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HALOPERIDOL 1MG/ML ORAL SOLUTION

Active substance(s): HALOPERIDOL

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Package leaflet: Information for the user

Haloperidol 1mg/ml Oral Solution
Depression
Abnormal muscle tension
Feeling dizzy, including upon sitting
up or standing up
Feeling sleepy
Upward movement of the eyes or fast
eye movements that you cannot
control
Problems with vision, such as blurred
vision
Low blood pressure
Nausea, vomiting
Constipation
Dry mouth or increased saliva
Skin rash
Being unable to pass urine or empty
the bladder completely
Difficulty getting and keeping an
erection (impotence)
Weight gain or loss
Changes that show up in blood tests
of the liver.
Uncommon (may affect up to 1 in 100
people):
Effects on blood cells – low number of
all types of blood cells, including
severe decreases in white blood cells
and low number of ‘platelets’ (cells
that help blood to clot)
Feeling confused
Loss of sex drive or decreased sex
drive
Fits (seizures)
Stiff muscles and joints
Muscle spasms, twitching or
contractions that you cannot control,
including a spasm in the neck causing
the head to twist to one side
Problems walking
Being short of breath
Inflamed liver, or liver problem that
causes yellowing of the skin or eyes
(jaundice)
Increased sensitivity of the skin to
sunlight
Itching
Excessive sweating
Changes in menstrual cycle (periods),
such as no periods, or long, heavy,
painful periods
Unexpected production of breast milk
Breast pain or discomfort
High body temperature
Swelling caused by fluid build up in
the body.
Rare (may affect up to 1 in 1,000
people):
High level of the hormone ‘prolactin’
in the blood
Narrowed airways in the lungs,
causing difficulty breathing
Difficulty or being unable to open the
mouth
Problems having sex.
The following side effects have also
been reported, but their exact
frequency is unknown:
High level of ‘antidiuretic hormone’ in
the blood (syndrome of inappropriate
antidiuretic hormone secretion)
Low level of sugar in the blood
Swelling around the voice box or brief
spasm of the vocal cords, which may
cause difficulty speaking or breathing

PIL/UK/MFG017/04/v9

Sudden liver failure
Decreased bile flow in the bile duct
Flaking or peeling skin
Inflamed small blood vessels, leading
to a skin rash with small red or
purple bumps
Breakdown of muscle tissue
(rhabdomyolysis)
Persistent and painful erection of the
penis
Enlarged breasts in men
Low body temperature.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store Haloperidol

Keep this medicine out of the sight
and reach of children.
Do not use after the expiry date
which is printed on the carton and
bottle label after ‘Exp’. The expiry
date refers to the last day of that
month.
Do not store above 25°C.
Discard 30 days after first opening.
Do not use this medicine if you notice
that the solution becomes discoloured
or shows any signs of deterioration.
Seek the advice of your pharmacist.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines you no longer use. These
measures will help protect the
environment.
6. Contents of the pack and other
information

What Haloperidol contains
The active substance is haloperidol.
Each ml of oral solution contains 1mg
haloperidol.
The other ingredients are (S)-lactic acid,
methyl parahydroxybenzoate (E218) and
purified water.
What Haloperidol looks like and
contents of the pack
Haloperidol is a clear, colourless oral
solution supplied in amber glass bottles
with tamper evident child resistant
plastic cap. The pack also contains a 1ml
oral syringe with 0.01ml graduation
mark and a 10ml oral syringe with 0.5ml
graduation mark and a syringe adaptor.
Haloperidol is supplied in bottles
containing 100ml and 200ml of
oral solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer:
Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK.
If this leaflet is hard to see or read,
please call +44 (0) 208 515 3700 for
help.
This leaflet was last revised in 09/2017.
------------------------------------------The following information is intended for
healthcare professionals only:
Haloperidol 1mg/ml Oral Solution is
supplied with a 1ml polypropylene oral
syringe with 0.01ml graduation mark and
a 10ml polypropylene oral syringe with
0.5ml graduation mark together with a
syringe adaptor for the bottle.
The quantity (ml) required to achieve a
given single dose using Haloperidol
1mg/ml Oral Solution is presented
below.
Conversion table for
1mg/ml Oral Solution
Dose in
milligrams
(mg)
haloperidol
0.5mg

Haloperidol

Volume in millilitres
(ml) of Haloperidol 1
mg/ml to be given
using dosing syringe
0.5ml

1mg

1.0ml

2mg

2.0ml

3mg

3.0ml

4mg

4.0ml

5mg

5.0ml

10mg

10.0ml

15mg

15.0ml

20mg

20.0ml

Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
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 only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Haloperidol
1mg/ml Oral Solution but it will be
referred to as ‘Haloperidol’ throughout
this leaflet.
What is in this leaflet:
1. What Haloperidol is and what it is
used for
2. What you need to know before you
take Haloperidol
3. How to take Haloperidol
4. Possible side effects
5. How to store Haloperidol
6. Contents of the pack and other
information
1. What Haloperidol is and what
it is used for

This medicinal product contains the
active substance haloperidol. This
belongs to a group of medicines called
‘antipsychotics’.
Haloperidol is used in adults, adolescents
and children for illnesses affecting the
way you think, feel or behave. These
include mental health problems (such as
schizophrenia and bipolar disorder) and
behavioural problems.
These illnesses may make you:
Feel confused (delirium)
See, hear, feel or smell things that
are not there (hallucinations)
Believe things that are not true
(delusions)
Feel unusually suspicious (paranoia)
Feel very excited, agitated,
enthusiastic, impulsive or hyperactive
Feel very aggressive, hostile or
violent.
In adolescents and children, Haloperidol
is used to treat schizophrenia in patients
aged 13 to 17 years, and to treat
behavioural problems in patients aged 6
to 17 years.
Haloperidol is also used:
In adolescents and children aged 10
to 17 years and in adults for
movements or sounds you can’t
control (tics), for example in severe
Tourette’s syndrome

PIL/UK/MFG017/04/v9

In adults to help control movements
in Huntington’s disease.
Haloperidol is sometimes used when
other medicines or treatments have not
worked or caused unacceptable side
effects.
2. What you need to know
before you take Haloperidol

Do not take Haloperidol if:
You are allergic to haloperidol or any
of the other ingredients of this
medicine (listed in section 6)
You are less aware of things around
you or your reactions become
unusually slow
You have Parkinson’s disease
You have a type of dementia called
‘Lewy body dementia’
You have progressive supranuclear
palsy (PSP)
You have a heart condition called
‘prolonged QT interval’, or any other
problem with your heart rhythm that
shows as an abnormal tracing on an
ECG (electrocardiogram)
You have heart failure or recently had
a heart attack
You have a low level of potassium in
your blood, which has not been
treated
You take any of the medicines listed
under ‘Other medicines and
Haloperidol – Do not take Haloperidol
if you are taking certain medicines
for’.
Do not take this medicine if any of the
above applies to you. If you are not sure,
talk to your doctor or pharmacist before
taking Haloperidol.
Warnings and precautions
Serious side effects
Haloperidol can cause problems with the
heart, problems controlling body or limb
movements and a serious side effect
called ‘neuroleptic malignant syndrome’.
It can also cause severe allergic
reactions and blood clots. You must be
aware of serious side effects while you
are taking Haloperidol because you may
need urgent medical treatment. See
‘Look out for serious side effects’ in
section 4.
Elderly people and people with
dementia
A small increase in deaths and strokes
has been reported for elderly people with
dementia who are taking antipsychotic
medicines. Talk to your doctor or
pharmacist before taking Haloperidol if
you are elderly, particularly if you have
dementia.
Talk to your doctor or pharmacist if
you have:
A slow heart beat, heart disease or
anyone in your close family has died
suddenly of heart problems

Low blood pressure, or feel dizzy
upon sitting up or standing up
A low level of potassium or
magnesium (or other ‘electrolyte’) in
your blood. Your doctor will decide
how to treat this
Ever had bleeding in the brain, or
your doctor has told you that you are
more likely than other people to have
a stroke
Epilepsy or have ever had fits
(convulsions)
Problems with your kidneys, liver or
thyroid gland
A high level of the hormone
'prolactin' in your blood, or cancer
that may be caused by high prolactin
levels (such as breast cancer)
A history of blood clots, or someone
else in your family has a history of
blood clots
Depression, or you have bipolar
disorder and start to feel depressed.
You may need to be more closely
monitored, and the amount of
Haloperidol you take may have to be
altered.
If you are not sure if any of the above
applies to you, talk to your doctor or
pharmacist before taking Haloperidol.
Medical check ups
Your doctor may want to take an
electrocardiogram (ECG) before or during
your treatment with Haloperidol. The
ECG measures the electrical activity of
your heart.
Blood tests
Your doctor may want to check the levels
of potassium or magnesium (or other
‘electrolyte’) in your blood before or
during your treatment with Haloperidol.
Children below 6 years of age
Haloperidol should not be used in
children below 6 years of age. This is
because it has not been studied
adequately in this age group.
Other medicines and Haloperidol
Tell your doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This includes
medicines that you buy without a
prescription or herbal medicines.
Do not take Haloperidol if you are
taking certain medicines for:
Problems with your heart beat (such
as amiodarone, dofetilide,
disopyramide, dronedarone, ibutilide,
quinidine and sotalol)
Depression (such as citalopram and
escitalopram)
Psychoses (such as fluphenazine,
levomepromazine, perphenazine,
pimozide, prochlorperazine,
promazine, sertindole, thiorizadine,
trifluoperazine, triflupromazine and
ziprasidone)

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PIL/UK/MFG017/04/v9

How much should you take
Your doctor will tell you how much
Haloperidol to take and for how long.
Your doctor will also tell you whether to
take Haloperidol one or more times a
day. It may be some time before you
feel the full effect of the medicine. Your
doctor will normally give you a low dose
to start, and then adjust the dose to suit

d) Turn the bottle the right way up
(figure 6A). Remove the syringe from
the adaptor (figure 6B).

9

10ml

7

8

5

6

3

4

1

2

Diagram of 10ml syringe

On the 10ml syringe each numbered
increment is 1ml which is equivalent to
1mg Haloperidol.
Instructions for the use of syringe:
a) Open the bottle: press the cap and
turn it anticlockwise (figure 1).
Separate the adaptor from the
syringe (figure 2).

b) Insert the adaptor into the bottle
neck (figure 3). Ensure it is properly
fixed. Take the syringe and put it in
the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the
syringe with a small amount of
solution by pulling the piston down
(figure 5A), then push the piston
upwards in order to remove any
possible bubble (figure 5B). Pull the
piston down to the graduation mark
corresponding to the quantity in
milliliters (ml) prescribed by your
tor (figure 5C).
doctor

e) During administration the oral syringe
should be directed towards the cheek
on the side of the mouth. Empty the
content of the syringe by pushing the
piston to the bottom of the syringe
(figure 7). Close the bottle with the
plastic screw cap. Wash the syringe
with water (figure 8).

If you are still not sure how to
administer the medicine, please ask
your pharmacist.
If you take more Haloperidol than
you should
If you take more Haloperidol than you
were told to or if someone else has taken
any Haloperidol, talk to a doctor or go to
the nearest hospital casualty department
straight away.
If you forget to take Haloperidol
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 stop taking Haloperidol
Unless your doctor tells you otherwise,
you should stop taking Haloperidol
gradually. Stopping treatment suddenly
may cause effects such as:
Nausea and vomiting
Difficulty sleeping.
Always follow your doctor’s instructions
carefully.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

A 10ml oral syringe is recommended
when a dose volume more than 1ml has
to be given
given.
A 1ml oral syringe is recommended when
a dose volume of 1ml or less has to be
given and when an additional volume of
0.1ml or more is required but less than 1
ml.

4. Possible side effects
Like all medicines, Haloperidol can cause
side effects, although not everybody gets
them.
Look out for serious side effects
Tell your doctor straight away if you
notice or suspect any of the following.
You may need urgent medical treatment.

Administration guidance
Diagram of 1ml syringe

0.9

3. How to take Haloperidol
Always take Haloperidol exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.

Your doctor, pharmacist or nurse will
show you how to administer this
medicine. The box containing this
medicine will contain a 1ml dosing
syringe, a 10ml dosing syringe, and a
syringe adaptor.

On the 1ml syringe each numbered
increment is 0.1ml which is equivalent to
0.1mg of Haloperidol.

Problems with the heart:
Abnormal heart rhythm – this stops
the heart working normally and may
cause loss of consciousness
Abnormally fast heart beat
Extra heart beats.

1.0 ml

Haloperidol contains:
Methyl parahydroxybenzoate (E218),
which may cause an allergic reaction
(possibly delayed).

Method of administration:
This medicinal product must be taken
orally.
Use the measuring syringe provided in
the pack to deliver the required dose.

0.7

Driving and using machines
Haloperidol can affect your ability to
drive and use tools or machines. Side
effects, such as feeling sleepy, may
affect your alertness, particularly when
you first start taking it or after a high
dose. Do not drive or use any tools or
machines without discussing this with
your doctor first.

Taking Haloperidol
Haloperidol is for oral use
You can mix Haloperidol oral solution
in some water before you take it, but
don’t mix it with any other liquids.

0.8

Fertility – Haloperidol may increase
your levels of a hormone called
‘prolactin’, which may affect fertility in
men and women. Talk to your doctor if
you have any questions about this.

Children and adolescents 6 to 17
years of age
Your dose will normally be between
0.5mg and 3mg each day
Adolescents up to 17 years of age
being treated for schizophrenia or
behavioural problems may have a
higher dose, up to 5mg each day.

0.5

Breast-feeding – talk to your doctor if
you are breast-feeding or planning to
breast-feed. This is because small
amounts of the medicine may pass into
the mother’s milk and on to the baby.
Your doctor will discuss the risks and
benefits of breast-feeding while you are
taking Haloperidol.

Elderly people
Elderly people will normally start on
0.5mg each day or half the lowest
adult dose
The amount of Haloperidol you take
will then be adjusted until the doctor
finds the dose that suits you best
The highest dose elderly people
should take is 5mg each day unless
your doctor decides a higher dose is
needed.

0.6

Haloperidol 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)
Pain (strong pain killers)
Depression (‘tricyclic
antidepressants’)
Lowering blood pressure (such as
guanethidine and methyldopa)
Severe allergic reactions (adrenaline)
Attention deficit hyperactivity
disorder (ADHD) or narcolepsy
(known as ‘stimulants’)

The following problems may occur in
newborn babies of mothers that take
Haloperidol in the last 3 months of their
pregnancy (the last trimester):
Muscle tremors, stiff or weak muscles
Being sleepy or agitated
Problems breathing or feeding.
The exact frequency of these problems is
unknown. If you took Haloperidol while
pregnant and your baby develops any of
these side effects, contact your doctor.

Adults
Your dose will normally be between
0.5 mg and 10 mg each day
Your doctor may adjust this to find
the dose that suits you best
The highest dose adults should take
depends on the condition you are
being treated for and varies between
5 mg and 20 mg each day.

0.3

Your doctor may have to change your
dose of Haloperidol if you are taking any
of these medicines.

Pregnancy, breast-feeding and
fertility
Pregnancy – if you are pregnant, think
you may be pregnant or are planning to
have a baby, ask your doctor for advice.
Your doctor may advise you not to take
Haloperidol while you are pregnant.

Your dose of Haloperidol will depend on:
Your age
What condition you are being treated
for
Whether you have problems with
your kidneys or liver
Other medicines you are taking.

0.4

Certain medicines may affect the
way that Haloperidol works or may
make heart problems more likely
Tell your doctor if you are taking:
Alprazolam or buspirone (for anxiety)
Duloxetine, fluoxetine, fluvoxamine,
nefazodone, paroxetine, sertraline, St
John’s Wort (Hypericum perforatum)
or venlafaxine (for depression)
Bupropion (for depression or to help
you stop smoking)
Carbamazepine, phenobarbital or
phenytoin (for epilepsy)
Rifampicin (for bacterial infections)
Itraconazole, posaconazole or
voriconazole (for fungal infections)
Ketoconazole tablets (to treat
Cushing’s syndrome)
Indinavir, ritonavir or saquinavir (for
human immunodeficiency virus or
HIV)
Chlorpromazine or promethazine (for
nausea and vomiting)
Verapamil (for blood pressure or
heart problems).
Also tell your doctor if you are taking any
other medicines to lower blood pressure,
such as water tablets (diuretics).

Haloperidol and alcohol
Drinking alcohol while you are taking
Haloperidol might make you feel sleepy
and less alert. This means you should be
careful how much alcohol you drink. Talk
to your doctor about drinking alcohol
while taking Haloperidol and let your
doctor know how much you drink.

you. It is very important you take the
correct amount.

0.1

Special monitoring may be needed if
you are taking lithium and
Haloperidol 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.

Parkinson’s disease (such as
levodopa)
Thinning the blood (phenindione).
Talk to your doctor before taking
Haloperidol if you are taking any of these
medicines.

0.2

Bacterial infections (such as
azithromycin, clarithromycin,
erythromycin, levofloxacin,
moxifloxacin and telithromycin)
Fungal infections (such as
pentamidine)
Malaria (such as halofantrine)
Nausea and vomiting (such as
dolasetron)
Cancer (such as toremifene and
vandetanib).
Also tell your doctor if you are taking
bepridil (for chest pain or to lower blood
pressure) or methadone (a pain killer or
to treat drug addiction).
These medicines may make heart
problems more likely, so talk to your
doctor if you are taking any of these and
do not take Haloperidol (see ‘Do not take
Haloperidol if’).

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PIL/UK/MFG017/04/v9

Heart problems are uncommon in people
taking Haloperidol (may affect up to 1 in
100 people). Sudden deaths have
occurred in patients taking this medicine,
but the exact frequency of these deaths
is unknown. Cardiac arrest (the heart
stops beating) has also occurred in
people taking antipsychotic medicines.
A serious problem called ‘neuroleptic
malignant syndrome’. This causes a
high fever, severe muscle stiffness,
confusion and loss of consciousness. It is
rare in people taking Haloperidol (may
affect up to 1 in 1,000 people).
Problems controlling movements of
the body or limbs (extrapyramidal
disorder), such as:
Movements of the mouth, tongue,
jaw and sometimes limbs (tardive
dyskinesia)
Feeling restless or difficulty sitting
still, increased body movements
Slow or reduced body movements,
jerking or twisting movements
Muscle tremors or stiffness, a
shuffling walk
Being unable to move
Lack of normal facial expression that
sometimes looks like a mask.
These are very common in people taking
Haloperidol (may affect more than 1 in
10 people). If you get any of these
effects, you may be given an additional
medicine.
Severe allergic reaction that may
include:
A swollen face, lips, mouth, tongue or
throat
Difficulty swallowing or breathing
Itchy rash (hives).
An allergic reaction is uncommon in
people taking Haloperidol (may affect up
to 1 in 100 people).
Blood clots in the veins, usually in
the legs (deep vein thrombosis or DVT).
These have been reported in people
taking antipsychotic medicines. The signs
of a DVT in the leg include swelling, pain
and redness in the leg, but the clot may
move to the lungs causing chest pain
and difficulty in breathing. Blood clots
can be very serious, so tell your doctor
straight away if you notice any of these
problems.
Tell your doctor straight away if you
notice any of the serious side effects
above.
Other side effects
Tell your doctor if you notice or suspect
any of the following side effects.
Very common (may affect more than 1
in 10 people):
Feeling agitated
Difficulty sleeping
Headache.
Common (may affect up to 1 in 10
people):
Serious mental health problem, such
as believing things that are not true
(delusions) or seeing, feeling, hearing
or smelling things that are not there
(hallucinations)

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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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