Risperidone 4mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Risperidone

可用日期:

Consilient Health Ltd

ATC代码:

N05AX08

INN（国际名称）:

Risperidone

剂量:

4mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04020100; GTIN: 3838989543907

资料单张

1952, 1953,
1954, 1955
04.01.19[22]
PATIENT INFORMATION LEAFLET
RISPERDAL
®
1MG TABLETS
RISPERIDONE 1MG TABLETS
RISPERDAL
®
2MG TABLETS
RISPERIDONE 2MG TABLETS
RISPERDAL
®
3MG TABLETS
RISPERIDONE 3MG TABLETS
RISPERDAL
®
4MG TABLETS
RISPERIDONE 4MG 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.
This medicine is available using any one of the above names but will
be
referred to as Risperdal throughout this leaflet.
Risperdal Tablets are also available in other strengths.
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
‘anti-psychotics’.
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 condu

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risperidone 4mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 4 mg risperidone
Excipient(s) with known effect:
Each film-coated tablet contains 199.5mg lactose (as lactose
monohydrate).
3
PHARMACEUTICAL FORM
Film-coated tablet
Green, oval film-coated tablets with breaking notch and embossed with
“4” 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 benefit fr