EMECON TABLET 10MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METOCLOPRAMIDE HYDROCHLORIDE

Boleh didapati daripada:

ZONTRON PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

METOCLOPRAMIDE HYDROCHLORIDE

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

TERAPUTICS SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EMECON TABLET
Metoclopramide Hydrochloride (10mg)
__________________________________________________________________________________________________
__________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Emecon Tablet is used for
2.
How Emecon Tablet works
3.
Before you use Emecon Tablet
4.
How to use Emecon Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Emecon
Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT EMECON TABLET IS USED FOR
Emecon is used in adults for the following:

for prevention of nausea and vomiting
after chemotherapy or radiotherapy

for symptomatic treatment of nausea
and vomiting due to acute migrane
and other causes
Emecon
is
used
in
children
for
the
following:

for prevention of nausea and vomiting
after chemotherapy as a second line
treatment option.
HOW EMECON TABLET WORKS
Emecon
Tablet
contains
the
active
ingredient metoclopramide hydrochloride.
It
works on a part on
your brain that
prevents you from feeling sick (nausea) or
being sick (vomiting).
BEFORE YOU USE EMECON TABLET
_- When you must not use it _
Do not take Emecon Tablet if:

you are allergic to metoclopramide or
any of the other ingredients in the
tablets

you have bleeding, obstruction or a
tear in your stomach or gut

you have or may have a rare tumor of
the adrenal gland, which sits near the
kidney (pheochromocytoma)

you
have
ever
had
stiff,
jerky
movement (tardive dyskinesia), when
you have been treated with a medicine

you have epilepsy

you have Parkinson’s disease

you
are
taking
levodopa
or
other
medicine for Parkinson’s disease

you
had
an
operation.
Metoclopramide should not be used
during
first
three
to
four
days
following operations

you have ever had abnormal blood
pigment
levels
(methaemoglobinemia)
or
NADH
cytochrome-b5 enzyme deficiency
Do not give metoclopramide

Ciri produk

PRODUCT LITERATURE
EMECON TABLET 10MG
Each tablet contains:
Metoclopramide Hydrochloride 10 mg
EMECON SYRUP 5MG / 5 ML
Each 5ml contains:
Metoclopramide Hydrochloride 5 mg
PRESERVATIVE IN SYRUP
Methyl Paraben 0.11% w/v
Propyl Paraben 0.015% w/v
DESCRIPTION
Syrup: Yellow coloured clear syrup with sweet taste fruity odour.
Tablet: Round white odourless tablet with score on one side and plain
on
other side
PHARMACODYNAMICS PROPERTIES
Metoclopramide hydrochloride is a substituted benzamide which
stimulates
the motility of the upper gastro-intestinal tract without affecting
gastric acid
secretion.
Metoclopramide
hydrochloride
increases
gastric
peristalsis
leading
to
accelerated gastric emptying. Duodenal peristalsis is also increased
which
decreases intestinal transit time. The resting tone of the
gastro-oesophageal
sphincter is increased and the pyloric sphincter is relaxed.
Metoclopramide possesses parasympathomimetic activity as well as being
a
dopamine receptor antagonist with a direct effect on the Chemoreceptor
trigger zone. Metoclopramide also increases prolactin secretion.
PHARMACOKINETICS PROPERTIES
RENAL IMPAIRMENT
The clearance of metoclopramide is reduced by up to 70% in patients
with
severe renal impairment, while the plasma elimination half-life is
increased
(approximately 10 hours for a creatinine clearance of 10-50 mL/minute
and
15 hours for a creatinine clearance <10 mL/minute).
HEPATIC IMPAIRMENT
In patients with cirrhosis of the liver, accumulation of
metoclopramide has
been observed, associated with a 50% reduction in plasma clearance.
INDICATION
ADULT POPULATION
Emecon is indicated in adults for:
•Prevention of delayed chemotherapy induced nausea and vomiting
(CINV)
•Prevention of radiotherapy induced nausea and vomiting (RINV)
•Symptomatic treatment of nausea and vomiting, including acute
migrane
induced nausea and vomiting
PAEDIATRIC POPULATION
Emecon is indicated in children (aged 1 – 18 years) for:
•Prevention of delayed chemotherapy induced nausea and vomiting
(CINV)
as a second lin