HALDOL 10MG TABLETS

Active substance: HALOPERIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2011

GB - P1602417P

tablets
Haloperidol
Haldol 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
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 or pharmacist

In this leaflet
1 What Haldol tablets are and what they are
used for
2 Before you take Haldol tablets
3 How to take Haldol tablets
4 Possible side effects
5 How to store Haldol tablets
6 Further information

1 What Haldol tablets are and what they are used for
The name of your medicine is Haldol tablets.
Haldol tablets contain a medicine called
haloperidol. This belongs to a group of medicines
called ‘neuroleptics’.
Haldol 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)
• Feel very excited, agitated, enthusiastic
or hyperactive
• Feel very aggressive or violent
Haldol tablets are also used for:
• Gilles de la Tourette syndrome and movements
you can’t control (tics)
• Hiccups that won’t go away

2 Before you take Haldol tablets
Do not take Haldol tablets if:

• You are allergic to anything in Haldol tablets
(listed in section 6 below)
• You have, or have had, certain types of heart
disease which cause your heart to beat with an
abnormal rhythm (arrhythmia) or unusually slowly
• You are taking any medicines which affect your
heart beat
• Your doctor tells you that the level of potassium
in your blood is too low
• You have Parkinson’s disease
• Your doctor tells you that you have a condition
that affects part of your brain called the ‘basal
ganglia’
• You are less aware of things around you or your
reactions become slower
Do not take this medicine if any of the above apply
to you. If you are not sure, talk to your doctor
or pharmacist before using Haldol tablets.

Take special care with Haldol tablets

If you are elderly, as you may be more sensitive
to the effects of Haldol.
If you or someone else in your family has a history
of blood clots, as medicines like these have been
associated with formation of blood clots.
Check with your doctor or pharmacist before using
Haldol tablets if you have:
• A heart problem or anyone in your close family
has died suddenly of heart problems
• Ever had bleeding in the brain, or your doctor has
told you that you are more likely than other people
to have a stroke
• Lower than normal levels of minerals (electrolytes)
in your blood. Your doctor will advise you
• Not been eating properly for a long time
• Liver or kidney problems
• Epilepsy or have ever had fits (convulsions)
as you may need more medicine to control them.
• Depression
• Problems with your thyroid gland
• A non-cancerous tumour of the adrenal gland
(phaeochromocytoma)
You may need to be more closely monitored,
and the amount of Haldol tablets you take may
have to be altered. If you are not sure if any
of the above apply to you, talk to your doctor
or pharmacist before taking Haldol tablets.

Medical check ups

Your doctor may want to take an electrocardiogram
(ECG) before or during your treatment with Haldol
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.
Special monitoring may be needed if you are
taking lithium and Haldol tablets at the same
time. Tell your doctor straight away and stop taking
both medicines if you get:
• Fever you can’t explain or movements you can’t
control
• Confused, disoriented, a headache, balance
problems and feel sleepy. These are signs
of a serious condition
Haldol tablets can affect the way the following
types of medicine work
Tell your doctor if you are taking medicines for:
• Calming you down or helping you to sleep
(tranquillisers)
• Illnesses that affect the way you think, feel
or behave (antipsychotics or neuroleptics)

• Pain (strong pain killers)
• Changes in your heart beat or are taking
medicines that affect your heart beat
• Coughs and colds
• Epilepsy
• Depression, such as ’tricyclic antidepressants’
and ’tetracyclic antidepressants’
• Lowering blood pressure, such as guanethidine
and methyldopa
• Severe allergic reactions, such as adrenaline
• Parkinson’s disease, such as levodopa
• Thinning the blood, such as phenindione
Talk to your doctor before taking Haldol tablets
if you are taking any of these medicines.
Certain medicines may affect the way that
Haldol tablets work
Tell your doctor if you are taking medicines for:
• Depression, such as fluoxetine and paroxetine
• Malaria, such as quinine and mefloquine
• Anxiety, such as buspirone
• Problems with your heart beat, such as quinidine,
disopyramide and procainamide, amiodarone,
sotalol and dofetilide
• Epilepsy, such as phenobarbital and
carbamazepine
• Allergies, such as terfenadine
• Serious infections, such as rifampicin
• Lowering blood pressure, such as water tablets
(diuretics)
• Infections such as sparfloxacin, moxifloxacin,
erythromycin IV
• A fungal infection, such as ketoconazole
Your doctor may have to change your dose
of Haldol tablets.

Taking Haldol tablets with food and
alcohol

You can take Haldol tablets with or without food.
Swallow the tablets with some water.
Drinking alcohol while you are taking Haldol 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 Haldol tablets
if you are pregnant, think you may be pregnant
or might become pregnant. The following symptoms
may occur in newborn babies of mothers that have
used Haldol 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 Haldol 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.

Elderly

If you suffer from a disorder with related memory
loss, you should talk first to your doctor, who will
decide if you can be given Haldol and will explain
the possible risks of its use.

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.

Important information about some of
the ingredients of Haldol 5 mg tablets

Haldol 5 mg tablets contain lactose. If your doctor
has told you that you are intolerant of some sugars,
discuss it with them before taking this medicine

3 How to take Haldol tablets
Always take Haldol 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 Haldol 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
• Whether you have other medical problems
• How you have reacted to similar medicines
in the past

Adults

• Your starting dose will normally be between
1.5 mg and 5 mg. You will take this two or three
times a day
• Your doctor may reduce the dose of Haldol
tablets when your symptoms begin to improve

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Children

• The dose for children depends on their weight
• Children will normally be given 0.025 to 0.05 mg
per kilogram each day
• Half the dose should be taken in the morning and
the other half in the evening
• The largest dose children should take each day
is 10 mg

Elderly people

• Elderly people are normally started on a lower
dose
• The amount of Haldol tablets you take will then be
adjusted until the doctor finds the dose that suits
you best

Taking Haldol tablets

• Haldol tablets should be taken by mouth
• Swallow the tablets with some water

© J-C 2011

GB - P1602417P

3 How to take Haldol tablets (continued)
When to stop taking Haldol 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 Haldol tablets gradually. Stopping
treatment suddenly may cause effects such as:
• Feeling sick (nausea) or being sick (vomiting)
• Difficulty sleeping
Always follow your doctor’s instructions carefully.

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

If you forget to take Haldol tablets

• 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
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Haldol tablets can cause side
effects, although not everybody gets them.
Tell your doctor or nurse straight away if you
notice or suspect any of the following. You may
need urgent medical treatment.
• 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.
• Sudden swelling of the face or throat. Hives (also
known as nettle rash or urticaria), severe irritation,
reddening or blistering 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)
This can occur in fewer than 1 in 1,000 people
• Your heart may beat abnormally (arrhythmia).
An arrhythmia can cause your heart to stop beating
(cardiac arrest). In elderly people with dementia,
a small increase in the number of deaths have
been reported for patients taking neuroleptics
compared with those not receiving neuroleptics.
The precise frequency of how often this occurs
is not known
• Jerky movements and problems such as slowness,
muscle stiffness, trembling and feeling restless.
More saliva than normal, twitching or unusual
movements of the tongue, face, mouth, jaw or
throat, or rolling of the eyes. If you get any of these
effects, you may be given an additional medicine
Tell your doctor or nurse if you notice or
suspect any of the following side effects:
• Feeling agitated or having difficulty sleeping
• Headache
These can affect more than 1 in 10 people
• Trembling, rigid posture, mask-like face, slow
movements and a shuffling, unbalanced walk
• Feeling restless, low or depressed or sleepy
• Feeling light headed or dizzy, particularly when
standing up
• Symptoms of psychosis such as abnormal
thoughts or visions, or hearing abnormal sounds
• Problems with sight including blurred vision and
rapid eye movements
These can occur in fewer than 1 in 10 people
• Liver problems including yellowing of the skin and
eyes, pale stools and dark coloured urine
• Feeling confused
• A fall in the number of white blood cells which can
cause frequent infections
• Fits or seizures (convulsions)

• Difficulty breathing or wheezing
• Hormone changes which may lead to:
• Changes in weight
• Difficulties with sex such as erection problems
• Some men experiencing swelling of their breast
or painful and prolonged erection
• Some people losing interest in sex
• Some women having irregular, painful or heavy
periods or no monthly period
• Some women unexpectedly producing breast
milk, having painful breasts
These can occur in fewer than 1 in 100 people
• Being unable to open mouth
This can occur in fewer than 1 in 1000 people
• Bleeding or bruising more easily than normal.
This can be caused by a fall in the number
of small blood cells called platelets
• Fluid retention affecting the brain, resulting
in weakness, tiredness or confusion
The precise frequency of how often these occur
is not known
Other side effects
Common side effects (affects fewer than
1 in 10 people)
• Rash
• Slow movements
• Dry mouth
• Feeling sick, being sick
• Constipation
• Difficulty passing water (urine)
Uncommon side effects (affects fewer than
1 in 100 people)
• Sensitivity of skin to sunlight
• Sweating more than usual
• Fever
• Swelling of the ankles
The following side effects have been reported,
however the precise frequency cannot be identified
and therefore how often they occur is classed
as unknown:
• Flaking or peeling of the skin
• Inflamed skin (red, hot to the touch and tender)
• Low body temperature
• In newborn babies of mothers that have used
Haldol in the last trimester (last three months
of 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.
Test results:
• Abnormal test results for liver function
• Low blood sugar levels (hypoglycaemia)
• Abnormal heart traces (electrocardiogram, ‘ECG’)
If you get side effects and they become serious
or if you notice any other side effects not listed
in this leaflet, please tell your doctor or nurse.

5 How to store Haldol tablets
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not take Haldol tablets after the expiry date
which is stated on the label. The expiry date refers
to the last day of that month.

Medicines should not be disposed of via
wastewater or household waste. These measures
will help protect the environment. Return any
leftover Haldol tablets to your pharmacist.

6 Further information
The active substance in Haldol tablets
is haloperidol. The tablets contain 5 mg or 10 mg
of haloperidol.
The other ingredients are different for the 5 mg
and 10 mg tablets. They are listed below.
Haldol 5 mg tablets: lactose monohydrate, maize
starch, talc, cottonseed oil- hydrogenated and
indigotindisulphonate sodium (E132).
Haldol 10 mg tablets: calcium hydrogen
phosphate dihydrate, maize starch, calcium stearate
and quinoline yellow (E104).
What Haldol tablets look like and contents
of the pack
Haldol 5 mg tablets are pale blue. They are marked
“Janssen” on one side and “X” on the other.
Haldol 10 mg tablets are yellow. They are marked
“Janssen” on one side and “H/10” on the other.
Haldol tablets are supplied in blister packs
of 100 tablets per pack.
The product licence is held by:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire, HP12 4EG, UK

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Haldol tablets are made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
Lusomedicamenta-Sociedade Tecnica
Farmaceutica SA, Estrada Consiglieri Pedroso
69-B, Queluz de Baixo, 2730-055 Barcarena,
Portugal
OR
McGregor Cory Ltd, Middleton Close, Banbury,
Oxfordshire, UK OX16 4RS

For information in large print,
tape, CD or Braille, telephone
0800 7318450.
This leaflet was last approved in Nov 2011

P1602417P.pdf - Page 3 of 3 - January 2, 2012 - 13:19:18

INSERT HALDOL
Article Number: P1602417P
Format Name : 3P_LUS/I/032/V2 (170x590)
Technical Info/Spec: NA
Pointsize: 9 pt
File Name : P1602417P.indd (CS4_PC)

Market: GB
Mat. ID Code: 960
Operator: Rajesh

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Date: 1. 02-01-2012
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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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