Risperidone 1mg/ml oral solution sugar free

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Risperidone

Disponibil de la:

Viatris UK Healthcare Ltd

Codul ATC:

N05AX08

INN (nume internaţional):

Risperidone

Dozare:

1mg/1ml

Forma farmaceutică:

Oral solution

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04020100; GTIN: 5016695002095

Prospect

PAGE 1 OF 11
PACKAGE LEAFLET
PAGE 2 OF 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 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 Risperidone is and what it is used for
2.
What you need to know before you take Risperidone
3.
How to take Risperidone
4.
Possible side effects
5.
How to store Risperidone
6.
Contents of the pack and other information
1.
WHAT RISPERIDONE IS AND WHAT IT IS USED FOR
Risperidone belongs to a group of medicines called
‘anti-psychotics’.
Risperidone 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.
Risperidone can help alleviate the symptoms of your disease and stop
your symptoms from coming
back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE
DO NOT TAKE RISPERIDONE:

If you are allergic (hypersensitive) to risperidone or any of the
other ingredients of this medicine
(l

Caracteristicilor produsului

OBJECT 1
RISPERIDONE 1 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 16-Oct-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Risperidone 1 mg/ml oral solution
2. Qualitative and quantitative composition
Each 1 ml of oral solution contains 1 mg of Risperidone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
The solution is clear and colourless.
4. Clinical particulars
4.1 Therapeutic indications
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the treatment of moderate to severe manic
episodes associated with bipolar
disorders.
Risperidone 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.
Risperidone 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_
Risperidone 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