TOLANZ ODT TABLETS 10 MG

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

OLANZAPINE

थमां उपलब्ध:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (इंटरनेशनल नाम):

OLANZAPINE

पैकेज में यूनिट:

10tablet Tablets; 30tablet Tablets; 60tablet Tablets; 100tablet Tablets

द्वारा बनाया गया:

TORRENT PHARMACEUTICALS LTD

सूचना पत्रक

TOLANZ ODT TABLETS
_ _
Olanzapine (5 mg, 10 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Tolanz ODT used for
2.
How Tolanz ODT works
3.
Before you use Tolanz ODT
4.
How to use Tolanz ODT
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Tolanz
ODT
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TOLANZ ODT IS USED FOR
Olanzapine
belongs
to
a
group
of
medicines called antipsychotics and is
used to treat the following conditions:
•
Schizophrenia,
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withdrawn.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.
•
Moderate
to
severe
manic
episodes,
a
condition
with
symptoms
of
excitement
or
euphoria.
Olanzapine has been shown to prevent
recurrence
of
these
symptoms
in
patients
with
bipolar
disorder
whose
manic
episode
has
responded
to
olanzapine treatment.
HOW TOLANZ ODT WORKS
Olanzapine is an atypical antipsychotic.
The
mode
of
action
of
olanzapine's
antipsychotic
activity
is
unknown.
It
may
involve
antagonism
at
serotonin
receptors.
BEFORE YOU USE TOLANZ ODT
-
_When you must not use it _
Do not take Tolanz ODT:
•
If you are allergic (hypersensitive)
to olanzapine or any of the other
ingredients
of
Tolanz
ODT.
An
allergic reaction may be recognized
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).
_Pregnancy and lactation_
_ _
Do not take Tolanz ODT if you are
pregnant or plan to become pregnant or
think you might be pregnant.
Do
not
take
Tolanz
ODT
if
you
are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start use it _
Medicines
of
this
type
may
cause
unusual movements mainly of the face
or
t

उत्पाद विशेषताएं

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BRAND OR PRODUCT NAME
TOLANZ ODT TABLETS 10 MG TOLANZ ODT TABLETS 5 MG
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
TOLANZ ODT TABLETS 5 MG
Each uncoated orodispersible tablet contains:
Olanzapine 5 mg
TOLANZ ODT TABLETS 10 MG
Each uncoated orodispersible tablet contains:
Olanzapine 10 mg
PRODUCT DESCRIPTION
TOLANZ ODT TABLETS 5 MG:
Yellow colored, round, flat, bevel edged uncoated tablets with break
line on one side and debossed “5” on other side.
TOLANZ ODT TABLETS 10 MG:
Yellow colored, round, flat, bevel edged uncoated tablets with break
line on one side and debossed “10” on other side.
DOSAGE FORM
Uncoated orodispersible tablet
PHARMACODYNAMICS
Olanzapine is an antipsychotic agent that demonstrates a broad
pharmacologic profile across a number of receptor systems. Olanzapine
exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin
5 HT2A/2C, 5 HT3, 5 HT6; dopamine D
1
, D
2
, D
3
, D
4
, D
5
; cholinergic
muscarinic receptors. It is reported that olanzapine reduced a
conditioned avoidance response, a test indicative of antipsychotic
activity,
at doses below those producing catalepsy, an effect indicative of
motor side-effects. Unlike some other antipsychotic agents, olanzapine
increases responding in an “anxiolytic” test.
Olanzapine produced a higher 5-HT
2
A than dopamine D
2
receptor occupancy. In addition, olanzapine-responsive patients had
lower striatal D
2
occupancy than some other antipsychotic and risperidone-responsive
patients, while being comparable to
clozapine-responsive patients. It is reported that olanzapine was
associated with statistically significantly greater improvements in
negative as well as positive symptoms.
It is reported that olanzapine demonstrated statistically significant
superiority over placebo on the primary endpoint of bipolar
recurrence.
Olanzapine also reported a statistically significant advantage over
placebo in terms of preventing either recurrence into mania or
recurrence into depression.
PHARMACOKINETICS
Olanzapine is well absorbed a