TERRY WHITE CHEMISTS DULOXETINE duloxetine (as hydrochloride) 30 mg enteric capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
duloxetine hydrochloride
Available from:
Apotex Pty Ltd
INN (International Name):
Duloxetine hydrochloride
Authorization status:
Registered
Patient Information leaflet
TERRY WHITE CHEMISTS
DULOXETINE
_Contains the active ingredient duloxetine (as duloxetine
hydrochloride)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
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 Terry
White Chemists 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 s
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Summary of Product characteristics
Product Information - Australia
Terry White Chemists Duloxetine Enteric Capsules
Page 1
TERRY WHITE CHEMISTS DULOXETINE ENTERIC CAPSULES
NAME OF THE MEDICINE
Duloxetine hydrochloride
Chemical Name:
(+)-(_S_)-N-methyl-γ-(1-naphthalenyloxy)-2-thiophenepropylamine
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.
Each capsule contains enteric-coated pellets of duloxetine
hydrochloride, equivalent to 30 mg or 60
mg duloxetine, that are designed to prevent degradation of the drug in
the acidic environment of the
stomach. In addition, each capsule contains Sugar Spheres (ARTG ID
2535), hypromellose, purified
talc, purified water, sucrose, hypromellose phthalate, triethyl
citrate, gelatin, titanium dioxide, brilliant
blue FCF, iron oxide yellow (60 mg capsule only), Tekprint SB-4020
Green Ink (ARTG ID 2652; 30 mg
capsule only) and TekPrint SW-0012 White Ink (ARTG ID 13175; 60 mg
capsule only).
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Duloxetine is a selective serotonin and noradrenaline reuptake
inhibitor, 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
noradrenergic activity in the CNS.
Duloxetine dose-dependently increased extracellular levels of
serotonin and noradrenaline in selected
brain
areas
of
animals,
and
neurochemical
and
behavioural
studies
in
animals
indicate
an
enhancement of central serotonin and noradrenaline neurotransmission.
Duloxetine undergoes
extensive metabolism, but the major circulating metabolites have not
been shown to contribute
significantly to the pharmacologic activity of duloxetine. Duloxetine
displayed analgesic activity in
rodent models of persistent, in
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