Zyprexa Tablet 10mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OLANZAPINE

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

OLANZAPINE

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

LILLY S.A.

Risalah maklumat

ZYPREXA TABLET /ZYPREXA ZYDIS
ORODISPERSIBLE TABLET
Olanzapine (5 mg, 10 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Zyprexa is used for
2.
How Zyprexa works
3.
Before you use Zyprexa
4.
How to use Zyprexa
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Zyprexa
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ZYPREXA
IS USED FOR
Zyprexa 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withdrawn.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.
_ _
Zyprexa has been shown to prevent
recurrence
of
manic,
depressive
or
mixed episodes in Bipolar Disorder.
_ _
HOW ZYPREXA WORKS
Zyprexa is an antipsychotic, antimanic
and mood stabilising agent. Zyprexa
contains
the
active
ingredient
olanzapine.
Zyprexa
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 ZYPREXA
_- When you must not use it _
•
If you are allergic (hypersensitive)
to olanzapine or any of the other
ingredients
of
this
medicine
(see
section
PRODUCT
DESCRIPTION
).
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 Parkinson’s disease.
•
If
you
have
been
previously
diagnosed
with
eye
problems
such
as
certain
kinds
of
glaucoma (increased pressure in
the eye).
•
The
use
if
Zyprexa
in
elderly
with
dementia
(symptoms
that
may
include
memory
loss
and
difficulties
with
thinking,
problem-solving or language) is
not recommended as it may have
serious side effects.
_- Before you start to use it_
Talk
to
your
doctor
or
pharmacist
before you take Zy

Ciri produk

Zyprexa_Zyprexa Zydis PI_EUSPC19Nov2020_28 Dec 2020
1.
NAME OF THE MEDICINAL PRODUCT
ZYPREXA/ZYPREXA ZYDIS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYPREXA 5 mg coated tablets
Each coated tablet contains 5 mg olanzapine.
Excipient with known effect: Each coated tablet contains 156 mg
lactose monohydrate.
ZYPREXA 10 mg coated tablets
Each coated tablet contains 10 mg olanzapine.
Excipient with known effect: Each coated tablet contains 312 mg
lactose monohydrate.
ZYPREXA ZYDIS 5 mg orodispersible tablets
Each orodispersible tablet contains 5 mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains
0.60 mg aspartame (E951),
0.1125 mg sodium methyl parahydroxybenzoate (E219),
0.0375 mg sodium propyl parahydroxybenzoate (E217).
ZYPREXA ZYDIS 10 mg orodispersible tablets
Each orodispersible tablet contains 10 mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains
0.80 mg aspartame (E951),
0.15 mg sodium methyl parahydroxybenzoate (E219),
0.05 mg sodium propyl parahydroxybenzoate (E217).
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
COATED TABLETS
ZYPREXA 5 mg Tablets are round, white, coated tablets imprinted with
"LILLY" and a numeric identicode
“4115”.
ZYPREXA 10 mg Tablets are round, white, coated tablets imprinted with
"LILLY" and a numeric
identicode “4117”.
ORODISPERSIBLE TABLET
ZYPREXA ZYDIS 5 mg and 10 mg Orodispersible Tablet is a yellow, round,
freeze dried, rapid-dispersing
preparation to be placed in the mouth or alternatively to be dispersed
in water or other suitable beverage for
administration.
Zyprexa_Zyprexa Zydis PI_EUSPC19Nov2020_28 Dec 2020
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining the clinical improvement during
continuing therapy in patients who
have shown initial treatment response.
Olanzapine is indicated for short-term treatment of acute manic
episode associated with Bipolar I Disorder.
Olanzapine is indicated for