QUETIAPINE SANDOZ PHARMA 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:

Sandoz 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:

100 tablets, 20 tablets, 60 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

Page: 1 of 7
QUETIAPINE SANDOZ PHARMA
Quetiapine fumarate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about QUETIAPINE SANDOZ
PHARMA. 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 SANDOZ PHARMA
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
SANDOZ PHARMA
TABLETS ARE USED FOR
QUETIAPINE SANDOZ PHARMA
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 SANDOZ PHARMA
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
SANDOZ PHARMA 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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
QUETIAPINE SANDOZ PHARMA (QUETIAPINE FUMARATE)
TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quetiapine Sandoz Pharma 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 Sandoz Pharma 25 mg 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 Sandoz Pharma 100 mg_ _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 Sandoz Pharma 200 mg_ _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 Sandoz Pharma 300 mg 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 Sandoz Pharma 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
DOSE AND METHOD OF ADMINISTRATI