PIL
CHEMMART DULOXETINE
_Contains the active ingredient duloxetine (as duloxetine
hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about duloxetine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au. All medicines
have risks and benefits. Your doctor
has weighed the risks of you using
this medicine against the benefits
they expect it will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Duloxetine. It contains the
active ingredient duloxetine
hydrochloride.
It is used to treat:
•
major depressive disorder (MDD)
•
generalised anxiety disorder
(GAD) - excessive worry.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Duloxetine belongs to a group of
medicines called serotonin and
noradrenaline reuptake inhibitors
(SNRIs). SNRIs are believed to work
by their action on serotonin and
noradrenaline in the brain. Serotonin
and noradrenaline are the chemical
messengers responsible for
controlling the psychological and
painful symptoms of depression.
_USE IN CHILDREN_
This medicine should not be used in
children and adolescents under the
age of 1
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SPC
Product Information
– Australia
Chemmart Duloxetine Enteric Capsules
Page 1
CHEMMART DULOXETINE ENTERIC CAPSULES
NAME OF THE MEDICINE
Duloxetine hydrochloride
Chemical Name:
(+)-(S)-N-methyl-
γ-(1-naphthalenyloxy)-2thiophenepropylamine hydrochloride
Structural Formula:
Molecular Formula:
C
18
H
19
NOS•HCl
Molecular Weight:
333.88
CAS Registry Number: 136434-34-9
DESCRIPTION
Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water.
Duloxetine is available as capsules for oral administration. Each capsule contains enteric-coated pellets
of duloxetine hydrochloride equivalent to 30mg or 60mg of duloxetine that are designed to prevent
degradation of the drug in the acidic environment of the stomach.
In addition each capsule fill contains the following inactive ingredients: methylcellulose, poloxamer,
hypromellose, purified talc, polyvinyl acetate phthalate and dibutyl sebacate.
In addition, each capsule shell contains the following inactive ingredients: gelatin, purified water, titanium
dioxide, indigo carmine, iron oxide yellow (60mg capsules only) and proprietary ink ((TekPrint SB-
4028 Green Ink (ARTG#107268) for 30mg
capsules), (TekPrint SB-0007P White Ink (ARTG#2216) for
60mg capsules)).
30MG
Hard gelatin capsules with a white opaque body and blue opaque cap. Imprinted “APO D30” in green ink.
Filled with white to off-white granules.
60MG
Hard gelatin capsules with a green opaque body and blue opaque cap. Imprinted
“APO D60” in white ink.
Filled with white to off-white granules.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Duloxetine is a selective se
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