ONDANOV 8mg Tablet

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Verfügbar ab:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Internationale Bezeichnung):

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Einheiten im Paket:

12tablet Tablets

Hergestellt von:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP)_
ONDANOV TABLET
ONDANSETRON (4MG, 8MG)
WHAT IS IN THIS LEAFLET
1. What ONDANOV Tablet is used
for
2. How ONDANOV Tablet works
3.
Before
you
use
ONDANOV
Tablet
4. How to use ONDANOV Tablet
5. While you are using it
6. Side effects
7. Storage
and
Disposal
of ONDANOV Tablet
8. Product Description
9. Manufacturer and
Product
Registration Holder
10. Date of revision
WHAT
ONDANOV
TABLET
USED
FOR
ONDANOV
Tablet
is
used
to
manage of nausea (feeling sick) and
vomiting (being sick) induced by
cytotoxic
chemotherapy
and
radiotherapy and for the prevention
and
treatment
of
postoperative
nausea and vomiting.
HOW ONDANOV TABLET WORKS
This
medicine
contains
ondansetron,
which belongs
to
a
group
of
medicines
called
anti-
emetics, which help to stop you
feeling or being sick.
BEFORE
YOU
USE
ONDANOV
TABLET
_When you must not use it _
•
Do
not
take
if
you
are
hypersensitivity to any component
of ONDANOV Tablet.
•
Do
not
take
if
you
are
taking
Parkinson;s
disease
medicine
(Apomorphine hydrochloride)
ONDANOV is not recommended
for use during pregnancy.
•
Tell
your
doctor
if
you
are
pregnant or planning to become
pregnant.
•
ONDANOV
may
harm
your
unborn baby.
•
If you do become pregnant during
treatment with ONDANOV, tell
your doctor.
If you are a woman of childbearing
age, your doctor will check if you are
pregnant and perform a pregnancy
test
if
necessary
before
starting
treatment with ONDANOV. If you
may become pregnant, you should
use
effective
birth
control
during
treatment and for at least 2 days after
stopping
ONDANOV.
Ask
your
doctor
about
options
of
effective
birth control.
_ _
_Before you start to take it _
_ _
Ondansetron is known to increase
large bowel transit time if you have a
blockage
of
your
intestines
or
constipation, as you will need to be
closely monitored by your doctor.
_ _
_Taking other medicines _
_ _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from
a pharmacy, supermarket or health
food shop

Fachinformation

ONDANOV 4MG TABLET
ONDANOV 8MG TABLET
Ondansetron
DESCRIPTION
_ONDANOV 4mg Tablet:_
Orange, round, shallow, convex, 6.80 – 7.20 mm in diameter and 2.80
– 3.80 mm in thickness film coated tablet
with break line on one side.
_ONDANOV 8mg Tablet:_
Orange, round, shallow, convex, 7.80 – 8.20 mm in diameter and 4.05
– 5.05 mm in thickness film coated tablet
with no break line on one side.
COMPOSITION
_ONDANOV 4mg Tablet:_
Each film-coated tablet contains 5mg Ondansetron Hydrochloride
Dihydrate equivalent to 4mg of Ondansetron.
_ONDANOV 8mg Tablet:_
Each film-coated tablet contains 10mg Ondansetron Hydrochloride
Dihydrate equivalent to 8mg of Ondansetron.
PHARMACODYNAMICS
Ondansetron is a potent, highly selective 5HT3 receptor antagonist.
Its precise mode of action in the control of
nausea and vomiting is not known. Chemotherapeutic agents and
radiotherapy may cause release of 5HT in the
small intestine initiating a vomiting reflex by activating vagal
afferents via 5HT3 receptors. Ondansetron blocks
the initiation of this reflex.
Activation of vagal afferents may also cause a release of 5HT in the
area postrema, located on the floor of the 4th
ventricle, and this may promote emesis through a central mechanism.
Thus, the effect of ondansetron in the
management of the nausea and vomiting induced by cytotoxic
chemotherapy and radiotherapy is probably due
to antagonism of 5HT3-receptors on neurons located both in the
peripheral and central nervous system. The
mechanisms of actions in postoperative nausea and vomiting are not
known but there may be common pathways
with cytotoxic-induced nausea and vomiting. Ondansetron does not alter
plasma protein concentrations.
PHARMACOKINETICS
Following oral administration, ondansetron is passively and completely
absorbed from the gastrointestinal tract
and undergoes first-pass metabolism. Peak plasma concentrations are
attained approximately 1.5 hrs after
dosing. For doses >8 mg, the increase in ondansetron systemic exposure
with dose is greater than proportional;
this may refl