Skip to Content

HALOPERIDOL 200MICROGRAMS/ML ORAL SOLUTION

Active substance(s): HALOPERIDOL

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user

Halkid® 200micrograms/ml Oral Solution
Other side effects
Tell your doctor if you or your child
notices or suspects 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)
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)

Conversion table for Halkid
200micrograms/ml Oral Solution
Dose in
milligrams (mg)
haloperidol

0.1mg

Volume in millilitres
(ml) of Halkid
200micrograms/ml
(0.2mg/ml) to be
given using dosing
syringe
0.5ml

0.2mg

1ml

0.25mg

1.25ml

0.3mg

1.5ml

0.4mg

2.0ml

0.5mg

2.5ml

1mg

5ml

2mg

10ml

TURN OVER

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
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 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
or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help
provide more information on the safety
of this medicine.

(haloperidol)

5. How to store Halkid
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 Halkid 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 Halkid looks like and
contents of the pack
Halkid is a clear, colourless oral solution
supplied in amber glass bottles with a
tamper evident child resistant plastic
cap. The pack also contains 10ml oral
syringe with 0.25ml graduation marks
and a syringe adaptor.
Halkid 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:
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 12/2017.
Halkid® is a registered trademark of
Thame Laboratories.

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.
The name of your medicine is Halkid
200micrograms/ml Oral Solution but it will
be referred to as ‘Halkid’ throughout this
leaflet.
What is in this leaflet:
1. What Halkid is and what it is used for
2. What you need to know before you
take or give Halkid
3. How to take or give Halkid
4. Possible side effects
5. How to store Halkid
6. Contents of the pack and other
information

1. What Halkid is and what it is
used for
This medicinal product contains the active
substance haloperidol. This belongs to a
group of medicines called
‘antipsychotics’.
Halkid is used in 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 or your
child:
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, Halkid is
used to treat schizophrenia in patients
aged 13 to 17 years, and to treat
behavioural problems in patients aged 6
to 17 years.
Halkid is also used in adolescents and
children aged 10 to 17 years for
movements or sounds you can’t control
(tics), for example in severe Tourette’s
syndrome.

PIL/UK/MFG017/03/v11

Halkid 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 or give Halkid
Do not take or give Halkid if you or
your child:
Are allergic to Halkid or any of the
other ingredients of this medicine
(listed in section 6)
Are less aware of things around you
or reactions become unusually slow
Have Parkinson’s disease
Have a type of dementia called ‘Lewy
body dementia’
Have progressive supranuclear palsy
(PSP)
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)
Have heart failure or recently
had a heart attack
Have a low level of potassium
in your blood, which has not been
treated
Take any of the medicines listed under
‘Other medicines and Halkid – Do not
take Halkid if you are taking certain
medicines for’.
Do not take or give 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 taking or giving
Halkid.
Warnings and precautions
Serious side effects
Halkid 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 or giving Halkid because
you or your child 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 Halkid if you
are elderly, particularly if you have
dementia.
Talk to your doctor or pharmacist if
you or your child 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 have bipolar disorder
and start to feel depressed.
You or your child may need to be more
closely monitored, and the amount of
Halkid you or your child take may have
to be altered.
If you are not sure if any of the above
applies to you or your child, talk to your
doctor or pharmacist before taking or
giving Halkid.
Medical check ups
Your doctor may want to take an
electrocardiogram (ECG) before or during
your or your child’s treatment with
Halkid. The ECG measures the electrical
activity of the heart.
Blood tests
Your doctor may want to check the levels
of potassium or magnesium (or other
‘electrolyte’) in your or your child’s blood
before or during your treatment with
Halkid.
Children below 6 years of age
Halkid 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 Halkid
Tell your doctor or pharmacist if you or
your child 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 or give Halkid if you are
taking or giving certain medicines
for:
Problems with your or your child’s
heart beat (such as amiodarone,
dofetilide, disopyramide,
dronedarone, ibutilide, quinidine and
sotalol)

TURN OVER

Also tell your doctor if you or your child
are taking any other medicines to lower
blood pressure, such as water tablets
(diuretics).
Your doctor may have to change your or
your child’s dose of Halkid if you are
taking or giving any of these medicines.

PIL/UK/MFG017/03/v11

How much should you take or give
Your doctor will tell you how much
Halkid to take or give and for how
long. Your doctor will also tell you
whether to take or give Halkid one
or more times a day. It may be some
time before you or your child feel the full
effect of the medicine.Your doctor will
normally give you or your child a low
dose to start, and then adjust the dose
to suit you or your child. It is very
important you take or give the correct
amount.
Your or your child’s dose of haloperidol
will depend on:
Age
What condition you or your child are
being treated for
Whether you or your child have
problems with the kidneys or liver
Other medicines you or your child are
taking.

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 or your child
not to take Halkid while you are pregnant.

Children and adolescents 6 to 17
years of age
The 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.

The following problems may occur in
newborn babies of mothers that take
Halkid 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 Halkid while
pregnant and your baby develops any of
these side effects, contact your doctor.

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

Fertility – Halkid 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.
Driving and using machines
Halkid can affect your or your child’s
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.

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).

If you stop taking or giving
Halkid
Unless your doctor tells you otherwise,
you or your child should stop taking
Halkid gradually. Stopping treatment
suddenly may cause effects such as:
Nausea and vomiting
Difficulty sleeping.
Always follow your doctor’s instructions
carefully.

Like all medicines, Halkid can cause
side effects, although not everybody gets
them.

10 mL

Look out for serious side effects
Tell your doctor straight away if you or
your child notice or suspect any of the
following. You or your child may need
urgent medical treatment.

10ml

9ml

7,5 mL
8ml

7ml

5 mL

3,75 mL

6,25 mL
6ml

5ml

4ml

2,5 mL

If you forgett to take or give
Halkid
If you or your child forget to take a
dose, take or give the next dose as
usual. Then keep taking or giving
your or your child’s medicine as your
doctor has told you.
Do not take or give a double dose.

4. Possible side effects

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

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

GO TO NEXT PAGE

If you take or give more Haloperidol
than you should
If you or your child takes more
Halkid than you were told to or if
someone else has taken any Halkid,
talk to a doctor or go to the nearest
hospital casualty department straight
away.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Diagram of 10ml syringe

On the 10ml syringe, each small
graduation mark equals 0.25ml the
equivalent of 50micrograms.
Graduations are numbered in increments
of 1ml. Each 1ml provides 200microgram
(same as 0.2mg) of Halkid.

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.

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

3ml

Breast-feeding – talk to your doctor if
you or your child 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 Halkid.

If you are not sure how to use the
syringe ask your pharmacist for help.

Method of administration:
Use the measuring syringe provided in
the pack to deliver the required dose.

1,75 mL

Certain medicines may affect the
way that Halkid works or may
make heart problems more likely
Tell your doctor if you or your child 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).

Halkid and alcohol
Drinking alcohol while you are taking
Halkid 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 Halkid, and let
your doctor know how much you drink.

Always take or give Halkid exactly
as your doctor has told you. Check with
your doctor or pharmacist if you are not
sure.

1,25 mL

Special monitoring may be needed if
you or your child are taking lithium
and Halkid at the same time.
Tell your doctor straight away and
stop taking or giving both medicines
if you or your child gets:
Fever that cannot be explained 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.

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

3. How to take or give Halkid

2ml

Also tell your doctor if you or your child
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 or your child are taking any
of these and do not take or give
Halkid (see ‘Do not take Halkid if’).

Halkid can affect the way the
following types of medicine work
Tell your doctor if you or your child
are taking medicines for:
Calming you or your child down or
helping you or your child 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’)
Parkinson’s disease (such as
levodopa)
Thinning the blood (phenindione).

1ml

Depression (such as citalopram and
escitalopram)
Psychoses (such as fluphenazine,
levomepromazine, perphenazine,
pimozide, prochlorperazine,
promazine, sertindole, thiorizadine,
trifluoperazine, triflupromazine and
ziprasidone)
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).

PIL/UK/MFG017/03/v11

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.
Heart problems are uncommon in people
taking Halkid (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.

TURN OVER

A serious problem called ‘neuroleptic
’. This causes a
malignant syndrome’.
high fever, severe muscle stiffness,
confusion and loss of consciousness. It is
rare in people taking Halkid (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
Halkid (may affect more than 1 in
10 people). If you or your child gets any
of these effects, you or your child 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 Halkid (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 or your child notices
any of these problems.
Tell your doctor straight away if you or
your child notices any of the serious side
effects above.

The following information is intended for
healthcare professionals only:
Halkid 200micrograms/ml Oral Solution
is supplied with a 10ml oral syringe and
is intended to be used for single doses of
0.1mg Halkid and above (equivalent to
0.5ml and above). Doses greater than
2mg (equivalent to 10ml oral solution)
should be administered using a 1mg/ml
Oral Solution.
The quantity (ml) required to achieve a
given single dose using Halkid
200micrograms/ml Oral Solution is
presented overleaf.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide