PHARMACOR DULOXETINE duloxetine hydrochloride 60 mg enteric capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
28-02-2017
Summary of Product characteristics
(SPC)
28-02-2017
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
Duloxetine hydrochloride
Available from:
Pharmacor Pty Ltd
INN (International Name):
Duloxetine hydrochloride
Patient Information leaflet
Pharmacor Duloxetine CMI 1
PHARMACOR DULOXETINE
(duloxetine hydrochloride)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PHARMACOR
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 shown on
the final page. More recent
information on this medicine may be
available. Make sure you speak to
your pharmacist or doctor to obtain
the most up to date information on
this medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
PHARMACOR DULOXETINE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
PHARMACOR
DULOXETINE
IS
USED FOR
PHARMACOR DULOXETINE is
used to treat major depressive
disorder (depression), Diabetic
Peripheral Neuropathic Pain (nerve
pain caused by diabetes) and
Generalised Anxiety Disorder
(excessive worry)
PHARMACOR 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 physical
symptoms of depression.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU. YOUR
DOCTOR MAY HAVE PRESCRIBED IT FOR
ANOTHER REASON.
This medicine is available only with
a doctor's prescription.
PHARMACOR DULOXETINE is
not recommended for use in children
and adolescents under the age of 18
years.
BEFORE YOU TAKE
PHARMACOR
DULOXETINE
_ _
_WHEN YOU MUST NOT TAKE IT _
DO
NOT
TAKE
PHARMACOR
DULOXETINE
IF
YOU
HAVE
AN
ALLERGY TO:
• any medicine containing
duloxetine hydrochloride;
• any of the ingredients listed at the
end of this leaflet.
Some of the
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Summary of Product characteristics
Pharmacor Duloxetine PI 1
PRODUCT INFORMATION
PHARMACOR DULOXETINE
(duloxetine hydrochloride, Pharmacor)
NAME OF THE DRUG
PHARMACOR DULOXETINE
(duloxetine hydrochloride)
PHARMACOR
DULOXETINE
is
a
selective
serotonin
and
noradrenaline
reuptake
inhibitor (SNRI) for oral administration.
It is chemically unrelated to tricyclics, alpha
adrenergic receptor agonists or antimuscarinics. Its chemical
designation is (+)-(_S_)-_N_-
methyl
-
ɤ
-(1-naphthalenyloxy)-2-thiophenepropanamine
hydrochloride.
The
empirical
formula is C
18
H
19
NOS•HCl, which corresponds to a molecular weight of 333.88. The
CAS number for duloxetine hydrochloride is 136434-34-9.
The structural formula is:
DESCRIPTION
Duloxetine hydrochloride is a white to off white powder, which is
freely soluble in
methanol, sparingly soluble in water and practically insoluble in
hexane.
Duloxetine is available as capsules for oral administration. Each
capsule contains enteric-
coated pellets of duloxetine hydrochloride equivalent to 30 mg or 60
mg of duloxetine
that are designed to prevent degradation of the drug in the acidic
environment of the
stomach.
Inactive
ingredients
include
sugar
spheres,
hypromellose,
hydroxypropylcellulose,
crospovidone,
talc-purified,
triethyl
citrate,
titanium
dioxide,
hypromellose phthalate. The 30 mg capsules also contain gelatin,
sodium lauryl sulphate,
indigo carmine, TEK SW 0012 –white ink (ARTG No.13175) and TEK SW
9008 –black
ink (ARTG No.2328). The 60 mg capsules also contain gelatin, sodium
lauryl sulphate,
iron oxide yellow, indigo carmine and TEK SW 0012 – white ink (ARTG
No.13175).
Pharmacor Duloxetine PI 2
PHARMACOLOGY
PHARMACODYNAMICS
Duloxetine is a selective serotonin and noradrenaline reuptake
inhibitor (SNRI), and
weakly
inhibits
dopamine
uptake
with
no
significant
affinity
for
histaminergic,
dopaminergic, cholinergic and adrenergic receptors.
Although the mechanism of the antidepressant action of duloxetine in
humans is
unknown, it is believed to be related to its potentiation of
serotonergic and noradrenerg
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