Olanzapine Accord 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olanzapine (form-1)

Available from:

Accord Healthcare Limited

ATC code:

N05AH; N05AH03

INN (International Name):

Olanzapine (form-1)

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; olanzapine

Authorization status:

Marketed

Authorization date:

2011-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE ACCORD 2.5 MG FILM-COATED TABLETS
OLANZAPINE ACCORD 5 MG FILM-COATED TABLETS OLANZAPINE ACCORD 7.5 MG FILM-COATED TABLETS
OLANZAPINE ACCORD 10 MG FILM-COATED TABLETS
OLANZAPINE ACCORD 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, please 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 or
nurse. This includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1. What Olanzapine Accord is and what it is used for
2. What you need to know before you take Olanzapine Accord
3. How to take Olanzapine Accord
4. Possible side effects
5. How to store Olanzapine Accord
6. Contents of the pack and other information
1. WHAT OLANZAPINE ACCORD IS AND WHAT IT IS USED FOR
Olanzapine Accord contains the active substance olanzapine. 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beliefs, unusual suspiciousness, and becoming withdrawn.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 Accord 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 ACCORD
DO NOT TAKE OLANZAPINE ACCORD

If you are allergic (hypersensitive) to olanzapine or any of the other
ingredients of this medicine (listed i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olanzapine Accord 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of Olanzapine.
Excipient with known effect: Lactose 112.48 mg
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white round biconvex, film coated tablets of 8.0 mm,
debossed with ‘O3’ on one side and plain on other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults_
Olanzapine Accord is indicated for the treatment of schizophrenia.
Olanzapine Accord is effective in maintaining the clinical improvement
during continuation therapy in patients
who have shown an initial treatment response. Olanzapine Accord is
indicated for the treatment of moderate to
severe manic episode.
In patients whose manic episode has responded to Olanzapine Accord
treatment, Olanzapine Accord 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 Accord is
10mg/day.
Manic episode: The starting dose is 15mg as a single daily dose in
monotherapy or 10mg daily in combination therapy
(see section 5.1).
Preventing recurrence in bipolar
disorder:
The recommended starting dose is 10mg/day. For patients who have
been receiving Olanzapine Accord for treatment of manic episode,
continue therapy for preventing recurrence at the
same dose. If a new manic, mixed, or depressive episode occurs,
Olanzapine Accord treatment should be continued
(with dose optimization 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 5-20mg/day. An increase to a dose
greater than the recommended starting dose is advised only after
a