RISPERDAL 0.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risperidone

Available from:

Janssen-Cilag Ltd

ATC code:

N05AX08

INN (International Name):

Risperidone

Dosage:

0.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

risperidone

Authorization status:

Marketed

Authorization date:

1996-12-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL 0.5, 1, 2, 3, 4 AND 6 MG FILM-COATED TABLETS
RISPERDAL QUICKLET 0.5, 1, 2, 3 AND 4 MG ORODISPERSIBLE TABLETS
risperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINEBECAUSE 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 Risperdalis and what it is used for
2.
What you need to know before you take Risperdal
3.
How to take Risperdal
4.
Possible side effects
5.
How to store Risperdal
6.
Contents of the pack and other information
1.
WHAT RISPERDAL IS AND WHAT IT IS USED FOR
Risperdal belongs to a group of medicines called ‘antipsychotics’.
Risperdal is used to treat the following:

Schizophrenia, where you may see, hear or feel things that are not
there, believe things that are not
true or feel unusually suspicious, or confused

Mania, where you may feel very excited, elated, agitated, enthusiastic
or hyperactive. Mania occurs in
an illness called “bipolar disorder”

Short-term treatment (up to 6 weeks) of long-term aggression in people
with Alzheimer’s dementia,
who harm themselves or others. Alternative (non-drug) treatments
should have been used previously

Short-term treatment (up to 6 weeks) of long-term aggression in
intellectually disabled children (at
least 5 years of age) and adolescents with conduct disorder.
Risperdal can help alleviate the symptoms of your disease and stop
your symptoms from coming back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERDAL
DO NOT TAKE RISPERDAL

If you are allergic (hypersensitive) to risperidone or any of
the other ingredie

Summary of Product characteristics

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20 September 2018
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Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RISPERDAL 0.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg of risperidone
Excipients with known effect
Each 0.5 mg film-coated tablet contains 91 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
0.5 mg risperidone as brownish-red, half-scored, oblong, biconvex
tablets of 9 mm x
5 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
Film-coated tablets are etched on one side with RIS 0.5. Additionally
JANSSEN may
be etched on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERDAL is indicated for the treatment of schizophrenia.
RISPERDAL is indicated for the treatment of moderate to severe manic
episodes
associated with bipolar disorders.
RISPERDAL is indicated for the short‑term treatment (up to 6 weeks)
of persistent
aggression in patients with moderate to severe Alzheimer's dementia
unresponsive
to non‑pharmacological approaches and when there is a risk of harm
to self or
others.
RISPERDAL is indicated for the short‑term symptomatic treatment (up
to 6 weeks) of
persistent aggression in conduct disorder in children from the age of
5 years and
adolescents with subaverage intellectual functioning or mental
retardation
diagnosed according to DSM‑IV criteria, in whom the severity of
aggressive or other
disruptive behaviours require pharmacologic treatment. Pharmacological
treatment
should be an integral part of a more comprehensive treatment
programme, including
Health Products Regulatory Authority
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CRN008DNQ
Page 2 of 28
psychosocial and educational intervention. It is recommended that
risperidone be
prescribed by a specialist in child neurology and child and adolescent
psychiatry or
physicians well familiar with the treatment of conduct disorder