ONDANSETRON AN ondansetron (as hydrochloride dihydrate) 4mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron hydrochloride dihydrate

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Ondansetron hydrochloride dihydrate

Authorization status:

Registered

Patient Information leaflet

_Ondansetron AN tablets – Consumer Medicine Information _
_ _
_Doc ID: 85.AN.M.2.0 _
_ _
_ _
_Page 1 _
ONDANSETRON AN TABLETS
_Ondansetron (as hydrochloride dihydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Ondansetron AN.
This
leaflet
answers
some
common
questions
about
Ondansetron AN.
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
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 IS USED FOR
ONDANSETRON AN contains a
medicine
called
ondansetron.
This
belongs
to
a
group
of
medicines
called
serotonin
receptor-3 antagonists.
ONDANSETRON AN are used
to
help
stop
the
nausea
(sick
feeling) and vomiting which can
occur
after
medical
treatments
and operations.
ONDANSETRON
AN
should
only be used to treat the nausea
and vomiting for which they have
been prescribed.
Your
doctor
may
have
prescribed Ondansetron AN for
another
reason.
If
you
want
more
information,
ask
your
doctor.
Ondansetron AN is not addictive.
BEFORE YOU TAKE
ONDANSETRON AN
_WHEN YOU MUST NOT TAKE _
_ONDANSETRON AN _
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’)

YOU ARE PREGNANT, TRYING TO
BECOME
PREGNANT
OR
BREASTFEEDING, UNLESS YOUR
DOCTOR SAYS IT IS SAFE

THE EXPIRY DATE PRINTED N
THE PACK HAS PASSED

THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING
TELL YOUR DOCTOR IF:

YOU ARE ALLERGIC TO FOODS,
DYES, PRESERVATIVES OR ANY
OTHER MEDICINES

YOU
HAVE
HAD
TO
STOP
TAKING
ANOTHER
MEDICINE
FOR
YOUR
NAUSEA
OR
VOMITING.

YOU

Summary of Product characteristics

_Ondansetron AN tablets Product Information Amneal Pharma Australia
Pty Ltd_
Doc ID: 85.AN.P.2.0
Page 1
ONDANSETRON AN
_ _
_(ONDANSETRON TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is ondansetron as ondansetron hydrochloride
dihydrate.
CHEMICAL NAME:
(3
_RS_
)-9-Methyl-3-[(2-methyl-]-1
_H_
-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-
4
_H_
-carbazol-4-one hydrochloride dihydrate.
MOLECULAR FORMULA:
C
18
H
19
N
3
O,HCl.2H
2
O
MOLECULAR WEIGHT:
365.9
CAS REGISTRY NUMBER: _[103639-04-9]_
DESCRIPTION
Ondansetron hydrochloride dihydrate is a white or almost white powder.
It is sparingly soluble in
water, alcohol, soluble in methanol and slightly soluble in methylene
chloride.
ONDANSETRON AN is available as tablets containing 4 & 8 mg of
ondansetron as hydrochloride.
_ONDANSETRON AN _
4 mg
White to off-white, oval shaped, film-coated tablets debossed with
‘E’ on one side and ‘01’ on
the other side.
_ONDANSETRON AN _
8 mg
Yellow colored, oval shaped, film-coated tablets debossed with ‘E’
on one side and ‘02’ on the
other side.
ONDANSETRON AN tablets contain the following inactive ingredients
:
Lactose anhydrous,
microcrystalline cellulose, pregelatinised maize starch and magnesium
stearate. The 4mg tablet
also contains glycerol triacetate, titanium dioxide and hypromellose.
The 8mg tablet also contains
opadry yellow 03K52033 (PI-ARTG No. 106488).
PHARMACOLOGY
_Ondansetron AN tablets Product Information Amneal Pharma Australia
Pty Ltd_
Doc ID: 85.AN.P.2.0
Page 2
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 th