Olazax Disperzi

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

olanzapine

Διαθέσιμο από:

Glenmark Pharmaceuticals s.r.o. 

Φαρμακολογική κατηγορία (ATC):

N05AH03

INN (Διεθνής Όνομα):

olanzapine

Θεραπευτική ομάδα:

Psycholeptics

Θεραπευτική περιοχή:

Schizophrenia; Bipolar Disorder

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Revision: 12

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-12-10

Φύλλο οδηγιών χρήσης

83
B. PACKAGE LEAFLET
84
PACKAGE LEAFLET: INFORMATION FOR THE USER
Olazax Disperzi 5 mg orodispersible tablets
Olazax Disperzi 10 mg orodispersible tablets
Olazax Disperzi 15 mg orodispersible tablets
Olazax Disperzi 20 mg orodispersible 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 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 Disperzi is and what it is used for
2.
What you need to know before you take Olazax Disperzi
3.
How to take Olazax Disperzi
4.
Possible side effects
5.
How to store Olazax Disperzi
6.
Contents of the pack and other information
1.
WHAT OLAZAX DISPERZI IS AND WHAT IT IS USED FOR
Olazax Disperzi contains the active substance olanzapine. Olazax
Disperzi 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withdrawn.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 Disperzi 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 DISPERZI
DO NOT TAKE OLAZAX DISPERZI
-
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,

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olazax Disperzi 5 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 5 mg olanzapine.
Excipient with known effect: Each orodispersible tablet contains 0.23
mg aspartame
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Yellow coloured circular flat bevelled edge orodispersible 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 clinica