Risperdal 3mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Risperidone

Disponible depuis:

Janssen-Cilag Ltd

Code ATC:

N05AX08

DCI (Dénomination commune internationale):

Risperidone

Dosage:

3mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04020100; GTIN: 5012674055700

Notice patient

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

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RISPERDAL 3mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3 mg of risperidone
Excipients with known effect
Each 3 mg film-coated tablet contains 195 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
•
3 mg risperidone as yellow, half-scored, oblong, biconvex tablets of
13.5 mm x
6.5 mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
Film-coated tablets are etched on one side with RIS 3. Additionally,
JANSSEN may
be etched on the other side.
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
_Schizophrenia _
_Adults_
RISPERDAL may be given once daily or twice daily.
Patients should start w