BIOFLOR 200MG CAPSULE,HARD

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

SACCHAROMYCES BOULARDII CNCM I-745

Διαθέσιμο από:

BIOCODEX (0000008304) 7 AVENUE GALLIENI, GENTILLY, 94250

Φαρμακολογική κατηγορία (ATC):

A07FA02

INN (Διεθνής Όνομα):

SACCHAROMYCES BULARDI

Δοσολογία:

200MG

Φαρμακοτεχνική μορφή:

CAPSULE,HARD

Σύνθεση:

SACCHAROMYCES BOULARDII CNCM I-745 (8000004690) 200MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

SACCHAROMYCES BULARDI

Περίληψη προϊόντος:

Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή; BOTTLE WITH 10 CAPS (990016601) 10 CAPSULE - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BIOFLOR 200 MG CAPSULES
_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 use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have 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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
WHAT IS IN THIS LEAFLET
1.
What BIOFLOR 200 mg capsules is and what it is used for
2.
What you need to know before you takeBIOFLOR 200 mg capsules
3.
How to take BIOFLOR 200 mg capsules
4.
Possible side effects
5.
How to store BIOFLOR 200 mg capsules
6.
Contents of the pack and other information
1.
WHAT BIOFLOR 200 MG CAPSULES IS AND WHAT IT IS USED FOR
The active substance of BIOFLOR is the yeast _Saccharomyces boulardii_
CNCM I-745.
_Saccharomyces boulardii _CNCMI-745 is a probiotic that means that it
is a live microorganism
which is beneficial to your organism.
BIOFLOR is indicated for the treatment and/or prevention of diarrhea
from different
aethiology, in adults and children such as:
-
Treatment of acute infectious diarrhea of adults and children;
-
Prevention and treatment of antibiotic-associated colitis and
diarrhea;
-
Addition
to
vancomycine/metronidazole
treatment
to
prevent
recurrence
of
_Clostridium difficile_ diseases;
-
Prevention of tube-feeding associated diarrhea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIOFLOR 200 MG CAPSULES
DO NOT TAKE BIOFLOR 200 MG CAPSULES:
-
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 (see Warnings and precautions).
-
If you are an immunocompromised or hospitalised patient (due

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
BIOFLOR 200 mg, capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For one capsule:
Active ingredient
Lyophilized _Saccharomyces boulardii_ CNCM
I-745.................................... 226 mg
(corresponding to 200 mg of lyophilized cells of _Saccharomyces
boulardii_ CNCM I-745 and
26 mg of lactose)
Other ingredients :
Magnesium stearate
..................................................................................
2.30 mg
Composition of the capsule envelope :
-
Gelatin………………………………………82.32 mg
-
Titanium dioxide…………………………..1.96 mg
3.
PHARMACEUTICAL FORM
Capsules.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
treatment of acute infectious diarrhea of adults and children ;
-
prevention and treatment of antibiotic-associated colitis and diarrhea
;
-
addition to vancomycine/metronidazole treatment to prevent recurrence
of _Clostridium_
_difficile_ diseases ;
-
prevention of tube-feeding associated diarrhea.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
1 or 2 capsules, given once or twice daily.
Capsules are to be either swallowed with a mouthful of water, or
opened to pour the
contents into a little sweetened beverage, on foods, or in a baby's
feeding-bottle.
In young children under 6 years of age, it is recommended not to
swallow capsules (risk of
false passage) but to open them and tip the contents into a beverage
or food.
4.3.
CONTRA-INDICATIONS
-
Hypersensitivity to one of the ingredients,
-
Patient with central venous catheter (see special warnings)
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE.
SPECIAL WARNINGS:
It is advisable not to open capsules in the surroundings of patients
with a central venous
catheter, to avoid any colonization, especially hand-borne, of the
catheter. There have
been reports in patients with a central venous catheter, even not
treated with
_Saccharomyces boulardii_ CNCM I-745, of very rare cases of fungemia
(penetration of
blood by yeast), mo