Olazax

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

olanzapine

Saatavilla:

Glenmark Pharmaceuticals s.r.o. 

ATC-koodi:

N05AH03

INN (Kansainvälinen yleisnimi):

olanzapine

Terapeuttinen ryhmä:

Psycholeptics

Terapeuttinen alue:

Schizophrenia; Bipolar Disorder

Käyttöaiheet:

AdultsOlanzapine 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 treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Tuoteyhteenveto:

Revision: 12

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-12-11

Pakkausseloste

101
B. PACKAGE LEAFLET
102
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLAZAX 5 MG TABLETS
Olazax 7.5 mg tablets
Olazax 10 mg tablets
Olazax 15 mg tablets
Olazax 20 mg tablets
Olanzapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any of the side effects talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Olazax is and what it is used for
2.
What you need to know before you take Olazax
3.
How to take Olazax
4.
Possible side effects
5.
How to store Olazax
6.
Contents of the pack and other information
1.
WHAT OLAZAX IS AND WHAT IT IS USED FOR
Olazax contains the active substance olanzapine. Olazax 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withdrawn.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.
Olazax has been shown to prevent recurrence of these symptoms in
patients with bipolar disorder
whose manic episode has responded to olanzapine treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLAZAX
DO NOT TAKE OLAZAX
-
If you are allergic (hypersensitive) to olanzapine or any of the other
ingredients of this
medicine (listed in section 6)
.
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 been previously diagnosed with

Valmisteyhteenveto

1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olazax 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg olanzapine.
Excipient with known effect: Each tablet contains 0.23 mg aspartame
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellow coloured circular flat bevelled edge tablets with ‘B’
debossed on one side.
4.
CLINICAL PARTICULARS
4.1
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 treatment of moderate to severe manic
episode. In patients whose
manic episode has responded to olanzapine treatment, olanzapine is
indicated for the prevention of
recurrence in patients with bipolar disorder (see section 5.1).
4.2
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 (see section 5.1).
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, as clinically indicated.
During treatment for schizophrenia, manic episode and recurrence
prevention in bipolar disorder,
daily dosage may subsequently be adjusted on the basis of individual
clinical status within the range
5-20 mg/day. An increase to a dose greater than the recommended
starting dose is advised only after
appropriate clinical reassessment and should generally occur at
intervals of not less than 24