Risperdal 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Risperidone

Available from:

Janssen-Cilag Ltd

ATC code:

N05AX08

INN (International Name):

Risperidone

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5012674055786

Patient Information leaflet

RISPERDAL
® 3MG TABLETS
RISPERDAL
® 4MG TABLETS
(risperidone)
PATIENT INFORMATION LEAFLET
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.
Risperdal Tablets are also available in the following strengths:
0.5mg,
1mg, 2mg and 6mg.
WHAT IS IN THIS LEAFLET:
1. What Risperdal is and what it is used for
2. What you need to know before you take Risperdal
3. How to take Risperdal
4. Possible side effects
5. How to store Risperdal
6. Contents of the pack and other information
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 th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RISPERDAL 4 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 4 mg of risperidone
Excipients with known effect
Each 4 mg film-coated tablet contains 260 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
_Film-coated tablet _
•
4 mg risperidone as green half-scored oblong biconvex tablets
_ _
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 4. 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 with 2 mg/day