INTESTIFLORA® PACKAGE INSERT
SCHEDULING STATUS: Nutritional supplement (Act 54/1972)
PROPRIETARY NAME (AND DOSAGE FORM): INTESTIFLORA® Capsules
COMPOSITION: Each capsule contains 121.1 mg of a probiotic mixture consisting of Lactobacillus acidophilus, Bifidobacterim bifidum and Bifidobacterim longum (in a lyophilised form), which yields in total not less than 1 billion (10^9) viable cells, and 300mg or a prebiotic, fucto-oligosaccharide, which selectively supports the growth of probiotic strains
PHARMACOLOGICAL ACTION: INTESTIFLORA® tablets contain a mixture of lyophilised lactic acid bacteria namely, Lactobacillus acidophilus, Bifidobacterium bifidum and Bifidobacterium longum which are natural inhabitants of children’s intestines.
INTESTIFLORA® is administered to restore the normal intestinal lactobacilli and bifidobacteria destroyed by broad-spectrum antibiotics, therefore limiting the overgrowth of pathogenic organisms. Administration of high doses of these bacteria helps to prevent diarrhoea associated with broad-spectrum antibiotic treatment. The resulting increase in the indigenous intestinal bacteria enhances the inhibition of the growth of pathogens.
INDICATIONS: INTESTIFLORA® “When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut”: (S0).
CONTRA-INDICATIONS: None known
DOSAGE AND DIRECTIONS FOR USE:
Treatment dose: 3 capsules to be taken three times per day with water (preferably on an empty stomach, 30 minutes before meals), for 1 to 2 weeks. In conjunction with antibiotic therapy, continue with the treatment for at least one week after the completion of the therapy.
Maintenance dose: 1 capsule per day to be taken three times per day with water (preferably on an empty stomach, 30 minutes before meals)
1 to 6 years old: 1 capsule per day
7 to 14 years old: 2 capsule per day
For children above 14 years: an adult dose is recommended
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Large doses may cause loose stools in some individuals.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Loose stools whereupon the administration of INTESTIFLORA® should be discontinued temporarily.
IDENTIFICATION: White gelatine capsules containing white to cream coloured, granular material with a slight lactic acid smell.
PRESENTATION: 90 tablets in Securitainers.
STORAGE CONDITIONS: Store in a cool, dry place below 8oC (in refrigerator or freezer).
KEEP OUT OF REACH OF CHILDREN.