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HALOPERIDOL 1MG/ML ORAL SOLUTION

Active substance(s): HALOPERIDOL / HALOPERIDOL

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Packa
age leafflet: Info
ormation for the
e user

Halop
peridol 1mg/ml Oral So
olution

Do not use this medicine if any of the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before using Haloperidol.
Warning and precautions
If you are elderly, as you may be more sensitive to
the effects of Haloperidol .
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 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 have ever had fits (convulsions) as you
may need more medicines to control them
Depression
Problems with your thyroid gland
A non-cancerous tumour of the adrenal gland
(phaeochromocytoma).

PIL/UK/MFG017/04/v8
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Certain medicines may affect the way that
Haloperidol 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
Haloperidol.
Haloperidol with food, drink and alcohol
You can take Haloperidol 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
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.

Adults
Your starting dose will normally be between 1.5mg
and 5mg. You will take this two or three times a
day
Your doctor may reduce the dose when your
symptom begin to improve.
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.
Elderly people
Elderly people are normally started on a lower
dose
The amount of Haloperidol you take will then be
adjusted until the doctor finds the dose that suits
you best.
Method of administration:
This medicinal product must be taken orally.
Use the measuring syringe provided in the pack to
deliver the required dose.
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.
A 10ml oral syringe is recommended when a dose
volume more than 1ml has to be 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.
Diagram of 1ml syringe
1.0 ml

You are allergic to anything in Haloperidol (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 which 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.

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.

0.8

Do not take Haloperidol if:

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

0.9

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

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

0.6

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 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.

3. How to take Haloperidol

0.7

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

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

0.5

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).

0.4

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.

0.3

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 applies to you,
talk to your doctor or pharmacist before taking
Haloperidol.

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 Haloperidol and will explain
the possible risks of its use.

0.2

The name of your medicine is Haloperidol 1mg/ml
Oral Solution but it will be referred to as ‘Haloperidol’
throughout this leaflet.

You may need to be more closely monitored, and the
amount of Haloperidol you take may have to be
altered.

0.1

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.

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

TURN OVER

10 mL

9

8

7

4.

6

5

4

3

2

1

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

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 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.

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 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 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
Take the medicine 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 tells you otherwise, you 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.

PIL/UK/MFG017/04/v8

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 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 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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