QUETIAPINE-AS XR quetiapine (as fumarate) 50mg modified release tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quetiapine fumarate

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Quetiapine fumarate

Authorization status:

Registered

Patient Information leaflet

QUETIAPINE-
AS XR
QUETIAPINE FUMARATE
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some of
the common questions
people ask about
QUETIAPINE-AS XR. 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 QUETIAPINE-
AS XR IS USED FOR
QUETIAPINE-AS XR helps to
correct chemical imbalances
in the brain. It is used to
treat conditions such as:
•
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.
•
Recurrent major
depressive disorder, an
illness where depression
is longer lasting and/or
more severe than the
"low moods" everyone
has from time to time
due to the stress of
everyday life. It is
thought to be caused by
a chemical imbalance in
parts of the brain. This
imbalance affects your
whole body and can
cause emotional and
physical symptoms such
as feeling low in spirit,
loss of interest in
activities, being unable
to enjoy life, poor
appetite or overeating,
disturbed sleep, often
waking up early, loss of
sex drive, lack of energy
and feeling guilty over
nothing.
•
Generalised anxiety
disorder, where patients
have excessive anxiety
and worry.
•
Schizophrenia, an illness
with disturbances in
thinking, feelings and
behaviour.
QUETIAPINE-AS XR belongs
to a group of medicines
called antipsychotics.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
QUETIAPINE-AS XR HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed this medicine for
another reason.
This

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - QUETIAPINE-AS XR (QUETIAPINE
FUMARATE) MODIFIED RELEASE TABLETS
1.
NAME OF THE MEDICINE
Quetiapine fumarate
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
Each modified release tablet contains quetiapine fumarate equivalent
to 50 mg, 200 mg, 300 mg or
400 mg of quetiapine free base.
Excipients with known effect: contains sugars (as lactose).
3.
PHARMACEUTICAL FORM
QUETIAPINE-AS XR 50 MG MODIFIED RELEASE TABLETS: Peach coloured, round
shaped, biconvex film
coated tablets, debossed with ‘Q50’ on one side and plain on
other.
QUETIAPINE-AS XR 200MG MODIFIED RELEASE TABLETS: Yellow coloured,
round shaped, biconvex film
coated tablets, debossed with ‘I2’ on one side and plain on other.
QUETIAPINE-AS XR 300MG MODIFIED RELEASE TABLETS: Light yellow
coloured, round shaped, biconvex
film coated tablets, debossed with ‘Q300’ on one side and plain on
other.
QUETIAPINE-AS XR 400MG MODIFIED RELEASE TABLETS: White coloured, round
shaped, biconvex, film
coated tablets, debossed with ‘I4’ on one side and plain on other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quetiapine modified release tablets are indicated for:
BIPOLAR DISORDER
•
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
2
•
Treatment of depressive episodes associated with bipolar disorder (see
Section 4.2 DOSE
AND METHOD OF ADMINISTRATION)
•
Treatment of acute mania associated with bipolar I disorder as
monotherapy or in
combination with lithium or sodium valproate
Efficacy of quetiapine modified release tablets in the treatment of
bipolar disorder indications was
established in part, on the basis of extrapolation from the
established effectiveness of quetiapine
immediate release tablets.
SCHIZOPHRENIA
Treatment of schizophrenia, prevention of relapse and maintenance of
clinical improvement during
continuation therapy.
MAJOR DEPRESSIVE DISORDER
Treatment of recurre