Olanzapine 2.5 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Olanzapine

Tilgjengelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

N05AH; N05AH03

INN (International Name):

Olanzapine

Dosering :

2.5 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Diazepines, oxazepines, thiazepines and oxepines; olanzapine

Autorisasjon status:

Marketed

Autorisasjon dato:

2009-12-18

Informasjon til brukeren

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLANZAPINE 2.5 MG FILM-COATED TABLETS
OLANZAPINE 5 MG FILM-COATED TABLETS
OLANZAPINE 7.5 MG FILM-COATED TABLETS
OLANZAPINE 10 MG FILM-COATED TABLETS
OLANZAPINE 15 MG FILM-COATED 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 Olanzapine tablets are and what they are used for
2.
What you need to know before you take Olanzapine tablets
3.
How to take Olanzapine tablets
4.
Possible side effects
5.
How to store Olanzapine tablets
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE TABLETS ARE AND WHAT THEY ARE USED FOR
Olanzapine tablets 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mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 tablets have 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 TABLETS
DO NOT TAKE OLANZAPINE TABLETS
-
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 swoll

Preparatomtale

Health Products Regulatory Authority
07 April 2020
CRN009PGR
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olanzapine 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg olanzapine.
Excipient(s) with known effect:
2.5 mg film-coated tablet contains 58.3 mg lactose anhydrous and 0.064
mg lecithin soya (E322).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex, white film-coated tablet 6 mm in diameter, marked
with “O” 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
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, therapy for preventing
recurrence should be continued 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