Skip to Content

UK Edition. Click here for US version.

HALOPERIDOL 10MG/5ML ORAL SOLUTION

Active substance(s): HALOPERIDOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Haloperidol 10mg/5ml Oral Solution
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 your 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.
What is in this leaflet:
1. What Haloperidol Oral Solution is and what it is used for
2. What you need to know before you take Haloperidol Oral Solution
3. How to take Haloperidol Oral Solution
4. Possible side effects
5. How to store Haloperidol Oral Solution
6. Contents of the pack and other information

1. What Haloperidol Oral Solution is and what it is used for
The full name of your medicine is Haloperidol 10mg/5ml Oral Solution. In this leaflet the shorter name Haloperidol is
used. Haloperidol belongs to a group of medicines called neuroleptics.
Haloperidol acts on the brain to calm your emotions.
Haloperidol can be used to treat:
■ schizophrenia
■ feeling and being sick
■ problems with behaviour in adults and children
■ persistent hiccups or severe tics
■ Gilles de la Tourette syndrome in adults and children
■ or to calm your emotions particularly if you feel agitated and restless if you are an older person, over-excited or
aggressive.

2. What you need to know before you take Haloperidol Oral Solution
Do not take Haloperidol and tell your doctor if:
■ you are allergic (hypersensitive) to haloperidol or any other ingredients in this liquid (listed in section 6). The signs of
allergic reaction can include a rash, itching or shortness of breath
■ you have a history of blood problems
■ you have or are at the risk of having an irregular or unusually slow heart beat, heart block or other heart problems
■ you are taking medicines that affect the beating of your heart such as verapamil and sotalol
■ you have dulled senses
■ you have Parkinson’s Disease
■ you have damage to the part of the brain known as the basal ganglia
■ you have been told by your doctor that you have low potassium levels in your blood (hypokalaemia).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before
taking Haloperidol.
Warnings and precautions
Talk to your doctor before taking Haloperidol if:
■ you have a heart problem or anyone in your close family has died suddenly from heart problems
■ you are pregnant or breast-feeding
■ you have kidney or liver problems
■ you have epilepsy or other problems that may cause fits such as brain damage or alcohol withdrawal
■ you have thyroid problems
■ you have a tumour of your adrenal gland that causes high blood pressure (phaeochromocytoma)
■ you are feeling depressed
■ you have been told by your doctor that you metabolise some drugs slower than other people
■ you have had a stroke or brain haemorrhage
■ you have been told you have low levels of potassium, calcium or magnesium in your blood
■ 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
■ you are an elderly patient with dementia
■ you suffer from a disorder with related memory loss
■ you have not been eating properly for a long time.
Available safety data in the paediatric population indicate a risk of extrapyramidal symptoms, including tardive
dyskinesia (involuntary, repetitive body movements), and sedation. No long-term safety data are available.
Other important information to take into account before you take this medicine:
if you or members of your family have heart problems (including heart failure, heart attack or uneven heart beats) or
you have low potassium or magnesium in your blood, your doctor may do some tests on your heart (ECG)
■ your doctor may also want to give you regular blood tests to check the levels of minerals (electrolytes) in your
blood. This is particularly true for patients taking water tablets (diuretics) or who have other related illnesses.


If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Haloperidol.
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 you buy without a prescription, including herbal medicines. This is because haloperidol can affect the way
some other medicines work. Also some medicines can affect the way haloperidol works.
Special monitoring may be needed if you are taking lithium and haloperidol liquid 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, disorientated, a headache, balance problems and feel sleepy. These are signs of a serious condition.
Haloperidol can affect the way medicines work.
Tell your doctor if you are taking:
■ medicines to treat high blood pressure such as guanethidine, methyldopa and water tablets (diuretics)
■ heart medicines to control your heart beat such as quinidine, amiodarone, disopyramide, procainamide, sotalol,
dofetilide and bretylium
■ medicines that control your emotions such as thioridazine, lithium, sertindole, pimozide and chlorpromazine
■ medicines for depression and anxiety such as fluvoxamine, fluoxetine, buspirone, venlafaxine, sertraline, paroxetine
and also ‘tricyclic antidepressants’ that include amitriptyline, and ‘tetracyclic antidepressants’ that include maprotiline
■ medicines that help you sleep such as sedatives or hypnotics such as temazepam and alprazolam
■ medicines to treat epilepsy such as phenobarbital and carbamazepine
■ medicines used to treat Parkinson’s Disease such as levodopa
■ adrenaline, used for severe allergies and other medicines that mimic the actions of natural substances in the body.
These are normally found in cough and cold medicines
■ phenindione, used to treat thrombosis
■ strong painkillers such as codeine
■ medicines to treat stomach problems such as cisapride
Certain medicines may affect the way that Haloperidol works. Tell your doctor if you are taking:
medicines to treat high blood pressure such as guanethidine, methyldopa and water tablets (diuretics)
heart medicines to control the heart beat such as quinidine, amiodarone, disopyramide, procainamide, sotalol,
dofetilide and bretylium
■ medicines for depression and anxiety such as amitriptyline, fluvoxamine, maprotiline, fluoxetine, buspirone,
venlafaxine, sertraline and paroxetine
■ medicines to treat epilepsy such as phenobarbital and carbamazepine
■ medicines used to treat malaria such as quinine, mefloquine and halofantrine
■ antibiotics such as moxifloxacin, sparfloxacin and erythromycin IV
■ medicines used to treat fungal infections such as itraconazole and ketoconazole
■ other medicines to treat allergies (antihistamines) such as terfenadine and promethazine
■ rifampicin used to treat serious infections
■ arsenic mesilate, given for leukaemia
■ dolasetron, used to treat nausea (feeling sick) and vomiting



Haloperidol with food, drink and alcohol
You must not drink alcohol whilst taking this medicine. This is because this medicine may make you feel drowsy and
drinking alcohol will make you even more drowsy. Drinking alcohol may also affect the condition you are suffering from.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine. You should not use this medicine unless your doctor feels it is absolutely necessary
if you are pregnant, or if you are breast-feeding as small amounts may pass into the mother’s milk.
The following symptoms may occur in newborn babies, of mothers that have used haloperidol 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.
Driving and using machines
Do not drive or use tools or machines if this medicine makes you drowsy or gives you blurred vision.
If you drink alcohol whilst taking Haloperidol, it may further affect your ability to drive and use machinery.
Important information about what is in this medicine:
Haloperidol Oral Solution contains:
■ methyl and propyl parahydroxybenzoates. These may cause an allergic reaction.
This allergy may happen some time after starting the medicine.

3. How to take Haloperidol Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Look on the label and check with your
doctor or pharmacist if you are not sure.
Taking this medicine
■ this medicine contains 10mg of haloperidol in each 5ml
■ take this medicine by mouth
■ if you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to
your doctor or pharmacist.
Adults
■ When used to treat schizophrenia, psychoses or mania your dose will normally be 2mg, but may be increased up
to 20mg
■ When used to treat agitation and behavioural problems your dose will normally be 1.5 mg to 5mg
■ It may be given as a single dose or split into smaller doses and given two to three times a day
■ Your doctor may reduce the dose of Haloperidol when your symptoms begin to improve
■ The maximum dose for all treatments is 20mg a day.
Children
Your doctor will work out the dose for your child according to their age and weight
The following doses will be split into smaller doses and given two to three times a day




Children aged 3 to 12 years
When used to treat childhood schizophrenia, the normal dose will be 1 to 4mg a day but may be increased up to
6 mg a day
■ When used to treat agitation and behavioural problems, the normal dose will be 0.5 to 3 mg a day but may be
increased up to 3 mg a day


P0797

Continued overleaf

Haloperidol 10mg/5ml Oral Solution

03.09.15

10mg/5ml

THREE

P0797

1 of 2

P0665
-

YES

-

100ml

268

150 x 500mm (folded 150 x 33mm)
1

Black

Keyline

Adolescents aged 13 to 17 years of age
■ When used to treat childhood schizophrenia, the normal dose will be 1 to 6 mg a day but may be increased up to
10 mg a day
■ When used to treat agitation and behavioural problems, the normal dose will be 2 to 6 mg a day but may be
increased up to 6 mg a day
Elderly people
■ Elderly people are normally started on half the adult dose
■ The amount of Haloperidol you take will then be adjusted until the doctor finds the dose that suits you best
If you take more Haloperidol than you should
Talk to a doctor or go to a hospital straight away. Take the medicine
pack with you so the doctor knows what you have taken. Signs of
an overdose may include low or high blood pressure, extreme
sleepiness, muscle spasms, fits, quick and shallow breaths and coma.
If you forget to take Haloperidol
■ Do not take a double dose (two doses at the same time) to
make up for forgotten doses.
■ Skip the missed dose then go on as before.
If you stop taking Haloperidol
Keep taking Haloperidol until your doctor tells you to stop. The doctor will lower your dose gradually.
If you stop taking the medicine suddenly you may get withdrawal symptoms.
Signs include:
■ feeling or being sick, sweating and difficulty sleeping (insomnia)
■ your original symptoms becoming worse
■ movements that you can’t control.
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 may need urgent medical treatment.
■ if you have an allergic reaction to Haloperidol. An allergic reaction may include sudden swelling of the face or
throat, sudden wheezing, fluttering or tightness of the chest or collapse. Any kind of skin rash such as hives (also
known as nettle rash or uticaria), itching, severe irritation, reddening, blistering or flaking of your skin, boils or sore
lips and mouth.
■ a severe skin rash that causes blistering, particularly the mouth and tongue. These may be signs of a condition
known as Stevens-Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN). If this happens seek medical advice
immediately. Your doctor may have to stop your treatment.
■ if you have any of the following symptoms:
- unusually fast heart beat, unstable blood pressure (feeling dizzy, light-headed or faint) and sweating
- very high body temperature, faster breathing, muscle stiffness or a change in consciousness leading to coma
- these are early warning signs of a disorder called ‘neuroleptic malignant syndrome’ caused by the type of medicine
you are taking.
■ 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. If you notice any of these
symptoms seek medical advice immediately
■ heart changes including fast heart beats, unusual heart beats, heart attack. Symptoms of a heart attack are chest
pain which may spread to the shoulders, neck or arms and shortness of breath. If you get these see a doctor
straight away. Unexplained deaths have been reported but it is not proven that they were caused by haloperidol
■ blood problems. You may notice signs such as high temperature or chills, sore throat, ulcers in your mouth or throat
and unusual tiredness.
If you get any of the following side effects, see your doctor as soon as possible:
Very Common side effects (affects more than 1 in 10 people)
■ feeling agitated
■ difficulty sleeping
■ headache
■ repetitive, involuntary muscle movements.
Common side effects (affects fewer than 1 in 10 people)
twitching often of the mouth, jaws, lips, eyes, tongue and throat
vision disturbance rapid eye movements and rolling of the eyes
feeling depressed or sleepy
symptoms of psychosis such as abnormal thoughts or visions, or hearing abnormal sounds
repetitive body movements and the presence of involuntary movements
sustained muscle contractions causing twisting of the body or a rigid or abnormal posture
decreased body movements, slow ability to start and continue movements
unable to sit still
increased tone of muscles and tremors. This can include trembling and shaking of the hands and feet
mask-like face
low blood pressure. You may feel dizzy when standing up
problems with erection
increase or decrease in weight
abnormal test results for liver function.
















Uncommon side effects (affects fewer than 1 in 100 people)
jerky movements and muscle problems such as spasms, stiffness and involuntary contractions
enlarged liver, yellowing of the skin and whites of your eyes (jaundice) with fever
feeling confused
feeling restless
increased heart rate
abnormal neck movements
fits or seizures (convulsions)
parkinsonism (characterised by tremor, rigidity, or instability when standing)
difficulty breathing or wheezing
blurred vision
frequent infections. This can be caused by a fall in the number of white blood cells
decrease or loss of sexual drive
irregular, painful or no monthly period
women unexpectedly producing breast milk, breast discomfort or pain.
















Rare side effects (affects fewer than 1 in 1000 people)
raised prolactin (hormone) levels in the blood
being unable to open mouth
muscle twitching, movement disorder, involuntary eye movements
spasm of the airways
heavy periods, menstrual disorder, sexual dysfunction
abnormal heart traces (electrocardiogram, ‘ECG’).








The following side effects have also been reported (frequency unknown)
high blood pressure
fluid retention affecting the brain, resulting in weakness, tiredness or confusion
bleeding or bruising more easily than normal. This can be caused by a fall in the number of small blood cells called
platelets
■ liver failure or biliary disorders
■ men experiencing painful or prolonged erection.




Other side effects:
Common side effects (affects fewer than 1 in 10 people)
■ feeling dizzy
■ feeling sick (nausea) or being sick (vomiting)
■ dry mouth or more saliva in the mouth than normal
■ skin rashes
■ constipation
■ water retention or difficulty in passing water (urine).
Uncommon side effects (affects fewer than 1 in 100 people)
skin reaction to direct sunlight
excessive sweating, itching or skin rash causing red patches
fever
difficulty walking, shuffling
build up of fluid (oedema).







The following side effects have also been reported (frequency unknown)
loss of appetite, upset stomach or indigestion
swelling of the breasts (particularly in men)
build up of fluid in the throat or spasm in the throat
low blood sugar levels (hypoglycaemia). The symptoms of this are hunger, shakiness, sweating, dizziness, confusion,
anxiety and weakness
■ inappropriate antidiuretic hormone secretion (where the body produces too much antidiuretic hormone)
■ feeling of dizziness or spinning (vertigo)
■ rapid or irregular heart beats
■ swelling of the face
■ flaking or peeling of the skin
■ inflamed skin (red, hot to the touch and tender) or inflammation of the blood vessels characterised by fever, pain in
the joints and muscles
■ low body temperature
■ feeling drowsy
■ in newborn babies, of mothers that have used haloperidol in the last trimester (last three months of their pregnancy),
side effects can occur. See section 2: Pregnancy and breast feeding.





In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking
antipsychotics compared with those not receiving antipsychotics.
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. Website: 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 Oral Solution







Keep this medicine out of the sight and reach of children
Store below 25°C. Protect from light
Do not use this medicine after the expiry date which is stated on the label and carton (exp: month, year)
The expiry date refers to the last day of that month
Do not use this medicine if you notice that the appearance or smell of your medicine has changed. Talk to your
pharmacist
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Haloperidol Oral Solution contains
■ The active ingredient is haloperidol
■ The other ingredients are propylene glycol (E1520), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),
lactic acid (E270) and purified water.
What Haloperidol Oral Solution looks like and contents of the pack
A colourless solution.
It comes in a brown glass bottle holding 100ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last revised in 09/2015.

P0797

Haloperidol 10mg/5ml Oral Solution

03.09.15

10mg/5ml

THREE

P0797

2 of 2

P0665
-

YES

-

100ml

268

150 x 500mm (folded 150 x 33mm)
1

Black

Keyline

Expand view ⇕

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.

Hide