HALOPERIDOL 5 MG TABLETS
Active substance(s): HALOPERIDOL
EAS1491a LEA HALOPERIDOL 1.5MG, 5MG, 10MG AND 20MG TAB TUK
07 September 2017
PANTONE® GREEN C
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 662
Page 1 of 3
Top of page cut-off to middle of registration mark: 44 mm.
Other medicines and Haloperidol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
Do not take Haloperidol if you are taking certain medicines for:
Package leaflet: Information for the patient
• Problems with your heart beat (such as amiodarone, dofetilide, disopyramide,
dronedarone, ibutilide, quinidine and sotalol)
Read all of this leaflet carefully before you start taking this medicine because it
• Depression (such as citalopram and escitalopram)
contains important information for you.
• Psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozide,
• Keep this leaflet. You may need to read it again.
prochlorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine
• 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
• Bacterial infections (such as azithromycin, clarithromycin, erythromycin,
harm them, even if their signs of illness are the same as yours.
levofloxacin, moxifloxacin and telithromycin)
• If you get any side effects, talk to your doctor or pharmacist. This includes any
• Fungal infections (such as pentamidine)
possible side effects not listed in this leaflet. See section 4.
• Malaria (such as halofantrine)
What is in this leaflet
• Nausea and vomiting (such as dolasetron)
• Cancer (such as toremifene and vandetanib).
1. What Haloperidol is and what it is used for
2. What you need to know before you take Haloperidol
Also tell your doctor if you are taking bepridil (for chest pain or to lower blood pressure)
3. How to take Haloperidol
or methadone (a pain killer or to treat drug addiction).
4. Possible side effects
These medicines may make heart problems more likely, so talk to your doctor if you are
5. How to store Haloperidol
taking any of these and do not take Haloperidol (see ‘Do not take Haloperidol if’).
6. Contents of the pack and other information
Special monitoring may be needed if you are taking lithium and Haloperidol at the
What Haloperidol is and what it is used for
Tell your doctor straight away and stop taking both medicines if you get:
• Fever you can’t explain or movements you can’t control
Haloperidol belongs to a group of medicines called ‘antipsychotics’.
• Confused, disoriented, a headache, balance problems and feel sleepy.
Haloperidol is used in adults, adolescents and children for illnesses affecting the
These are signs of a serious condition.
way you think, feel or behave. These include mental health problems (such as
Certain medicines may affect the way that Haloperidol works or may make heart
schizophrenia and bipolar disorder) and behavioural problems.
problems more likely
These illnesses may make you:
Tell your doctor if you are taking:
• Feel confused (delirium)
• Alprazolam or buspirone (for anxiety)
• See, hear, feel or smell things that are not there (hallucinations)
• Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St John’s
• Believe things that are not true (delusions)
Wort (Hypericum, perforatum) or venlafaxine (for depression)
• Feel unusually suspicious (paranoia)
• Bupropion (for depression or to help you stop smoking)
• Feel very excited, agitated, enthusiastic, impulsive or hyperactive
• Carbamazepine, phenobarbital or phenytoin (for epilepsy)
• Feel very aggressive, hostile or violent.
• Rifampicin (for bacterial infections)
In adolescents and children, Haloperidol is used to treat schizophrenia in patients
• Itraconazole, posaconazole or voriconazole (for fungal infections)
aged 13 to 17 years, and to treat behavioural problems in patients aged 6 to 17 years.
• Ketoconazole tablets (to treat Cushing’s syndrome)
Haloperidol is also used:
• Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV)
• In adolescents and children aged 10 to 17 years and in adults for movements or
• Chlorpromazine or promethazine (for nausea and vomiting)
sounds you can’t control (tics), for example in severe Tourette’s syndrome
• Verapamil (for blood pressure or heart problems).
• In adults to help control movements in Huntington’s disease.
Also tell your doctor if you are taking any other medicines to lower blood pressure,
such as water tablets (diuretics).
Haloperidol is sometimes used when other medicines or treatments have not
worked or caused unacceptable side effects.
Your doctor may have to change your dose of Haloperidol if you are taking any of these
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:
Do not take Haloperidol if:
• Calming you down or helping you to sleep (tranquillisers)
• You are allergic to haloperidol or any of the other ingredients of this medicine
• Pain (strong pain killers)
(listed in section 6)
• You are less aware of things around you or your reactions become unusually slow • Depression (‘tricyclic antidepressants’)
• Lowering blood pressure (such as guanethidine and methyldopa)
• You have Parkinson’s disease
• Severe allergic reactions (adrenaline)
• You have a type of dementia called ‘Lewy body dementia’
• Attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as ‘stimulants’)
• You have progressive supranuclear palsy (PSP)
• Parkinson’s disease (such as levodopa)
• You have a heart condition called ‘prolonged QT interval’, or any other problem
• Thinning the blood (phenindione).
with your heart rhythm that shows as an abnormal tracing on an ECG
Talk to your doctor before taking Haloperidol if you are taking any of these medicines.
Haloperidol and alcohol
• You have heart failure or recently had a heart attack
Drinking alcohol while you are taking Haloperidol might make you feel sleepy and less
• You have a low level of potassium in your blood, which has not been treated
• You take any of the medicines listed under ‘Other medicines and Haloperidol – Do alert. This means you should be careful how much alcohol you drink. Talk to your
doctor about drinking alcohol while taking Haloperidol, and let your doctor know how
not take Haloperidol if you are taking certain medicines for’.
much you drink.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to
Pregnancy, breast-feeding and fertility
your doctor or pharmacist before taking Haloperidol.
Pregnancy – if you are pregnant, think you may be pregnant or are planning to have a
Warnings and precautions
baby, ask your doctor for advice. Your doctor may advise you not to take Haloperidol
Serious side effects
while you are pregnant.
Haloperidol can cause problems with the heart, problems controlling body or limb
The following problems may occur in newborn babies of mothers that take Haloperidol
movements and a serious side effect called ‘neuroleptic malignant syndrome’. It can
in the last 3 months of their pregnancy (the last trimester):
also cause severe allergic reactions and blood clots. You must be aware of serious
• Muscle tremors, stiff or weak muscles
side effects while you are taking Haloperidol because you may need urgent medical
• Being sleepy or agitated
treatment. See ‘Look out for serious side effects’ in section 4.
• Problems breathing or feeding.
Elderly people and people with dementia
The exact frequency of these problems is unknown. If you took Haloperidol while
A small increase in deaths and strokes has been reported for elderly people with
pregnant and your baby develops any of these side effects, contact your doctor.
dementia who are taking antipsychotic medicines. Talk to your doctor or pharmacist
before taking Haloperidol if you are elderly, particularly if you have dementia.
Breast-feeding – talk to your doctor if you are breast-feeding or planning to
breast-feed. This is because small amounts of the medicine may pass into the mother’s
Talk to your doctor or pharmacist if you have:
• A slow heart beat, heart disease or anyone in your close family has died suddenly of milk and on to the baby. Your doctor will discuss the risks and benefits of
breast-feeding while you are taking Haloperidol.
• Low blood pressure, or feel dizzy upon sitting up or standing up
Fertility – Haloperidol may increase your levels of a hormone called ‘prolactin’, which
• A low level of potassium or magnesium (or other ‘electrolyte’) in your blood. Your
may affect fertility in men and women. Talk to your doctor if you have any questions
doctor will decide how to treat this
• Ever had bleeding in the brain, or your doctor has told you that you are more likely
Driving and using machines
than other people to have a stroke
Haloperidol can affect your ability to drive and use tools or machines. Side effects,
• Epilepsy or have ever had fits (convulsions)
such as feeling sleepy, may affect your alertness, particularly when you first start
• Problems with your kidneys, liver or thyroid gland
taking it or after a high dose. Do not drive or use any tools or machines without
• A high level of the hormone 'prolactin' in your blood, or cancer that may be caused
discussing this with your doctor first.
by high prolactin levels (such as breast cancer)
Haloperidol 1.5 mg, 5 mg, 10 mg and 20 mg tablets contain Lactose
• A history of blood clots, or someone else in your family has a history of blood clots
If you have been told by your doctor that you have an intolerance to some sugars,
• Depression, or you have bipolar disorder and start to feel depressed.
contact your doctor before taking this medicinal product
You may need to be more closely monitored, and the amount of Haloperidol you take
Haloperidol 5 mg tablets contain tartrazine (E102) and azorubine, carmoisine (E122)
may have to be altered.
May cause allergic reactions.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist
Haloperidol 5 mg tablets contain ponceau 4R red (E124)
before taking Haloperidol.
May cause allergic reactions.
Medical check ups
• Patients who are intolerant to lactose should note that Haloperidol tablets contain a
Your doctor may want to take an electrocardiogram (ECG) before or during your
small amount of lactose. If your doctor has told you that you have an intolerance to
treatment with Haloperidol. The ECG measures the electrical activity of your heart.
some sugars, contact your doctor before taking this medicine.
• Patients should also note that the 5 mg Tablets contain tartrazine (E102) and
Your doctor may want to check the levels of potassium or magnesium (or other
azorubine, carmoisine (E122), and the 10 mg Tablets contain ponceau 4R red (E124),
‘electrolyte’) in your blood before or during your treatment with Haloperidol.
as colouring agents. These may cause allergic reactions.
Children below 6 years of age
Haloperidol should not be used in children below 6 years of age. This is because it has
not been studied adequately in this age group.
Haloperidol 1.5 mg, 5 mg,
10 mg and 20 mg tablets
EAS1491a LEA HALOPERIDOL 1.5MG, 5MG, 10MG AND 20MG TAB TUK
07 September 2017
PANTONE® GREEN C
PAGE 2: REAR FACE (OUTSIDE OF REEL)
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)
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• Abnormal muscle tension
How much should you take
• Feeling dizzy, including upon sitting up or standing up
Your doctor will tell you how many tablets to take and for how long. Your doctor will also
• Feeling sleepy
tell you whether to take Haloperidol one or more times a day. It may be some time before
• Upward movement of the eyes or fast eye movements that you cannot control
you feel the full effect of the medicine. Your doctor will normally give you a low dose to
• Problems with vision, such as blurred vision
start, and then adjust the dose to suit you. It is very important you take the correct
• Low blood pressure
• Nausea, vomiting
Your dose of haloperidol will depend on:
• Your age
• Dry mouth or increased saliva
• What condition you are being treated for
• Skin rash
• Whether you have problems with your kidneys or liver
• Being unable to pass urine or empty the bladder completely
• Other medicines you are taking.
• Difficulty getting and keeping an erection (impotence)
• Weight gain or loss
• Your dose will normally be between 0.5 mg and 10 mg each day.
• Changes that show up in blood tests of the liver.
• Your doctor may adjust this to find the dose that suits you best.
Uncommon (may affect up to 1 in 100 people):
• The highest dose adults should take depends on the condition you are being treated
• Effects on blood cells – low number of all types of blood cells, including severe
for and varies between 5 mg and 20 mg each day.
decreases in white blood cells and low number of ‘platelets’ (cells that help blood to
• Elderly people will normally start on 0.5 mg each day or half the lowest adult dose.
• Feeling confused
• The number of tablets you take will then be adjusted until the doctor finds the dose
• Loss of sex drive or decreased sex drive
that suits you best.
• Fits (seizures)
• The highest dose elderly people should take is 5 mg each day unless your doctor
• Stiff muscles and joints
decides a higher dose is needed.
• Muscle spasms, twitching or contractions that you cannot control, including a
spasm in the neck causing the head to twist to one side
Children and adolescents 6 to 17 years of age
• Problems walking
• Your dose will normally be between 0.5 mg and 3 mg each day.
• Being short of breath
• Adolescents up to 17 years of age being treated for schizophrenia or behavioural
• Inflamed liver, or liver problem that causes yellowing of the skin or eyes (jaundice)
problems may have a higher dose, up to 5 mg each day.
• Increased sensitivity of the skin to sunlight
• Haloperidol is for oral use.
• Excessive sweating
• Swallow the tablets with some water.
• Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful
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
• Unexpected production of breast milk
Haloperidol, talk to a doctor or go to the nearest hospital casualty department straight
• Breast pain or discomfort
• High body temperature
If you forget to take Haloperidol
• Swelling caused by fluid build up in the body.
• If you forget to take a dose, take your next dose as usual. Then keep taking your
Rare (may affect up to 1 in 1,000 people):
medicine as your doctor has told you.
• High level of the hormone ‘prolactin’ in the blood
• Do not take a double dose.
• Narrowed airways in the lungs, causing difficulty breathing
If you stop taking Haloperidol
• Difficulty or being unable to open the mouth
Unless your doctor tells you otherwise, you should stop taking Haloperidol gradually.
• Problems having sex.
Stopping treatment suddenly may cause effects such as:
The following side effects have also been reported, but their exact frequency is
• Nausea and vomiting
• Difficulty sleeping.
• High level of ‘antidiuretic hormone’ in the blood (syndrome of inappropriate
Always follow your doctor’s instructions carefully.
antidiuretic hormone secretion)
If you have any further questions on the use of this medicine, ask your doctor or
• 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
Possible side effects
• Sudden liver failure
• Decreased bile flow in the bile duct
Like all medicines, this medicine can cause side effects, although not everybody gets
• Flaking or peeling skin
• Inflamed small blood vessels, leading to a skin rash with small red or purple bumps
Look out for serious side effects
• Breakdown of muscle tissue (rhabdomyolysis)
Tell your doctor straight away if you notice or suspect any of the following. You may need • Persistent and painful erection of the penis
urgent medical treatment.
• Enlarged breasts in men
• Low body temperature.
Problems with the heart:
• Abnormal heart rhythm – this stops the heart working normally and may cause loss of Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
• Abnormally fast heart beat
side effects not listed in this leaflet. You can also report side effects directly via the
• Extra heart beats.
Yellow Card Scheme
Heart problems are uncommon in people taking Haloperidol (may affect up to 1 in 100
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google
people). Sudden deaths have occurred in patients taking this medicine, but the exact
Play or Apple App Store. By reporting side effects you can help provide more
frequency of these deaths is unknown. Cardiac arrest (the heart stops beating) has also information on the safety of this medicine.
occurred in people taking antipsychotic medicines.
How to store Haloperidol
A serious problem called ‘neuroleptic malignant syndrome’. This causes a high fever,
severe muscle stiffness, confusion and loss of consciousness. It is rare in people taking
Keep this medicine out of the sight and reach of children.
Haloperidol (may affect up to 1 in 1,000 people).
Problems controlling movements of the body or limbs (extrapyramidal disorder), such as: Do not use this medicine after the expiry date which is stated on the blister or carton.
The expiry date refers to the last day of that month.
• Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
Store below 25º C. Store in the original package and protect from light.
• Feeling restless or difficulty sitting still, increased body movements
• Slow or reduced body movements, jerking or twisting movements
Do not throw away any medicines via wastewater or household waste. Ask your
• Muscle tremors or stiffness, a shuffling walk
pharmacist how to throw away medicines you no longer use. These measures will help
• Being unable to move
protect the environment.
• Lack of normal facial expression that sometimes looks like a mask.
Contents of the pack and other information
These are very common in people taking Haloperidol (may affect more than 1 in 10
people). If you get any of these effects, you may be given an additional medicine.
What Haloperidol tablets contain:
Severe allergic reaction that may include:
• The active substance is haloperidol, either 1.5 mg, 5 mg, 10 mg or 20 mg
• A swollen face, lips, mouth, tongue or throat
• The other ingredients are lactose, povidone, maize starch, magnesium stearate
• Difficulty swallowing or breathing
(E572), and stearic acid
• Itchy rash (hives).
An allergic reaction is uncommon in people taking Haloperidol (may affect up to 1 in 100 • The 5 mg tablet also contains the colours acid brilliant green BS (E142), tartrazine
(E102), patent blue V (E131) and azorubine, carmoisine (E122)
• The 10 mg tablet also contains colloidal anhydrous silica and the colour ponceau
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 What Haloperidol tablets look like and contents of the pack:
chest pain and difficulty in breathing. Blood clots can be very serious, so tell your doctor • The 1.5 mg tablet is white biconvex marked 3S2 on one side
• The 5 mg tablet is light green biconvex marked 4S2 on one side
straight away if you notice any of these problems.
• The 10 mg tablet is pink biconvex marked 5S2 on one side
Tell your doctor straight away if you notice any of the serious side effects above.
• The 20 mg tablet is white biconvex marked 6S2 on one side
Other side effects
• The product is available in pack sizes of 25, 28, 50, 56, 84, 100, 250, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Tell your doctor if you notice or suspect any of the following side effects.
Marketing Authorisation Holder and Manufacturer
Very common (may affect more than 1 in 10 people):
Marketing Authorisation holder and company responsible for manufacture: TEVA UK
• Feeling agitated
Limited, Eastbourne, BN22 9AG.
• Difficulty sleeping
This leaflet was last revised: August 2017
How to take Haloperidol
Page 2 of 3
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.