RANOZYP TABLETS 10 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OLANZAPINE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

OLANZAPINE

Unit dalam pakej:

4x7tablets0 Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

Ranozyp Tablets
Page 1
RANOZYP TABLETS _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_OLANZAPINE TABLETS 5/10 MG _
WHAT IS IN THIS LEAFLET
1.
What
RANOZYP TABLETS
are used for
2.
How
RANOZYP TABLETS
work
3.
Before
you
use
RANOZYP
TABLETS
4.
How
to
use
RANOZYP
TABLETS
5.
While you are using it
6.
Side Effects
7.
Storage
and
disposal
of
RANOZYP TABLETS
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
This
leaflet
answers
some
common
questions
about
RANOZYP
TABLETS
.
It does not contain all of the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you
taking
RANOZYP
TABLETS
against the benefits it is expected to
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
RANOZYP
TABLETS
ARE
USED FOR
RANOZYP
TABLETS
belong
to
a
group
of
medicines
called
antipsychotics. These help to correct
chemical imbalances in the brain, which
may cause mental illness.
RANOZYP
TABLETS
are
used
to
treat a 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withdrawn.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.
RANOZYP
TABLETS
are
used
to
treat a condition with symptoms such as
feeling
"high",
having
excessive
amounts of energy, needing much less
sleep than usual, talking very quickly
with racing ideas and sometimes severe
irritability. It is also a mood stabiliser
that prevents further occurrences of the
disabling
high
and
low
(depressed)
extremes of mood associated with this
condition.
Your doctor may have prescribed
RANOZYP
TABLETS
for
another
reason.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
RANOZYP
TABLETS HAVE BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor's prescription.
HOW RANOZYP TABLETS WORK
RANOZYP
TABLETS
co

Ciri produk

_For the use only of a Registered Medical Practitioner _
_ _
PRESCRIBING INFORMATION
RANOZYP TABLETS
(OLANZAPINE TABLETS 5/10 MG)
COMPOSITION
Ranozyp Tablets 5 mg
Each tablet contains:
Olanzapine…………………..5 mg
Ranozyp Tablets 10 mg
Each tablet contains:
Olanzapine………………….. 10 mg
EXCIPIENTS:
Lactose anhydrous
Microcrystalline Cellulose
L-Hydroxy propyl cellulose
Magnesium Stearate
DESCRIPTION
RANOZYP
TABLETS
contain
olanzapine,
is
an
atypical
psychotropic
that
belongs
to
the
thienobenzodiazepine class. It is chemically designated as
2-methyl-4-(4-methyl-1-piperazinyl)-
10_H_-thieno[2,3-_b_] [1,5]benzodiazepine. The molecular formula is C
17
H
20
N
4
S, which corresponds to
a molecular weight of 312.44. The chemical structure is:
OLANZAPINE
PRODUCT DESCRIPTION:
For 5 mg strength: Light yellow to yellow coloured, round, biconvex
tablets debossed with ‘O5’ on
one side and plain on other side.
For 10 mg strength: Light yellow to yellow coloured, round, biconvex
tablets debossed with ‘O7’ on
one side and plain on other side.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Olanzapine binds with high affinity to the following receptors:
serotonin 5HT
2A/2C
, 5HT
6
(Ki=4, 11,
and 5 nM, respectively), dopamine D
1-4
(Ki=11-31 nM), histamine H
1
(Ki=7 nM), and adrenergic
α
1
receptors (Ki=19 nM). Olanzapine is an antagonist with moderate
affinity binding for serotonin
5HT
3
(Ki=57 nM) and muscarinic M1-5 (Ki=73, 96, 132, 32, and 48 nM,
respectively). Olanzapine
binds weakly to GABAA, BZD, and β-adrenergic receptors (Ki>10 μM).
Antagonism at receptors other than dopamine and 5HT
2
may explain some of the other therapeutic
and side effects of olanzapine. Olanzapine’s antagonism of
muscarinic M
1-5
receptors may explain
its anticholinergic-like effects. Olanzapine’s antagonism of
histamine H
1
receptors may explain the
somnolence observed with this drug. Olanzapine’s antagonism of
adrenergic α
1
receptors may
explain the orthostatic hypotension observed with this