DULOXECOR duloxetine hydrochloride 30 mg enteric capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
10-02-2021
Summary of Product characteristics
(SPC)
10-02-2021
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
duloxetine hydrochloride, Quantity: 33.66 mg
Available from:
Pharmacor Pty Ltd
INN (International Name):
Duloxetine hydrochloride
Pharmaceutical form:
Capsule, enteric
Composition:
Excipient Ingredients: triethyl citrate; hypromellose; purified water; isopropyl alcohol; hyprolose; purified talc; dichloromethane; hypromellose phthalate; crospovidone; titanium dioxide; quinoline yellow; Gelatin; sodium lauryl sulfate; patent blue V; maize starch; sucrose
Administration route:
Oral
Units in package:
28 (2 blisters x 14 capsules)
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
DULOXETINE is indicated for the treatment of major depressive disorder (MDD).,DULOXETINE is indicated for the treatment of diabetic peripheral neuropathic pain (DPNP).,DULOXETINE is indicated for the treatment of generalised anxiety disorder (GAD).
Product summary:
Visual Identification: White to off white enteric coated pellets filled in size 2 HGC, white body&blue-cap printed "Dulox" on cap in white ink and 30 mg on body in black ink; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-06-05
Patient Information leaflet
Duloxecor CMI (V-02) 1
DULOXECOR
(duloxetine hydrochloride)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DULOXECOR. 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
DULOXECOR 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 DULOXECOR
IS
USED FOR
DULOXECOR is used to treat major
depressive disorder (depression),
Diabetic Peripheral Neuropathic Pain
(nerve pain caused by diabetes) and
Generalised Anxiety Disorder
(excessive worry)
DULOXECOR 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.
DULOXECOR is not recommended
for use in children and adolescents
under the age of 18 years.
BEFORE YOU TAKE
DULOXECOR
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DULOXECOR 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; sw
Read the complete document
Summary of Product characteristics
DULOXECOR PI (V-02)
Page
1
of
31
AUSTRALIAN PRODUCT INFORMATION - DULOXECOR
(
DULOXETINE HYDROCHLORIDE) CAPSULES
1.
NAME OF THE MEDICINE
Duloxetine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DULOXECOR 30 MG CAPSULES:
Each capsule contains enteric-coated pellets of duloxetine
hydrochloride equivalent to
30 mg of duloxetine.
DULOXECOR 60 MG CAPSULES:
Each capsule contains enteric-coated pellets of duloxetine
hydrochloride equivalent to
60 mg of duloxetine.
For the full list of excipients, see
SECTION 6.1 - LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Each
capsule
contains
enteric-coated
pellets
of
duloxetine
hydrochloride
that
are
designed to prevent degradation of the drug in the acidic environment
of the stomach.
The 30 mg capsule has a white body & blue cap printed "Dulox" on cap
in white ink and
"30mg" on body in black ink.
The 60 mg capsule has a green body & blue cap printed "Dulox" on cap
and "60mg" on
body in white ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DULOXECOR is indicated for the treatment of major depressive disorder
(MDD).
DULOXECOR is indicated for the treatment of diabetic peripheral
neuropathic
pain (DPNP).
DULOXECOR is indicated for the treatment of generalised anxiety
disorder (GAD).
DULOXECOR PI (V-02)
Page
2
of
31
4.2
DOSE AND METHOD OF ADMINISTRATION
MAJOR DEPRESSIVE DISORDER
DULOXECOR should be administered for the treatment of major depressive
disorder at
a dose of 60 mg once daily, with or without food. There is no adequate
evidence
suggesting that patients not responding to 60 mg once daily will
benefit from having
their dose increased.
DIABETIC PERIPHERAL NEUROPATHIC PAIN
The
starting
and
maintenance
dose
of
DULOXECOR
in
diabetic
peripheral
neuropathic pain is 60 mg once daily. As the progression of diabetic
neuropathy is
highly variable and management of pain is empirical, effectiveness of
DULOXECOR
should be assessed on an individual basis.
GENERALISED ANXIETY DISORDER
The recommended starting dose of DULOXECOR in patients with
generalized anxiety
disorder
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