QUETIAPINE AN quetiapine (as fumarate) 200 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

quetiapine fumarate

Inapatikana kutoka:

Amneal Pharma Australia Pty Ltd

INN (Jina la Kimataifa):

Quetiapine fumarate

Idhini hali ya:

Registered

Taarifa za kipeperushi

_Quetiapine AN tablets – Consumer Medicine Information _
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_Doc ID: 91.AN.M.1.0 _
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_Page 1 _
QUETIAPINE AN TABLETS
_Quetiapine fumerate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about Quetiapine AN. 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
Quetiapine
AN
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 QUETIAPINE AN
IS USED FOR
Quetiapine AN 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 own (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.
Quetiapine
AN
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 IT
_WHEN YOU MUST NOT TAKE _
_QUETIAPINE AN: _
_ _
DO NOT TAKE QUETIAPINE AN IF
YOU HAVE AN ALLERGY TO

QUETIAPINE,
THE
ACTIVE
INGREDIENT IN QUETIAPINE AN

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 QUETIAPINE

Tabia za bidhaa

_Quetiapine AN tablets Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd _
QUETIAPINE AN
_ _
_(QUETIAPINE FUMARATE TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is 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
46
H
54
N
6
O
8
S
2
MODULAR WEIGHT
: 883.1
CAS NUMBER
: [
_111974-72-2_
]
DESCRIPTION
Quetiapine fumarate is white to off white powder. It is a weak acid
(pKa 3.3, 6.8) which
exhibits moderate pH dependent solubility 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 has no chiral centres and only one morphological
entity has been detected
throughout development.
Quetiapine fumarate displays good solid state stability, has moderate
aqueous solubility at
25°C and exhibits suitable tableting properties when combined with
appropriate excipients.
Quetiapine AN 25 mg tablets, 100 mg tablets, 200 mg tablets and 300 mg
tablets contains
quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg and 300 mg
quetiapine free base
respectively. The inactive ingredients are: Lactose, sodium starch
glycollate (Type A), calcium
hydrogen
phosphate, povidone,
microcrystalline cellulose, magnesium
stearate and
film-
coating
contains:
OPADRY
complete
film
coating
system
03B84929
PINK
(ARTG
Quetiapine AN PI v2.0
Page 1
_Quetiapine AN tablets Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd _
No.106711) [25 mg], OPADRY complete film coating system 03B52117
yellow (ARTG
No.106712) [100 mg], hypromellose, macrogol 400 and titanium dioxide
[200 mg, 300 mg]
PHARMACOLOGY
MECHANISM OF ACTION
Quetiapine is an atypical antipsychotic agent. Quetiapine and the
human plasma metabolite,
norquetiapine, interact with a broad range of neurotransmitter
receptors. Quetiapine and
norquetiapine exhibit affinity for brain serotonin (5HT
2
) and dopamine D
1
and D
2
receptors;
this combination of receptor