SEROQUEL 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 Pharmaceutical Co. Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SEROQUEL TABLET
Quetiapine Fumarate (25mg, 100mg, 200mg, 300mg)
1
WHAT IS IN THIS LEAFLET
1.
What Seroquel is used for
2.
How Seroquel works
3.
Before you use Seroquel
4.
How to use Seroquel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Seroquel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT SEROQUEL IS USED FOR
Seroquel can be used to treat
schizophrenia in people 13 years of age
or older with symptoms, such as
hallucinations (for example unexplained
voices), strange and frightening thoughts,
changes in behaviour, feeling alone and
confused.
Seroquel can also be used to treat adults
with Bipolar Disorder, either in a manic
or in a depressed 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. In a
depressed state individuals with this
condition may feel sad or depressed, feel
guilty, lack energy, lose their appetite
and/or can’t sleep.
Seroquel can also be used to treat manic
episodes associated with bipolar disorder
in children ages 10 to 17 years old.
Your doctor may continue to give you
Seroquel even when you are feeling
better to prevent your symptoms of
bipolar disorder from returning.
HOW SEROQUEL WORKS
Seroquel contains quetiapine fumarate.
Seroquel belongs to a group of medicines
called antipsychotics. It helps to correct
chemical imbalances in the brain.
BEFORE YOU USE SEROQUEL
-
_When you must not use it _
Do not take Seroquel if you have ever
had an allergic reaction to Seroquel or to
any of its ingredients (see section
PRODUCT DESCRIPTION
).
Do not take Seroquel if you are taking
any of the following medicines:
•
HIV-protease inhibitor for Human
Immunodeficiency Virus (HIV)
•
azole medicines (for fungal
infections)
•
erythromycin or clarithromycin (for
infections)
•
nefazodone (for depression)
If you are not sure, talk to your docto

Ciri produk

Page 1 of 23
Issued to the Medical Profession Only
PACKAGE LEAFLET TEXT
‘SEROQUEL’
quetiapine fumarate
Trademark
Presentation
25 mg tablet: round, 6 mm, peach coloured, biconvex, film -coated tablet containing quetiapine
fumarate delivering a dose of 25 mg of quetia pine free base.
100 mg tablet: round, 8.5 mm, yellow coloured, biconvex, film -coated tablet containing
quetiapine fumarate delivering a dose of 100 mg of quetiapine free base.
200 mg tablet: round, 11 mm, white, biconvex, film -coated tablet containing quet iapine
fumarate delivering a dose of 200 mg of quetiapine free base.
300 mg tablet: capsule shaped, 19 mm x 7.62 mm, white, film -coated tablet containing
quetiapine fumarate delivering a dose of 300 mg of quetiapine free base.
For excipients see ‘Pharmace utical Particulars ’.
Clinical Particulars
Indications
Treatment of schizophrenia
The antipsychotic efficacy of Seroquel was established in short -term (6 weeks) controlled trials
of adults and one 6 -week trial in adolescents (13 -17 years) schizophrenic in patients.
The effectiveness of Seroquel in long -term use, that is, for more than 6 weeks, has not been
systematically evaluated in controlled trials. Therefore, the physician who elects to use
Seroquel for extended periods should periodically re -evaluate the long -term useful ness of the
drug for the individual patient .
Treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy
or adjunct to lithium or divalproex
The efficacy of Seroquel in acute bipolar mania was establish ed in two 12 -week monotherapy
trials in adults, in one 3 -week adjunct ive trial in adults, and in one 3-week monotherapy trial
in p aediatric patients (10 -17 years) .
Treatment of depressive episodes associated with bipolar disorder
The efficacy of Seroquel was established in two identical 8 -week randomised, placebo -
controlled double -blind clinical studies that included either bipolar I or bipolar II patients with
and without rapid cycling courses (See ‘ Pharmacodynamic