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ORAP 4MG TABLETS

Active substance(s): PIMOZIDE

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170mm

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.

• K
 eep 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

460mm

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 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.

Warnings and precautions

Talk to your doctor or pharmacist before using Orap
• if you have a heart problem or anyone in your close
family has died suddenly of heart problems
• if you have liver or kidney problems
• if you have epilepsy or any other problem that can
cause fits (convulsions)
• if you have problems with your thyroid gland
• if you have a non-cancerous tumour of the adrenal
gland (phaeochromocytoma)
• if you have 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.

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.

Other medicines and Orap

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other 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

3. How to take Orap
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
You can take Orap tablets with or without food. Swallow
the tablets with some water.

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
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• 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.
• 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.

Orap with food, drink and alcohol
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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
The following symptoms may occur in newborn babies
of mothers that have used Orap 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.
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.
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.

Use in adults and children over 12 years old

• Y
 our starting dose will normally be between 2 mg and
4 mg. 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

Use in children under 12 years old
Not recommended.

Use in elderly people

• E
 lderly 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
The tablet can be divided into equal doses.

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If you stop taking 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.
Unless your doctor tells you otherwise, you should stop
taking Orap tablets gradually. Stopping treatment
suddenly may cause effects such as:
• Feeling sick (nausea) or being sick (vomiting)
• Difficulty sleeping
• Sweating
Always follow your doctor’s instructions carefully.

If you take more Orap than you should

If you take more Orap tablets than you were told to or if
someone else has taken any Orap tablets, talk to a
doctor or go to the nearest hospital casualty
department straight away.

If you forget to take Orap

• If you forget to take a dose, take your next dose as
usual. Then keep taking your medicine as your doctor
has told you
• Do not take a double dose to make up for a forgotten
dose
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Stop using Orap tablets and tell your doctor
straight away if you notice or suspect any of
the following. You may need urgent medical
treatment.

• R
 ash, hives (also known as nettle rash or urticaria),
severe irritation of your skin. These may be signs of a
severe allergic reaction. This only happens in a small
number of people
• A serious problem called ‘neuroleptic malignant
syndrome’. The signs may include:
- Fast heart beat, changing blood pressure and
sweating followed by fever
- Faster breathing, muscle stiffness, reduced
consciousness and coma
- Raised levels of a protein in your blood (an
enzyme called creatine phosphokinase)
• Your heart:
- Beats abnormally (arrhythmia)
- Flutters (fibrillates)
- Beats unusually fast (tachycardia)
An arrhythmia can cause your heart to stop beating
(cardiac arrest). Unexplained deaths have occurred
rarely in patients taking this type of medicine
• Jerky movements and problems such as slowness,
muscle stiffness or spasm, shaking, trembling or
tremors, feeling restless and stiff neck. More saliva
than normal, twitching or unusual movements of the
tongue, face, mouth, jaw or throat, difficulty speaking
or rolling of the eyes. If you get any of these effects,
you may be given an additional medicine
• Low sodium levels in the blood which can cause
tiredness and confusion, muscle twitching, fits or
coma.

Tell your doctor or pharmacist straight away
if you notice or suspect any of the following
side effects:
Very common side effects (affects more than
1 in 10 patients)





 weating more than usual
S
Urinating (passing water) at night
Feeling dizzy
Feeling sleepy

Common side effects (affects up to
1 in 10 patients)











Feeling agitated or restless
 eeling low or depressed
F
Difficulty sleeping
Feeling tired or lacking in energy
Loss of appetite
Dry mouth
Being sick
Constipation
Headache







 lurred vision
B
Very oily skin
Need to pass water (urine) more often than usual
In men, erection problems
Weight gain

Uncommon side effects (affects up to
1 in 100 patients)

• In women, no monthly period
• Swollen face

Not known (cannot be estimated from the
available data)

• F
 its or seizures (convulsions)
• Hormone changes which may lead to:
- Some women unexpectedly producing breast milk
- Some men experiencing swelling of their breast
- Some people losing interest in sex
• Body temperature changes

Test results:

• S
 ugar in the urine
• High blood sugar levels (if you already have
diabetes)
• Abnormal heart traces (electrocardiogram, ‘ECG’) or
brain traces (electroencephalogram ‘EEG’)
Medicines similar to Orap may cause blood clots in the
veins especially in the legs (symptoms include swelling,
pain and redness in the leg), which may travel through
blood vessels to the lungs causing chest pain and
difficulty in breathing. If you notice any of these
symptoms seek medical advice immediately
Medicines similar to Orap used by mothers in the last
trimester (last three months of pregnancy) have been
associated with the following symptoms in newborn
babies: 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.
In elderly people with dementia, a small increase in the
number of deaths has been reported for patients taking
neuroleptics compared with those not receiving
neuroleptics.

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on
the safety of this medicine.

5. How to store Orap
Keep this medicine out of the sight and reach of
children.
Do not store above 30 °C.
Do not use this medicine after the expiry date which is
stated on the label after EXP. The expiry date refers to
the last day of that month.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other information
What Orap contains

• T
 he active substance is pimozide. The tablets contain
4 mg of pimozide.
• The other ingredients are calcium hydrogen
phosphate dihydrate, maize starch, microcrystalline
cellulose, polyvidone, talc, cottonseed
oil-hydrogenated, ferric oxide (E172) and
indigotindisulphonate sodium (E132).

For information in large print, tape, CD or
Braille, telephone 0800 7318450
This leaflet was last revised in June 2016.

What Orap looks like and contents of the
pack

Orap 4 mg tablets are green, circular tablets. They are
marked “ORAP 4” on one side and have a score line on
the other.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
EUMEDICA S.A.
Winston Churchill Avenue, 67
BE-1180 Brussels
Belgium
Manufacturers
Lusomedicamenta-Sociedade Tecnica
Farmaceutica SA
Estrada Consiglieri Pedroso 69-B, Queluz de Baixo
2730-055 Barcarena
Portugal
OR
McGregor Cory Ltd
Middleton Road, Banbury
Oxfordshire, UK OX16 4RS

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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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