SIZONORM 25 (Quetiapine Tablets USP 25mg)

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

QUETIAPINE FUMARATE

Dostopno od:

RANBAXY (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

QUETIAPINE FUMARATE

Enote v paketu:

03x10 Tablets

Izdeluje:

Sun Pharmaceutical Industries Limited

Navodilo za uporabo

SIZONORM (Quetiapine Tablets USP 25, 100, 200mg)
Page 1
SIZONORM_ _
_ _
_ _
(
Quetiapine Tablets USP 25, 100, 200mg)
_ Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1. What SIZONORM is used for
2. How SIZONORM works
3. Before you use SIZONORM
4. How to use SIZONORM
5. While you are using SIZONORM
6. Side Effects
7. Storage and Disposal of SIZONORM
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of Revision
This
leaflet
answers
some
common
questions about
SIZONORM.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you
taking
SIZONORM
against
the
benefits it is expected to have for you.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SIZONORM IS USED FOR
SIZONORM
contains
a
substance
called quetiapine which
is used to treat
conditions 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.

Mania:
where
you
may
feel
very
excited, elated, agitated, enthusiastic
or
hyperactive
or
have
poor
judgment including being aggressive
or disruptive.

Bipolar depression: where you feel
sad.
You
may
find
that
you
feel
depressed, feel guilty, lack energy,
lose your appetite or can’t sleep.
HOW SIZONORM WORKS
Quetiapine
belongs
to
a
group
of
medicines
called
anti-
psychotics.
It
helps to correct chemical imbalances in
the brain.
BEFORE YOU USE SIZONORM
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE SIZONORM:

if you are allergic to quetiapine or
any of the other ingredients of this
medicine

if
you
are
taking
any
of
the
following medicines:
-
Some
medicines
for
HIV
(protease inhibitors)
-
Azole
medicines
(for
fungal
infections)
-
Erythromycin or clarithromycin
(for infections)
-
Nefazodone (for depression).
Do
not
take
this
medicine
after
the
expiry date printed on the pack or if the
packaging is
torn
or
shows
signs
of
tampering.
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR IF YO

Lastnosti izdelka

1
_For the use of a Registered Medical Practitioner_ _Only _
PRESCRIBING INFORMATION
SIZONORM
(QUETIAPINE TABLETS USP 25MG, 100MG, 200MG)
COMPOSITION
SIZONORM 25
QUETIAPINE TABLET USP 25MG
EACH FILM COATED TABLET CONTAINS:
Quetiapine fumarate 28.78 mg
Equivalent to quetiapine .......…25 mg USP
SIZONORM 100
QUETIAPINE TABLET USP 100MG
EACH FILM COATED TABLET CONTAINS:
Quetiapine fumarate 115.12mg
Equivalent to quetiapine .......…100 mg USP
SIZONORM 200
QUETIAPINE TABLET USP 200MG
EACH FILM COATED TABLET CONTAINS:
Quetiapine fumarate 230.24mg
Equivalent to quetiapine .......…200 mg USP
_EXCIPIENTS:_
Silicified microcrystalline cellulose, Crospovidone, Colloidal
anhydrous silica, Anhydrous citric
acid, Polysorbate 80, Silicon dioxide, Magnesium stearate, Opadry II
33F58617 white, Opadry II 33F84535
Pink, Opadry II 33F82557 yellow, Purified water._ _
DESCRIPTION
SIZONORM 25
Peach, round, biconvex, film coated tablets plain on both sides.
SIZONORM 100
Yellow, round, biconvex, film coated tablets plain on one side and
Break-line on other side.
THE SCORED LINE IS JUST FOR IDENTIFICATION PURPOSE AND NOT MEANT TO BE
HALVED.
SIZONORM 200
2
White, round, biconvex, film coated tablets plain on one side and
Break-line on other side.
THE SCORED LINE IS JUST FOR IDENTIFICATION PURPOSE AND NOT MEANT TO BE
HALVED.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: Antipsychotics, ATC code: N05A H04
_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.
Quetiapine has no affinity