Hovid Olanzapine Orodispersible Tablets 10mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OLANZAPINE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

OLANZAPINE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Jubilant Generics Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOVID OLANZAPINE ORODISPERSIBLE TABLETS
Olanzapine (5mg, 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What
Hovid
Olanzapine
Orodispersible Tablets is used for
2.
How
Hovid
Olanzapine
Orodispersible Tablets works
3.
Before you use Hovid Olanzapine
Orodispersible Tablets
4.
How
to
use
Hovid
Olanzapine
Orodispersible Tablets
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Hovid
Olanzapine Orodispersible Tablets
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
HOVID
OLANZAPINE
ORODISPERSIBLE TABLETS IS USED FOR
Olanzapine
is
used
to
treat
the
following conditions:
•
Schizophrenia,
a
mental
disease
with
symptoms
such
as
hearing,
seeing or sensing things which are
not there, mistaken beliefs, unusual
suspiciousness,
and
becoming
withdrawn. People with this disease
may also feel depressed, anxious or
tense.
•
Short-term treatment of acute manic
episode
associated
with
Bipolar
Disorder.
•
Hovid
Olanzapine
Orodispersible
Tablets has been shown to prevent
recurrence of manic, depressive or
mixed episodes in Bipolar Disorder.
HOW
HOVID
OLANZAPINE
ORODISPERSIBLE TABLETS WORKS
Olanzapine
belongs
to
a
group
of
medicines
called
antipsychotics.
It
helps to correct chemical imbalances in
the
brain
which
may
cause
mental
illness.
BEFORE
YOU
USE
HOVID
OLANZAPINE
ORODISPERSIBLE TABLETS
_- When you must not use it_
•
If you are allergic (hypersensitive)
to olanzapine or any of the other
ingredients
of
this
medicine.
An
allergic reaction may be recognised
as a rash, itching, a swollen face,
swollen lips or shortness of breath.
If
this
has
happened
to
you,
tell
your doctor.
•
If
you
have
been
previously
diagnosed with eye problems such
as
certain
kinds
of
glaucoma
(increased pressure in the eye).
•
If you have Parkinson's disease
_- Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before you take olanzapine.
•
Have
or
are
at
a
risk
of
having
diabetes (e.g. being overweight or a
family
history
of
diab

Ciri produk

DESCRIPTION
HOVID OLANZAPINE ORODISPERSIBLE TABLETS 5MG: Yellow coloured, round,
flat face
bevelled edge tablets with characteristic flavour, debossed with
“D5” on one side and
“CO” on other side.
HOVID OLANZAPINE ORODISPERSIBLE TABLETS 10MG: Yellow coloured, round,
flat face
bevelled edge tablets with characteristic flavour, debossed with
“D10” on one side and
“CO” on other side.
COMPOSITION
HOVID OLANZAPINE ORODISPERSIBLE TABLETS 5MG: Each orodispersible
tablet contains
Olanzapine Ph. Eur. 5mg.
HOVID OLANZAPINE ORODISPERSIBLE TABLETS 10MG: Each orodispersible
tablet contains
Olanzapine Ph. Eur. 10mg.
ACTIONS AND PHARMACOLOGY
The exact mechanism by which olanzapine exerts its antipsychotic
effect is unknown.
Olanzapine is a selective monoaminergic antagonist with a strong
affinity for serotonin
5-HT
2A
and 5-HT
2C
receptors, and dopamine D
1
, D
2
, D
3
, and D
4
receptors. It weakly
binds to gammaaminobutyric acid type A (GABA
A
), benzo- diazepine (BZD), and
beta-adrenergic receptors.
Olanzapine's high affinity binding to and antagonism of, muscarinic M
1
, M
2
, M
3
, M
4
, and
M
5
receptors may explain its anticholinergic effects. Olanzapine also
binds with high
affinity to histamine H
1
and α
1
-adrenergic receptors.
PHARMACOKINETICS
Olanzapine is well absorbed from the gastro-intestinal tract after
oral doses but
undergoes considerable first-pass metabolism. Peak plasma
concentrations occur
about 5 to 8 hours after oral doses and about 15 to 45 minutes after
an intramuscular
dose. Olanzapine is about 93% bound to plasma proteins. It is
extensively metabolized
in the liver, mainly by direct glucuronidation and by oxidation
mediated through the
cytochrome P450 isoenzymes CYP1A2, and, to a lesser extent, CYP2D6.
The 2 major
metabolites, 10-N-glucuronide and 4’-N-desmethyl olanzapine, appear
to be inactive.
About 57% of a dose is excreted in the urine, mainly as metabolites,
and about 30%
appears in the faeces. The mean plasma elimination half-life has been
variously
reported to be about 30