ONDANSETRON AN ODT ondansetron 8 mg orally disintegrating tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Ondansetron

Authorization status:

Registered

Patient Information leaflet

_Ondansetron AN ODT tablets – Consumer Medicine Information _
_ _
_Ondansetron AN CMI v3 _
_ _
_ _
_Page 1 _
ONDANSETRON AN ODT TABLETS
_Ondansetron orally disintegrating tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Ondansetron AN
ODT.
This
leaflet
answers
some
common
questions
about
Ondansetron AN ODT.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
Ondansetron
AN
ODT
against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR DOCTOR OR PHARMACIST.
Keep
this
leaflet
with
your
medicine.
You may need to read it again.
WHAT ONDANSETRON
AN ODT IS USED FOR
ONDANSETRON AN contains a
medicine
called
ondansetron.
This
belongs
to
a
group
of
medicines called antiemetics.
ONDANSETRON AN ODT works
by helping to stop the nausea
(sick feeling) and vomiting which
can
occur
after
medical
treatments.
ONDANSETRON
AN
ODT
should only be used to treat the
nausea and vomiting for which
they have been prescribed.
Your doctor may have prescribed
Ondansetron
AN
ODT
for
another reason.
Ask your doctor if you have any
questions
about
why
Ondansetron AN ODT has been
prescribed for you.
Ondansetron
AN
ODT
is
not
addictive.
BEFORE YOU TAKE
ONDANSETRON AN ODT
_WHEN YOU MUST NOT TAKE _
_ONDANSETRON AN ODT _
DO NOT TAKE ONDANSETRON AN IF:
•
YOU
ARE
TAKING
APOMORPHINE (USED TO TREAT
PARKINSONS DISEASE)
•
YOU
HAVE
EVER
HAD
AN
ALLERGIC
REACTION
TO
ONDANSETRON OR ANY OF THE
INGREDIENTS LISTED TOWARDS
THE END OF THIS LEAFLET (SEE
‘INGREDIENTS’)
Symptoms
of
an
allergic
reaction
may
be
mild
or
severe. They usually include
some or all of the following:
wheezing,
swelling
of
the
lips/mouth,
difficulty
in
breathing,
hayfever,
lumpy
rash ("hives") or fainting.
•
YOU ARE PREGNANT, TRYING TO
BECOME
PREGNANT
OR
BREASTFEEDING, UNLESS YOUR
DOCTOR SAYS IT IS SAFE

Summary of Product characteristics

_Ondansetron AN ODT Product Information _
_ Amneal Pharma Australia Pty Ltd _
Ondansetron AN ODT PI v3
Page 1
ONDANSETRON AN ODT
_ _
_(ONDANSETRON ORALLY DISINTEGRATING TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is ondansetron.
CHEMICAL NAME: _3RS_
-1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)
methyl]-4H-
carbazol-4-one
MOLECULAR FORMULA:
C
18
H
19
N
3
O
MOLECULAR WEIGHT:
293.4
CAS REGISTRY NUMBER:
_[99614-02-5]_
DESCRIPTION
It is a white to off-white powder. Ondansetron is very soluble in acid
solution, practically
insoluble in water.
ONDANSETRON AN ODT is available as orally disintegrating tablets
containing 4 mg & 8 mg
ondansetron.
ONDANSETRON
AN ODT
tablets
contain
the
following
inactive
ingredients:
Mannitol,
crospovidone, lactose monohydrate, microcrystalline cellulose,
aspartame, colloidal anhydrous
silica, magnesium stearate and strawberry guarana 586997 AP0551.
PHARMACOLOGY
MODE OF ACTION
Ondansetron is a potent, highly selective 5HT
3
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 5HT
3
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 fourth
ventricle, and this may also promote emesis through a central
mechanism. Thus, the effect of
_Ondansetron AN ODT Product Information _
_ Amneal Pharma Australia Pty Ltd _
Ondansetron AN ODT PI v3
Page 2
ondansetron in the management of the nausea and vomiting induced by
cytotoxic chemotherapy
and
radiotherapy is
due to
antagonism
of 5HT
3
receptors
on neurones located
both in the
peripheral and central nervous system. The mechanisms of action in
post-operative nausea and
vomiting are not known but there may be common pathways with cytotoxic
induced nausea and
vomiting. In psychomotor testing