DELUCON 150

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)

29-11-2017

Active ingredient:

quetiapine fumarate, Quantity: 172.683 mg (Equivalent: quetiapine, Qty 150 mg)

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; lactose monohydrate; sodium starch glycollate type A; microcrystalline cellulose; purified talc; colloidal anhydrous silica; magnesium stearate; povidone; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

90, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bipolar disorder,Adults,? Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes,? Treatment of depressive episodes associated with bipolar disorder (See Dosage and administration),? Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate,Children/adolescents aged 10 to 17 years,? Monotherapy treatment of acute mania associated with bipolar I disorder,Schizophrenia (adults and adolescents aged 13 to 17 years),? Treatment of schizophrenia

Product summary:

Visual Identification: Light yellow, round, biconvex, film-coated tablets imprinted with 'E 54' on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-10-18

Patient Information leaflet

DELUCON
CONSUMER MEDICINE INFORMATION
Ver 1.2
Page 1 of 5
DELUCON 25, 100, 150, 200 & 300
Quetiapine (as fumarate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
of
the
common questions people ask about
DELUCON. 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
will
have
weighed the risks of you taking it
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 DELUCON IS USED
FOR
DELUCON
helps
to
correct
chemical imbalances in the brain. It
is used to treat conditions such as:
•
Schizophrenia,
an
illness
with
disturbances in thinking, feelings
and behaviour
•
Bipolar
disorder,
an
illness
in
which
there
are
sustained
mood
swings either up (mania) or down
(depression).
During
mania,
patients
experience
episodes
of
overactivity, elation or irritability.
During
depression,
patients
may
feel
depressed
or
guilty,
lack
energy,
lose
their
appetite
and
have trouble sleeping.
DELUCON belongs to a group of
medicines called antipsychotics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your
doctor
may
prescribe
this
medicine for another reason.
It is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
DELUCON
WHEN
YOU
MUST
NOT
TAKE
DELUCON
DO NOT TAKE DELUCON IF YOU
HAVE AN ALLERGY TO
•
quetiapine, the active ingredient in
the medicine
•
any of the other 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 or
you may feel faint.
DO
NOT
GIVE
DELUCON
TO
CHILDREN
OR
ADOLESCENTS
UNLESS
RECOMMENDED BY YOUR DOCTOR.
The effects of DELUCON have

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Summary of Product characteristics

Product Information:
DELUCON (Quetiapine Tablets 25, 100, 150, 200 & 300 mg)
Ver 1.3
Page 1 of 35
PRODUCT INFORMATION
DELUCON 25 (25 MG QUETIAPINE AS FUMARATE)
DELUCON 100 (100 MG QUETIAPINE AS FUMARATE)
DELUCON 150 (150 MG QUETIAPINE AS FUMARATE)
DELUCON 200 (200 MG QUETIAPINE AS FUMARATE)
DELUCON 300 (300 MG QUETIAPINE AS FUMARATE)
NAME OF THE MEDICINE
The name of the medicine is Quetiapine as Quetiapine fumarate
CHEMICAL NAME:
Bis[2-[2-(4-dibenzo[b,f] [1,4]thiazepin-11-yl)piperazin-1-yl]
ethoxy)ethanol]
fumarate.
MOLECULAR FORMULA:
(C
21
H
25
N
3
O
2
S)
2
.C
4
H
4
O
4
MOLECULAR WEIGHT:
883.10
CAS REGISTRY NUMBER:
_[111974-72-2]_
DESCRIPTION
Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits
moderate pH dependent
solubility (94.3 mg/mL to 2.37 mg/mL at pH values from 1 to 9) and
lypophilicity characteristics
(Log P) which vary with pH (0.45 in water, 1.37 at pH 5, 2.65 at pH 7
and 2.59 at pH 9).
Quetiapine fumarate is a white to off white powder. It is freely
soluble in glacial acetic acid,
soluble in N,N-dimethylformamide, sparingly soluble in methanol.
Inactive: Calcium hydrogen phosphate, lactose,
cellulose-microcrystalline (Avicel PH-101 & PH-
102), sodium starch glycollate type A, povidone, silica-colloidal
anhydrous, talc-purified &
magnesium stearate.
The 25 mg tablet also contains opadry film coating pink 03B84904
(PI-ARTG No. 106472).
The 100 mg tablet also contains opadry film coating yellow 03B82923
(PI-ARTG No. 106480).
The 150 mg tablet also contains opadry film coating yellow 03B82924
(PI-ARTG No. 106483).
The 200 mg tablet also contains hypromellose, macrogol 400 & titanium
dioxide.
The 300 mg tablet also contains hypromellose, macrogol 400 & titanium
dioxide.
Product Information:
DELUCON (Quetiapine Tablets 25, 100, 150, 200 & 300 mg)
Ver 1.3
Page 2 of 35
The 100mg, 150mg, 200mg & 300mg tablets also contains Opacode Black
S-1-17823 (PI-ARTG
No. 12108) as imprinting ink.
PHARMACOLOGY
MECHANISM OF ACTION
Quetiapine is an atypical antipsychotic agent. Quetiapine and the
human plasma m

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