INTEFLORA SACHETS POWDER

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

POWDER

Composition:

EACH SACHET CONTAINS SACCHAROMYCES BOULARDII 250,0 mg

Authorization status:

Registered

Authorization date:

2018-11-11

Patient Information leaflet

Applicant: Pharmacare Limited
Product Name: INTEFLORA Sachet
Dosage form and strength: Each sachet contains 250 mg
_Saccharomyces boulardii _
MODULE 1
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30 May 2022 (CC)
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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S0
INTEFLORA SACHET POWDER
_SACCHAROMYCES BOULARDII_ CNCM I-745 250 MG PER SACHET
CONTAINS SUGARS: FRUCTOSE : 471, 90 MG, LACTOSE 32,5 MG AND SORBITOL
0,11 MG PER
SACHET
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
INTEFLORA SACHET is available without a doctor’s prescription, for
you to treat a mild
illness. Nevertheless, you still need to use INTEFLORA SACHET
carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share INTEFLORA SACHET with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
You must see a doctor if your symptoms worsen or do not improve within
2 days.
WHAT IS IN THIS LEAFLET
1.
What INTEFLORA SACHET is and what it is used for
2.
What you need to know before you take INTEFLORA SACHET
3.
How to take INTEFLORA SACHET
4.
Possible side effects
5.
How to store INTEFLORA
SACHET
Applicant: Pharmacare Limited
Product Name: INTEFLORA Sachet
Dosage form and strength: Each sachet contains 250 mg
_Saccharomyces boulardii _
MODULE 1
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30 May 2022 (CC)
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6.
Contents of the pack and other information
1.
WHAT INTEFLORA SACHET IS AND WHAT IT IS USED FOR
INTEFLORA SACHET belongs to a group of medicines called antidiarrheal
microorganisms
and is used in:
•
Non-specific acute diarrhoea.
•
Diarrhoea associated with antibiotic therapy.
Suitable for use in infants, children, adults and the elderly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INTEFLORA SACHET
Diarrhoea may be a symptom of a more serious underlying disease. If
diarrhoea persist for
more than 2 days or there is blood in stools or fever develops consult
your doctor (see
section Warnings and precautions below).
DO NOT TAKE INTEFLORA SACHET
•
If you, your child

Summary of Product characteristics

Applicant: Pharmacare Limited
Product Name: INTEFLORA SACHET
Dosage form and strength: Each sachet contains 250 mg
_Saccharomyces boulardii _
MODULE 1
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30 May 2022 (CC)
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_ _
1.3.1.1
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S0
1.
NAME OF THE MEDICINE
INTEFLORA SACHET powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of INTEFLORA SACHET contains 250 mg lyophilised cells of
_Saccharomyces boulardii_ CNCM I-
745
_ _
.
_ _
Contains sugars:
Fructose: 471,90 mg per sachet
Lactose monohydrate 32,5 mg per sachet
Sorbitol 0,11 mg per sachet
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sachets
A very light brown powder with an odour of fruit.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INTEFLORA SACHET has been used for:
Applicant: Pharmacare Limited
Product Name: INTEFLORA SACHET
Dosage form and strength: Each sachet contains 250 mg
_Saccharomyces boulardii _
MODULE 1
1.3.1.1
30 May 2022 (CC)
Page 2 of 10
_ _
•
Diarrhoea associated with antibiotic therapy.
•
Non-specific acute diarrhoea.
Suitable for use in infants, children, adults and in the elderly.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
May be taken in conjunction with antibiotics and other anti-diarrhoeal
medication.
Length of treatment can range from 1 week to 3 weeks.
DIARRHOEA ASSOCIATED WITH ANTIBIOTIC THERAPY
Adults: Take two sachets twice a day.
NON-SPECIFIC ACUTE DIARRHOEA
Adults: Take one sachet twice a day.
PAEDIATRIC POPULATION
DIARRHOEA ASSOCIATED WITH ANTIBIOTIC THERAPY
_Infants and children:_ Give one sachet twice a day.
NON-SPECIFIC ACUTE DIARRHOEA
_Infants and children:_ Give one sachet twice a day.
METHOD OF ADMINISTRATION
For oral administration.
Pour the contents of the sachet(s) in a little amount of water or
sweetened beverage, mix and drink
immediately (see section 4.4). Due to a risk of airborne
contamination, sachets should not be opened in
Applicant: Pharmacare Limited
Product Name: INTEFLORA SACHET
Dosage form and strength: Each sachet contains