HALDOL INJECTION

Active substance: HALOPERIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2012

GB - 10000000103372 R

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injection
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 nurse
• 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 nurse

In this leaflet
1 What Haldol injection is and what it is used for
2 Before you are given Haldol injection
3 How Haldol injection is used
4 Possible side effects
5 How Haldol injection is stored
6 Further information

1 What Haldol injection is and what it is used for
The name of your medicine is Haldol injection.
Haldol injection contains a medicine called haloperidol.
This belongs to a group of medicines called
‘neuroleptics’.
Haldol injection 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 injection is also used to treat feelings of sickness
or actually being sick (nausea and vomiting).

2 Before you are given Haldol injection
Do not use Haldol injection if:

• You are allergic to anything in Haldol injection
(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 that 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 nurse before being given Haldol
injection.

Take special care with Haldol injection

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 before being given Haldol
injection 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 any other problem that can cause 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 injection you are given may have to be
altered.
If you are not sure if any of the above applies to you,
talk to your doctor or nurse before you are given Haldol
injection.

Medical check ups

Your doctor may want to take an electrocardiogram
(ECG) before or during your treatment with Haldol
injection. 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 nurse 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 injection at the same time.
Tell your doctor or nurse straight away and stop taking
both medicines if you get:
• Confused, disoriented, a headache, balance problems
and feel sleepy. These are signs of a serious condition

Haldol injection 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
• 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 or nurse before being given Haldol
injection if you are taking any of these medicines.
Certain medicines may affect the way that Haldol
injection 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
injection.

Haldol injection and alcohol

Drinking alcohol while you are using Haldol injection
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 being given Haldol
injection 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 injection if your
doctor thinks you need to.
Ask your doctor for advice before you breast-feed.
This is because small amounts of the medicine 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.

3 How Haldol injection is used
Your doctor or nurse will inject Haldol injection into
a muscle.

How much medicine will you be given

Your doctor will decide how much Haldol injection you
need and for how long. Your doctor will adjust the dose
to suit you. 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 2 and
10 mg (or 1 and 2 mg if you are having it for nausea
and vomiting)
• In some cases, you may be given a starting dose
of 18 mg
• Further doses may be given every 4 to 8 hours,
up to a maximum of 18 mg a day
Your doctor may change your treatment from
an injection to tablets or liquid, depending on your
response to the injection.

Children

• Haldol injection should not be used in children

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Elderly or ill people

• Elderly people or people who are weak due to ill health
are normally started on half the usual adult dose
• The amount of Haldol injection you have will then
be adjusted until the doctor finds the dose that suits
you best

Stopping Haldol injection

The medicine should be used 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 decides otherwise, Haldol injection
will be stopped 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 miss a dose or have too much Haldol
injection
A doctor or nurse will give this medicine to you, so it is
unlikely that you will miss a dose or be given too much.
If you are worried, tell the doctor or nurse.
If you have any further questions on the
use of this product, ask your doctor
or nurse.

© J-C 2012

GB - 10000000103372 V

4 Possible side effects
Like all medicines, Haldol injection 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

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• 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)
• Reactions at the site of injection
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 Haldol injection is stored
Haldol injection is stored:
• Out of the reach and sight of children
• In its outer carton to protect it from light

Haldol injection should not be used after the expiry date
which is stated on the carton and ampoule label.
The expiry date refers to the last day of that month.

6 Further information
The active substance in Haldol injection is haloperidol
(5 mg/ml).
The other ingredients are lactic acid and water for
injection.

What Haldol injection looks like and
contents of the pack

Haldol injection is supplied in amber glass ampoules
containing 1 ml of colourless solution. The ampoules are
supplied in packs of 5.

The product licence is held by:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way,
High Wycombe, Bucks, HP12 4EG, UK
Haldol injection is made by:
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana N. 90 (loc. San Polo)
43056 Torrile (PR)
Italy
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: 10000000103372
Format Name: 3P_G/I/D10071/V3.0 (170x560)
Technical Info/Spec: - NA
Pointsize: 9 pt
File Name: 10000000103372.indd (CS4_PC)

Market: GB
Mat. ID Code: 10000000103372
Operator: Rajesh

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Tel. Inge Vermeiren: +32 14606915 - E-mail: ivermei1@its.jnj.com
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JANSSEN-CILAG

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Date: 1. 27-01-2012
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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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