Risperidone 3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Risperidone

Available from:

Teva UK Ltd

ATC code:

N05AX08

INN (International Name):

Risperidone

Dosage:

3mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5017007016311

Patient Information leaflet

Package leaflet: Information for the user
Risperdal
®
3mg tablets
(risperidone)
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 ingredients of
this medicine (listed in section 6).
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before using
Risperdal.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Risperdal if:
 You have a heart problem. Examples include
an irregular heart rhythm or if you are prone to
low blood pressure or if you are using
medicines for your blood pressure. Risperdal
may cause low blood pressure. Your dose may
need to be adjusted
 You know of any factors which would favour
you having a stroke, such as high blood
pressure, cardiovascular disorder or blood
vessel problems in the brain
 You have ever experienced involuntary
movements of the tongue, mouth and face
 You have ever had a condition whose
symptoms include high temperature, muscle
stiffness, sweating or a lowered level of
consciousness (also known as Neurolept

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risperidone 3mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3 mg risperidone
Excipient(s) with known effect:
Each film-coated tablet contains 149.625 mg lactose (as lactose
monohydrate).
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, oval film-coated tablets with breaking notch and embossed with
“3”
on one side.
The tablet can be divided into equal doses.
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 sub-average 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 benefi