This medicine is used as adjuvant treatment for diarrhea, in addition to rehydration.
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 (associated disease…)
 

Posology
Only for adults and children above 6 years of age.
1 capsule per day.
Mode of administration
Oral route.
Capsules should be swallowed with a glass of water.
In young children under 6 years of age, it is recommended not to swallow capsules because of the risk of
false passage
The lyophilisation of the active substance guarantees the great stability and vitality of Saccharomyces
boulardii.
Handling of the product in the presence of crtically ill or immunocompromised patient, or patient
with central or peripheric venous catheter:
Due to a risk of airborne contamination, sachets or capsules 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 section 4.4)
 

Special warnings
In children above 6 years, if diarrhea persists after 2 days of treatment, management must be reviewed and
the need for rehydration using an oral or intravenous solution be envisaged.

This medicine contains lactose; its use is contra-indicated in patients suffering from an intolerance to
galactose, a lactase Lapp deficit or glucose and galactose malabsorption syndrome (rare hereditary
diseases).
There have been very rare cases of fungaemia (and blood cultures positive for Saccharomyces strains) and
sepsis 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 sections 4.3 and 4.8).
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 section 4.2).
In addition, enteral administration of Floratil should be avoided because of the risk for environmental
contamination and cross-contamination when the seal of the capsule is opened.
Special precautions for use
Adults and children above 6 years old 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,
 preferring grilled meats and rice.
Since FLORATIL 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.
 

Because of its fungal nature, FLORATIL must not be administered with systemic or oral antifungal drugs.
No other drug interactions are expected.
 

Pregnancy
Category C. Animal reproduction studies have not been conducted with FLORATIL.
Clinically, no malformative nor foetotoxic effect has been reported to date. 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
Saccharomyces boulardii is not absorbed. In the absence of data, it is preferable to weight benefit/risk before
using it during lactation.
 

Not relevant
 

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.

-To report any side effect(s):
National Pharmacovigilance and Drug Safety Centre (NPC)
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa/
 

Because of the nature and the pharmacokinetic of the product, no symptoms are to be observed because of
the overdose.
 

Pharmaco-therapeutic class: Antidiarrheal microorganisms
Code ATC: A07F A02
A: Digestive tract and metabolism
Flora substitute.
Saccharomyces boulardii is an intestinal replacement flora, which acts as antidiarrhoel microorganisms in the
digestive tract. Pharmacodynamics of Saccharomyces boulardii, live probiotic yeast, have been established
on various models by in vitro and in vivo, animal, and human studies which demonstrates it has:
- anti-inflammatory (enterohemorrhagic E. coli)
- anti-microbial (enterohemorrhagic E. coli ; C. difficile; S. typhimurium ; Yersinia enterocolitica ;
C. albicans ; C. krusei ; C. pseudotropicalis)
- enzymatic (disaccharidases; leucine aminopeptidase; spermine; spermidine),
- metabolic,
- anti-toxinic (C. diff. toxin A; cholera toxin),
- and immune-enhancing (secretory-IgA and immunoglobulins) activities
which are beneficial when Saccharomyces boulardii is used to treat diarrhoea of various origins
(infectious-viral, bacterial- or not) in humans.
 

After repeated oral administration, Saccharomyces boulardii passes alive in the intestinal tract without
colonization.
Saccharomyces boulardii disappears rapidly from the stools, 2 to 5 days after the end of treatment.
 

Not applicable
 

Lactose, magnesium stearate,
Capsule’s shell: gelatin, titanium dioxide (E171), red iron dioxide (E172), indigo carmine (E132)
 

Not applicable.
 

To be stored at a temperature below 30°C and away from humidity
 

Glass type III bottle with polyethylene cap, in a cardboard box, containing 10 capsules.
 

None