INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo INTEFLORA 250 CAPSULES

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME:
(and dosage form)

INTEFLORA 250 CAPSULES

COMPOSITION:
Each capsule contains 250 mg lyophilised
Saccharomyces boulardii 17

PHARMACOLOGICAL CLASSIFICATION:
A.11.9.2 Antidiarrhoeals, other.

PHARMACOLOGICAL ACTION:
Acute infectious diarrhoea results from a disruption of the gastrointestinal ecosystem, thus favouring the colonization by enteropathogens and promoting their ability to upset the enterosystemic water cycle. Thus, along with specific antidiarrhoeal medication, there should also be active rehydration of the patient. INTEFLORA 250 contains a living yeast, Saccharomyces boulardii 17, which is active in the gastrointestinal tract. This yeast has an antagonistic effect against the overgrowth of different enteropathogenic bacteria (Shigella dysenteriae, Salmonella typhi, Escherichia coli) and Candida albicans.
It also enhances non-specific immune defences in the case of experimental bacteria (Staphylococcus aureus, Salmonella enteritidis) or fungal (Candida albicans) invasions. These actions re-establish the equilibrium of the gastrointestinal ecosystem and so reduced diarrhoea.
Saccharomyces boulardii 17 also synthesisers and supplies Vitamin B components within the gastrointestinal tract.
This yeast is genetically resistant to antibacterial agents and can be taken in conjunction with antibiotics to prevent diarrhoea.

INDICATIONS:
a) Prophylaxis and treatment of the intestinal and muco-cutaneous side-effects induced by antibiotic therapy: diarrhoea, colitis, candidiasis.
b) Non-specific diarrhoea.
c) Colitis, enterocolitis.
d) Prevention of diarrhoea during continuous enteral feeding.
e) Suitable for use in infants, children, adults and in the elderly.

CONTRA-INDICATIONS:
None

DOSAGE AND DIRECTIONS FOR USE:
One capsule twice daily or as prescribed. Maybe taken in conjunction with antibiotics and other anti-diarrhoeal medication.
Saccharomyces boulardii 17 is sensitive to concomitant anti-fungal agents, hot beverages and alcohol.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
None recorded.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
Saccharomyces boulardii 17 is not absorbed into the blood circulation and any overdose is merely excreted via the gastrointestinal tract.

IDENTIFICATION:
Size 0, opaque white capsules.

PRESENTATION:
Glass bottles containing 10 or 20 capsules.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 25°C. Keep out of reach of children.

APPLICATION NUMBER:
T194

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Co. Ltd.
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 March 1985

28059
12/2001

New to this site: November 2004
Current: September 2005
Source: Community Pharmacy

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