SYQUET quetiapine (as fumarate) 300 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

60 tablets, 20 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2014-04-02

Patient Information leaflet

SYQUET
1
SYQUET
_Quetiapine fumarate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
SYQUET. 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 it
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 YOUR
MEDICINE.
You may need to read it again.
WHAT SYQUET IS USED
FOR
SYQUET 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.
SYQUET 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.
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 SYQUET 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 symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin or
you may feel faint.
DO NOT GIVE SYQUET TO CHILDREN
OR ADOLESCENTS UNLESS
RECOMMENDED BY YOUR DOCTOR.
The effects of SYQUET have only
been studied in children aged
between 10 and 17 years with mania
and in children aged

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
SYQUET (QUETIAPINE FUMARATE) TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SYQUET 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
SYQUET 25mg are presented as a pink coloured, round, biconvex,
film-coated tablets plain
on both side; each tablet contains 25 mg of quetiapine (as fumarate)
SYQUET 100mg are presented as a yellow coloured, round, biconvex,
film-coated tablet plain
on both sides; each tablet contains 100 mg of quetiapine (as
fumarate).
SYQUET 200mg 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).
SYQUET 300mg 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
SYQUET 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
2
Schizophrenia (adults and adolescents aged 13 to 17 years)

Treatment of schizophrenia
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
Chronic antipsychotic treatment should generally be reserved for
patients who appear to suffer
from a chronic illn