BIOFLOR 250mg capsules

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

SACCHAROMYCES BOULARDII

Inapatikana kutoka:

SERVIER MALAYSIA SDN BHD

INN (Jina la Kimataifa):

SACCHAROMYCES BOULARDII

Vitengo katika mfuko:

10capsule Capsules; 50 Capsules; 30 Capsules; 40 Capsules

Viwandani na:

Biocodex

Taarifa za kipeperushi

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BIOFLOR
®
CAPSULES/SACHETS
_Saccharomyces boulardii_
(250mg)
1
WHAT IS IN THIS LEAFLET
1. What
_BIOFLOR_
_®_
is used for
2. How
_BIOFLOR_
_®_
works
3. Before you use
_BIOFLOR_
_® _
4. While you are using it
5. Side effects
6. Storage and Disposal of
_BIOFLOR_
_®_
7. Product Description
8. Manufacturer and Product
Registration Holder
9. Date of revision
WHAT
_BIOFLOR_
_®_
IS
USED
FOR
_BIOFLOR_
_®_
is
indicated
for
acute
diarrhoea
in
infants,
children
and
adults;
prevention
of
antibiotic-
associated diarrhoea in children and
adults;
prevention
of
recurrence
of
_Clostridium _
_difficile_
in
adults
and
prevention
of
diarrhoea
during
continuous
enteral
tube
feeding
in
adults.
Ask your doctor or pharmacist if you
are not sure why you need to take
_BIOFLOR_
_®_
.
HOW _BIOFLOR_
_® _
WORKS
_Saccharomyces _
_boulardii_
is
an
intestinal
replacement
flora
(live
probiotic
yeast)
which
acts
as
antidiarrhoeal micoorganisms in the
digestive
tract.
_Saccharomyces _
_boulardii_
protects the digestive tract
against pathogens, improves digestion
and restore normal flora.
BEFORE YOU USE _BIOFLOR_
_® _
_- When you must not use it_
Do not use if you
•
Have
hypersensitivity
to
any
ingredient of
_BIOFLOR_
_®_
•
Have fructose or lactose intolerance
•
Have
congenital
galactosemia,
glucose
and
galactose
malabsorption syndrome or lactose
deficit
•
Are immunocompromised (altered/
weakened immune system) or have
central venous catheter
_ _
_Pregnancy and lactation _
Do not take
_BIOFLOR_
_®_
if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take
_BIOFLOR_
_®_
if you are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking
any medicine.
_BIOFLOR_
_®_
contains
lactose
monohydrate. If you have been told by
your
doctor
that
you
have
an
intolerance
to
some
sugars,
contact
your
doctor
before
taking
this
medicinal product.
_BIOFLOR_
_® _
sachet contains fructose:
This
medicine
contains
471.90
mg
fructose in each sachet. In case o

Tabia za bidhaa

1. IDENTIFICATION OF MEDICINAL PRODUCT
NAME:
BIOFLOR
®
250 mg, capsules
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Saccharomyces boulardii_
CNCM I-745....250 mg (lyophilized yeast cells)
Each capsule is required to present a minimum
_Saccharomyces boulardii_
CNCM I-745 of 2.5 x 10
9
CFU
Excipients of the capsule: lactose, magnesium stearate.
Composition of the capsule shell: gelatin, titanium dioxide (E171).
PRODUCT DESCRIPTION
Light brown powder in opaque white capsule, with characteristic odor.
PHARMACEUTICAL FORM
Capsule: Bottle of 10 and 50 capsules - Blister of 30 and 40 capsules.
PHARMACOTHERAPEUTIC CLASSIFICATION
ANTI-DIARRHOEA, Replacement flora (A: digestive system and
metabolism).
2. PHARMACODYNAMICS
_Saccharomyces boulardii_
(Sb) CNCM I-745 is an intestinal replacement flora which acts as
antidiarrhoeal microorganisms in the digestive tract. Pharmacodynamics
of
_Saccharomyces boulardii_
CNCM I-745, live probiotic yeast, have been established on various
models by
_in vitro_
and
_in vivo_
,
animal, and human studies which demonstrated it acts at 3 levels:
LUMINAL ACTION:
Sb may interfere with pathogen toxins, preserve cellular physiology,
interfere with
pathogens attachment (anti-toxinic effect against
_C. difficile_
, cholera,
_E. coli_
through preservation of
tight junctions, adhesion of the bacteria to Sb enabling to stop the
bacterial invasion), interact with
normal microbiota or assist in re-establishing short chain fatty acid
levels.
TROPHIC ACTION:
Sb reduces mucositis, restores fluid transport pathways, stimulates
protein and energy
production or act through a trophic effect by releasing spermine and
spermidine or other brush border
enzymes that aid in the maturation of enterocytes. Immune response: Sb
increases the IgA levels in the
intestine.
MUCOSAL ACTION – ANTI-INFLAMMATORY EFFECT:
Sb may interfere with NF-

B mediated signal
transduction pathways which stimulate pro-inflammatory cytokine
production.
In lyophilized form,
_S. boulardii_
CNCM I-745 survives gastric acid and bile and can b