RISPERDAL 1 Milligram Film Coated Tablet

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

RISPERIDONE

Sẵn có từ:

B & S Healthcare

Mã ATC:

N05AX08

INN (Tên quốc tế):

RISPERIDONE

Liều dùng:

1 Milligram

Dạng dược phẩm:

Film Coated Tablet

Loại thuốc theo toa:

Product subject to prescription which may not be renewed (A)

Khu trị liệu:

Other antipsychotics

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2009-11-20

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER 
RISPERDAL
®
 1MG FILM-COATED 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. 

The name of your medicine is Risperdal 1mg film-coated tablets but
will be referred to as 
Risperdal throughout this leaflet. 

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 

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risperdal 1mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg risperidone.
Excipients: Also contains lactose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product sourced from Spain:_
Each 1mg film-coated tablet is white, oblong, plain on one side and scored on the other side, with ‘RIS’ and ‘1’ either
side of the score line. The score line serves to facilitate the breaking of the tablet to swallow better, and not to divide
into equal doses.
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�