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

Logo CULTURELLE capsules
CULTURELLE chewtabs
CULTURELLE paediatric sachets

SCHEDULING STATUS:
Not applicable

PROPRIETARY NAME
(and dosage form):

CULTURELLE capsules
CULTURELLE chewtabs
(chewable tablet)
CULTURELLE paediatric sachets

COMPOSITION:
Each enteric coated capsule contains a minimum of 10 x 107 viable Bifidobacterium longum and Lactobacillus rhamnosus cells.
Alternatively known as
lactic acid bacteria or probiotics.
Other ingredients: Fructo-oligosaccharides, glucose, potato starch and locus bean gum.

Each chew tablet contains a minimum of 10 x 107 viable Bifidobacterium longum and Lactobacillus rhamnosus cells which have been microencapsulated with natural protein.
Alternatively known as lactic acid bacteria or probiotics.
Other ingredients: Oligosaccharides, lactic acid, magnesium stearate and tangerine flavour and odour.

Each 1,5 g sachet contains a minimum of 10 x 107 viable Bifidobacterium longum, Lactobacillus acidophilus and Streptococcus thermophilus cells which have been microencapsulated.
Alternatively known as lactic acid bacteria or probiotics.
Other ingredients: Oligosaccharides, silicon dioxide and magnesium stearate.

PHARMACOLOGICAL CLASSIFICATION:
A: 34 Other

PHARMACOLOGICAL ACTION:
Probiotics compete with pathogenic bacteria for enteric sites (within the intestine) thereby inhibiting the pathogenic bacteria from establishing themselves.
Furthermore, probiotics compete with pathogenic bacteria for nutrients thereby inhibiting the pathogenic bacteria from multiplying (proliferating) and becoming the dominant bacteria.

INDICATIONS:
To assist in restoring the intestinal flora imbalance caused by factors such as diarrhoea, bacterial infections, stress, travelling, antibiotic treatment, alcohol consumption, poor diet and other factors.

CONTRA-INDICATIONS:
No known contra-indications.

DOSAGE AND DIRECTIONS FOR USE:
Capsule and Chewtab:
PREVENTATIVE: 1 capsule or chew tablet twice a day.
During ANTIBIOTIC TREATMENT: 2 capsules or chew tablet twice a day.
Paediatric sachet:
PREVENTATIVE:
Children under 1 year: Administer the contents of 1 (one) sachet mixed in water or milk twice a day.
Children over 1 year: Administer the contents of 2 (two) sachets mixed in water or milk twice a day.
During ANTIBIOTIC TREATMENT:
Children under 1 year: Administer the contents of 2 (two) sachets mixed in water or milk twice a day.
Children over 1 year: Administer the contents of 4 (four) sachets mixed in water or milk twice a day.
While receiving oral antibiotic therapy, it is recommended that Culturelle be taken 3 hours after the antibiotic.
Or as directed by your Healthcare Professional

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
No known side-effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms of overdosage.

IDENTIFICATION:
Culturelle capsules: Opaque white to off-white hard gelatine capsule.
Culturelle chewtabs: Round, off-white, yellow speckled biconvex tablet.
Culturelle paediatric sachets: White to off white powder having a characteristic odour and flavour.

PRESENTATION:
Culturelle capsules: Containers of 30 capsules
Culturelle chewtabs: Containers of 30 chewtabs
Culturelle Paediatric sachet: Boxes of 10 sachets each containing 1,5 g.

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

NAME AND BUSINESS ADDRESS:
Pharma Dynamics (Pty) Ltd
F02 Grapevine House
Steenberg Office Park
Westlake
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 2002

New to this site: March 2003
Source: Pharmaceutical Industry

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