DEPRETA 30 duloxetine 30 mg (as hydrochloride) enteric capsule blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

Duloxetine hydrochloride

Verfügbar ab:

Aurobindo Pharma Australia Pty Ltd

INN (Internationale Bezeichnung):

Duloxetine hydrochloride

Gebrauchsinformation

DEPRETA
CONSUMER MEDICINE INFORMATION
Ver 1.3
Page 1 of 5
DEPRETA 30 & DEPRETA 60
Duloxetine as hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers some
common
questions about DEPRETA. It does
not
contain
all
the
available
information. It does not take the place
of
talking
to
your
doctor
or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you
taking
DEPRETA
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 DEPRETA USED FOR
DEPRETA
is
used
to
treat
major
depressive disorder (depression) and
Generalised
Anxiety
Disorder
(excessive worry)
DEPRETA
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.
DEPRETA is not recommended for
use in children and adolescents under
the age of 18 years.
BEFORE YOU TAKE DEPRETA
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE DEPRETA 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 symptoms of an allergic
reaction
may
include
shortness
of
breath,
wheezing
or
difficulty
breathing; swelling of the face, lips,
tongue
or
other
parts
of
the
body;
rash, itching or hives on the skin.
DO NOT TAKE DEPRETA IF YOU HAVE
LIVER DISEASE.
This could increase the chance of you
having
liver
problems
during
treatment with DEPRETA.
DO NOT TAKE THIS MEDICINE IF YOU ARE
TAKING
ANOTHER
MEDICINE
FOR
D

Fachinformation

Product Information:
DEPRETA (Duloxetine Gastro-Resistant Capsules 30 mg & 60 mg)
Ver 1.3
Page 1 of 21
PRODUCT INFORMATION
DEPRETA 30 (DULOXETINE 30 MG PRESENT AS HYDROCHLORIDE)
DEPRETA 60 (DULOXETINE 60 MG PRESENT AS HYDROCHLORIDE)
NAME OF THE MEDICINE
The name of the medicine is Duloxetine (as hydrochloride).
CHEMICAL NAME:
(+)-(
_S_
)-
_N_
-methyl-γ-(1-naphthalenyloxy)-2-thiophenepropanamine
hydrochloride
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 powder,
which is sparingly
soluble in water, freely soluble in methanol, soluble in anhydrous
ethanol, practically insoluble in
hexane.
DEPRETA is available as capsules containing 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.
_DEPRETA 30 _
Blue opaque/White opaque, size ‘3’ hard gelatin capsule filled
with white to off-white pellets
and imprinted with ‘X’ on blue opaque cap and ‘02’ on white
opaque body with black ink.
_ _
_DEPRETA 60 _
Blue opaque/Green opaque, size ‘1’ hard gelatin capsule filled
with white to off-white pellets
and imprinted with ‘X’ on blue opaque cap and ‘03’ on green
opaque body with black ink.
INACTIVE
INGREDIENTS:
Each
capsule
contains
hypromellose,
hydroxypropylcellulose,
crospovidone,
sugar
spheres,
triethyl
citrate,
titanium
dioxide,
hypromellose
phthalate
and
purified talc as excipients.
Product Information:
DEPRETA (Duloxetine Gastro-Resistant Capsules 30 mg & 60 mg)
Ver 1.3
Page 2 of 21
The capsule shells (size ‘3’ ARTG # 107904 and size ‘1’ ARTG #
107905) contain
indigo
carmine, titanium dioxide, gelatin and sodium lauryl sulphate. The 60
mg capsule shells also
contain iron oxide yellow. The capsule shells are printed with Tek
Print SW-9008 Black Ink
(ARTG # 2328).
PHARMACOLOGY
PHARMACODYNAMICS
Duloxetine is a selective serotonin an