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Package Leaflet: Information for the User

1.5mg, 5mg, 10mg & 20mg
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• 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.
Haloperidol belongs to a group of medicines called ‘neuroleptics’.
Haloperidol is used to treat:
• Schizophrenia and other psychological disturbances.
• Mental or behavioural disorders including hyperactivity or aggressive
behaviour, in adults and children.
• Gilles de la Tourette syndrome and severe tics.
• Restlessness and agitation in the elderly.
• Hiccups that will not stop.
Do not take Haloperidol Tablets if you:
• are allergic (hypersensitive) to haloperidol or any of the other ingredients
(listed in section 6)
• have Parkinson’s disease
• have or have had serious heart problems, unusually slow heart beat or a
history of arrhythmias
• are taking medicines that affect your heart
• are in a comatose state (extremely drowsy)
• are less aware of things around you or your reactions are slower
• have a condition that affects part of your brain called the ‘basal ganglia’
• have a low level of potassium in your blood.
Talk to your doctor or pharmacist before you take this medicine if you have:
• liver disease, thyroid problems or kidney failure
• epilepsy or a condition that might lead to epilepsy, such as alcohol withdrawal
or brain damage
• heart problems (or anyone in your close family has had heart problems)
• depression
• a tumour of the adrenal gland (phaeochromocytoma)
• bleeding in the brain (subarachnoid haemorrhage) or have been told that you
are at risk of a stroke
• low levels of minerals in your blood
• not been eating properly or are an alcoholic
• if you are elderly, as you may be more sensitive to side 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.
Your doctor may take an ECG (to measure the electrical activity of your heart)
before or during treatment. Blood tests may also be done to check the levels of
minerals (electrolytes).
Available data in the children indicate a risk of extrapyramidal symptoms, including
tardive dyskinesia (involuntary, repetitive body movements), and sedation. No longterm safety data are available.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following:
• tranquillisers, hypnotics, sedatives or strong painkillers
• antipsychotics or neuroleptics, e.g. phenothiazines, pimozide, chlorpromazine and
used to treat mental illness
• anticonvulsants for epilepsy, e.g. phenobarbital or carbamazepine
• antidepressants, e.g. paroxetine, fluoxetine, amitriptyline, maprotiline,
venlafaxine, fluvoxamine or sertraline
• medicines to lower the blood pressure e.g. guanethidine, methyldopa or
diuretics (water tablets)
• medicines to treat malaria, e.g. quinine and mefloquine
• medicines to treat abnormal heart beats e.g. quinidine disopyramide, bretylium,
procainamide, amiodarone, sotalol and dofetilide
• medicines to treat infections e.g. rifampicin, sparfloxacin, moxifloxacin,
erythromycin IV
• medicines for coughs and colds
• ketoconazole or itraconazole, used to treat fungal infections
• adrenaline, used to treat severe allergic reactions
• levodopa for Parkinson’s disease
• phenindione, used to thin the blood
• busipirone or alprazolam used to treat anxiety
• antihistamines, e.g. terfenadine or promethazine, used to treat allergies
• lithium, used to treat certain forms of mental illness. You may need
special monitoring. Tell your doctor immediately if you are taking
lithium and haloperidol and experience confusion, headache,
disorientation, balance problems or drowsiness.
Taking Haloperidol Tablets with alcohol
You should be careful how much alcohol you drink while taking Haloperidol
Tablets as you might feel drowsy and less alert.
Pregnancy and breast-feeding
Talk to your doctor before taking Haloperidol Tablets if you are pregnant, think
you may be pregnant or are planning to become pregnant.
The following symptoms may occur in newborn babies, of mothers that have used
haloperidol in the last trimester (last 3 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
Talk to your doctor if you are breast-feeding. This is because small amounts of
haloperidol may pass into the mother’s milk.
Driving and using machines
Haloperidol may cause dizziness or drowsiness. If affected do not drive or
operate machinery.
Important information about some of the ingredients
Haloperidol Tablets contain lactose monohydrate. If your doctor has told you that
you are intolerant of some sugars, discuss it with them before taking this

Always take Haloperidol Tablets exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
• The tablets should be swallowed with a drink of water.
• Take them with or shortly after food.
Continued overleaf
• The starting dose is normally between 1.5 mg and 5 mg, taken 2 or 3 times
a day. Your doctor may reduce the dose when symptoms improve.
• The elderly usually start on a lower dose.
• The dose is normally 0.025 to 0.05 mg per kilogram body weight each day.
• Half the dose should be taken in the morning and the other half in the
• The maximum dose each day is 10 mg.
If you take more Haloperidol Tablets than you should or if someone else
has taken any tablets, talk to a doctor or go to the nearest hospital casualty
department immediately.
If you forget to take Haloperidol Tablets take your next dose as usual.
Then keep taking your medicine as your doctor has told you. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Haloperidol Tablets
You should not stop taking the tablets suddenly as this may cause nausea or
vomiting and difficulty sleeping. If you are advised to stop taking this medicine
it should be done gradually.
Like all medicines, Haloperidol Tablets can cause side effects, although not
everybody gets them.
Stop taking the tablets and tell your doctor or go to the nearest hospital
casualty department immediately if you notice any of the following.
You may need urgent medical treatment:
• Swelling of the face or throat, rash, difficulty breathing. These may be signs
of a severe allergic reaction.
• 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.
• Abnormal heartbeats (arrhythmia). This can cause your heart to stop
• 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.
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.
Tell your doctor or pharmacist if you notice any of the following:

Very common side effects (affects more than 1 in 10 people)
• Feeling agitated, excessive movement of the muscles

• Headache or having difficulty sleeping
Common side effects (affects fewer than 1 in 10 people)
• Trembling, rigid posture, mask-like face, slow movements, abnormal involuntary
movements causing twisting, jerking or abnormal postures, restlessness, lack of
• Feeling dizzy, depressed or sleepy
• Feeling light headed, particularly when standing up (low blood pressure)
• Symptoms of psychosis such as abnormal thoughts or visions, or hearing abnormal
• Abnormal test results for liver function
• Problems with sight, rapid eye movements
• Rash
• Feeling sick, being sick, dry mouth, excessive salivation
• Constipation, difficulty passing water (urine)
• Weight changes
• Problems with erection
Uncommon side effects (affects fewer than 1 in 100 people)
• Liver problems including yellowing of the skin and eyes, pale stools and dark
coloured urine
• Feeling confused or restless, unsteady when walking
• Jerky or involuntary movements, muscle spasm, rigidity or stiffness
• A fall in the number of white blood cells which can cause frequent infections
• Fits or seizures (convulsions)
• Difficulty breathing
• Sensitivity of skin to sunlight, itching, nettle rash
• Blurred vision
• Sweating more than usual, fever
• Swelling of the ankles
• High blood pressure, increased heart rate
• Unexpected production of breast milk, irregular, painful or missed periods, pain or
swelling of the breast; loss of interest or problems with sex.
Rare side effects (affects less than 1 in 1000 people)
• Raised prolactin hormone levels in the blood
• Being unable to open mouth, spasm of the airways, involuntary eye movements
• Muscle twitching
• Red itchy skin rash
• Heavy periods, menstrual disorder, sexual dysfunction
• Drowsiness, vertigo
• Abnormal ECG heart traces
Other side effects (frequency unknown)
• Reduction in the number of red and white blood cells and platelets. May cause
bleeding or bruising more easily than normal
• Low blood sugar, inappropriate antidiuretic hormone secretion
• Fluid in the throat, spasm of the airways
• Liver failure, biliary disorders
• Inflammation of the blood vessels characterised by fever, muscle and joint pain

• Excitement
• Loss of appetite, indigestion
• Flaking or peeling of the skin
• Enlarged breasts in males, painful erection
• Low body temperature
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not store above 25ºC. Keep the container well closed. Protect from light.
Do not use Haloperidol Tablets after the expiry date, which is stated on
the label.
What Haloperidol Tablets contain:
The active substance is haloperidol 1.5mg, 5mg, 10mg or 20mg
The other ingredients are lactose monohydrate, maize starch, povidone,
magnesium stearate; stearic acid (20mg tablets only); sodium starch
glycollate and erythrosine (E127) (5 & 10mg tablets only).
What Haloperidol Tablets look like and pack sizes
1.5mg: White, round tablets with ‘M & A’ logo and ‘104’ on either side of a
break line. Plain on the reverse.
5mg: Red, round tablets with ‘M & A’ logo and ‘113’ on either side of a
break line. Plain on the reverse.
10mg: Pink, round tablets with ‘M & A’ logo and ‘124’ on either side of a
break line. Plain on the reverse.
20mg: White, round, flat tablets with ‘M & A’ logo and ‘H20’ on either
side of a break line. Plain on the reverse.
Pack sizes: 28, 30, 50, 100, 250, 500 & 1000 tablets (1.5, 5 and 10mg
tablets), 50, 100, 250, 500 & 1000 tablets (20mg tablets). Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
M & A Pharmachem Ltd, Bolton BL5 2AL, UK.
This leaflet was last revised in 11/2013

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