OLENZA 10MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

OLANZAPINE

Available from:

Noripharma Sdn. Bhd.

INN (International Name):

OLANZAPINE

Units in package:

28Tablet Tablets

Manufactured by:

Noripharma Sdn. Bhd.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
OLENZA TABLET
Olanzapine (5mg, 10mg)
Page | 1
WHAT IS IN THIS LEAFLET
1.
What OLENZA Tablet is used for
2.
How OLENZA Tablet works
3.
Before you use OLENZA Tablet
4.
How to use OLENZA Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of OLENZA
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT OLENZA TABLET IS USED FOR
OLENZA Tablet 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withdrawn.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.
•
Short-term treatment of acute
manic episode associated with
Bipolar Disorder.
OLENZA has been shown to prevent
recurrence of manic, depressive or
mixed episodes in Bipolar Disorder.
HOW OLENZA TABLET WORKS
OLENZA TABLET contains the active
ingredient Olanzapine. OLENZA
TABLET belongs to a group of
medicines called atypical
antipsychotics.
It helps to correct chemical imbalances
in the brain which may cause mental
illness
BEFORE YOU USE OLENZA TABLET
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to olanzapine or any of the other
ingredients of this medicine.

OLENZA Tablet contains lactose.
Do not take this medicine if you
have intolerance to some kind of
sugar called lactose

If you have been previously
diagnosed with eye problems such
as certain kinds of glaucoma
(increased pressure in the eye).
-
_Before you start to use it _
Tell your doctor if you:

have had an allergic reaction to any
medicine which you have taken
previously to treat your current
condition

have or are at a risk of having
diabetes (e.g. being overweight or a
family history of diabetes). Your
doctor should check your blood
sugar before you start taking
Olenza tablet and regularly during
treatment

Have risk factors for developing
blood clots such as: a family history
o

Summary of Product characteristics

1
OLENZA TABLET
COMPOSITION:
OLENZA 5MG TABLET: Each tablet contains 5mg Olanzapine
OLENZA 10MG TABLET: Each tablet contains 10mg Olanzapine
DESCRIPTION:
OLENZA 5MG TABLET: A white to off white round shaped film coated
tablet with score
on one side.
OLENZA 10MG TABLET: A white to off white round shaped film coated
tablet with score
on one side.
PHARMACODYNAMICS:
Pharmacotherapeutic group: Diazepines, oxazepines and thiazepines. ATC
code: NO5A
H03. Olanzapine is an antipsychotic agent that demonstrates a broad
pharmacological
profile across a number of receptor systems. It is a
thienbenozodiazepine atypical
antipsychotic. It has affinity for dopamine (D1, D2, and D4),
histamine (H1), serotonin
(5HT 2A/2C) and adrenergic (α1) receptors.
PHARMACOKINETICS:
Olanzapine is well absorbed from the gastrointestinal tract after oral
administration but
undergoes considerable first-pass metabolism. Peak plasma
concentrations are achieved
about 5-8 hours after oral administration and about 15 to 45 minutes
after intramuscular
administration. The absorption is not affected by food. Oral
bioavailability relative to
intravenous administration has not been determined.
Olanzapine is metabolised in the liver by conjugative and oxidative
pathways. The major
circulating metabolite is the 10-N-glucuronide, which does not pass
the blood brain
barrier. Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the
formation of
the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited
significantly less in
vivo pharmacological activity than olanzapine in animal studies. The
pre-dominant
pharmacologic activity is from the parent olanzapine. After oral
administration, the mean
terminal elimination half-life of olanzapine varied on the basis of
age and gender. In
healthy elderly
mean t
1/2
is
51.8 hours. In non-elderly subjects the mean t
1/2
is 33.8 hours.
In female versus male subjects the mean elimination t
½
was
36.7 versus 32.3 hours.
In renally impaired patients (creatinine clearance <10 ml/min) versus
healthy subjects,
there was no