Freeze-dried yeast Saccharomyces boulardii.
1 hard gelatine capsule contains: 250 mg of yeast from Saccharomyces cerevisiae HANSEN CBS 5926 (Medical synonym: Saccharomyces boulardii).
Source of gelatin: Bovine.
Pharmacology: Mechanism: Saccharomyces boulardii (S. boulardii) appears to be taken up by the intestinal villi and to adhere to cells in the jejunum, increasing brush border enzyme activity of lactase, alpha-glucosid normal enterocyte maturation. S. boulardii also exerts a protective effect on epithelial cells infected with E. coli by decreasing the level of intracellular infection & reducing the apoptotic effect of E. coli on intestinal epithelium.
S. boulardii has also been shown to increase intestinal secretory IgA production. In addition, prevents Entamoeba histolytica from adhering to human erythrocytes, a model of the first step in amoebic infection in humans. In C. difficile-related diarrhea and pseudomembranous colitis, Clostridium toxins bind to membrane receptors, causing intestinal fluid secretion and increased permeability of intestinal mucosa. S. boulardii contains a protease that neutralizes C. difficile toxins A and B, and also digests membrane receptors that bind to C. difficile toxin in the brush border epithelium of the ileum, thus exerting a protective effect on the gut lining.
Pharmacokinetics: Subsequent to oral administration and transport to the gastrointestinal tract. S. boulardii cells undergo irreversible degradation. In the large intestine, live cells are exposed to saccharolytic enzymes produced by the normal intestinal flora that hydrolyze polysaccharides in the cell wall. These same enzymes act to further degrade dead cells as well. Ultimately, S. boulardii appears in the bowel and feces. S. boulardii does not appear to colonize the intestinal tract, and a single oral dose is rapidly eliminated in the feces. When S.boulardii was monitored in stools of patients given a dose of 1 gram daily, only 1 % of the ingested dose was present and the organism was cleared completely from the stool within 3 days. In studies of patients taking ampicillin, S. boulardii recovery in the stool was increased 2.4 times, indicating when normal intestinal flora is altered, the level of S. boulardii in the intestine is elevated.
Treatment of acute diarrhea in children and adults.
Prevention of antibiotic-associated diarrhea in children and adults.
Prevention of tube feeding associated diarrhea in adults.
Addition to vancomycin/metronidazole-treatment to prevent recurrence of Clostridium difficile diseases in adults.
Children (> 6 years old): 1 to 2 capsules daily.
Adults: 1 or 2 capsules, once or twice daily.
Capsules should be swallowed with a glass of water. The capsules can be taken either during, before or after meals.
For children below 6 years old (who are unable to swallow), discard the capsule shell & empty the contents into a feeding bottle or a glass of water/juice.
Treatment duration: Treatment of acute infectious diarrhoea of children and adults: approximately 1 week.
Prevention of antibiotic-associated diarrhoea in children and adults: treatment should be started within 48 to 72 hours of the beginning of treatment with antibiotics and it should continue for at least three days and not longer than 4 weeks after the treatment with antibiotics is ended.
Addition to vancomycin/metronidazole-treatment to prevent recurrence of Clostridium difficile diseases in adults: treatment should be started as soon as possible after the beginning of antibiotic treatment and it should continue for 4 weeks.
Prevention of tube-feeding associated diarrhea in adults: during the period of tube-feeding.
The maximum duration of treatment in the usual indications is 4 weeks.
Hypersensitivity to one of the components.
Patients with central venous catheter.
Critically ill patients or immunocompromised patients due to a risk of fungaemia.
There have been very rare cases of fungaemia 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 Side Effects).
With diarrhea lasting longer than 2 days or accompanied by blood in the stool or a rise in temperature, patient should consult a doctor. With diarrheal diseases, especially in children, attention must be paid to the use of fluid and electrolytes as the most important therapeutic measure.
Saccharomyces boulardii is a living microorganism, which under inappropriate conditions, that occur in patients with an impaired immune defense system, may cause systemic fungal infections by migration from the intestinal tract in the blood or by external contamination of central venous catheter. Isolated cases of such fungal infections have been reported in hospitalized patients with central venous catheter suffering from several basic diseases.
Saccharomyces boulardii is not recommended due to lack of sufficient data for the safe use during pregnancy and breast feeding.
Infections and Infestations: Very rare: Fungaemia in patients with a central venous catheter and in critical ill or immunocompromised patients.
May often cause flatulence. (See Precautions).
Normagut can cause side effects to gastro intestine (flatulence), skin (rash, cutaneous allergy, urticarial, pruritus), immune system (allergy response including swelling below the skin surfaces and breathing difficulties.
The concomitant administration of this medicinal product and antimycotic agents may impair the effect of Saccharomyces boulardii.
The concomitant administration of monoamine oxidase inhibitors may increase the blood pressure.
Note: Read the instructions carefully before use.
Do not use the product if there are significant changes in appearance of the capsules.
Store below 25°C in a dry place, away from direct sunlight.
A07FA02 - saccharomyces boulardii ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.