii 250 mg.
Each sachet contains lyophilized Saccharomyces boulardii 282.5 mg corresponding to yeast 250 mg and lactose 32.5 mg.
Excipients/Inactive Ingredients: Capsule: Lactose, magnesium stearate. Composition of the capsule shell: Gelatin, titanium dioxide (E171).
Pharmacotherapeutic Group: ANTI-DIARRHEA, Replacement flora (A: digestive system and metabolism).
Pharmacology: Pharmacodynamics: Mechanism of Action: Antidiarrheal agent of biological origin. Saccharomyces boulardii exerts antimicrobial and antitoxigenic effects. It also acts through trophic effects on the intestinal mucosa.
Treatment of acute infectious diarrhoea of adults and children.
Prevention and treatment of antibiotic-associated colitis and diarrhoea.
Addition to vancomycin/metronidazole-treatment to prevent recurrence of Clostridium difficile diseases.
Prevention of tube-feeding associated diarrhoea.
Treatment of irritable bowel syndrome.
Dosage/Direction for Use
Capsule: 1 to 2 caps, once or twice daily.
Powd for oral soln (sachet): 1 or 2 sachets, given once or twice.
Administration: Capsule: Capsules should be swallowed with a glass of water. In young children under 6 years of age, it is recommended not to swallow capsules (risk of false passage) and (to use the powder for oral suspension in sachet.
Powd for oral soln (sachet):
The contents of the sachet should be mixed with water or another liquid or food. It should not be poured on or mixed with very cold or very hot liquids or food, or alcoholic drinks.
No case reported. If the patient has taken more Bioflor than the patient should, contact the pharmacist or physician for advice.
Hypersensitivity to one of the components.
Patients with central venous catheter (See Precautions), critically ill (patients in intensive care units) and immunocompromised patients.
Special Precautions
Consult the physician immediately in the following cases: in absence of improvement after 2 days of treatment; in case of fever, vomiting; in case of presence of blood or mucus in the stools; in case of intense thirst, dryness of tongue: these signs show the beginning of the dehydration, that means an important loss of liquid due to the diarrhea. The physician will decide the necessity to prescribe a rehydration which could be administered by oral or IV route.
BIOFLOR 250 mg contains living cells. This drug should therefore not be mixed with very hot (over 50°C), iced or alcoholic drinks or food.
It is advisable not to open capsules in the surroundings of patients with a central venous catheter to avoid any colonization, especially hand-borne, of the catheter. There have been reports in patients, with a central venous catheter, even not treated with S. boulardii, of very rare cases of fungemia (penetration of blood by yeast), most often resulting in pyrexia and blood cultures positive for Saccharomyces. The outcome in all these cases has been satisfactory after administration of antifungal treatment and, when necessary, removal of the catheter.
Because of the presence of lactose, this medicine is contraindicated in patients suffering from congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.
Use In Pregnancy & Lactation
It is advisable not to use this medicine during pregnancy.
If discovered to be pregnant during the treatment, consult the physician as only the physician can decide if it is necessary to go on the treatment.
As a general rule, during pregnancy or lactation it is advisable to ask the physician or pharmacist for advice before taking any medicine.
Adverse Reactions
Some rare epigastric disturbances have been reported, not requiring that treatment be discontinued.
Side Effects
Some rare epigastric disturbances have been reported, not requiring that treatment be discontinued. Constipation: unknown frequency.
Drug Interactions
Do not use this medicine at the same time as an antifungal agent.
Caution For Usage
Precautions for use: This drug is a complement of dietetic rules: rehydration by abundant, salted or sweetened drinks, in order to compensate for the loss of liquid due to the diarrhoea (the average daily ration of water in adult is 2 liters); to feed during the diarrhoea; by excluding certain supply and particularly fruits, green vegetables, spiced dishes, as well as food or frozen drinks; by privileging roasted meals and rice.
Store away from humidity at a temperature below 30°C.
MIMS Class
ATC Classification
A07FA02 - saccharomyces boulardii ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.
Cap 250 mg x 10's, 2 x 5's. Powd for oral soln (sachet) 250 mg x 10's.
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