Risperidone 1mg orodispersible tablets sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Risperidone

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

N05AX08

INN (International Name):

Risperidone

Dosage:

1mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5015525186110

Patient Information leaflet

1
Package leaflet: Information for the user
Risperidone 1mg Orodispersible Tablets
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
to risperidone or any of the other ingredients of this medicine
(listed in section 6).
2
If you are

Summary of Product characteristics

OBJECT 1
RISPERIDONE 1 MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 28-Oct-2016 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Risperidone 1 mg Orodispersible Tablets
2. Qualitative and quantitative composition
Each orodispersible tablet contains 1 mg risperidone.
Each tablet also contains 0.563mg aspartame.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Orodispersible tablet
Pink coloured, mottled, circular, flat beveled tablets, debossed with
'R' on one side and '1' on the other
side.
4. Clinical particulars
4.1 Therapeutic indications
Risperidone Orodispersible Tablets is indicated for the treatment of
schizophrenia.
Risperidone Orodispersible Tablets is indicated for the treatment of
moderate to severe manic episodes
associated with bipolar disorders.
Risperidone Orodispersible Tablets 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 Orodispersible Tablets 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 behaviors 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 Orodispersible Tablets may be given once daily or twice
daily.