QUETIA 100 quetiapine (as fumarate) 100 mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

quetiapine fumarate, Quantity: 115.12 mg (Equivalent: quetiapine, Qty 100 mg)

Dostupno od:

Arrotex Pharmaceuticals Pty Ltd

INN (International ime):

Quetiapine fumarate

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; povidone; lactose monohydrate; sodium starch glycollate type A; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400

Administracija rute:

Oral

Jedinice u paketu:

90 Tablets, 20 Tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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 Dosage and 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

Proizvod sažetak:

Visual Identification: Yellow coloured, round, biconvex, film-coated tablet, plain on both sides.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2014-04-02

Uputa o lijeku

QUETIA TABLETS
_QUETIAPINE FUMARATE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about Quetia tablets. 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
Quetia 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 QUETIA ARE USED
FOR
Quetia belongs to a group of
medicines called antipsychotics.
It helps to correct chemical
imbalances in the brain and is
used to treat conditions such as:
•
schizophrenia, an illness
with disturbances in
thinking, feelings and
behaviour
•
bipolar disorder, an illness
in which there are sustained
mood swings either up
(mania) or down
(depression). During mania,
patients experience episodes
irritability. During
depression, patients may
feel depressed or guilty, lack
energy, lose their appetite
and have trouble sleeping.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may prescribe this
medicine for another reason.
You may find it helpful to tell a
friend or relative that you are
suffering from these symptoms,
and ask them to read this leaflet.
You might ask them to tell you if
they think your symptoms are
getting worse, or if they are
worried about any other changes
in your behaviour.
It is not addictive.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE QUETIA IF YOU HAVE
AN ALLERGY TO:
•
quetiapine, the active
ingredient in Quetia tablets
•
any of the other ingredients
listed at the end of this
leaflet.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of
the face, lips, tongue or other
parts of t

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – QUETIA (QUETIAPINE
FUMARATE) TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUETIA 25, 100, 200 and 300 tablets contain quetiapine fumarate
equivalent to 25 mg, 100 mg, 200
mg and 300 mg quetiapine free base respectively.
Excipient(s) with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
QUETIA 25 is a pink coloured, round, biconvex, film-coated tablet
plain on both sides.
QUETIA 100 is a yellow coloured, round, biconvex, film-coated tablet
plain on both sides.
QUETIA 200 is a white to off white, round, biconvex, film-coated
tablet plain on both sides.
QUETIA 300 is a white to off white, capsule shaped, biconvex,
film-coated tablet with ‘300’ debossed
on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
QUETIA tablets are 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)
2
•
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
D
OSE AND METHOD OF ADMINISTRATION
Chronic antipsychotic treatment should generally be reserved for
patients who appear to suffer from
a chronic illness that (1) is known to respond to antipsychotic drugs,
and (2) for whom alternative
equally effective but potentially less harmful treatments are not
available or appropriate. In patients
who do require chronic treatment, the smallest dose and the s