Rolyprexa DisTab 10 mg orodispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olanzapine

Available from:

Rowex Ltd

ATC code:

N05AH; N05AH03

INN (International Name):

Olanzapine

Dosage:

10 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

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

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; olanzapine

Authorization status:

Not marketed

Authorization date:

2011-09-16

Patient Information leaflet

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 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.
This includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Rolyprexa DisTab is and what it is used for
2. What you need to know before you take Rolyprexa DisTab
3. How to take Rolyprexa DisTab
4. Possible side effects
5. How to store Rolyprexa DisTab
6. Contents of the pack and other information
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROLYPREXA DISTAB 5 MG ORODISPERSIBLE TABLETS
ROLYPREXA DISTAB 10 MG ORODISPERSIBLE TABLETS
ROLYPREXA DISTAB 15 MG ORODISPERSIBLE TABLETS
ROLYPREXA DISTAB 20 MG ORODISPERSIBLE TABLETS
olanzapine
Continued on the next page
››
1
WHAT ROLYPREXA DISTAB IS AND WHAT IT
IS USED FOR
Rolyprexa DisTab contains the active substance
olanzapine. It 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becoming withdrawn.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.
Rolyprexa DisTab 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 ROLYPREXA DISTAB
DO NOT TAKE ROLYPREXA DISTAB
• If you are allergic to olanzapine or any of the other
ingredients of this medicine (listed in section 6). An
allergic reaction may be recognised as

Summary of Product characteristics

Health Products Regulatory Authority
10 October 2019
CRN0096XW
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rolyprexa DisTab 10 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg of olanzapine.
Excipient(s) with known effect
Each orodispersible tablet contains 115.1 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
_10 mg orodispersible tablets:_
Yellow, round, flat, approximately 8.2 mm in diameter and 2.4 mm in
thickness.
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 inc