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

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

quetiapine fumarate, Quantity: 345.408 mg (Equivalent: quetiapine, Qty 300 mg)

Доступна с:

Pharmacor Pty Ltd

ИНН (Международная Имя):

Quetiapine fumarate

Фармацевтическая форма:

Tablet, film coated

состав:

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

Администрация маршрут:

Oral

Штук в упаковке:

60, 20, 100

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Quetiapine 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 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

Обзор продуктов:

Visual Identification: White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизация:

Licence status A

Дата Авторизация:

2014-02-13

тонкая брошюра

ALKEM
QUETIAPINE
_Quetiapine (as fumarate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions
people ask about ALKEM QUETIAPINE. 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 THE MEDICINE.
You may need to read it again.
WHAT ALKEM QUETIAPINE IS
USED FOR
ALKEM QUETIAPINE 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.
ALKEM QUETIAPINE 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 ALKEM QUETIAPINE 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 difficult

Характеристики продукта

_____________________________________________________________________________
ALKEM QUETIAPINE PI (V-05)
Page 1 of 45
AUSTRALIAN PRODUCT INFORMATION – ALKEM
QUETIAPINE (QUETIAPINE FUMARATE)
1.
NAME OF THE MEDICINE
Quetiapine fumarate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALKEM QUETIAPINE 25 mg, 100 mg, 150 mg, 200 mg and 300 mg contains
quetiapine
fumarate equivalent to 25 mg, 100 mg, 150 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
Tablets, film coated
ALKEM QUETIAPINE 25 MG TABLETS: peach coloured round, biconvex,
film-coated
tablet; debossed with “262” on one side and plain on the other
side.
ALKEM QUETIAPINE 100 MG TABLETS: yellow coloured round, biconvex,
film-coated
tablet; debossed with “261” on one side and plain on the other
side.
ALKEM QUETIAPINE 150 MG TABLETS: pale yellow coloured, round,
biconvex, film-
coated tablet; debossed with “353” on one side and plain on the
other side.
ALKEM QUETIAPINE 200 MG TABLETS: white coloured round, biconvex,
film-coated
tablet; debossed with “260” on one side and plain on the other
side.
ALKEM QUETIAPINE 300 MG TABLETS: white coloured, capsoid, film-coated
tablet;
debossed with “259” on one side and plain on the other side.
_____________________________________________________________________________
ALKEM QUETIAPINE PI (V-05)
Page 2 of 45
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALKEM QUETIAPINE 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
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 v