MOTIDONE TABLET 10MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
03-02-2021
Ciri produk Ciri produk (SPC)
03-02-2021

Bahan aktif:

DOMPERIDONE

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

DOMPERIDONE

Unit dalam pakej:

500 Tablet Tablets; 500Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA (M) SDN. BHD.

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
MOTIDONE TABLET
Domperidone (10mg)
WHAT IS IN THE LEAFLET
1.
What MOTIDONE is used
for
2.
How MOTIDONE works
3.
Before
you
use
MOTIDONE
4.
How to use MOTIDONE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
MOTIDONE
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
MOTIDONE
IS
USED
FOR
The
indigestion
symptom
complex
that
is
often
associated with delayed gastric
emptying,
gastro-oesophageal
reflux
and
oesophagus
inflammation:
•
epigastric sense of fullness,
early
satiety,
feeling
of
abdominal distension, upper
abdominal pain;
•
bloating, burping, flatulence
•
nausea and vomiting;
•
heartburn
with
or
without
back flow of gastric contents
in the mouth.
HOW MOTIDONE WORKS
MOTIDONE is an antiemetic
and
a prokinetic
medicine.
It
works by blocking the action
of a chemical messenger in the
brain which causes the feeling
of nausea and vomiting, as well
as increasing the movement or
contractions
of
the
stomach
and intestines, allowing food to
move more easily through the
stomach.
BEFORE YOU USE MOTIDONE
-
_When you must not use it_
Do not take MOTIDONE if:
•
you
have
an
allergy
to
MOTIDONE or any of the
ingredients
at
the
end
of
this leaflet.
•
you have a tumour of the
pituitary
gland
called
prolactinoma
•
bleeding,
obstruction
or
perforation in the stomach
and intestines.
•
prevention of post-operative
vomiting
or for long
term
usage
•
you
have
cardiac
diseases
such as heart failure due to
increased risk of abnormal
heart beat
Do
not
take
MOTIDONE
if
you
are
taking
any
of
the
following
medicines:
clarithromycin (antibiotic).
-
_Before you start to use it_
You must tell your doctor if:
•
you
are
pregnant
or
planning
to
become
pregnant.
This
medicine
should
be
used
during
pregnancy
only
if
clearly
needed.
•
you have or have had liver
disease.
•
you had breast cancer.
•
you
have
experience
any
cardiac symptoms.
If
you
have
not
told
your
doctor or pharmacist about any
of the above,
                                
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Ciri produk

                                [DUOPHARMA (M) SDN BHD]
Page 1 of 2
[REVISION DATE: 01.02.2021]
MOTIDONE TABLET 10MG
DESCRIPTION:
An oblong shaped tablet, pink in colour with marking "DUO".
COMPOSITION:
Each tablet contains Domperidone 10 mg.
PHARMACODYNAMICS:
Pharmacologically, domperidone is a dopamine antagonist with
antiemetic properties similar to those of metoclopramide and certain
neuroleptic drugs. Unlike these drugs, however, domperidone does
not readily cross the blood brain barrier. It seldom causes
extra-pyrimidal side effects, but does cause a rise in prolactin
levels. Its antiemetic effect may be due to a combination of
peripheral (gastro-
kinetic) effects and antagonism of central dopamine receptors in the
chemo-receptor trigger zone which lies in the area postrema and is
regarded as being outside the blood brain barrier. Animal studies
have shown that domperidone has no effect on plasma concentrations of
homovanillic acid, a metabolite of dopamine. It also antagonises the
behavioural effects of dopamine much more effectively when
administered intracerebrally than when given systemically. These
findings, together with the low concentrations found in the brain,
indicate a predominantly peripheral effect of domperidone on dopamine
receptors.
Studies in humans have shown intravenous and oral domperidone to
increase the duration of antral and duodenal contractions, to increase
the gastric emptying of liquids and semi solids in healthy subjects
and in patients in whom, it was delayed, and to increase lower
oesophageal sphincter pressure in healthy subjects. Domperidone has no
effect on gastric secretion.
PHARMACOKINETICS:
Domperidone is rapidly absorbed following intramuscular and oral
administration with peak plasma concentrations occurring at
approximately 10 and 30 minutes respectively. Systemic bioavailability
of
oral domperidone is 13 to 17%. The low oral bioavailability is
probably due to "first-pass" gut wall and hepatic metabolism. Oral
bioavailability is decreased by prior administration of cimetidine or
sodium
bicarbonate. T
                                
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