Orap 4 mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: myHealthbox

Thành phần hoạt chất:

Pimozide

Sẵn có từ:

Eumedica S.A.

Mã ATC:

N5A9

INN (Tên quốc tế):

Pimozide

Liều dùng:

4 mg

Dạng dược phẩm:

Tablets

Tuyến hành chính:

Oral use

Các đơn vị trong gói:

Blister packs containing 28, 100 or 250 tablets. 28 and 250 not marketed

Loại thuốc theo toa:

POM - Prescription Only Medicine

Sản xuất bởi:

Lusomedicamenta-Sociedade Tecnica Farmaceutica SA, McGregor Cory Ltd

Chỉ dẫn điều trị:

It is an antipsychotic of the diphenylbutyl-piperidine series and is indicated in: chronic schizophrenia, for the treatment of symptoms and prevention of relapse; other psychoses, especially paranoid and monosymptomatic hypochondriacal psychoses (eg delusional parasitosis).

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2015-02-13

Tờ rơi thông tin

- 1 - 
Version 2.0 

PACKAGE LEAFLET: INFORMATION FOR THE USER  

ORAP
®
 4 MG TABLETS

Pimozide  

Orap is a registered trademark  
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, nurse
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 you get side effects and they become serious or if you
notice any side effects 
not listed in this leaflet, please
tell your doctor, nurse or pharmacist  

IN THIS LEAFLET  
1.   WHAT ORAP TABLETS ARE AND WHAT THEY ARE USED FOR  
2.   BEFORE YOU TAKE ORAP TABLETS   
3.   HOW TO TAKE ORAP TABLETS  
4.   POSSIBLE SIDE EFFECTS  
5.   HOW TO STORE ORAP TABLETS  
6.   FURTHER INFORMATION  

1. WHAT ORAP TABLETS ARE AND WHAT THEY ARE USED FOR  
The name of your medicine is Orap 4 mg tablets. They are
called ‘Orap tablets’ or just 
‘Orap’ in this leaflet. 

Orap tablets contain a
medicine called pimozide. This belongs to
a group of medicines 
called ‘neuroleptics’.  

Orap tablets are used for illnesses affecting the way you
think, feel or behave. These 
illnesses may make you:  
• 
Feel confused  
• 
See, hear or feel things that are not there
(hallucinations)  
• 
Believe things that are not true (delusions)  
• 
Feel unusually suspicious (paranoia)  

IMPORTANT - it may take some time before you
feel the full effect of the medicine but it 
is important that you carry on
taking it for as long as your doctor has told you.   

2. BEFORE YOU TAKE ORAP TABLETS  
DO NOT TAKE ORAP TABLETS IF:  
• 
You are aller

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Orap™ 4 mg tablets. 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains pimozide 4 mg. 

3 PHARMACEUTICAL 
FORM 

Tablet 

Green, circular, biconvex, normally arched tablets, cross-scored
on one side 
and ‘JANSSEN’ on the other side. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Orap is an antipsychotic of the diphenylbutyl-piperidine series and
is indicated 
in: 

•  Chronic schizophrenia, for the treatment of symptoms and
prevention of 
relapse. 
•  Other psychoses, especially paranoid and monosymptomatic 
hypochondriacal psychoses  
    (eg delusional parasitosis). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Orap is intended for once daily oral administration in adults and
children over 
12 years of age. 

Since individual response to antipsychotic drugs is variable, dosage
should be 
individually determined and is best initiated and titrated
under close clinical 
supervision.  In determining the initial dose, consideration
should be given to 
the patient's age, severity of symptoms and previous response to
other 
neuroleptic drugs.  Dose increases should be made at
weekly intervals or 
longer, and by increments of 2-4 mg in the daily dose. 

The patient should be reviewed regularly to ensure the minimum
effective 
dose is being used. 

_Chronic schizophrenia:_ 

The dose ranges between 2 and 20 mg daily, with 2 mg as
a starting dose.  
This may be increased according to response and tolerance to
achieve an 
optimum response. 
_ _
_Other psychoses, paranoid states and monosymptomatic
hypochondriacal _
_psychoses (MHP):_ 

An initial dose of 4 mg daily which
may then be gradually increased, if 
necessary, according to response, to a maximum of 16 mg daily. 

_Use in elderly:_ 

Elderly patients require half the normal starting dos