Olanzapine Actavis 20mg Orodispersible Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Olanzapine

זמין מ:

Actavis Group PTC ehf

קוד ATC:

N05AH; N05AH03

INN (שם בינלאומי):

Olanzapine

כמות:

20 milligram(s)

טופס פרצבטיות:

Orodispersible tablet

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Diazepines, oxazepines, thiazepines and oxepines; olanzapine

מצב אישור:

Marketed

תאריך אישור:

2010-08-06

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPINE ACTAVIS 5 MG ORODISPERSIBLE TABLET
OLANZAPINE ACTAVIS 10 MG ORODISPERSIBLE TABLET
OLANZAPINE ACTAVIS 15 MG ORODISPERSIBLE TABLET
OLANZAPINE ACTAVIS 20 MG ORODISPERSIBLE TABLET
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 OLANZAPINE ACTAVIS IS AND WHAT IT IS
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
OLANZAPINE ACTAVIS
3
HOW TO TAKE OLANZAPINE ACTAVIS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE OLANZAPINE ACTAVIS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT OLANZAPINE ACTAVIS IS AND WHAT IT IS
USED FOR
Olanzapine Actavis contains the active substance
olanzapine. Olanzapine Actavis 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beliefs, unusual suspiciousness and becoming withdrawn.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.
Olanzapine Actavis 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
OLANZAPINE ACTAVIS
DO NOT TAKE OLANZAPINE ACTAVIS
• 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 recogni

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olanzapine Actavis 20mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 20mg olanzapine.
Excipients: aspartame (E951) 11.2mg, respectively.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Orodispersible tablet.
A round biconvex, yellow tablet 10 mm in diameter and marked with
“O3” on one side, rapid-dispersing preparation to
be placed in the mouth or alternatively to be dispersed in water or
other suitable beverage for administration.
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
Posology
_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.
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