Progit 50mg Tablets

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

ITOPRIDE HYDROCHLORIDE

Fáanlegur frá:

PHARMENG TECHNOLOGY SDN. BHD.

INN (Alþjóðlegt nafn):

ITOPRIDE HYDROCHLORIDE

Einingar í pakka:

20 Tablets; 30 Tablets; 40 Tablets; 90 Tablets; 100 Tablets

Framleitt af:

PRO.MED.CS Praha a.s.

Upplýsingar fylgiseðill

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PROGIT 50 MG TABLETS
Itopride Hydrochloride (50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Progit is used for
2.
How Progit works
3.
Before you use Progit
4.
How to use Progit
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Progit
8.
Product Description
9.
Manufacturer,
Product
Registration
Holder
and
Distributor
10.
Date of revision
WHAT PROGIT IS USED FOR
Progit is used in the treatment of
gastrointestinal
symptoms
of
functional,
nonulcer
dyspepsia
(chronic gastritis) i.e. sensation of
bloating,
early
satiety,
upper
abdominal
pain
or
discomfort,
anorexia,
heartburn,
nausea
and
vomiting.
HOW PROGIT WORKS
Progit
helps
to
normalize
or
enhance
and
accelerate
bowel
movement
(motility).
It
has
an
antiemetic effect which can cause
suppression
of
vomiting.
Their
administration
accelerates
stomach
emptying
and
has high
specific
action
in
upper
part
of
gastrointestinal tract. Progit does
not
influence
plasma
concentrations of gastrin.
BEFORE YOU USE PROGIT
-
_When you must not use it _
Do not take Progit
-
if you are allergic to itopride or
any of the other ingredients of
this medicine,
-
if accelerated gastric emptying
can be harmful for you, e. g. if
you suffer from gastrointestinal
bleeding,
obstruction
or
perforation.
Progit is not intended for children
under
the
age 16, pregnant
and
breast-feeding women.
-
_Before you start to use it _
PREGNANCY AND BREAST-FEEDING
If
you
are
pregnant
or
breast-
feeding,
think
you
may
be
pregnant or are planning to have a
baby,
ask
your
doctor
or
pharmacist
for
advice
before
taking this medicine.
Progit should not be used during
pregnancy
unless
the
benefits
outweigh the potential risks.
Because
of
lack
of
experience
with
use
of
Progit
during
breast-feeding
it
is
not
recommended
for
breast-feeding
women.
-
_Taking other medicines _
Tell your doctor or pharmacist if
you
are
taking,
have
recently
taken
or
might
take
any
other
medicines.
The effect of Progit and of the
other
concomitantly
used
medicines may interact.
-
An

Vara einkenni

PROGIT 50 MG TABLETS
Itopride Hydrochloride (50 mg)
DESCRIPTION
White to almost white round biconvex scored film-coated tablets,
diameter 7 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
COMPOSITION
Each film-coated tablet contains 50 mg of itopride hydrochloride.
Excipients with known effect: Each film-coated tablet contains 74.68
mg of lactose monohydrate.
List of excipients:
Lactose monohydrate, Pregelatinized maize starch, Croscarmellose
sodium, Silica colloidal anhydrous,
Magnesium
stearate
and
coating
composition
Opadry
II
White
85F18422
(partially
hydrolyzed
polyvinylalcohol, titanium dioxide, macrogol 3350, talc).
PHARMACODYNAMICS
Pharmacotherapeutic group: drugs for functional gastrointestinal
disorders, propulsives.
ATC code: A03FA07
Mechanism of action
Itopride activates the gastrointestinal propulsive motility by
dopamine D
2
receptors antagonistic action and
acetylcholine esterase inhibitory action. Itopride activates
acetylcholine release and inhibits its degradation.
In addition itopride has an antiemetic action which is based on
interaction with dopamine D
2
receptors in
chemoreceptor zone.
Itopride accelerates stomach emptying in humans.
Itopride has high specific action in upper part of gastrointestinal
tract.
Itopride does not influence plasma concentrations of gastrin.
PHARMACOKINETICS
Absorption
Itopride is absorbed rapidly and almost completely from
gastrointestinal tract. Relative bioavailability about
60% is due to liver first pass metabolism. Food does not affect
bioavailability of the product. Maximum
plasma concentrations are reached in 30 to 45 minutes after
administration of 50 mg of itopride.
After repeated administration of doses in the range of 50 to 200 mg 3
times a day for period of 7 days,
itopride and its metabolites have shown pharmacokinetics of linear
type with minimal accumulation.
Distribution
About 96% of itopride is bound on plasma proteins, mainly albumin.
Less than 15% of itopride bound part
is bound on alph