MUCOSTA TABLETS 100 MG

Country: Malaysia

Language: English

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

Active ingredient:

REBAMIPIDE; REBAMIPIDE

Available from:

A. MENARINI SINGAPORE PTE. LTD.

INN (International Name):

REBAMIPIDE; REBAMIPIDE

Units in package:

100 Tablets

Manufactured by:

KOREA OTSUKA PHARMACEUTICAL CO LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MUCOSTA TABLETS 100MG
Rebamipide (100mg)
1
WHAT IS IN THIS LEAFLET
1.
What MUCOSTA is used for
2.
How MUCOSTA works
3.
Before you use MUCOSTA
4.
How to use MUCOSTA
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
MUCOSTA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MUCOSTA IS USED FOR
MUCOSTA is used to treat gastric
ulcers
and
treatment
of
gastric
mucosal lesions (erosion, bleeding,
redness
and
edema)
in
the
following
conditions:
acute
gastritis
(severe
inflammation
of
the lining of the stomach caused
by food poisoning, overeating or
bacterial
or
viral
infection)
and
acute
exacerbation
of
chronic
gastritis (an inflammation of the
stomach
lining
that
may
occur
repeatedly
or
continue
over
a
period of time).
HOW MUCOSTA WORKS
Mucosta
containing
the
active
ingredient
rebamipide.
It
has
the
preventive
and
healing
effects
in
gastric ulcer.
It
can
protect
the
mucosa
from
injury
and
it
can
also
promote
healing
of
the
mucosal
inflammation
associated
with
gastritis (swelling or inflammation
in the lining of the stomach).
BEFORE YOU USE MUCOSTA
_-When you must not use it _
You must not take MUCOSTA if
you are:
•
hypersensitive
to
any
ingredient of this drug.
•
Nursing a child
_-Before you start use it _
Patients are advised:
•
To read the patient package
insert
for
MUCOSTA
carefully
before
starting
therapy and to reread it each
time
therapy
is
renewed
in
case
the
information
has
changed.
Please
tell
your
doctor
or
pharmacist if you are pregnant
or nursing a child.
_-Taking other medicines _
Please inform your doctor or
pharmacist drugs that you are
taking
including
those
you
obtain
form
pharmacies
without a prescription. HOW TO USE MUCOSTA
_-How much to use _
The
usual
adult
dosage
of
MUCOSTA is 100mg 3 times
daily.
_-When to use it _
MUCOSTA should be taken
in the morning, in the evening
and before at bedtime.
_-How long to use it _
It is important to follow and
finish up the prescribed dose
by

Summary of Product characteristics

-ANTI-GASTRITIS AND ANTI-GASTRIC ULCER DRUG –
MUCOSTA
® TABLETS 100
< Rebamipide>
DESIGNATED DRUG AND PRESCRIPTION-ONLY DRUG
STORAGE:
Store below 30
⁰
C
.
EXPIRATION DATE
: Three years after the date of manufacture.
(The expiration date is indicated on the package.)
DESCRIPTION
1. Composition
MUCOSTA Tablets 100:
Each
MUCOSTA
Tablet
contains
100
mg
of
rebamipide
and
the
following
inactive
ingredients:
microcrystalline
cellulose,
low
substituted
hydroxypropylcellulose,
hvdroxypropylcellulose,
magnesium
stearate, hypromellose,
macrogol 6000, and titanium oxide.
2. Product Description
MUCOSTA Tablets 100 are white film-coated tablets.
INDICATION
- Gastric ulcers
- Treatment of gastric mucosal lesions (erosion, bleeding, redness and
edema) in the following conditions:
acute gastritis and acute exacerbation of chronic gastritis.
DOSAGE AND ADMINISTRATION
• Gastric ulcers: The usual adult dosage of rebamipide is 100mg
(1MUCOSTA Tablet) taken by the oral route
three times daily, in the morning, in the evening, and before at
bedtime.
•Treatment of gastric mucosal lesions (erosion, bleeding, redness,
and edema) in the following conditions;
acute gastritis and acute exacerbation of chronic gastritis: The usual
adult dosage of rebamipide is 100 mg (1
MUCOSTA Tablet) three times daily taken by the oral route.
PRECAUTIONS
1. Adverse Reactions
Of 10,047 patients treated, adverse reactions, including abnormal
laboratory findings, were reported in 54
patients (0.54%). Of 3,035 patients aged over 65 years, adverse
reactions were noted in 18 patients (0.59%).
The nature and incidence of adverse reactions were not different
between the same in elderly and younger
patients. The following summary of data includes adverse reactions
voluntari1y reported after marketing
(Figures are total cases reported at the time of approval and at the
completion of reexamination of
MUCOSTA Tablet 100)
CONTRAINDICATIONS
(MUCOSTA Tablets are contraindicated in the following patients)
Patients with a history of hypersensitivity to any ingredien