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ORAP 4MG TABLETS

Active substance(s): PIMOZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Orap® 4mg Tablets
(pimozide)
This medicine is available as the above name but will be
referred to as Orap tablets throughout this leaflet.
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 4mg 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 allergic to anything in Orap tablets (listed in section
6 below)
 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 sometimes runs in families and can only be
confirmed by an electrocardiogram (ECG). An ECG
measures the electrical activity of your heart
 You have lower than normal levels of minerals (electrolytes)
in your blood. Your doctor will advise you
 You have Parkinson’s disease
 You are suffering from depression
 You are less aware of things around you or your reactions
become slower
Do not take this medicine if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before using
Orap tablets.
Take special care with Orap tablets
Check with your doctor or pharmacist before using Orap tablets if
you have:
 A heart problem or anyone in your close family has died
suddenly of heart problems
 Liver or kidney problems
 Epilepsy or any other problem that can cause fits
(convulsions)
 Problems with your thyroid gland
 A non-cancerous tumour of the adrenal gland
(phaeochromocytoma)
 A history of blood clots, or someone else in your family has
(as medicines like this have been associated with formation
of blood clots)
 If you exercise hard, are going somewhere very hot or don’t
drink enough
You may need to be more closely monitored, and the amount of
Orap tablets you take may have to be altered.
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking Orap tablets.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before
or during your treatment with Orap tablets. The ECG measures the
electrical activity of your heart.
Blood tests
Your doctor may want to check the levels of minerals (electrolytes)
in your blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines that
you buy without a prescription or herbal medicines.

In particular, do not take this medicine and tell your doctor if
you are taking any of the following medicines:
 for fungal infections such as ketoconazole, itraconazole,
miconazole, fluconazole
 certain antibiotics such as erythromycin, clarithromycin,
azithromycin, troleandomycin
 antiviral protease inhibitors such as indinavir, ritonavir,
saquinavir
 for the heart such as quinidine, disopyramide, procainamide,
amiodarone, sotalol, bretylium
 for allergies such as terfenadine
 for some digestive problems such as cisapride
 for treating or preventing malaria such as mefloquine,
quinine
 for depression such as nefazodone, amitriptyline,
maprotiline, sertraline, paroxetine, citalopram, escitalopram
 for mental illness such as chlorpromazine, thioridazine,
sertindole
 for weight control such as sibutramine
Do not start taking Orap tablets and tell your doctor if you are taking
any of the above.
Tell your doctor before taking any of the following medicines.
They may need to alter the dose of Orap tablets or your other
medicine:
 Anxiety or help you to sleep (tranquillisers)
 Severe pain (strong painkillers)
 Parkinson's disease
 Epilepsy or fits (convulsions)
 Sickness such as metoclopramide
 High blood pressure such as calcium channel blockers and
diuretics
Tell your doctor before taking any of the above. They may need to
alter the dose of Orap tablets or your other medicine.
Taking Orap tablets with food and alcohol
You can take Orap tablets with or without food. Swallow the tablets
with some water.
Do not drink grapefruit juice while taking Orap tablets.
Drinking alcohol while you are taking Orap tablets might make you
feel drowsy and less alert. This means you should be careful how
much alcohol you drink.
Pregnancy and breast-feeding
Talk to your doctor before taking Orap tablets if you are pregnant,
think you may be pregnant or might become pregnant.
You may still be able to take Orap tablets if your doctor thinks you
need to.
Do not take this medicine if you are breast-feeding. This is because
small amounts may pass into the mother’s milk.
The following symptoms may occur in newborn babies, of mothers
that have used Orap tablets in the last trimester (last three months
of their pregnancy): shaking, muscle stiffness and/or weakness,
sleepiness, agitation, breathing problems and difficulty in feeding.
If your baby develops any of these symptoms you may need to
contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine
if you are pregnant or breast-feeding.
Driving and using machines
This medicine may affect you being able to drive. Do not drive or
use any tools or machines without discussing this with your doctor
first.
3.

How to take Orap tablets

Always take Orap tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
How much should you take
Your doctor will tell you how many Orap tablets to take and for how
long. Your doctor will adjust the dose to suit you. It is very important
you take the correct amount.
Your dose will depend on:
 Your age
 How serious your symptoms are
 How you have reacted to similar medicines in the past
Adults and children over 12 years old
 Your starting dose will normally be between 2 mg and 4mg.
You will take this once a day
 Your doctor may want to gradually increase this dose to find
the dose which suits you best. The maximum amount that
you should take in one day is 20 mg
 Your doctor may reduce the dose of Orap tablets when your
symptoms begin to improve
Children under 12 years old
Not recommended.
Elderly people
 Elderly people are normally started on a lower dose
 The amount of Orap tablets you take will then be adjusted until
the doctor finds the dose that suits you best
When to stop using Orap tablets
Take the medicine for as long as your doctor has told you.
It may be some time before you feel the full effect of the medicine.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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