Auro-Quetiapine 25

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Quetiapine fumarate 28.78mg equivalent to 25 mg quetiapine

Доступно од:

Aurobindo Pharma NZ Limited

INN (Међународно име):

Quetiapine fumarate 28.78 mg (equivalent to 25 mg quetiapine)

Дозирање:

25 mg

Фармацеутски облик:

Film coated tablet

Састав:

Active: Quetiapine fumarate 28.78mg equivalent to 25 mg quetiapine Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry pink 03B84904 Povidone Purified talc Sodium starch glycolate

Јединице у пакету:

Blister pack, PVC/Aluminium, 20 tablets

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Aurobindo Pharma Limited

Терапеутске индикације:

Acute and chronic psychoses, including schizophrenia.

Резиме производа:

Package - Contents - Shelf Life: Blister pack, PVC/Aluminium - 20 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aluminium - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Датум одобрења:

2010-10-06

Информативни летак

AURO-QUETIAPINE
CONSUMER MEDICINE INFORMATION
Ver 1.3
Page 1 of 5
AURO-QUETIAPINE 25, 100, 150, 200 & 300
Quetiapine (as fumarate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
of
the
common questions people ask about
AURO-QUETIAPINE.
It
does
not
contain all
the
information that
is
known about AURO-QUETIAPINE.
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
AURO-QUETIAPINE
IS USED FOR
AURO-QUETIAPINE
is
used
to
treat
schizophrenia
and
bipolar
disorder.
Schizophrenia
is
an
illness
with
disturbances
in
thinking,
feelings
and behaviour.
Bipolar
disorder
is
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.
Your
doctor
may continue to give
you
AURO-QUETIAPINE
when
you
are
feeling
better
to
prevent
symptoms from returning.
AURO-QUETIAPINE belongs to a
group
of
medicines
called
anti-
psychotics,
which
improve
the
symptoms of certain types of mental
illness.
Your
doctor
will
help
you
understand
the
benefits
of
taking
AURO-QUETIAPINE and why you
are taking it.
Ask your
doctor
for
further information if you have any
questions.
AURO-QUETIAPINE
is
not
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
AURO-QUETIAPINE
WHEN YOU MUST NOT USE IT
DO NOT
USE AURO-QUETIAPINE
IF
YOU HAVE AN ALLERGY TO AURO-
QUETIAPINE
OR
TO
ANY
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
If you have an allergic reaction,
you
may
get
a
skin
rash,
hay
fever,
difficulty breathing or feel faint.
AURO-QUETIAPINE
is
not
a

Карактеристике производа

Data Sheet:
AURO-QUETIAPINE (Quetiapine Tablets 25, 100, 150, 200 & 300 mg)
Ver 1.4
Page 1 of 20
NEW ZEALAND DATA SHEET
AURO-QUETIAPINE
GENERIC NAME
Quetiapine fumarate
DOSE FORM AND STRENGTH
25, 100, 150, 200 and 300 mg film coated tablet
PRESENTATION
AURO-QUETIAPINE quetiapine as fumarate 25 mg
Peach round, biconvex, film-coated tablet debossed with ‘E52’on one side and plain on the
other.
AURO-QUETIAPINE quetiapine as fumarate 100 mg
Yellow round, biconvex, film-coated tablet imprinted with ‘E53’on one side and plain on the
other.
AURO-QUETIAPINE quetiapine as fumarate 150 mg
Light yellow round, biconvex, film-coated tablet imprinted with ‘E54’on one side and plain on
the other.
AURO-QUETIAPINE quetiapine as fumarate 200 mg
White round, biconvex, film-coated tablet imprinted with ‘E55’on one side and plain on the
other.
AURO-QUETIAPINE quetiapine as fumarate 300 mg
White capsule shaped, biconvex, film-coated tablet imprinted with ‘E56’on one side and plain
on the other.
INDICATIONS
AURO-QUETIAPINE is indicated for the treatment of:
 Acute and chronic psychoses, including schizophrenia
 Bipolar Disorder including:
o treatment of manic episodes satisfying DSM-IV criteria for mania associated with
bipolar disorder
o treatment of depressive episodes associated with bipolar disorder
o
maintenance treatment of bipolar I disorder, in combination with a mood stabiliser, for
the prevention of recurrence of manic, depressive or mixed episodes
DOSAGE AND ADMINISTRATION
ADULTS
FOR THE TREATMENT OF ACUTE AND CHRONIC PSYCHOSES, INCLUDING SCHIZOPHRENIA:
Quetiapine should be administered twice daily, with or without food.
The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg
(Day 3) and 300 mg (Day 4).
Data Sheet:
AURO-QUETIAPINE (Que