Bioflor 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.