CYMBALTA duloxetine 60 mg (as hydrochloride) enteric capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

duloxetine hydrochloride, Quantity: 67.3 mg (Equivalent: duloxetine, Qty 60 mg)

Available from:

Eli Lilly Australia Pty Ltd

INN (International Name):

Duloxetine hydrochloride

Pharmaceutical form:

Capsule, enteric

Composition:

Excipient Ingredients: hypromellose; triethyl citrate; indigo carmine; purified talc; sodium lauryl sulfate; Gelatin; iron oxide yellow; sucrose; hypromellose acetate succinate; titanium dioxide; propylene glycol; ethanol; isopropyl alcohol; Shellac; povidone; tert-butyl alcohol; sodium hydroxide; maize starch

Administration route:

Oral

Units in package:

7 capsules, 28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CYMBALTA is indicated for the treatment of major depressive disorder (MDD).,Treatment of Diabetic Peripheral Neuropathic Pain (DPNP). Treatment of Generalised Anxiety Disorder.

Product summary:

Visual Identification: Opaque green body and opaque blue cap imprinted with "9542" and "60 mg" using white ink; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-03-14

Patient Information leaflet

CYMBALTA
®
_Duloxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CYMBALTA. 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. You can also download the
most up to date leaflet from
www.lilly.com.au. The updated
leaflet may contain important
information about CYMBALTA and
its use that you should be aware of.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking CYMBALTA
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 CYMBALTA IS
USED FOR
CYMBALTA is used to treat major
depressive disorder (depression),
Diabetic Peripheral Neuropathic Pain
(nerve pain caused by diabetes) and
Generalised Anxiety Disorder
(excessive worry)
CYMBALTA 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.
CYMBALTA is not recommended
for use in children and adolescents
under the age of 18 years.
BEFORE YOU TAKE
CYMBALTA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CYMBALTA IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
duloxetine hydrochloride;
•
any of the ingredients

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
vA12.0_Oct20
SUPERSEDES: vA11.0_Jul19
Page 1 of 28 CYMBALTA (DULOXETINE) TABLETS
1.
NAME OF THE MEDICINE
CYMBALTA
®
(duloxetine hydrochloride).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 indigo carmine CI73015, gelatin,
hypromellose, hypromellose
acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres NF
30/35, purified talc,
titanium dioxide CI77891, Chroma-Tone DDB8257-W 609421 and triethyl
citrate.
The 30mg capsules also contain TekPrint SB-4028 Green Ink (ARTG No.
107268).
The 60 mg capsules also contain iron oxide yellow CI77492 and TekPrint
SB-0007P White
Ink (ARTG No. 2216).
3.
PHARMACEUTICAL FORM
The 30 mg capsule has an opaque white body and opaque blue cap
imprinted with “9543”
and “30 mg” using green ink.
The 60 mg capsule has an opaque green body and opaque blue cap
imprinted with “9542”
and “60 mg” using white ink.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CYMBALTA is indicated for the treatment of major depressive disorder
(MDD).
CYMBALTA is indicated for the treatment of diabetic peripheral
neuropathic pain (DPNP).
CYMBALTA is indicated for the treatment of generalised anxiety
disorder (GAD).
4.2
DOSE AND METHOD OF ADMINISTRATION
MAJOR DEPRESSIVE DISORDER
CYMBALTA 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.
vA12.0_Oct20
SUPERSEDES: vA11.0_Jul19
Page 2 of 28
DIABETIC PERIPHERAL NEUROPATHIC PAIN
The starting and maintenance dose of CYMBALTA in diabetic peripheral
neuropathic pain is
60 mg once daily. As the progression of diab