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Bioflora have Saccharomyces boulardii 100 mg, Treatment of acute infectious diarrhoea in adults and children associated with oral rehydration therapy, Prevention of antibiotic-associated diarrhoea in adults and children

NORMAGUT indications for maintenance of a well-functioning intestinal flora and a good intestinal health

Duphalac Indications  Constipation: regulation of the colonic physiological rhythm

Rovamycine 3M treatment of certain infections ENT, bronchopulmonary, cutaneous

COMPOSITION

Saccharomyces boulardii 100.00 mg

Excipients: lactose monohydrate, fructose, anhydrous colloidal silica, tutti frutti aroma for one sachet of 306 mg.

Bioflora contain Saccharomyces boulardii 100 mg

DOSAGE FORM – PACKING SIZE

Powder for oral suspension in sachet. Box of 20 sachets.

INDICATIONS

Bioflora Treatment of acute infectious diarrhoea in adults and children associated with oral rehydration therapy;

Prevention of antibiotic-associated diarrhoea in adults and children;

Prevention of the recurrence of diarrhoea due to Clostridium difficile injection.

POSOLOGY AND METHOD OF ADMINISTRATION Adults and children: 2 sachets twice per day.

Oral route. Pour the contents of the sachet into a glass of water.

The lyophilization of the active substance ensures the good stability and the vitality of Saccharomyces boulardii and allows establishing of suspension rapidly.

CONTRA-INDICATION Hypersensitivity to one of the ingredients.

Patients with central venous catheter.

SPECIAL WARNINGS

It is advisable not to open sachet in the surroundings of patients with a central venous catheter, to avoid any 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.

Due to the presence of lactose, this medicine should not be used in case of galactose intolerance, Lapp lactase deficiency or glucose and galactose malabsorption syndrome (rare metabolic diseases).

Due to the presence of fructose, this medicine should not be used in case of fructose intolerance.

PRECAUTIONS FOR USE

BIOFLORA contains living yeast cells growing at 37°C, this medicine should therefore not be mixed with very hot (over 50°C), iced or alcoholic drinks or food.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Not applicable

INTERACTION WITH OTHER DRUGS, OTHER FORMS OF INTERACTIONS

Due to its yeast nature, Bioflora must not be administered with antifungal drugs.

PREGNANCY- LACTATION

Clinically, no malformative nor fetotoxic effect has been reported to date. Hence, as precautionary measure, it is preferable to avoid using this medicine during pregnancy.

UNDESIRABLE EFFECTS

Immune system: rarely allergic reactions (may be Quincke’s angioedema), rash, itchy.

Skin and subcutaneous tissue dlsorders urtlcaria rarely.

inform your doctor about any undesirable effects related to the drug use.

OVERDOSES

Due to its nature and its pharmacokinetics of Bioflora, no symptoms of overdosage are respected.

STORAGE-SHELF LIFE Keep out of reach of children.

Storage at temperature below 30°C and away from humidity.

Do not exceed the expiry date indicated on the outer pack.

Shelf-life: 36 months from manufacturing date.

Read carefully the leaflet before use. For more information ask your physician.

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