SEROQUEL TABLET 100MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

QUETIAPINE FUMARATE

Boleh didapati daripada:

Luye Pharma (Malaysia) 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)
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 doctor

Ciri produk

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Profile
Technical Info
N/A
0296
ISP-P-75002A
CN62-816B
26-09-2021
106084317/402553803 0010
Seroquel Leaflet professional MY
SGK is a Matthews International Corporation
Black
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
quetiapine
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
quetiapine 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 ‘_Pharmaceutical 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 usefulness 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 established in two
12-week monotherapy trials in adults, in one 3-week adjunctive trial
in adults,
and in one 3-week monotherapy trial in paediatric patients (10-17
years).
_Treatment of depressive episodes associated with bipolar disorder_
The efficacy of Seroquel was establish