Symptomatic treatment for diarrhea in addition to the rehydration.
The importance of rehydration with oral rehydration solution or intravenous should be related to the intensity
of diarrhea, the age and particularity of patient (associated disease…)
 

Posology
Only for adults and children above 2 years old.
2 sachets per day, as 2 divided doses.

Mode of administration
Oral route.
Pour the contents of the sachet in a little water.
The lyophilisation of the active substance guaranties 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
This medicine contains lactose and fructose. Its use is not advisable in patients not tolerant to galactose or
fructose, having a lactase Lapp deficit or presenting syndromes of bad absorption of glucose, galactose or
fructose (rare heredity diseases).

In children between 2 and 6 years old, rehydration could be the principal element in the treatment of acute
diarrhea in children. It has to be systematically considered.
• Prevention or treatment of dehydration will have to be done by oral rehydration solution. It is
recommended to use solution provided to this purpose and to respect the mode of reconstitution and
administration.
• The Na+ concentration will have to be between 30 and 60 mmol/L, the solutions less concentrated
(30 mmol/L) are designated for not severe dehydration.
• An intake of chlorine and potassium is necessary to correct the digestive loss.
• The recommended concentration in glucose is between 74 and 110 mmol/L
• The intake of hydrolyzed proteins or amino acids does not seem to improve neither rehydration nor
the nutritional state.
• It is essential to propose to the child to drink very often, every quarter of an hour for example. For
guidance, the volume of rehydration solution proposed should be equivalent of the weight loss,
which means 50 to 100mL/kg for a rehydration of 5 to 10 % of body’s weight.
• In case of severe or prolonged diarrhea, or important vomit or the refuse of food, an intravenous
rehydration will have to be considered.

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

Special precautions for use
Children between 2 and 6 years old in case of prescription of rehydration by solution for rehydration, both
way of use and way of reconstitution will have to be clearly and precisely explained.
However, if there is no necessity to prescribe this kind of rehydration, it is necessary to clearly explain the
need:
- to rehydrate the children 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. The
suppression of milk and other dairies should be considered if necessary.
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, fructose, colloidal anhydrous silica, tutti frutti flavor
 

Not applicable
 

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

Cardboard box containing sachets made of paper-aluminium-polyethylene laminate. Box of 20 sachets.
 

None