Bioflor Powder for Oral Solution 250mg

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

SACCHAROMYCES BOULARDII

Beschikbaar vanaf:

Biocodex 7 Avenue Gallieni- 94250 Gentilly, France

ATC-code:

A07FA02

INN (Algemene Internationale Benaming):

SACCHAROMYCES BOULARDII 250 mg

farmaceutische vorm:

POWDER FOR ORAL SOLUTION

Samenstelling:

SACCHAROMYCES BOULARDII 250 mg

Prescription-type:

OTC

Therapeutisch gebied:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Autorisatie-status:

Authorised

Autorisatie datum:

2006-02-27

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BIOFLOR 250MG POWDER FOR ORAL SUSPENSION IN SACHET
_SACCHAROMYCES BOULARDII_ CNCM I-745
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or your pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 2 days.
WHAT IS IN THIS LEAFLET
1.
What BIOFLOR 250mg powder for oral suspension in sachet is and what it
is used for
2.
What you need to know before you take BIOFLOR 250mg powder for oral
suspension in
sachet
3.
How to take BIOFLOR 250mg powder for oral suspension in sachet
4.
Possible side effects
5.
How to store BIOFLOR 250mg powder for oral suspension in sachet
6.
Contents of the pack and other information
1.
WHAT BIOFLOR 250MG POWDER FOR ORAL SUSPENSION IN SACHET IS AND WHAT IT
IS USED
FOR
Pharmacotherapeutic group: Anti-diarrhea. Replacement flora. (A:
Digestive system and metabolism).
Therapeutic indications:
•
Treatment of acute infectious diarrhoea of adults and children.
•
Prevention and treatment of antibiotic-associated colitis and
diarrhoea.
•
Addition to vancomycin/metronidazole-treatment to prevent recurrence
of _Clostridium difficile_
diseases.
•
Prevention of tube-feeding associated diarrhoea.
•
Treatment of irritable bowel syndrome.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIOFLOR 250MG POWDER FOR ORAL
SUSPENSION IN SACHET
DO NOT TAKE BIOFLOR 250MG POWDER FOR ORAL SUSPENSION IN SACHET:
-
If you are allergic to _Saccharomyces boulardii_ CNCM I-745 or any of
the other ingredients of this
medicine (listed in section 6).
-
If you have a central venous catheter.
-
In immunocompromised or h

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BIOFLOR
® 250MG, POWDER FOR ORAL SUSPENSION IN SACHET.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Saccharomyces boulardii_ CNCM I-745
............................................................................
250.00mg
(lyophilized cells of _Saccharomyces boulardii _CNCM I-745)
Excipients with known effect: lactose, fructose, sorbitol (contained
in tutti frutti aroma)
For the full list of excipients: see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension in sachet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
Treatment of acute infectious (viral or bacterial) diarrhea.
-
Preventive and curative treatment of antibiotic-associated diarrhea
and colitis.
-
Preventive
treatment
of
recurrence
of
_Clostridium _
_difficile_
disease
in
addition
to
vancomycin/metronidazole.
-
Preventive treatment of tube-feeding associated diarrhea.
-
Treatment of irritable bowel syndrome.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
1 or 2 sachets, given once or twice daily.
_METHOD OF ADMINISTRATION _
Oral route.
Pour the contents of the sachet in a little water or sweetened
beverage, mix, and drink. The powder can also
be mixed with food or poured into a baby’s feeding-bottle.
Due to a risk of airborne contamination, sachets should not be opened
in patient rooms. Healthcare providers
should wear gloves during handling of probiotics for administration,
then promptly discard the gloves and
properly wash their hands (see section 4.4).
4.3.
CONTRA-INDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
Patient with central venous catheter
-
Critically ill patients or immunocompromised patients due to a risk of
fungaemia (see section 4.4).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist for more than 2 days of treatment at usual
posology, the therapeutic approach will be re-
evaluated.
The treatment does not replace rehydration when this is necessary. The
rehydration d