Bioflor

Bioflor

Manufacturer:

Servier

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Lyophilized Saccharomyces boulardii CNCM I-745.
Description
Capsule: 250 mg of Saccharomyces boulardii CNCM I-745 (lyophilized yeast cells).
Each capsule is required to present a minimum Saccharomyces boulardii CNCM I-745 of 2.5 x 109 CFU.
Powder for oral suspension: 250 mg of Saccharomyces boulardii CNCM I-745 (lyophilized yeast cells).
Each sachet is required to present a minimum Saccharomyces boulardii CNCM I-745 of 2.5 x 109 CFU.
Appearance after reconstitution: liquid suspension with a milky appearance.
Excipients/Inactive Ingredients: Capsule: lactose, magnesium stearate.
Composition of the capsule shell: gelatin, titanium dioxide (E171).
Powder for oral suspension:
lactose, fructose, colloidal anhydrous silica, tutti-frutti flavour.
Action
Pharmacotherapeutic classification: ANTI-DIARRHOEA, Replacement flora (A: digestive system and metabolism).
Pharmacology: Pharmacodynamics: Saccharomyces boulardii (Sb) CNCM I-745 is an intestinal replacement flora which acts as antidiarrhoeal microorganisms in the digestive tract. Pharmacodynamics of Saccharomyces boulardii CNCM I-745, live probiotic yeast, have been established on various models by in vitro and in vivo, animal, and human studies which demonstrated it acts at 3 levels: Luminal action: Sb may interfere with pathogen toxins, preserve cellular physiology, interfere with pathogens attachment (anti-toxinic effect against C. difficile, cholera, E. coli through preservation of tight junctions, adhesion of the bacteria to Sb enabling to stop the bacterial invasion), interact with normal microbiota or assist in re-establishing short chain fatty acid levels.
Trophic action: Sb reduces mucositis, restores fluid transport pathways, stimulates protein and energy production or act through a trophic effect by releasing spermine and spermidine or other brush border enzymes that aid in the maturation of enterocytes. Immune response: Sb increases the IgA levels in the intestine.
Mucosal action - anti-inflammatory effect: Sb may interfere with NF-κB mediated signal transduction pathways which stimulate pro-inflammatory cytokine production.
In lyophilized form, S. boulardii CNCM I-745 survives gastric acid and bile and can be detected alive throughout the entire digestive system (if ingested daily in freeze-dried form). S. boulardii CNCM I-745 is also resistant to proteolysis. So it acts all along the intestine.
Pharmacokinetics: Saccharomyces boulardii CNCM I-745 is not absorbed. After repeated oral doses, it transits in the digestive tract without colonizing it, rapidly attaining significant intestinal concentrations which are maintained at a constant level throughout the administration period. Saccharomyces boulardii CNCM I-745 is no longer present in the stools 2 to 5 days after discontinuation of treatment.
After 3 days of administration, a stable concentration in the intestinal content is reached. Within 1 week after stopping the administration, S. boulardii CNCM I-745 becomes undetectable.
Saccharomyces boulardii CNCM I-745 is not absorbed from the intestinal tract. The number of living yeast cells in faeces decreases fast after discontinued treatment, and 5 days after discontinuation the level hereof is below measurable level.
Indications/Uses
Treatment of acute infectious diarrhoea of infants (powder for oral suspension only), children and adults;
Prevention of antibiotic-associated diarrhoea in children and adults;
Addition to vancomycin/metronidazole-treatment to prevent recurrence of Clostridium difficile diseases in adults;
Prevention of tube-feeding associated diarrhoea in adults.
Dosage/Direction for Use
Recommended Dosage: Capsule: Children (> 6 years old): 1 to 2 capsules daily.
Adults: 1 or 2 capsules, once or twice daily. Capsules should be swallowed with a glass of water.
The capsules can be taken either during, before or after meals. 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.
Powder for oral suspension: Infants and children: 1 or 2 sachets daily.
Adults: 1 or 2 sachets, once or twice daily.
The sachets can be taken either during, before or after meals. Pour the contents of the sachet in a glass of water or sweetened beverage, mix, and drink. The powder can also be mixed with food or poured into a baby's feeding-bottle.
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.
Treatment duration: Treatment of acute infectious diarrhoea of infants, children and adults: approximately 1 week.
Prevention of antibiotic-associated diarrhoea in children and adults: treatment should be started within 48 to 72 hours of the beginning of treatment with antibiotics and it should continue for at least three days and not longer than 4 weeks after the treatment with antibiotics is ended.
Addition to vancomycin/metronidazole-treatment to prevent recurrence of Clostridium difficile diseases in adults: treatment should be started as soon possible after the beginning of antibiotic treatment and it should continue for 4 weeks.
Prevention of tube-feeding associated diarrhoea in adults: during the period of tube-feeding.
The maximum duration of treatment in the usual indications is 4 weeks.
Method and Route of 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.
Powder for oral suspension: Pour the contents of the sachet in a little amount of water or sweetened beverage, mix, and drink. The powder can also be mixed with food or poured into a baby's feeding-bottle. It should not be poured or mixed with very cold or very hot liquids or food nor alcoholic drinks.
Overdosage
No case reported. If the patient has taken more Bioflor than the patient should, contact a pharmacist or a physician for advice.
Contraindications
Hypersensitivity to one of the components;
Patients with central venous catheter (see Precautions).
Critically ill patients or immunocompromised patients due to a risk of fungaemia. (See Precautions.)
IF IN DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF A DOCTOR OR A PHARMACIST.
Special Precautions
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 meats and rice.
IN CASE OF DOUBT, DO NOT HESITATE TO SEEK THE ADVICE OF A DOCTOR OR A PHARMACIST.
The patient must consult immediately a physician 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 diarrhoea. The physician will decide the necessity to prescribe a rehydration which could be administered by oral or IV route.
BIOFLOR 250 mg capsule and sachet contain living cells. This drug should therefore not be mixed with very hot (over 50°C), iced or alcoholic drinks or food.
Because of the presence of lactose, this medicine is contraindicated in patients suffering from congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficit.
Because of the risk of generalized Saccharomyces boulardii infection, in case of patients with modified immune system (e.g. HIV infection, chemotherapy, irradiation) the drug should be administered only under strict medical control.
There have been very rare cases of fungaemia reported mostly in patients with central venous catheter, critically ill or immunocompromised patients, most often resulting in pyrexia. In most cases, the outcome has been satisfactory after cessation of treatment by Saccharomyces boulardii, administration of antifungal treatment and removal of the catheter when necessary. However, the outcome was fatal in some critically ill patients (see Contraindications and Adverse Reactions).
Powder for oral suspension: Because of the presence of fructose, this medicine is contraindicated in patients with fructose intolerance.
Use In Pregnancy & Lactation
It is not recommended to prescribe this drug during pregnancy and lactation due to lack of sufficient data.
If the patient discovers that she is pregnant during the treatment, consult a 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 a physician or a pharmacist for advice before taking any medicine.
Adverse Reactions
Adverse reactions encountered most often are as follows: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing severity. (See table.)

Click on icon to see table/diagram/image

Very rare cases of fungemia with fewer cases of positive Saccharomyces blood culture have been reported in hospitalized patients with central venous catheter, in immunodepressed patients and in patients with a severe gastrointestinal disease.
Drug Interactions
Do not use this medicine at the same time with an antifungal agent (medicine active against fungus infections).
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, IT IS ESSENTIAL TO ROUTINELY INFORM THE DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT THAT THE PATIENT MAY BE TAKING.
Storage
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.
Presentation/Packing
Cap 250 mg (light brown powder in opaque white capsule, with characteristic odor) x 30's. Powd for oral susp 250 mg (very light-brown powder with an odor of fruit in sachet; tutti-frutti flavour) x 10's.
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