QUTERO 300 (Quetiapine Fumarate Tablets 300mg)

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

QUETIAPINE FUMARATE

Prieinama:

UNIMED SDN BHD

INN (Tarptautinis Pavadinimas):

QUETIAPINE FUMARATE

Vienetai pakuotėje:

10 X 10tablet Tablets

Pagaminta:

Hetero Labs Limited

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
QUTERO TABLETS
Quetiapine (100mg, 200mg, 300mg)
1
WHAT IS IN THIS LEAFLET?
1.
What QUTERO Tablets is used for
2.
How QUTERO works
3.
Before you take QUTERO
4.
How to use QUTERO
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of QUTERO
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT QUTERO IS USED FOR
QUTERO can be used to treat several
illnesses, such as:
•
Schizophrenia: where you may hear
or
feel
things
that
are
not
there,
believe things that are not true or feel
unusually
suspicious,
anxious,
confused, guilty, tense or depressed.
•
Acute
Mania
episode:
where
you
may
feel
very
excited,
elated,
agitated, enthusiastic or hyperactive
or
have
poor
judgment
including
being aggressive or disruptive.
•
Associated
with
bipolar
disorder:
(extreme mood swings ranging from
episodes
of
depression
to
mania)
where you may feel sad all the time
or
you
may
find
that
you
feel
depressed, feel guilty, lack energy,
lose your appetite or can’t sleep.
Your doctor may continue to prescribe
QUTERO
even
when
you
are
feeling
better.
HOW QUTERO WORKS
QUTERO
contains
a
substance
called
quetiapine.
It
belongs
to
a
group
of
medicines
called
anti-psychotics.
Illnesses that affects the brain, such as
psychotic disorders may cause by lack of
certain chemicals in the brain. QUTERO
helps
to
put
right
this
imbalance
of
chemicals in certain parts of the brain-
mainly dopamine and serotonin.
BEFORE YOU USE QUTERO
_When you must not use it _
Do not take QUTERO if:
•
you are allergic (hypersensitive) to
quetiapine
or
any
of
the
other
ingredients of QUTERO
•
QUTERO
contains
lactose
monohydrate
which
is
a
type
of
sugar. If you have been told by your
doctor that you have an intolerance to
some
sugars,
contact
your
doctor
before taking this medicine.
•
If you are taking any of the following
medicines:
Some
medicines
for
human
immunodeficiency
virus
(HIV);
azole
medicines
(for
fungal
infections);
medicines
for
an
infection
(li

Prekės savybės

QUTERO 100 / 200 / 300 (QUETIAPINE TABLETS 100MG/ 200MG/ 300MG)
DESCRIPTION AND COMPOSITION:
QUTERO 100 (Quetiapine Tablets 100mg):
_Description:_
Yellow colored, round shaped, biconvex, film-coated tablets debossed
with
‘55’ on one side and ‘I’ on other side.
_Composition:_
Each film-coated tablet contains Quetiapine Fumarate equivalent to 100
mg
of Quetiapine.
QUTERO 200 (Quetiapine Tablets 200mg):
_Description:_
White to off white colored, round shaped, biconvex, film-coated
tablets
debossed with ‘56’ on one side and ‘I’ on other side.
_Composition:_
Each film-coated tablet contains Quetiapine Fumarate equivalent to 200
mg
of Quetiapine.
QUTERO 300 (Quetiapine Tablets 300mg):
_Description:_
White to off white colored, capsule shaped, biconvex, film-coated
tablets
debossed with ’45’ on one side and ‘I’ on other side.
_Composition:_
Each film-coated tablet contains Quetiapine Fumarate equivalent to 300
mg
of Quetiapine.
PHARMACODYNAMICS
_MECHANISM OF ACTION _
Quetiapine is an atypical antipsychotic agent. Quetiapine and the
active human plasma
metabolite, norquetiapine interact with a broad range of
neurotransmitter receptors.
Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT
2
) and dopamine
D
1
- and D
2
- receptors. It is this combination of receptor antagonism with a
higher
selectivity for 5HT
2
relative to D
2
- receptors, which is believed to contribute to the
clinical antipsychotic properties and low extrapyramidal side effect
(EPS) liability of
quetiapine.
Additionally,
norquetiapine
has
high
affinity
for
the
norepinephrine
transporter (NET). Quetiapine and norquetiapine also have high
affinity at histaminergic
and adrenergic α
1
receptors, with a lower affinity at adrenergic α
2
and serotonin 5HT
1
A
receptors.
Quetiapine
has
no
appreciable
affinity
at
cholinergic
muscarinic
or
benzodiazepine receptors.
_PHARMACODYNAMIC EFFECTS _
Quetiapine is active in tests for antipsychotic activity, such as
conditioned avoidance. It
also
blocks
the
action
of
dopamine
ag