Seroquel XR Extended Release Tablet 200mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

QUETIAPINE FUMARATE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

QUETIAPINE FUMARATE

Unit dalam pakej:

60Tablet Tablets

Dikeluarkan oleh:

AstraZeneca Pharmaceuticals LP

Risalah maklumat

SEROQUEL XR EXTENDED RELEASE TABLET
Quetiapine Fumarate (50mg, 200mg, 300mg, 400mg)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Seroquel XR is used for
2.
How Seroquel XR works
3.
Before you use Seroquel XR
4.
How to use Seroquel XR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Seroquel
XR
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT SEROQUEL XR
IS USED FOR
Seroquel XR can be used to treat:
•
Adults with schizophrenia, a disease
with symptoms, such as
hallucinations (for example
unexplained voices), strange and
frightening thoughts, changes in
behaviour, feeling alone and
confused.
•
Adults with bipolar disorder, either
in a moderate to severe manic or in a
major depressive state. In a manic
state people may find they are more
talkative and have racing thoughts or
ideas whereby they feel 'high' or
excited. They may also feel
unusually irritable, sad and guilty,
lack energy, lose their appetite
and/or can’t sleep. Whereas
depressed adults who do not feel
high or excited, these individuals
have prolonged periods of feeling
sad, lack energy, are often tearful,
and have changes in sleep or
appetite.
•
Seroquel XR can be used to prevent
relapse in individuals with
schizophrenia whose condition has
been stabilized.
•
Seroquel XR can be used to prevent
relapse in individuals with bipolar
disorder whose moderate to severe
manic or major depressive episodes
were successfully treated with
quetiapine.
•
Seroquel XR can be used to treat
recurrent
major depressive disorder
in individuals for whom other
antidepressant treatments are not
suitable (either because they do not
work well or because of side
effects).
Your doctor may continue to give you
Seroquel XR even when you are feeling
better to prevent your symptoms from
returning.
HOW SEROQUEL XR
WORKS
Seroquel XR contains quetiapine
fumarate. Seroquel XR belongs to a
group of medicines called antipsychotics.
It helps t

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Issued to the Medical Profession Only
PACKAGE LEAFLET TEXT
Seroquel XR
50 mg extended -release tablets
200 mg extended -release tablets
300 mg extended -release tablets
400 mg extended -release tablets
Qualitative and quantitative composition
Seroquel XR 50 mg contains 50 mg quetiapine (as quetiapine fumarate)
Seroquel XR 200 mg contains 200 mg quetiapine (as quetiapine fumarate)
Seroquel XR 300 mg contains 300 mg quetiapine (as quetiapine fumarate)
Seroquel XR 400 mg contains 400 mg quetiapine (as que tiapine fumarate)
Seroquel XR contains lactose monohydrate.
Pharmaceutical form
50 mg tablet: Peach, film -coated, capsule shaped, biconvex, intagliated tablet with ‘XR50’ on 1 side
and plain on the other.
200 mg tablet: Yellow, film -coated, capsule shaped, biconvex, intagliated tablet with ‘XR200’ on 1
side and plain on the other.
300 mg tablet: Pale yellow, film -coated, capsule shaped, biconvex, intagliated tablet with ‘XR300’
on 1 side and plain on the other.
400 mg ta blet: White, film -coated, capsule shaped, biconvex, intagliated tablet with ‘XR400’ on 1
side and plain on the other.
Clinical Particulars
Therapeutic indications
Seroquel XR is indicated for the treatment of schizophrenia.
Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been
maintained on Seroquel XR.
Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of
bipolar disorder.
Seroquel XR i s indicated for the treatment of major depressive episodes in bipolar disorder.
Seroquel XR is indicated f or the prevention of recurrence in patients with bipolar disorder, in patients
whose manic or depressive episode has responded to quetiapine treatme nt.
Seroquel XR is indicated for the maintenance treatment of bipolar I disorder as adjunctive therapy to
lithium or divalproex .
The efficacy of Seroquel XR in bipolar disorder was established, in part, on the basis of extrapolation
from the established effectiveness of Seroquel (see ‘Clinical