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HALOPERIDOL 200MICROGRAMS/ML ORAL SOLUTION

Active substance(s): HALOPERIDOL / HALOPERIDOL

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Packa
age leafflet: Info
ormation for the
e user

Haloperidol 200micrograms/ml Oral Solution

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
Haloperidol if you or your child 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 tim e
Liver or kidney problems

PIL/UK/MFG017/03/v8

Your doctor may have to change your dose of
Haloperidol.
Haloperidol with food, drink and alcohol
Haloperidol can be taken with or without food.
Drinking alcohol while you are taking Haloperidol
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 Haloperidol if you
are pregnant, think you may be pregnant or might
become pregnant

The 3ml oral syringe should be used when the dose
volume to be administered is more than 1ml.
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.

1.0 ml

0.9

0.8

0.7

Diagram of 1ml syringe

On the 1ml syringe, each numbered increment is
0.1ml which is equivalent to 0.02mg (or 20
microgram) of Haloperidol.
Administration guidance
There are two different strengths available for
this product: the 200mcg/ml strength and the
1mg/ml strength. Check which of the two
strengths has been prescribed for you.
It should be noted that when using the 1ml
syringe with the different strength, the volume
will provide a different dose.
For single dose of 0.5 mg or below (equivalent
to 2.5ml or less of the 200mcg/ml oral solution)
the 200 mcg/ml oral solution should be used.
Any dosage greater than 0.5 mg (equivalent to
more than 2.5ml of the 200mcg/ml oral
solution) should use the 1mg/ml oral solution.
Diagram of 3ml syringe
3.0ml

Take special care with your or your child’s
medicine
If you are elderly, as you may be more sensitive to
the effects of Haloperidol .

Certain medicines may affect the way that
Haloperidol works
Tell your doctor if you or your child 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, pharmacist or nurse will show you how
to administer this medicine. The box containing this
medicine will contain a 1ml dosing syringe, a 3 ml
dosing syringe, and a syringe adaptor.

2.50ml

Do not use this medicine if any of the above applies to
you or your child. If you are not sure, talk to your
doctor or pharmacist before using Haloperidol.

Talk to your doctor before taking Haloperidol if you or
your child are taking any of these medicines.

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

0.6

You or your child are allergic to anything in
Haloperidol (listed in section 6 below)
You or your child have, or have had, certain
types of heart disease which cause your heart to
beat with an abnormal rhythm (arrhythmia) or
unusually slowly
You or your child are taking any medicines which
affect heart beat
Your doctor tells you that the level of potassium in
your or your child’s blood is too low
You have Parkinson’s disease
Your doctor tells you that you or your child have
a condition that affects part of your brain called
the ‘basal ganglia’
You or your child are less aware of things around
you or your reactions become slower.

Children
The dose for children depends on their weight
Children will normally be given 0.025 to 0.05mg
per kilogram body weight 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
10mg.

2.0ml

Do not take Haloperidol if:

Your dose will depend on:
Age
How serious symptoms are
Whether you or your child have other medical
problems
How you or your child have reacted to similar
medicines in the past.

0.5

2. What you need to know before you take
Haloperidol

Haloperidol can affect the way the following
types of medicine work
Tell your doctor if you or your child are taking
medicines for:
Calming down or helping you or your child to
sleep (tranquillisers)
Illnesses that affect the way you or your child
think, feel or behave (antipsychotics or
neuroleptics)
Pain (strong pain killers)
Changes in your or your child’s 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.

How much should you take
Your doctor will tell you how much Haloperidol to take
or give and for how long. Your doctor will adjust the
dose to suit you or your child. It is very important you
take or give the correct amount.

1.50ml

Haloperidol is also used for:
Gilles de la Tourette syndrome and movements
you can’t control (tics)
Hiccups that won’t go away.

Special monitoring may be needed if you or your
child 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 or your
child can’t control
Confused, disoriented, a headache, balance
problems and feel sleepy. These are signs of a
serious condition.

Always take or give Haloperidol exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.

0.3

Haloperidol is used for: illnesses that affect the way
you think, feel or behave. They may make you or
your child:
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.

Other medicines and Haloperidol
Please tell your doctor or pharmacist if you
or your child are taking or have recently
taken any other medicines. This includes medicines
that you buy without a prescription or herbal
medicines.

3. How to take Haloperidol

0.4

This medicinal product contains haloperidol. This
belongs to a group of medicines called ‘neuroleptics’ .

Blood tests
Your doctor may want to check the levels of minerals
(electrolytes) in your blood.

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

1.0ml

1. What Haloperidol is and what it is used for

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.

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.

0.1

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

If you are not sure if any of the above apply to you or
your child, talk to your doctor or pharmacist before
taking Haloperidol.

You may still be able to use Haloperidol 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 breastfeeding.

0.2

The name of your medicine is Haloperidol
200micrograms/ml Oral Solution but it will be referred
to as ‘Haloperidol’ throughout this leaflet.

Epilepsy or have ever had fits (convulsions) as you
or your child may need more medicines 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 Haloperidol you take may have to be
altered.

0.50ml

Read all of this leaflet carefully before
you start taking or giving this medicine
to a child to whom it has been prescribed
because it contains important information for
you and your child.
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 or your
child 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 or your child get any side effects, talk to
your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See
section 4.

On the 3ml syringe, each numbered increment is
0.5ml and 1ml which is equivalent to 0.1 mg and 0.2
mg of Haloperidol respectively.
If you are not sure which syringe to use ask your
pharmacist for help.
TURN OVER

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 millilitres (ml) prescribed by your
doctor (figure 5C).

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

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 or your child takes 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 or your child forget a dose, take the 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
Take the medicine for as long as your doctor has told
you. It may be some time before you or your child
feels the full effect of the medicine.
Unless your doctor tells you otherwise, you or your
child should stop taking Haloperidol gradually.
Stopping treatment suddenly may cause effects such
as:
Feeling sick (nausea) or being sick (vomiting)
Difficulty sleeping (insomnia).
Always follow your doctor’s instructions carefully.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Haloperidol 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 or
your child 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
PIL/UK/MFG017/03/v8

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
You or your child’s 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 or your child
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.

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 pharmacist.
Reporting of side effects
If you or your child gets 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 200micrograms
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 3 ml
oral syringe with 0.1ml graduation marks and an
adaptor.
Haloperidol Oral Solution is supplied in bottles
containing 100ml and 200ml of oral solution.
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer:
Syri Limited,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
Trading as
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 12/2016.

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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