OLANZAPINE ACCORD 20 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OLANZAPINE (FORM-1)

Available from:

Accord Healthcare Limited

INN (International Name):

OLANZAPINE (FORM-1)

Dosage:

20 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Authorization status:

Withdrawn

Authorization date:

2013-09-16

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 ACCORD 20 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 your 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.
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 belongs to a group of 
medicines called antipsychotics. 
Olanzapine Accord is used to treat 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withdrawn.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.
Olanzapine Accord is used to treat a condition with 
symptoms such as feeling "high", having 
excessive amounts of energy, needing much less 
sleep than usual, talking very quickly with racing 
ideas and sometimes severe irritability. It is also a 
mood stabilizer that prevents further occurrences 
of the disabling high and low (depressed) 
extremes of mood associa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olanzapine Accord 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of Olanzapine.
Excipient with known effect: Lactose 224.96 mg
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Light pink coloured, round, biconvex, film coated tablets of 9.6 mm, plain on both sides.
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, d