OLANGEM OD 5 (Olanzapine Orodispersible Tablets 5 mg)

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

OLANZAPINE

Διαθέσιμο από:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Διεθνής Όνομα):

OLANZAPINE

Μονάδες σε πακέτο:

4 X 7`s Tablets

Κατασκευάζεται από:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Φύλλο οδηγιών χρήσης

OLANGEM OD TABLETS
_Consumer Medication Information Leaflet (RiMUP)_
Olanzapine (5 mg, 10 mg)
1
WHAT IS IN THIS LEAFLET
1.
What OLANGEM OD is used
for
2.
How OLANGEM OD works
3.
Before you use OLANGEM OD
4.
How to use OLANGEM OD
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
OLANGEM OD
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS OLANGEM OD USED FOR
Olanzapine
belongs
to
a
group
of
medicines called antipsycotics 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withdrawn.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 OLANGEM OD WORKS
Olanzapine
is
in
a
class
of
medications
called
atypical
antipsychotics. It works by changing
the
activity
of
certain
natural
substances in the brain.
BEFORE YOU USE OLANGEM OD
-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
or
any
other
unusual
symptoms. 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).
-Before you start to use it
Talk to your doctor or pharmacist
before you take Olangem OD.

The
use
of
Olangem
OD
in
elderly patients with dementia is
not recommended as it may have
serious side effects.

Medicines of this type may cause
unusual
movements
mainly
of
the face or tongue. If this happens
after
you
have
been
given
Olangem OD tell your doctor.

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
_Rx Only_
NAME OF DRUG PRODUCT:
Olanzapine Orodispersible Tablets 5 mg
Olanzapine Orodispersible Tablets 10 mg
(TRADE) NAME OF PRODUCT:
OLANGEM OD 5
OLANGEM OD 10
STRENGTH:
5 mg & 10 mg.
PHARMACEUTICAL DOSAGE FORM: Orodispersible Tablet.
ROUTE OF ADMINISTRATION:
Oral use.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
Olanzapine Orodispersible Tablets 5 mg
Each Orodispersible tablet contains Olanzapine Ph.Eur 5 mg.
Olanzapine Orodispersible Tablets 10 mg
Each Orodispersible tablet contains Olanzapine Ph.Eur 10 mg
PHARMACEUTICAL FORM:
Olanzapine Orodispersible Tablets 5 mg: Yellow colored, circular, flat
faced beveled edge tablets,
debossed with “C” on one side and “51” on the other side.
Olanzapine Orodispersible Tablets 10 mg: Yellow colored, circular,
flat faced beveled edge tablets,
debossed with “C” on one side and “52” on the other side.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
ADULTS
Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining the clinical improvement during
continuation therapy in patients
who have shown an initial treatment response.
Olanzapine is indicated for the short-term treatment of acute manic
episode associated with Bipolar I
disorder. Olanzapine is indicated for preventing recurrence of manic,
mixed or depressive episodes in
Bipolar I Disorder.
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
_Schizophrenia: _The recommended starting dose for olanzapine is 10
mg/day.
_Manic episode: _The starting dose is 15 mg as a single daily dose in
monotherapy or 10 mg daily in
combination therapy.
_Preventing recurrence in bipolar disorder: _The recommended starting
dose is 10 mg/day. For patients
who have been receiving olanzapine for treatment of manic episode,
continue therapy for preventing
recurrence at the same dose. If a new manic, mixed, or depressive
episode occurs, olanzapine treatment
should be continued (with dose optimisation as needed), with
supplementary therapy to treat mood
symptoms.
Duri