TERRY WHITE QUETIAPINE quetiapine (as fumarate) 300mg film-coated tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

quetiapine fumarate

Dostupné s:

Apotex Pty Ltd

INN (Mezinárodní Name):

Quetiapine fumarate

Stav Autorizace:

Registered

Informace pro uživatele

TERRY WHITE CHEMISTS
QUETIAPINE
_Quetiapine fumarate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about quetiapine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Quetiapine tablets. It
contains the active ingredient
quetiapine (as quetiapine fumarate).
It is used to treat:
•
the symptoms of schizophrenia,
an illness which affects the way
people think, feel and behave.
•
Bipolar 1 disorder, an illness 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. Quetiapine
may both treat and prevent
bipolar disorder from recurring.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Que

Charakteristika produktu

1 AUSTRALIAN PRODUCT INFORMATION
TERRY WHITE CHEMISTS QUETIAPINE (QUETIAPINE
FUMARATE) TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of
quetiapine fumarate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TERRY WHITE CHEMISTS QUETIAPINE TABLETS 25 MG:
Peach, round, biconvex, film coated tablet. Engraved “APO” on one
side, “QUE” over “25” on
the other side.
TERRY WHITE CHEMISTS QUETIAPINE TABLETS 100 MG:
Yellow, round, biconvex, film coated tablet. Engraved “APO” on one
side, “QUE” over “100” on
the other side.
TERRY WHITE CHEMISTS QUETIAPINE TABLETS 150 MG:
Pale yellow, round, biconvex, film coated tablet. Engraved “APO”
on one side, “QUE” over
“150” on the other side.
TERRY WHITE CHEMISTS QUETIAPINE TABLETS 200 MG:
White, round, biconvex, film coated tablet. Engraved “APO” on one
side, “QUE” over “200” on
the other side.
TERRY WHITE CHEMISTS QUETIAPINE TABLETS 300 MG:
White, capsule shaped, biconvex, film coated tablet. Engraved
“APO” on one side, “QUE 300”
on the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quetiapine is indicated for:
BIPOLAR DISORDER
Adults
•
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)
•
Treatment of acute mania associated with bipolar I disorder as
monotherapy or in
combination with lithium or sodium valproate
Children/adolescents aged 10 to 17 years
•
Monotherapy treatment of acute mania associated with bipolar I
disorder
SCHIZOPHRENIA (ADULTS AND ADOLESCENTS AGED 13 TO 17 YEARS)
•
Treatment of schizophrenia
4.2
DOSE AND METHOD OF ADMINISTRATION
Terry White Chemists Quetiapine tablets are intend