DULOXETINE DR-LUPIN duloxetine (as hydrochloride) 60mg enteric capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

duloxetine hydrochloride, Quantity: 67.36 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

Duloxetine hydrochloride

Pharmaceutical form:

Capsule, enteric

Composition:

Excipient Ingredients: croscarmellose sodium; purified talc; pregelatinised maize starch; lactose monohydrate; hypromellose; triethyl citrate; polysorbate 80; isopropyl alcohol; hypromellose phthalate; magnesium stearate; dichloromethane; methanol; titanium dioxide; propylene glycol; butan-1-ol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide; iron oxide yellow; Gelatin; acetic acid; silicon dioxide; sodium lauryl sulfate; citric acid; indigo carmine aluminium lake; ethanol; strong ammonia solution; iron oxide black

Administration route:

Oral

Units in package:

14 Capsules (2 x 7 Capsules), 7 Capsules (1 x 7 Capsules), 28 Capsules (4 x 7 Capsules)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Duloxetine Hydrochloride is indicated for the following:,-Treatment of major depressive disorder (MDD). ,-Treatment of generalised anxiety disorder (GAD).

Product summary:

Visual Identification: Size '1' Capsules with dark blue cap & green body, imprinted with "DU" in white ink on cap & "60" in black ink on body,containing twelve mini tablets.; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-04-29

Patient Information leaflet

1
DULOXETINE DR –LUPIN CAPSULES
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Duloxetine DR-Lupin
Capsules. 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 DR-Lupin Capsules 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-DR
Lupin Capsules against the benefits they expect it will have for you.
ALWAYS FOLLOW THE INSTRUCTIONS THAT YOUR DOCTOR AND PHARMACIST GIVE
YOU ABOUT DULOXETINE DR–
LUPIN CAPSULES.
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 DR–LUPIN CAPSULES ARE USED FOR
Duloxetine DR-Lupin Capsules is used to treat major depressive
disorder (depression), Generalised
Anxiety Disorder (excessive worry) Duloxetine DR-Lupin Capsules
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 DR-Lupin Capsules is not recommended for use in children
and adolescents un

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Summary of Product characteristics

PRODUCT INFORMATION
Duloxetine DR Lupin Capsule-PI_v4.0
Page 1 of 32
DULOXETINE DR-LUPIN CAPSULE
(LUPIN AUSTRALIA PTY.LTD)
NAME OF THE MEDICINE
Duloxetine (as hydrochloride)
Duloxetine Hydrochloride is a selective serotonin and noradrenaline
reuptake inhibitor
(SNRI) for oral administration.
Chemical Formula: C
18
H
19
NOS.HCl
Molecular Weight: 333.9
CAS No: 136434-34-9
Chemical Structure:
DESCRIPTION
DULOXETINE HYDROCHLORIDE
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.
It is a white to cream coloured powder, which is sparingly soluble in
water,
freely soluble in methanol and practically insoluble in hexane.
Duloxetine DR Lupin Capsule 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.
EXCIPIENTS
Inactive ingredients include Lactose, Croscarmellose Sodium,
Pregelatinised maize starch,
Polysorbate 80, Magnesium stearate, Hypromellose, Hypromellose
phthalate,
Purified talc,
Triethyl citrate.
Duloxetine DR Lupin Capsule-PI_v4.0
Page 2 of 32
Empty Hard Gelatin Capsule:
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 sulphate.
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-900B 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
inhi

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