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

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

quetiapine fumarate, Quantity: 345.39 mg (Equivalent: quetiapine, Qty 300 mg)

থেকে পাওয়া:

Sandoz Pty Ltd

INN (International Name):

Quetiapine fumarate

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

Excipient Ingredients: povidone; calcium hydrogen phosphate dihydrate; silicon dioxide; lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type A; titanium dioxide; hypromellose; macrogol 4000

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

60 film-coated tablets

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Quetiapine Sandoz 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 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

পণ্য সারাংশ:

Visual Identification: QUETIAPINE SANDOZ 300mg is presented as a white coloured, capsoid in shape, scored on both sides, film-coated tablet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Licence status A

অনুমোদন তারিখ:

2011-04-28

তথ্য লিফলেট

QUETIAPINE SANDOZ
®
1
QUETIAPINE SANDOZ
®
_quetiapine fumarate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Quetiapine Sandoz.
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 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 IS USED FOR
This medicine is used to treat mental
illnesses 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
over activity, elation or
irritability. During depression,
patients may feel depressed or
guilty, lack energy, lose their
appetite and have trouble
sleeping.
_HOW QUETIAPINE SANDOZ _
_WORKS _
It contains the active ingredient
quetiapine fumarate and belongs to a
group of medicines called
antipsychotics. It works by correcting
chemical imbalances in the brain,
which may cause mental illness.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY QUETIAPINE
SANDOZ 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, of 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
QUETIAPINE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
quetiapine, the active ingredient
o

পণ্য বৈশিষ্ট্য

211028-Quetiapine Sandoz-pi
Page 1 of 41
AUSTRALIAN PRODUCT INFORMATION
QUETIAPINE SANDOZ
® (QUETIAPINE FUMARATE) TABLETS
1
NAME OF THE MEDICINE
Quetiapine fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quetiapine Sandoz 25 mg, 100 mg, 200 mg and 300 mg tablets contain
quetiapine fumarate
equivalent to 25 mg, 100 mg, 200 mg and 300 mg quetiapine free base
respectively.
Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits
moderate pH dependent
solubility
(94.3
mg/mL
to
2.37
mg/mL
at
pH
values
from
1
to
9)
and
lypophilicity
characteristics (Log P) which vary with pH (0.45 in water, 1.37 at pH
5, 2.65 at pH 7 and 2.59
at pH 9).
Quetiapine fumarate displays good solid state stability, has an
aqueous solubility of 3.29
mg/mL at 25 °C and exhibits suitable tableting properties when
combined with appropriate
excipients.
_Excipient(s) with known effect_
: contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Quetiapine Sandoz 25 mg, 100 mg, and 200 mg are round, film-coated
tablets. Quetiapine
Sandoz 300 mg is capsoid, film-coated tablets.
QUETIAPINE SANDOZ 25 mg is presented as a peach coloured, round,
film-coated tablet;
available in blister packs and bottles of 60 tablets.
QUETIAPINE SANDOZ 100 mg is presented as a yellow coloured, round,
scored on one side,
film-coated tablet; available in blister packs and bottles of 90
tablets.
QUETIAPINE SANDOZ 200 mg is presented as a white coloured, round,
scored on one side,
film-coated tablet; available in blister packs and bottles of 60
tablets.
QUETIAPINE SANDOZ 300 mg is presented as a white coloured, capsoid in
shape, scored on
both sides, film-coated tablet; available in blister packs and bottles
of 60 tablets.
_Not all presentations may be marketed in Australia. _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Quetiapine Sandoz is indicated for:
_BIPOLAR DISORDER _
ADULTS
•
Maintenance treatment of bipolar I disorder, as monotherapy or in
combination with
lithium or sodium valpro