AURO-QUETIAPINE 100
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
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: 115.122 mg (Equivalent: quetiapine, Qty 100 mg)
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Quetiapine fumarate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; colloidal anhydrous silica; lactose monohydrate; sodium starch glycollate type A; purified talc; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400
Administration route:
Oral
Units in package:
60, 20, 90
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: Yellow, round, biconvex, film-coated tablets imprinted with 'E 53' 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
AURO-QUETIAPINE
CONSUMER MEDICINE INFORMATION
Ver 1.2
Page 1 of 5
AURO-QUETIAPINE 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
AURO-QUETIAPINE.
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
AURO-QUETIAPINE
IS USED FOR
AURO-QUETIAPINE
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.
AURO-QUETIAPINE 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
AURO-QUETIAPINE
WHEN
YOU
MUST
NOT
TAKE
AURO-QUETIAPINE
DO NOT TAKE AURO-QUETIAPINE
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 AURO-QUETIAPINE
TO CHILDRE
Read the complete document
Summary of Product characteristics
Product Information:
AURO-QUETIAPINE (Quetiapine Tablets 25, 100, 150, 200 & 300 mg)
Ver 1.3
Page 1 of 35
PRODUCT INFORMATION
AURO-QUETIAPINE 25 (25 MG QUETIAPINE AS FUMARATE)
AURO-QUETIAPINE 100 (100 MG QUETIAPINE AS FUMARATE)
AURO-QUETIAPINE 150 (150 MG QUETIAPINE AS FUMARATE)
AURO-QUETIAPINE 200 (200 MG QUETIAPINE AS FUMARATE)
AURO-QUETIAPINE 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:
AURO-QUETIAPINE (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 atypica
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