HALDOL DECANOATE 100MG/ML

Active substance: HALOPERIDOL DECANOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2012

GB - AW_81136

decanoate
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 decanoate is and what it
is used for
2 Before you are given Haldol decanoate
3 How Haldol decanoate is used
4 Possible side effects
5 How Haldol decanoate is stored
6 Further information

1 What Haldol decanoate is and what it is used for
The name of your medicine is Haldol
decanoate.
Haldol decanoate contains a medicine called
haloperidol decanoate.
This belongs to a group of medicines called
‘neuroleptics’.

Haldol decanoate 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

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

• You are allergic to sesame oil. Haldol
decanoate contains sesame oil.
See ‘Important information about some of
the ingredients of Haldol decanoate’ below
• You are allergic to any of the other
ingredients of Haldol decanoate (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 certain drugs which affect
the rhythm of your heart beat
• You have a low level of potassium in your
blood
• Your doctor tells you that you have
a condition that affects part of your brain
called the 'basal ganglia'
• You have Parkinson’s disease
• 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
decanoate.

Take special care with Haldol
decanoate

If you are elderly, as you may be more
sensitive to the effects of Haldol decanoate
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 decanoate 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 decanoate you are
given may have to be altered. If you are not
sure if any of the above apply to you, talk to
your doctor or nurse before you are given
Haldol decanoate.

Medical check ups

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

Haldol decanoate and alcohol

Drinking alcohol while you are using Haldol
decanoate 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
decanoate 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
decanoate 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 decanoate
if your doctor thinks you need to.
Ask your doctor for advice before you breastfeed. 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 decanoate 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
decanoate

Haldol decanoate contains sesame oil. This
may rarely cause severe allergic reactions.
See ‘Do not use Haldol decanoate if’ above.

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© J-C 2012

GB - AW_81136

3 How Haldol decanoate is used
Your doctor or nurse will inject Haldol
decanoate deep into a muscle. A single
dose will normally last for one month.

How much medicine will you
be given

Your doctor will decide how much Haldol
decanoate 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 50 mg
every 4 weeks
• Your doctor may increase the dose
by 50 mg every 4 weeks
• The dose may be increased to 300 mg
every 4 weeks. In some cases higher
doses might be needed
The dose will be halved if your doctor thinks
you should have the medicine every
2 weeks.

Children

• Haldol decanoate should not be used in
children

.
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Elderly people

• Elderly people are normally started
on a lower dose
• The dose is usually 12.5 mg to 25 mg
every 4 weeks

Stopping Haldol decanoate

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 decanoate 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 decanoate

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.

4 Possible side effects
Like all medicines, Haldol decanoate
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)
• 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
• Abscess at the site of injection
• In newborn babies of mothers that have
used Haldol decanoate 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 decanoate is stored
Haldol decanoate is stored:
• Out of the reach and sight of children
• In its outer carton to protect it from light
Do not store above 25°C. This medicine
should not be refrigerated or frozen.
Haldol decanoate should not be used after
the expiry date which is stated on the label.
The expiry date refers to the last day of that
month.

If stored for long periods in the cold, solid
particles may form in Haldol decanoate.
These may disappear when stored at
room temperature. If these particles do not
disappear, the ampoule should be thrown
away.

6 Further information

The other ingredients are benzyl alcohol
(15 mg/ml) and sesame oil.

Haldol decanoate is made by:
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana N. 90
(loc. San Polo)
43056 Torrile (PR)
Italy

What Haldol decanoate looks like
and contents of the pack

McGregor Cory Ltd, Middleton Close,
Banbury, Oxfordshire, OX16 4RS, UK

The active substance in Haldol decanoate
is haloperidol decanoate. Haldol decanoate
comes in two strengths: 50 mg/ml and
100 mg/ml.

Haldol decanoate is a solution for injection.
It is supplied in glass ampoules containing
1 ml of 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

OR

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in September 2013

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AW_81136.pdf - Page 2 of 3 - September 19, 2013 - 09:17:34

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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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