QUETIA XR quetiapine (as fumarate) 400mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quetiapine fumarate, Quantity: 460.52 mg (Equivalent: quetiapine, Qty 400 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: titanium dioxide; carrageenan; lactose monohydrate; magnesium stearate; povidone; light magnesium oxide; macrogol 400; microcrystalline cellulose

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bipolar disorder - Maintenance treatment of bipolar 1 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 incombination with lithium or sodium valproate. Efficacy of quetiapine 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 (MDD)- Treatment of recurrent major depressive disorde in patients who are intolerant of, or who have an inadequate response to alternative therapies. Generalised anxiety disorder (GAD). Treatment of generalised anxiety disorder.

Product summary:

Visual Identification: White to off-white, capsule shaped, biconvex, coated tablet, plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-01-17

Patient Information leaflet

QUETIA XR CMI
1
QUETIA XR
_contains the active ingredient quetiapine (as fumarate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about QUETIA 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 QUETIA XR IS USED FOR
QUETIA XR helps to correct
chemical imbalances in the brain. It
is used to treat conditions such as:
•
Bipolar disorder, an illness of 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.
QUETIA XR belongs to a group of
medicines called antipsychotics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY QUETIA XR
HAS BEEN PRESCRIBED FOR YOU. Your
doctor may have prescribed this
medicine for another

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION -
QUETIA XR (QUETIAPINE (AS FUMARATE)) TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUETIA XR modified release tablets come in five strengths and contain
quetiapine fumarate
equivalent to 50 mg, 150 mg, 200 mg, 300 mg and 400 mg of quetiapine
free base.
Excipients of known effect: Contains sugars as lactose.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
_QUETIA XR 50 MG_
Quetiapine (as fumarate) 50 mg modified release tablet; Light pink
to pink, capsule shaped, biconvex, coated tablet, plain on both
sides.
_QUETIA XR 150 MG_
Quetiapine (as fumarate) 150 mg modified release tablet; White to
off-white, round, biconvex, coated tablet, plain on both sides.
_QUETIA XR 200 MG_
Quetiapine (as fumarate) 200 mg modified release tablet; Yellow,
capsule shaped, biconvex, coated tablet, plain on both sides.
_QUETIA XR 300 MG_
Quetiapine (as fumarate) 300 mg modified release tablet; Pale
yellow, capsule shaped, biconvex, coated tablet, plain on both
sides.
_QUETIA XR 400 MG_
Quetiapine (as fumarate) 400 mg modified release tablet; White to
off-white, capsule shaped, biconvex, coated tablet, plain on both
sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
QUETIA XR is 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
•
Treatment of depressive episodes associated with bipolar disorder (SEE
SECTION 4.2
DOSE AND METHOD OF ADMINISTRATION)
2
•
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 sc