Floratil

Floratil

Manufacturer:

Biocodex

Distributor:

Integrated Market Services
Full Prescribing Info
Contents
Saccharomyces boulardii.
Description
Each capsule contains: Saccharomyces boulardii CNCM I-745 250 mg (lyophilized cells of Saccharomyces boulardii CNCM I-745).
Each sachet contains: Saccharomyces boulardii CNCM I-745 250 mg (lyophilized cells of Saccharomyces boulardii CNCM I-745).
Action
ATC Code: A07F A02.
Pharmacodynamics:
Saccharomyces boulardii is an intestinal replacement flora, which acts as antidiarrheal 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 demonstrated 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-toxic (C. diff. toxin A; cholera toxin); And immuno-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.
Pharmacokinetics: After repeated oral doses, Saccharomyces boulardii transits in the digestive tract without colonizing it.
Saccharomyces boulardii is no longer present in the stools 2 to 5 days after discontinuation of treatment.
Indications/Uses
Adjuvant treatment of diarrhea in addition to rehydration and dietetic measures. Prophylaxis and treatment of antibiotic-associated diarrhea.
Dosage/Direction for Use
One or two capsules once or twice daily, unless otherwise prescribed by the physician. In young children under 6 years of age, it is recommended not to swallow capsules (risk of false passage).
One or two sachet once or twice daily. 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.
Contraindications
Hypersensitivity to one of the components.
Patients with central venous catheter (see Precautions).
Special Precautions
If symptoms persist for more than two days of treatment at usual posology, the therapeutic approach will be reevaluated.
Saccharomyces boulardii (Floratil) contains living cells. This drug should therefore not be mixed with very hot (over 50°C), iced or alcoholic drinks or food.
The treatment does not replace rehydration when this is necessary. The rehydration dose and it route of administration (oral-IV) should be adapted to the severity of the diarrhea and to the age and state of health of the patient.
It is advisable not to open the capsule or sachet in the surroundings of patients with a central venous catheter, to avoid 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, Saccharomyces boulardii (Floratil) is contraindicated in patients suffering from congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficit.
Because of the presence of fructose, Saccharomyces boulardii (Floratil) sachet is contraindicated in case of fructose intolerance.
Use In Pregnancy & Lactation
There are no reliable animal teratogenesis data. Clinically, no malformative nor fetotoxic effect has been reported to date. However, monitoring of pregnancies exposed to this drug is insufficient to rule out any risk.
Hence, as precautionary measure, it is preferable to avoid using this during pregnancy.
In the absence of data, it is preferable to avoid using the drug during lactation.
Adverse Reactions
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare cases of flatulence have been reported with the use of Saccharomyces boulardii.
Very rare cases of allergic reactions have been reported in the form of pruritus, wheal formation (urticaria), skin rash, either locally restricted or affecting the entire body (local or generalized exanthema) as well as swelling of the connective tissue of the face(angioedema).
Very rare cases of anaphylactic reaction or even shock have been reported.
Very rare cases of fungemia in patients with a Central Venous Catheter.
If you get any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Drug Interactions
Because of its fungal nature, Saccharomyces boulardii (Floratil) must not be administered with oral or systemic antifungal drugs.
Storage
Store at a temperature not exceeding 25°C.
ATC Classification
A07FA02 - saccharomyces boulardii ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.
Presentation/Packing
Cap 250 mg x 20's. Powd for oral susp (sachet) 250 mg x 20's.
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