PATIENT INFORMATION LEAFLET

P0237T
HALOPERIDOL
Tablets 0.5mg, 1.5mg, 5mg, 10mg and 20mg
Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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.

In this leaflet: • adrenaline (used for severe allergic reactions such as bee stings),
1. What Haloperidol Tablets are and what they are used for drugs used to treat asthma such as salbutamol and terbutaline, and
2. Before you take Haloperidol Tablets ephedrine for nasal congestion
3. How to take Haloperidol Tablets • medicines used to treat high blood pressure such as guanethidine
and methyldopa and water tablets (diuretics)
4. Possible side effects
• medicines for changes in your heart beat or that affect your heart
5. How to store Haloperidol Tablets
beat (e.g. quinidine, disopyramide, procainamide, amiodarone,
6. Further information sotalol, dofetilide, bretylium)
1. W
 hat Haloperidol Tablets are and what they • medicines for malaria e.g. quinine and mefloquine
are used for • rifampicin, sparfloxacin, moxifloxacin, erythromycin IV, ketoconazole,
itraconazole used to treat infections
This medicine belongs to a group of drugs know as neuroleptics. These • phenindione (used to treat blood clotting disorders).
medicines treat illnesses that affect the way you think, behave or feel
such as schizophrenia. Other special warnings:­­
Before you have any kind of surgery, it is important to tell the doctor or
Haloperidol is used to treat illnesses that can make you: dentist in charge that you are taking this medicine.
feel confused; see, feel or hear things that are not there (hallucinations);
believe things that are not true (delusions); be very suspicious of things Medical check ups and blood tests:
(paranoia); feel very excited, restless, agitated or hyperactive; feel very Your doctor may want to take an electrocardiogram (ECG) to measure
aggressive or violent. the electrical activity of your heart before or during your treatment,
Haloperidol can also be used to treat persistent hiccups, to control and may want to perform blood tests to check the levels of minerals
the symptoms of Tourette’s Syndrome and severe tics (sounds or (electrolytes) in your blood.
movements you can’t control), and behavioural problems in children.
Elderly:
2. Before you take Haloperidol Tablets 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
Do not take these tablets if you: will explain the possible risks of its use.
• are allergic to Haloperidol or to any of the other ingredients (see
section 6) Pregnancy and breast feeding:
• have, or have had, certain types of heart disease which cause Talk to your doctor before taking this medicine if you are pregnant,
abnormal or unusually slow heart beat think you may be pregnant or might become pregnant. Do not take this
• are taking any medicines which affect your heart beat medicine if you are breast feeding.
• have low levels of potassium in your blood The following symptoms may occur in newborn babies, of mothers that
• have Parkinson’s disease have used haloperidol in the last trimester (last three months of their
• have a lesion that affects part of your brain called the basal ganglia pregnancy): shaking, muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems, and difficulty in feeding. If your baby
• are less aware of things around you or your reactions become slower. develops any of these symptoms you may need to contact your doctor.
Your doctor will not use this medicine if you are in a coma.
Children:
Check with your doctor before taking these tablets if you:
Available safety data in the paediatric population indicate a risk of
• or someone else in your family has a history of blood clots, as extrapyramidal symptoms, including tardive dyskinesia (involuntary,
medicines like these have been associated with formation of blood
clots repetitive body movements), and sedation. No long-term safety data is
available.
• have a heart problem or anyone in your close family has died
suddenly of heart problems Effects on driving or operating machinery:
• have ever had bleeding in the brain, or your doctor has told you that This medicine may cause sedation and make you feel drowsy. Do not
you are more likely than other people to have a stroke drive or operate machinery if the medicine has this effect on you.
• have lower than normal levels of minerals (electrolytes) in your blood
• have not been eating properly for a long time Haloperidol Tablets and alcohol:
• have liver disease, kidney failure or an overactive thyroid gland Haloperidol may increase the effects of alcohol, making you feel drowsy
and less alert. You should be careful with how much alcohol you drink.
• have a tumour of the adrenal gland (near the kidney)
• suffer from depression Important information about some of the ingredients of
• suffer from epilepsy or convulsions (fits) this medicine:
• drink too much alcohol. These tablets contain lactose. If you have been told by your doctor that
You may need to be more closely monitored and the amount of tablets you have an intolerance to some sugars, contact your doctor before
you take may have to be altered. taking this medicinal product.
Taking other medicines: Also contains the colourants E102, E122 (5mg tablets) and E124 (10mg
tablets) which may cause allergic reactions.
Tell your doctor or pharmacist if you are taking any other medicines,
including any that you can buy without a prescription. This is particularly 3. How to take Haloperidol Tablets
important if you are taking:
• lithium (used to treat mental depression) as it can increase the risk Swallow the tablets with water.
of getting serious side effects. Your doctor will monitor lithium levels The usual doses are as given below but your doctor will decide the
in your blood. Tell your doctor straightaway and stop taking both dose that is best for you depending on the condition being treated and
medicines if you get a fever, movements you can’t control, or if you how severe it is. The pharmacist’s label will tell you how many tablets to
get confused, disoriented, a headache, balance problems and feel take and how often. If you are not sure about anything, ask your doctor
sleepy. These are signs of a serious condition or pharmacist.
• medicines for calming you down or to help you sleep (tranquillisers) Adults:
or for anxiety (e.g. buspirone, alprazolam)
For all indications except Tourette’s syndrome, severe tics and
• medicines to treat epilepsy (e.g. phenobarbital, carbamazepine) uncontrollable hiccups.
• antihistamine medicines for hayfever or other allergies (e.g. Starting dose:
terfenadine, promethazine)
• medicines for coughs and colds Moderate symptoms: 1.5-3.0 mg two to three times daily.
• strong pain killers Severe symptoms / resistant patients: 3.0-5.0 mg two to three times
daily.
• medicines to treat illnesses that affect the way you think, feel or
behave (antipsychotics or neuroleptics) In resistant schizophrenics, a maximum daily dose of up to 30 mg may
be necessary to successfully control symptoms. The same starting dose
• medicines for depression e.g. amitriptyline, maprotiline, fluoxetine, may be used in adolescents, who may, in certain cases require up to
paroxetine, venlafaxine, fluvoxamine, sertraline 30 mg per day.
• medicines used to treat Parkinson’s disease such as levodopa Maintenance dose: 5 mg or 10 mg per day.
For Tourette’s syndrome, severe tics and uncontrollable hiccups. • tremor, stiffness and shuffling, unbalanced walk, difficulty moving,
Starting dose: involuntary muscle contractions, stiff neck
• a fall in the number of white blood cells which can cause frequent
1.5 mg three times daily. infections
A daily maintenance dose of 10 mg may be required for Tourette’s • fits or convulsions
syndrome.
• fluid retention which may cause swelling in your body
Elderly: • sensitivity of skin to sunlight, itching, sweating more than usual
All indications except restlessness and agitation. • feeling confused or restless
Half the adult dose. • some people losing interest in sex
• painful periods or no monthly period
For restlessness or agitation. • change in milk flow from the breasts, painful breasts
Starting dose: 1.5-3.0 mg two to three times daily. • blurred vision
Maintenance dose: 1.5-30 mg daily. • breathlessness
• fever.
Children: Rare effects that may happen to less than 1 in 1000 people:
For childhood behavioural disorders / schizophrenia. • difficulty breathing or wheezing
Maintenance dose: Your doctor will work out the correct dose based • being unable to open the mouth
on the bodyweight of the child. The correct dose is written on the
pharmacist’s label. Half the total dosage should be given in the morning • some women unexpectedly producing breast milk
and the other half in the evening, up to a maximum of 10 mg daily. • irregular or heavy periods
• difficulties with sex such as problems with ejaculation
For Tourette’s syndrome. • uncontrolled eye movements.
Maintenance dose: up to 10 mg per day. Other effects:
Stopping Haloperidol and withdrawal effects: • a reduction in the number of blood cells which may cause
weakness, or bleeding or bruising more easily than normal and
This medicine is not to be stopped suddenly; keep taking your medicine make infections more likely
until your doctor tells you how to reduce the dose slowly. If you stop
taking these tablets suddenly, you may feel or be sick, have difficulty • fluid retention affecting the brain, resulting in weakness, tiredness or
sleeping or your medical condition may get worse. confusion
• flaking or peeling of the skin, inflamed skin (red, hot to the touch
If you forget to take a dose: and tender)
If you miss a dose of this medicine, take it as soon as possible. • red or purple raised spots on the skin which may be painful or itchy
However, if it is almost time for your next dose, skip the missed dose • puffy face
and continue with the regular dosing schedule. DO NOT DOUBLE THE • swelling of the throat, temporary inability to breathe or speak
DOSES. • low body temperature
If you have taken too many tablets: • unpleasant feelings of dullness or slowness
If you think you have taken too many tablets, contact your doctor • excitement
straight away or go to the nearest hospital casualty department. Take • swelling of the breasts in men or painful and prolonged erection
with you any remaining tablets and the container so the medicine can • loss of appetite, indigestion.
be identified.
Test results:
4. Possible side effects Abnormal test results for liver function, low blood sugar levels
(hypoglycaemia) and abnormal heart traces (electrocardiogram, ECG)
Like all medicines, haloperidol can cause side effects, although not have been observed.
everybody gets them.
Reporting of side effects:
Tell your doctor STRAIGHT AWAY if you notice any of the following If you get any side effects, talk to your doctor, pharmacist or nurse.
effects as you may need urgent medical attention: This includes any possible side effects not listed in this leaflet. You can
• blood clots in the veins especially in the legs (symptoms include also report side effects directly via the Yellow Card Scheme at:
swelling, pain and redness in the leg), which may travel through www.mhra.gov.uk/yellowcard. By reporting side effects you can help
blood vessels to the lungs causing chest pain and difficulty in provide more information on the safety of this medicine.
breathing
• difficulty breathing or dizziness; hives (raised red weals), severe 5. How to store Haloperidol Tablets
irritation, reddening or blistering of your skin; sudden swelling of Keep this medicine in the container provided. Store below 25°C and
the face, throat or lips. These may be signs of a serious allergic protect from light and moisture.
reaction. This only happens in a small number of people
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF
• a serious condition called “neuroleptic malignant syndrome” which CHILDREN
can occur in less than 1 in 1,000 people. Symptoms may include:
fast heart beat, changing blood pressure and sweating followed by Unless your doctor tells you to, do not keep any tablets that you no
fever; faster breathing, muscle stiffness, reduced consciousness longer need. Return them to the pharmacist.
and coma; raised levels of a protein in your blood (an enzyme Do not take the tablets if the expiry date on the label has passed.
called creatine phosphokinase)
• your heart may beat abnormally (arrhythmia). An arrhythmia can 6. Further information
cause your heart to stop beating (cardiac arrest). In elderly people
with dementia, a small increase in the number of deaths have been Ingredients:
reported for patients taking antipsychotics compared with those not Each tablet contains 0.5mg, 1.5mg, 5mg, 10mg or 20mg of the active
receiving antipsychotics. The precise frequency of how often this ingredient Haloperidol.
occurs is not known All the tablets also contain the inactive ingredients: lactose, povidone,
• jerky movements and problems such as slowness, muscle stiffness, maize starch, magnesium stearate and stearic acid. The 5 mg tablets
trembling and feeling restless. More saliva than normal, twitching also contain the colourants green S (E142), tartrazine (E102), patent
or unusual movements of the tongue, face, mouth, jaw or throat, or blue V (E131) and carmoisine (E122). The 10 mg tablets also contain
rapid blinking of the eyes. the colourant ponceau 4R (E124) and colloidal anhydrous silica.
Tell your doctor if you notice any of the following effects: What the medicine looks like:
Very common effects that may happen to more than 1 in 10 people: All Haloperidol Tablets are round and marked with the company logo on
• agitation, difficulty sleeping one side.
• headache. Haloperidol Tablets 0.5 mg are white and marked with A488 on one
Common effects that may happen to less than 1 in 10 people: side.
• symptoms of psychosis such as abnormal thoughts or visions, or Haloperidol Tablets 1.5 mg are white and marked with A489 on one
hearing abnormal sounds side.
• feeling low or depressed or sleepy Haloperidol Tablets 5 mg are light green and marked with A490 on one
• inability to sit still, trembling, rigid posture, mask-like face, slow side.
movements Haloperidol Tablets 10 mg are pink and marked with A491 on one side.
• feeling light headed or dizzy, particularly when standing up Haloperidol Tablets 20 mg are white and marked with A492 on one side.
• problems with sight, rolling of the eyes This medicine is available in pack sizes of 28, 30, 42, 56, 60, 84, 90
• problems getting an erection and 112 tablets. (Not all pack sizes may be marketed).
• rash
• changes in weight Who makes this medicine and holds the Product Licence:
• dry mouth, feeling or being sick, constipation Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,
• difficulty passing urine. Polhampton Lane, Overton, Hants, RG25 3ED
Uncommon effects that may happen to less than 1 in 100 people: Date leaflet revised: June 2013
• liver problems, signs include yellowing of the skin and eyes, pale If you would like this leaflet in a different format please contact the
stools and dark coloured urine licence holder at the above address.