SEQUASE XR quetiapine (as fumarate) 50 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

10-12-2020

Summary of Product characteristics (SPC)

10-12-2020

Public Assessment Report (PAR)

10-11-2017

Active ingredient:

quetiapine fumarate, Quantity: 57.56 mg (Equivalent: quetiapine, Qty 50 mg)

Available from:

Luye Pharma Australia Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium citrate dihydrate; hypromellose; magnesium stearate; macrogol 400; titanium dioxide; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SEQUASE 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 DOSAGE AND ADMINISTRATION) - Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate. Efficacy of SEQUASE XR in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine IR. Schizophrenia: Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. Major depressive disorder: Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies. Generalised anxiety disorder: Treatment of generalised anxiety disorder (GAD).

Product summary:

Visual Identification: peach film coated capsule shaped biconvex intagliated tablet with "XR 50" on 1 side & plain on the other; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-07-03

Patient Information leaflet

SEQUASE XR
®
1
SEQUASE XR
®
_Quetiapine fumarate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
SEQUASE 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 SEQUASE XR IS
USED FOR
SEQUASE 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.
SEQUASE XR belongs to a group of
medicines called antipsychotics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SEQUASE
XR HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is o

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Summary of Product characteristics

1 of 41
Australian PRODUCT INFORMATION
SEQUASE XR
®
(QUETIAPINE FUMARATE) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEQUASE XR 50 mg, 150 mg, 200 mg, 300 mg and 400 mg tablets contain
quetiapine fumarate
equivalent to 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine
free base.
_Excipient(s) with known effect:_
lactose monohydrate
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablet, modified release.
SEQUASE XR 50 mg, 150 mg, 200 mg, 300 mg and 400 mg are capsule shaped
modified release
tablets which are peach (50 mg), white (150 mg), yellow (200 mg), pale
yellow (300 mg) or white
(400 mg) in colour. All tablets are embossed with “XR” and the
strength on one side, while the
other side is plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SEQUASE 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 4.4)

Treatment of acute mania associated with bipolar I disorder as
monotherapy or in combination
with lithium or sodium valproate

Efficacy of SEQUASE XR in the treatment of bipolar disorder
indications was established in
part, on the basis of extrapolation from the established effectiveness
of quetiapine immediate
release.
SCHIZOPHRENIA
Treatment of schizophrenia, prevention of relapse and maintenance of
clinical improvement during
continuation therapy.
MAJOR DEPRESSIVE DISORDER
Treatment of recurrent major depressive disorder (MDD) in patients who
are intolerant of, or who
have an inadequate response to alternative therapies.
2 of 41
GENERALISED ANXIETY DISORDER
Treatment of generalised anxiety disorder (GAD).
4.2
DOSE AND METHOD OF ADMINISTRATION
Chronic antipsychotic treatment should generally be reserved for
patients who appear to suffer

Read the complete document