DULOXETINE GH duloxetine (as hydrochloride) 60mg enteric capsules blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

duloxetine hydrochloride

Dostępny od:

Lupin Australia Pty Limited

INN (International Nazwa):

Duloxetine hydrochloride

Status autoryzacji:

Registered

Ulotka dla pacjenta

Duloxetine GH CMI v2 Sep2017
Page 1 of 6
CONSUMER MEDICINE INFORMATION
DULOXETINE GH
duloxetine hydrochloride
What is in this leaflet
This leaflet answers some
common questions about
Duloxetine GH. It does not
contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist. Always
follow the instructions that
your doctor and pharmacist
give you about the medicine.
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. The updated leaflet
may contain important
information about Duloxetine
GH and its use that you
should be aware of.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking Duloxetine GH against
the benefits they expect it will
have for you.
Always follow the
instructions that your
doctor and pharmacist give
you about Duloxetine GH.
If you have any concerns,
or are unsure about taking
this medicine, ask your
doctor or pharmacist for
more advice.
Keep this leaflet with the
medicine. Do not throw this
leaflet away.
You may need to read it
again.
What Duloxetine GH is
used for
Duloxetine GH is used to
treat major depressive
disorder (depression) and
Generalised Anxiety Disorder
(excessive worry). Duloxetine
GH 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.
This medicine is available
only with a doctor's
prescription.
Duloxetine GH is not
recommended for use in
children and adolescents
under the age of 18 years.
Before you take
Duloxetine GH
When not to take it
Do no

Charakterystyka produktu

PRODUCT INFORMATION
Duloxetine GH
NAME OF THE MEDICINE
Duloxetine (as hydrochloride)
Duloxetine Hydrochloride 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-γ-(1-naphthalenyloxy)-2-
thiophenepropanamine hydrochloride.
Chemical Formula: C
18
H
19
NOS

HCl
Molecular Weight: 333.9
CAS No: 136434-34-9
Chemical Structure:
DESCRIPTION
_DULOXETINE HYDROCHLORIDE _
It is a white to cream coloured powder, which is sparingly soluble in
water, freely soluble in
methanol and practically insoluble in hexane.
Duloxetine GH is a delayed release capsule for oral administration.
Each capsule contains enteric-
coated mini tablets 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.
_ _
_ _
_ _
2
DULOXETINE GH
_Version 1, 4 June 2013_
_EXCIPIENTS _
Inactive
ingredients
include
Lactose,
Croscarmellose
sodium,
Pregelatinised
maize
starch,
Polysorbate 80, Magnesium stearate, Hypromellose, Hypromellose
phthalate, Purified talc, Triethyl
citrate.
The 30 mg capsule is a Size 3 hard gelatin capsule (ARTG No. 108081)
with a dark blue cap and a
white body and contains Indigo carmine CI73015, Gelatin, Titanium
dioxide and Sodium lauryl
sulfate.
The 60 mg capsule is a Size 1 hard gelatin capsule (ARTG No. 108080)
with a dark blue cap and a
green body and contains Indigo carmine CI73015, Gelatin, Titanium
dioxide, Iron oxide yellow
CI77492 and Sodium lauryl sulfate.
Both capsule shells are imprinted with TekPrint SW-9008 Black Ink,
(ARTG No. 2328) and TekPrint
SW-0012 White Ink (ARTG No. 13175).
PHARMACOLOGY
_PHARMACODYNAMIC PROPERTIES AND MECHANISM OF ACTION _
Duloxetine
is a
selective
serotonin and noradrenaline
reuptake
inhibitor, and weakly inhibits
dopamine
uptake
with no significant affinity for histaminergic, dopaminergic,
cholinergi