Bioflor

Bioflor

Manufacturer:

Biocodex

Distributor:

DKSH

Marketer:

Servier
Full Prescribing Info
Contents
Saccharomyces boulardii CNCM I-745.
Description
Capsule: Each capsule contains lyophilized yeast cells Saccharomyces boulardii 250 mg.
Powder for oral suspension: Saccharomyces boulardii CNCM I-745 250.00mg (lyophilized cells of Saccharomyces boulardii CNCM I-745).
Excipients with known effect: lactose, fructose.
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 flavor.
Action
Pharmacotherapeutic group: Anti-diarrhoea. Replacement flora. ATC code: A07FA02. (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.
Pharmacokinetics: Powder for oral suspension: After repeated oral doses, Saccharomyces boulardii CNCM I-745 transits in the digestive tract without colonizing it. S. boulardii CNCM I-745 quickly disappears from stools 2 to 5 days after treatment is stopped.
Toxicology: Preclinical safety data: Powder for oral suspension: There is no animal toxicity.
Indications/Uses
Treatment of acute infectious (viral or bacterial) diarrhea of adults and children.
Preventive and curative treatment of antibiotic-associated diarrhea and colitis.
Preventive treatment of recurrence of Clostridium difficile disease in addition to vancomycin/metronidazole.
Preventive treatment of tube-feeding associated diarrhea.
Treatment of irritable bowel syndrome.
Dosage/Direction for Use
Posology: Capsule: 1 to 2 caps, once or twice daily.
Powder for oral suspension: 1 or 2 sachets, given once or twice daily.
Method of aministration: 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: Oral route.
Pour the contents of the sachet in a little water or sweetened beverage, mix, and drink. The powder can also be mixed with food or poured into a baby's feeding-bottle.
Due to a risk of airborne contamination, sachets should not be opened in patient rooms. Healthcare providers should wear gloves during handling of probiotics for administration, then promptly discard the gloves and properly wash their hands (see Precautions).
Overdosage
No case of overdose reported. If the patient has taken more Bioflor than the patient should, contact the pharmacist or physician for advice.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Patient with central venous catheter.
Critically ill patients or immunocompromised patients due to a risk of fungaemia (see Precautions).
Special Precautions
Capsule: 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 foods.
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.
Powder for oral suspension: The treatment does not replace rehydration when this is necessary. The rehydration dose and its route of administration (oral-IV) should be adapted to the severity of the diarrhoea and to the age and state of health of the patient.
There have been very rare cases of fungaemia (and blood cultures positive for Saccharomyces strains) 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).
As with all medicines made from living micro-organisms, special attention must be paid to the handling of the product in the presence of patients mainly with central venous catheter but also with peripheral catheter, even not treated with Saccharomyces boulardii, in order to avoid any contamination by hands and/or the spread of microorganisms by air (see  Dosage & Administration).
Because of the presence of lactose, this medicine is contra-indicated in patients suffering from congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficit.
Because of the presence of fructose, this medicine is contra-indicated in case of fructose intolerance.
The patients must be told of the need: To rehydrate themselves by drinking copious amounts of salty or sweet drinks, in order to compensate for fluid losses due to diarrhea (mean daily water requirement of an adult is 2 liters); To eat while they have diarrhea: excluding certain types of food and especially raw salads, fruit, green vegetables, spicy foods and iced foods or drinks, and preferring grilled meats and rice.
Since BIOFLOR 250mg, powder for oral suspension in sachet consists of living cells that develop at 37°C: do not mix it with a liquid or food which is too hot (more than 50°C), iced or containing alcohol.
Effects on ability to drive and use machines: Not relevant.
Use In Pregnancy & Lactation
Pregnancy: Capsule: 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.
Powder for oral suspension: There are no reliable animal teratogenesis data.
There have been no clinical reports to date of any malformative or fetotoxic effect. However, the monitoring of pregnancies exposed to this medicine is insufficient to rule out any risk. Hence, as a precautionary measure, this medicine should not be used during pregnancy.
Breast-feeding: Powder for oral suspension: Due to the absence of data about the excretion of this drug in breast milk, the use of it has to be avoided during breast-feeding.
Adverse Reactions
Capsule: Some rare epigastric disturbances have been reported, not requiring that treatment be discontinued. Constipation: unknown frequency.
Powder for oral suspension: The side effects which have been reported are classified hereafter by system-organ class and by frequency defined as: 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Drug Interactions
Because of its fungal nature, BIOFLOR must not be administered with oral or systemic antifungal drugs.
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.
Powder for oral suspension: Incompatibilities: Not applicable.
Special precautions for disposal: No special requirements.
Storage
Store away from humidity at a temperature below 30°C.
Shelf-life: Powder for oral suspension: 3 years.
MIMS Class
Antidiarrheals
ATC Classification
A07FA02 - saccharomyces boulardii ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.
Presentation/Packing
Cap 250 mg x 10's, 2 x 5's. Powd for oral susp (sachet) 250 mg x 10's.
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