Normagut Saccharomyces boulardii 250mg Capsules

Country: Malaysia

Language: English

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

Active ingredient:

SACCHAROMYCES BOULARDII

Available from:

MEGA LIFESCIENCES SDN. BHD.

INN (International Name):

SACCHAROMYCES BOULARDII

Units in package:

10 Capsules; 60 Capsules; 30 Capsules; 50 Capsules

Manufactured by:

Ardeypharm GmbH

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
1
NORMAGUT CAPSULES
Saccharomyces Boulardii 250mg
WHAT IS IN THIS LEAFLET
1.
What NORMAGUT is used for
2.
How NORMAGUT works
3.
Before you use NORMAGUT
4.
How to use NORMAGUT
5.
While
you
are
using
NORMAGUT
6.
Side effects
7.
Storage
and
disposal
of
NORMAGUT
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT NORMAGUT IS USED
FOR
NORMAGUT is indicated for
-
Treatment
of
acute
diarrhea
in
children and adults
-
Prevention
of
antibiotic-associated
diarrhea in children and adults
- Prevention of tube feeding associated
diarrhea in adults.
-
Addition
to
vancomycin
/
metronidazole
treatment
to
prevent
recurrence
of
Clostridium
difficile
diseases in adults.
HOW NORMAGUT WORKS
Saccharomyces
boulardii
is
an
intestinal
replacement
flora
(live
probiotic
yeast)
which
acts
as
antidiarrheal
microorganisms
in
the
digestive
tract.
Saccharomyces
boulardii protects the digestive tract
against pathogens and restore normal
flora.
BEFORE YOU USE NORMAGUT
-
When you must not use it
•
Hypersensitivity
to
one
of
the
components
•
Patients
with
central
venous
catheter
•
Critically
ill
patients
or
immunocompromised
patients
due to a risk of fungaemia.
_- Pregnancy and Lactation _
Saccharomyces
boulardii
is
not
recommended due to lack of sufficient
data for the safe use during pregnancy
and breast feeding.
_- Before you start to use it _
•
Consult your doctor or pharmacist
if
you
are
critically
ill
/
immunocompromised
_- Taking other medicines _
•
Inform
your
doctor
if
you
are
taking antifungal medicine or any
other
medicines,
including
any
that
you
buy
without
a
prescription
from
a
pharmacy,
supermarket or health food shop.
HOW TO USE NORMAGUT
-
_How much to use _
Children
(>
6
years
old):
1
to
2
capsules daily.
Adults: 1 or 2 capsules, once or twice
daily. Capsules should be swallowed
with a glass of water.
The
capsules
can
be
taken
either
during,
before
or
after
meals.
For
children below 6 years old (who are
unable
to
swallow),
disca