Risperidone 1mg orodispersible tablets sugar free

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:

Krka UK Ltd

ATC代码:

N05AX08

INN（国际名称）:

Risperidone

剂量:

1mg

药物剂型:

Orodispersible 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: 3838989544010

资料单张

1.3.1
Risperidone
SPC, Labeling and Package Leaflet
GB
SmPCPIL008634/3
09.02.2010 – Updated: 12.04.2010
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 1 MG ORODISPERSIBLE TABLETS
Risperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Risperidone is and what it is used for
2.
Before you take Risperidone
3.
How to take Risperidone
4.
Possible side effects
5.
How to store Risperidone
6.
Further 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.
2.
BEFORE YOU TAKE RISPERIDONE
DO NOT TAKE RISPERIDONE
•
You are allergic (hypersensitive) to risperidone or any of the other
ingredients of Risperidone
(listed in Section 6 below).
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using
Risperidone.
TAKE SPECIAL CARE WITH RISPERIDONE

产品特点

OBJECT 1
RISPERIDONE 1 MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 07-Jun-2013 | Consilient
Health Ltd
1. Name of the medicinal product
Risperidone 1 mg orodispersible tablets
2. Qualitative and quantitative composition
Each orodispersible tablet contains 1 mg risperidone.
1 MG
Aspartame
0.80
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Orodispersible tablet.
Round, slightly convex, pink marbled tablet.
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 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_
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 from daily doses betwee