HALDOL TM 2 MG/ML ORAL LIQUID

Active substance: HALOPERIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2011

GB - 984667

oral liquid
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 liquid is and what it is
used for
2 Before you use Haldol liquid
3 How to use Haldol liquid
4 Possible side effects
5 How to store Haldol liquid
6 Further information

1 What Haldol liquid is and what it is used for
The name of your medicine is Haldol oral liquid.
It is called ‘Haldol liquid’ in this leaflet.
Haldol liquid contains a medicine called
haloperidol. This belongs to a group
of medicines called ‘neuroleptics’.
Haldol liquid is 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 liquid is also used for:
• Gilles de la Tourette syndrome and movements
you can’t control (tics)
• Hiccups that won’t go away

2 Before you use Haldol liquid
Do not use Haldol liquid if:

• You are allergic to anything in Haldol liquid
(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 use this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before using Haldol liquid.

Take special care with Haldol liquid

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 liquid 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 liquid 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 liquid.

Medical check ups

Your doctor may want to take an electrocardiogram
(ECG) before or during your treatment with Haldol
liquid. 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 liquid 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 liquid 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 liquid
if you are taking any of these medicines.
Certain medicines may affect the way that
Haldol liquid works
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 liquid.

Taking Haldol liquid with food and
alcohol

You can take Haldol liquid with or without food.
Drinking alcohol while you are taking Haldol
liquid 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 using Haldol liquid
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 use Haldol liquid if your
doctor thinks you need to.
Do not use 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 liquid

Haldol liquid contains methyl
parahydroxybenzoate (E218). This may cause
an allergic reaction. This reaction may happen
some time after you have taken Haldol liquid.

3 How to use Haldol liquid
Always use Haldol liquid 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 much Haldol liquid
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

984667.pdf - Page 1 of 3 - January 19, 2012 - 13:27:34

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
liquid when your symptoms begin to improve

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

© J-C 2011

GB - 984667

3 How to use Haldol liquid (continued)
Elderly people

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

Using the pipette to take Haldol liquid
You must take Haldol liquid using the pipette.
• Place the bottle on a flat surface
• Remove the cap from the bottle by pushing
down on the cap while turning it anti-clockwise
(figure A)
• One end of the pipette has a plunger. Place the
other end into the liquid in the bottle
• While holding the lower ring on the pipette,
pull the top ring upwards. Do this, until the
mark that matches the number of millilitres (ml)
or milligrams (mg) is just visible (figure B)
Fig. A
Fig. B

• Holding the lower ring, remove the whole
pipette from the bottle (figure C)
• Empty the contents of the pipette into a cup.
Do this by sliding the upper ring down while
still holding the lower ring
• Drink the Haldol liquid straight away
• Close the bottle, then rinse the pipette with
some water

When to stop using Haldol liquid

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 liquid 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 liquid than
you should

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

If you forget to take Haldol liquid

• 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 liquid 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 liquid
Keep out of the reach and sight of children.
Do not store above 25°C. Do not refrigerate
or freeze the medicine.
Do not use Haldol liquid after the expiry date
which is stated on the carton and bottle 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 liquid to your
pharmacist.

6 Further information
The active substance in Haldol liquid
is haloperidol. The liquid contains 2 mg
of haloperidol in each millilitre.

Haldol liquid is made by:
Janssen-Cilag SA, Campus de Maigremont,
27100 Val de Reuil, France

The other ingredients are lactic acid, methyl
parahydroxybenzoate and water.

OR

What Haldol liquid looks like and contents
of the pack
Haldol liquid is supplied in an amber bottle
containing 100 ml of a clear, colourless liquid.
The product licence is held by:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire, HP12 4EG, UK.

Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close, Banbury,
Oxfordshire, OX16 4RS, UK

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

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INSERT HALDOL
Article Number: 984667
Format Name: B/I/007/V1 (145x520)
Technical Info/Spec: NA
Pointsize: 8 pt
File Name: 984667.indd (CS4_PC)

Market: GB
Mat. ID Code: 471
Operator: Rajesh

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JANSSEN-CILAG

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Date: 1. 19-01-2012
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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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