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ORAP 4MG TABLETS

Active substance(s): PIMOZIDE / PIMOZIDE / PIMOZIDE

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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.
2.
3.
4.
5.
6.

What Orap is and what it is used for
What you need to know before you take Orap
How to take Orap
Possible side effects
How to store Orap
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 ‘QTprolongation’. 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

- 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 breastfeeding. This is because small amounts may pass
into the mother’s milk.

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

Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or breastfeeding.

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

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
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.

Your dose will depend on:
- Your age
- How serious your symptoms are
- How you have reacted to similar medicines in
the past

How much should you take

Use in adults and children over 12 years
old

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.

204028-MAH-5

- Your 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

- 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

The tablet can be divided into equal doses.

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.

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.

Unless your doctor tells you otherwise, you
should stop taking Orap tablets gradually.

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.

- Rash, 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)
- Sweating more than usual
- Urinating (passing water) at night
- Feeling dizzy
- Feeling sleepy

Common side effects (affects up to 1 in
10 patients)
- Feeling agitated or restless
- Feeling low or depressed
- Difficulty sleeping
- Feeling tired or lacking in energy
- Loss of appetite
- Dry mouth
- Being sick
- Constipation

- Headache
- Blurred vision
- 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)

- Fits 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:

- Sugar 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

- The 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).

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
Eumedica S.A.
Chemin de la Nauwelette 1
BE-7170 Manage
Belgium
For information in large print, tape, CD or
Braille, telephone 0800 7318450
This leaflet was last revised in October 2016.
P1604033O

Expand Transcript

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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