APX-QUETIAPINE quetiapine (as fumarate) 300 mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

quetiapine fumarate, Quantity: 345.36 mg (Equivalent: quetiapine, Qty 300 mg)

Disponible des:

Accord Healthcare Pty Ltd

Designació comuna internacional (DCI):

Quetiapine fumarate

formulario farmacéutico:

Tablet, film coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

100 tablets, 60 tablets, 20 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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

Resumen del producto:

Visual Identification: White to off white, capsule shaped, biconvex, film-coated tablet, with '300' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2014-04-02

Informació per a l'usuari

QUETIAPINE APOTEX
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2019- Page: 1 of 6
QUETIAPINE APOTEX
Quetiapine fumarate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about QUETIAPINE APOTEX. 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
QUETIAPINE APOTEX 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 QUETIAPINE
APOTEX ARE USED FOR
QUETIAPINE APOTEX helps to
correct chemical imbalances in
the brain. It 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 of overactivity, elation
or irritability. During depression,
patients may feel depressed or
guilty, lack energy, lose their
appetite and have trouble
sleeping.
QUETIAPINE APOTEX belongs to
a group of medicines called
antipsychotics.
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 QUETIAPINE
APOTEX IF YOU HAVE AN ALLERGY
TO
* QUETIAPINE, THE ACTIVE
INGREDIENT IN THE MEDICINE;
* ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Some of the sym

Fitxa tècnica

V1 2019
1
AUSTRALIAN PRODUCT INFORMATION
QUETIAPINE APOTEX (QUETIAPINE FUMARATE) TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quetiapine APOTEX tablets contain quetiapine fumarate equivalent to 25
mg, 100 mg, 200 mg
and 300 mg quetiapine free base respectively.
Excipients with known effect
Lactose monohydrate
For the full list of excipients see section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
Quetiapine APOTEX (25 mg tablets) are presented as a pink coloured,
round, biconvex, film-
coated tablets plain on both side; each tablet contains 25 mg of
quetiapine (as fumarate).
Quetiapine APOTEX (100 mg tablets)
are presented as a yellow coloured, round, biconvex,
film-coated tablet plain on both sides; each tablet contains 100 mg of
quetiapine (as fumarate).
Quetiapine APOTEX (200 mg tablets) are presented as a white to off
white, round, biconvex,
film-coated tablet, plain on both sides; each tablet contains 200 mg
of quetiapine (as fumarate).
Quetiapine APOTEX (300 mg tablets) are presented as a white to off
white, capsule shaped,
biconvex, film-coated tablet, with ‘300’ debossed on one side and
plain on other side; each
tablet contains 300 mg of quetiapine (as fumarate).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quetiapine APOTEX 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)

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
V1 2019
2
Schizophrenia (adults and adolescents aged 13 to 17 years)

Treatment of schizophrenia
4.2
DOSE AND METHOD