QUETIACCORD TABLETS 100 mg

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Quetiapine fumarate

Commercializzato da:

Accord Healthcare Pty Ltd

INN (Nome Internazionale):

Quetiapine fumarate

Foglio illustrativo

QUETIACCORD TABLETS
CONSUMER MEDICINE INFORMATION Version: 2.0
-2012- Page: 1 of 6
QUETIACCORD TABLETS
Quetiapine Tablets
Quetiapine fumarate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about
Quetiaccord
Tablets.
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
Quetiaccord Tablets 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 QUETIACCORD
TABLETS ARE USED FOR
Quetiaccord
Tablets
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.
Quetiaccord Tablets 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
IT
DO NOT TAKE QUETIACCORD
TABLETS IF YOU HAVE AN ALLERGY
TO
* QUETIAPINE, THE ACTIVE
INGREDIENT IN QUETIACCORD
TABLETS
* 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 QUET

Scheda tecnica

Quetiaccord Tablets (Quetiapine Tablets) Version 2.0
-2012- Page: 1 of 43
PRODUCT INFORMATION
QUETIACCORD TABLETS 25 MG, 100 MG, 200 MG, 300 MG
(QUETIAPINE TABLETS 25 MG, 100 MG, 200 MG, 300 MG)
NAME OF THE MEDICINE
Quetiapine fumarate
Chemical name:-
Bis[2-[2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl] ethoxy]
ethanol] fumarate.
Quetiapine fumarate has no chiral centres and only one morphological
entity has been
detected throughout development.
Structural formula:
CAS number: 111974-72-2
Quetiapine fumarate has a molecular formula of C
46
H
54
N
6
O
8
S
2
and a molecular weight of
883.1.
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.
Quetiaccord Tablets (Quetiapine Tablets) Version 2.0
-2012- Page: 2 of 43
Quetiapine fumarate displays good soild state stability, has moderate
aqueous solubility
at 25°C and exhibits suitable tableting properties when combined with
appropriate
excipients.
Quetiaccord Tablets 25 mg are presented as pink coloured, round,
biconvex, film-coated
tablets plain on both side.
Quetiaccord Tablets 100 mg are presented as yellow coloured, round,
biconvex, film-
coated tablet plain on both sides.
Quetiaccord Tablets 200 mg are presented as white to off white, round,
biconvex, film-
coated tablet, plain on both sides.
Quetiaccord Tablets 300 mg are presented as white to off white,
capsule shaped,
biconvex, film-coated tablet, with ‘300’ debossed on one side and
plain on other side.
Quetiaccord Tablets 25 mg, 100 mg, 200 mg and 300 mg contain
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 03B8492