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HALDOL DECANOATE 100MG/ML

Active substance(s): HALOPERIDOL DECANOATE / HALOPERIDOL DECANOATE / HALOPERIDOL DECANOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB - 672115
© J-C 2016

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
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 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.

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.

© J-C 2016

GB - 672115

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 active substance in Haldol
decanoate is haloperidol decanoate.
Haldol decanoate comes in two
strengths: 50 mg/ml and 100 mg/ml.
The other ingredients are benzyl
alcohol (15 mg/ml) and sesame oil.

What Haldol decanoate looks like
and contents of the pack

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
Haldol decanoate is made by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium
OR
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

672115.pdf - Page 2 of 3 - December 16, 2016 - 12:16:02

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised
in December 2016.

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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