Pharmacotherapeutic group: Antidiarrhoeal microorganisms, Saccharomyces boulardii.
ATC code: A07FA02
Enterol contains viable cells which, as they pass through the gastrointestinal tract, exert a biological effect similar to the protective properties of the physiological intestinal flora.
The basic principles underlying the action of Saccharomyces boulardii CNCM I-745 in the prevention and treatment of diarrhoea are:
Inhibition of the action of certain pathogenic microorganisms and/or their toxins, in particular Clostridium difficile (the principal cause of diarrhoea complicating antibiotic therapy) and Vibrio cholerae (a typical bacterium that produces a toxin causing secretory diarrhoea).
The trophic and immunostimulant effect on the gastrointestinal tract comprises a markedly significant increase in the total and specific activity of intestinal disaccharidases (invertase, maltase and lactase) and a distinct increase in the concentration of secretory IgA in the intestinal fluid.
⚠️ Warnings
If symptoms persist beyond 2 days of treatment, the treatment should be reassessed.
The product contains viable cells and must therefore not be mixed with very hot (above 50°C) or ice-cold drink or food. It must not be mixed with alcohol.
Treatment with Enterol is not a substitute for rehydration. The volume of rehydration and the route of administration (oral, intravenous) must be adapted to the severity of the diarrhoeal illness, the patient's age and current state of health.
Saccharomyces boulardii CNCM I-745 is a viable microorganism associated with a risk of systemic fungal infection through gastrointestinal transfer or contamination from the hands.
Very rarely, cases of fungaemia (and blood cultures positive for Saccharomyces strains) and sepsis have been reported, mostly in patients with a central venous catheter and in critically ill and immunocompromised patients, most often leading to fever. In most cases the outcome was satisfactory after discontinuation of treatment with Saccharomyces boulardii; where necessary, antifungal treatment was administered and the catheter was removed. In some critically ill patients, however, the outcome was fatal (see sections 4.3 and 4.8).
As with all medicinal products containing live microorganisms, particular care must be taken when handling the product in the presence of patients, especially those with a central venous catheter, but also with a peripheral catheter, even if they are not being treated with Saccharomyces boulardii, in order to prevent any contamination of the hands and/or airborne spread of the microorganisms (see section 4.2).
The product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this product.
The product contains fructose and sorbitol. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. The additive effect of concomitantly administered products containing fructose (or sorbitol) and the dietary intake of fructose (or sorbitol) must be taken into account.
The sorbitol content of medicinal products for oral administration may affect the bioavailability of other concomitantly administered medicinal products taken orally.
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