Orap 4mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Pimozide

Предлага се от:

Eumedica Pharmaceuticals

АТС код:

N05AG02

INN (Международно Name):

Pimozide

дозиране:

4mg

Лекарствена форма:

Tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04020100; GTIN: 5012674049419

Листовка

uk-pl-4mgen071
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ORAP
® 4 MG TABLETS
Pimozide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Orap is and what it is used for
2.
What you need to know before you take Orap
3.
How to take Orap
4.
Possible side effects
5.
How to store Orap
6.
Contents of the pack and other information
1.
WHAT ORAP IS AND WHAT IT IS 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORAP
DO NOT TAKE ORAP:
-
if you are allergic to pimozide or any of the other ingredients of
this medicine (listed in section
6).
-
You are allergic to similar medicines
-
You have ever had an irregular heart beat (arrhythmia) or unusually
slow heart beat
(bradycardia)
-
You have recently had a heart attack or have heart failure
-
You suffer from a heart problem known as ‘QT-prolongation’. This
problem som

Данни за продукта

OBJECT 1
ORAP 4 MG TABLETS
Summary of Product Characteristics Updated 20-Mar-2018 | EUMEDICA SA
1. Name of the medicinal product
Orap™ 4 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains pimozide 4 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Green, circular, biconvex, normally arched tablets, single-scored on
one side and 'ORAP 4' on the other
side.
The tablet can be divided into equal doses.
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).
Orap is indicated in adults and children over 12 years old.
4.2 Posology and method of administration
Posology
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 dose of pimozide.
_Paediatric popu