Risperidone 1mg/ml Oral Solution

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

RISPERIDONE

থেকে পাওয়া:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

এটিসি কোড:

N05AX08

INN (International Name):

RISPERIDONE 1 mg/ml

ফার্মাসিউটিকাল ফর্ম:

ORAL SOLUTION

রচনা:

RISPERIDONE 1 mg/ml

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

PSYCHOLEPTICS

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2016-07-11

তথ্য লিফলেট

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 1MG/ML ORAL SOLUTION
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.
The name of your medicine is Risperidone 1mg/ml Oral Solution but it
will be referred to as
Risperidone throughout this leaflet.
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

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risperidone 1mg/ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 1mg risperidone.
Excipients with known effect:
Each ml of oral solution contains 0.25mg benzoic acid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
A clear, colourless solution
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 ml/day (2 mg/day) risperidone. The dosage
may be increased on
the second day to 4 ml (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
ml (4 and 6 mg). In some