Risperdal 1mg/ml oral solution

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Risperidone

Disponível em:

Janssen-Cilag Ltd

Código ATC:

N05AX08

DCI (Denominação Comum Internacional):

Risperidone

Dosagem:

1mg/1ml

Forma farmacêutica:

Oral solution

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04020100; GTIN: 5012674426203

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL 1 MG/ML ORAL SOLUTION
Risperidone
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 Risperdal is 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 to risperidone or any of the other ingredients of
this medicine (listed in section 6).
If you are not sure if the above applies to you, talk to

Características técnicas

OBJECT 1
RISPERDAL 1 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 15-Mar-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
RISPERDAL 1 mg/ml oral solution
2. Qualitative and quantitative composition
1 ml oral solution contains 1 mg of risperidone
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
The oral solution is clear and colourless.
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
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 of children and adolescents.
4.2 Posology and method of administration
Posology
_Schizophrenia _
_Adults_
RISPERDAL may be given once daily or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be
increased on the second day to 4 mg.
Subsequently, the dosage can be maintained unchanged, or further
individualised, if needed. Most
patients will benefit from daily doses between 4 and 6 mg. In some
patients, a slower titration phase and a
lowe