OLANZAPINE ODT GENERICHEALTH 5 olanzapine 5 mg orodispersible tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

olanzapine, Quantity: 5 mg

Disponível em:

Torrent Australasia Pty Ltd

DCI (Denominação Comum Internacional):

Olanzapine

Forma farmacêutica:

Tablet, orally disintegrating

Composição:

Excipient Ingredients: mannitol; aspartame; crospovidone; microcrystalline cellulose; magnesium stearate

Via de administração:

Oral

Unidades em pacote:

28 tablets in blisters

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Treatment of schizophrenia and related psychoses. Short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes assoicated with bipolar I disorder. Preventing recurrence of manic, mixed or depressive episodes in bipolar I disorder.

Resumo do produto:

Visual Identification: Yellow coloured, round, flat, bevel edged uncoated orodispersible tablet with break line on one side and plain on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2012-01-18

Folheto informativo - Bula

CONSUMER MEDICINE INFORMATION
OLANZAPINE ODT GENERICHEALTH
(olanzapine) orally disintegrating tablets
What is in this leaflet
This leaflet is designed to
provide you with answers to
some common questions about
this medicine. It does not
contain all the available
information and does not take
the place of talking with your
doctor.
The information in this leaflet
was last updated on the date
shown on the final page. More
recent information about this
medicine may be available.
Make sure you speak to your
pharmacist or doctor to obtain
the most up to date information
on this medicine. The updated
leaflet may contain important
information about Olanzapine
ODT generichealth and its use
that you should be aware of.
All medicines have risks and
benefits.
Your doctor has more
information about this medicine
than is contained in this leaflet.
Also, your doctor has had the
benefit of taking a full and
detailed history from you and is
in the best position to make an
expert judgement to meet your
individual needs.
If you have any concerns
about taking this medicine,
talk to your doctor or
pharmacist.
Keep this leaflet with this
medicine. You may need to
read it again.
What Olanzapine ODT
generichealth is used for
Olanzapine ODT generichealth
belongs to a group of medicines
called antipsychotics. It helps to
correct chemical imbalances in
the brain, which may cause
mental illness.
Olanzapine ODT generichealth
is used to treat symptoms of
schizophrenia and related
psychoses. Schizophrenia is a
mental illness with disturbances
in thinking, feelings and
behaviour.
Olanzapine ODT generichealth
alone, or in combination with
lithium or valproate, is used for
the short-term treatment of
acute manic episodes
associated with Bipolar I
Disorder. Olanzapine ODT
generichealth is also a mood
stabiliser that prevents further
occurrences of the disabling
high and low (depressed)
extremes of mood associated
with Bipolar I Disorder.
Bipolar I Disorder is a mental
illness with symptoms such as
feeling “high”, having excessive
amounts of en

Características técnicas

AUSTRALIAN PRODUCT INFORMATION – OLANZAPINE ODT
GENERICHEALTH
(OLANZAPINE) ORALLY DISINTEGRATING TABLET
1
NAME OF THE MEDICINE
Olanzapine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine ODT generichealth is available as 5 mg and 10 mg orally
disintegrating tablets. Olanzapine
ODT generichealth contains olanzapine as the active ingredient.
List of excipients with known effects: aspartame.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Olanzapine ODT generichealth 5 mg tablets: Yellow coloured, round,
flat, bevel-edged uncoated
orodispersible tablet with a break line on one side and plain on the
other side.
Olanzapine ODT generichealth 10 mg tablets: Yellow coloured, round,
flat, bevel-edged uncoated
orodispersible tablet with a break line on one side and plain on the
other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Olanzapine ODT generichealth is indicated for:
•
Treatment of schizophrenia and related psychoses.
•
Short-term treatment, alone or in combination with lithium or
valproate, of acute manic episodes
associated with Bipolar I Disorder.
•
Preventing recurrence of manic, mixed or depressive episodes in
Bipolar I Disorder.
4.2 DOSE AND METHOD OF ADMINISTRATION
SCHIZOPHRENIA AND RELATED DISORDERS
The recommended starting dose for olanzapine is 5 mg/day to 10 mg/day,
administered as a single daily
dose without regard to meals. Daily dosage may subsequently be
adjusted on the basis of individual
clinical status within the range of 5 mg to 20 mg daily. An increase
to a dose greater than the routine
therapeutic dose of 10 mg/day is recommended only after appropriate
clinical reassessment.
Olanzapine ODT generichealth v2.0
Page 2 of 22
(olanzapine) orally disintegrating tablet
ACUTE MANIA ASSOCIATED WITH BIPOLAR DISORDER
The recommended starting dose for olanzapine is 10 or 15 mg
administered once a day as monotherapy
or 10 mg administered once daily in combination therapy with lithium
or valproate. It may be given
without regard to meals. Do