UK Edition. Click here for US version.
HALOPERIDOL TABLETS BP 5MG
231-30-85109-ZA LEA HALOPERIDOL A/S TAB TUK
08 May 2015
PAGE 1: FRONT FACE (INSIDE OF REEL)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
• 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. 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.
WHAT HALOPERIDOL IS AND WHAT IT IS USED FOR
Haloperidol belongs to a group of drugs known as antipsychotics.
Pharma code 555
Haloperidol is used to treat:
• schizophrenia and other similar mental disorders such as mania
(feeling elated or over-excited, which causes unusual behaviour) and
paranoia as well as violent or dangerous impulsive behaviour
• aggression, overactivity, and self-mutilation in patients who are
mentally ill and are likely to behave dangerously
• Tourette’s syndrome and tics (repeated and largely involuntary
• restlessness and agitation in the elderly
• behavioural disorders in children, especially those associated with
hyperactivity and aggression.
BEFORE YOU TAKE HALOPERIDOL
DO NOT take Haloperidol and talk to your doctor if you:
• are allergic (hypersensitive) to haloperidol or any of the other
ingredients of this medicine
• are breast-feeding
• suffer from Parkinson’s disease
• have been told by your doctor that you have a condition that affects
part of your brain called the “basal ganglia”
• suffer from uncorrected hypokalaemia (low levels of potassium in
• have severe heart problems e.g. recent heart attack, heart failure,
irregular heart beat for which you need to take medicine
• have a family history of unexplained fainting, blackouts or heart
• are taking certain other medicines which can affect the heart (see
‘Taking other medicines’)
• have a rare hereditary problem of galactose intolerance, the Lapp
lactose deficiency or glucose-galactose malabsorption
• are less aware of things around you or your reactions become
Haloperidol should not be given to patients if they are in a coma.
Warnings and precautions
Talk to your doctor before you start to take this medicine if you:
• are elderly as you may be more sensitive to the effects of Haloperidol
• are at risk of blood clot in the vein (deep vein thrombosis)
• have or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood
• suffer from epilepsy or conditions that might cause epilepsy such as
alcohol withdrawal or brain damage
• have diseased arteries
• suffer from dementia
• suffer from depression
• have low blood pressure, calcium or magnesium levels or have not
eaten for a prolonged length of time
• have problems with alcohol abuse or alcoholism
• have ever had any problems with your liver, kidneys or heart, or there
is a history in your family of heart problems or sudden death
• have previously had a stroke, transient ischaemic attack (TIA) or have a
family history of strokes
• have ever had a growth in your adrenal gland (phaeochromocytoma)
or trouble with your thyroid gland, which caused too much thyroid
hormone to be made (thyrotoxicosis).
You may need to be more closely monitored, and the amount of
Haloperidol tablets you take may have to be altered. If you are not sure if
any of the above apply to you, talk to your pharmacist before taking
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or
during your treatment with Haloperidol tablets. The ECG measures the
electrical activity of your heart.
Your doctor may want to check the levels of minerals (electrolytes) in
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
will explain the possible risks of its use.
Special monitoring may be needed if you are taking lithium and
Haloperidol tablets at the same time. Tell your doctor straight away and
stop taking both medicines if you get:
• confused, disoriented, a headache, balance problems and feel sleepy.
These are signs of serious conditions.
DO NOT take Haloperidol if you are taking:
• certain other medicines which can affect the heart e.g. quinidine,
bretylium, disopyramide, procainamide, amiodarone, sotalol, dofetilide.
IN THIS LEAFLET:
1. What Haloperidol is and what it is used for
2. Before you take Haloperidol
3. How to take Haloperidol
4. Possible side effects
5. How to store Haloperidol
6. Further information
Taking other medicines
Talk to your doctor if you are taking any of the following:
• any other medicine similar to haloperidol known as a neuroleptic e.g.
sertindole, pimozide, promazine, amisulpride
• certain medicines for the treatment of depression e.g. fluoxetine,
amitriptyline, maprotiline, trazodone, lithium, phenothiazines,
chlorpromazine, sertraline, fluvoxamine, venlafaxine
• sleeping tablets, sedatives or strong pain killers
• medicines which can affect the chemicals in your bloodstream known
as electrolytes, such as diuretics, e.g. furosemide
• medicines for changes in your heart beat or are taking medicines that
affect your heart beat
• certain antibiotics e.g. moxifloxacin, sparfloxacin, erythromycin,
• levodopa, for Parkinson’s disease
• certain other medicines called antidyskinetic drugs often used for
treatment of Parkinson’s disease e.g. procyclidine, trihexyphenidyl and
• bromocriptine, used for a number of conditions including absence of
menstrual periods, infertility, abnormal discharge of milk from the
breast, Parkinson’s disease
• quinine and mefloquine, for malaria
• guanethidine, medicine used for high blood pressure
• cisapride, medicine for some types of indigestion
• indomethacin, for rheumatoid arthritis
• methyldopa, to lower your blood pressure
• carbamazepine and phenobarbital, for epilepsy
• any antihistamine, for an allergy or hay-fever e.g. promethazine
• medicine for anxiety, e.g. buspirone, alprazolam
• any antimuscarinic drug e.g. ipratropium, atropine, hyoscine
• sympathomimetic agents e.g. found in cold and flu remedies – please
check with your pharmacist
• adrenaline, used in emergency situations e.g. to treat severe allergic
• medicines for fungal infection, such as ketoconazole, itraconazole
• phenindione, to prevent and treat blood clots.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
Important information about some of the ingredients of Haloperidol
• Patients who are intolerant to lactose should note that Haloperidol
tablets contain a small amount of lactose. If your doctor has told you
that you have an intolerance to some sugars, contact your doctor
before taking this medicine.
• Patients should also note that the 5 mg Tablets contain tartrazine (E102)
and azorubine, carmoisine (E122), and the 10 mg Tablets contain
ponceau 4R red (E124), as colouring agents. These may cause allergic
Taking Haloperidol with food and drink
• DO NOT drink alcohol while you are taking Haloperidol.
Pregnancy and breast-feeding
• 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
• DO NOT take Haloperidol if you are breast-feeding. This is because
small amounts may pass into mother’s milk.
• If you are pregnant or planning to become pregnant, ask your doctor
for advice before taking this medicine.
Driving and using machines
• Haloperidol may cause drowsiness or impaired alertness, especially at
the start of your treatment or when taken at higher doses. If you are
affected, DO NOT drive or operate machinery without discussing this
with your doctor first.
HOW TO TAKE HALOPERIDOL
Always take Haloperidol exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
You may not feel better for several weeks after you start to take your tablets.
The tablets should be swallowed preferably with a drink of water. The
usual dose is:
• Mental disorders
The most common dose is between 1.5 mg and 20 mg a day, taken as a
single dose or two smaller doses. Your doctor may increase this dose
up to a maximum of 30 mg a day in some cases. When your doctor is
happy that you are responding to your treatment, he may gradually
reduce the dose. This could be as low as 3 mg to 10 mg a day.
Page 1 of 3
Top of page cut-off to middle of registration mark: 44 mm.
Available safety data in the paediatric population indicate a risk of
extrapyramidal symptoms, including tardrive dyskinesia (involuntary,
repetitive body movements), and sedation. No long-term safety data is
HALOPERIDOL 1.5 mg, 5 mg,
10 mg AND 20 mg TABLETS
TEVA UK Ref:
231-30-85109-ZA LEA HALOPERIDOL A/S TAB TUK
08 May 2015
PAGE 2: REAR FACE (OUTSIDE OF REEL)
• rapid heart beat
• shortness of breath
• inflammation of the liver or jaundice (your skin and the whites of your
eyes may become yellow) due to a change in the way your liver works
• skin reactions (for example red, flaky skin), your skin may become
sensitive to the sun and severe inflamed patches may appear on your
If you are elderly, your doctor will probably give you half the doses
• itching, sweating more than usual
• if you are a woman, you may unexpectedly produce milk, have painful
breasts and your periods may become infrequent or stop
• shuffling, unbalanced walk, tilted neck
Your doctor will work out the dose depending on your child’s weight. The
• feeling too warm (hyperthermia)
usual dose is 25 to 50 micrograms for each kilogram (kg) of body weight
• fluid may build up in your body causing swollen feet or ankles.
up to a maximum of 10 mg. Teenagers may be given up to 30 mg a day.
If you take more Haloperidol than you should
• if you are a woman, your body may make too much of the hormone
If you (or someone else) swallow a lot of the tablets all together, or if you
think a child has accidentally swallowed any of the tablets, contact your
• getting excited, symptoms of psychosis such as abnormal thoughts or
nearest hospital casualty department or your doctor immediately.
vision, or hearing abnormal sounds
An overdose is likely to cause muscle weakness, muscle stiffness, shaking, • difficulty breathing or wheezing
low blood pressure, drowsiness.
• unable to open your mouth (Trismus)
Please take this leaflet, any remaining tablets, and the container with you
• abnormal heavy and prolonged menstrual periods at regular intervals
to the hospital or doctor so that they know which tablets were consumed.
• abnormal heart rhythms.
Other side effects
If you forget to take Haloperidol
• bleeding or bruising more easily than normal. This can be caused by a
If you forget to take a tablet, take one as soon as you remember, unless it
fall in the number of small blood cells called platelets
is nearly time to take the next one. DO NOT take a double dose to make up
• Feeling unwell, confused or weak, feeling sick (nausea), loss of
for a forgotten dose. If it is nearly time to take the next dose, wait until
appetite, feeling irritable. This could be an illness called ‘syndrome of
then and then carry on as before.
inappropriate anti-diuretic hormone secretion’ (SIADH).
• low level of blood glucose (hypoglycaemia)
If you stop taking Haloperidol
DO NOT stop taking Haloperidol without talking to your doctor first even if • excitement
• feeling drowsy and mentally dulled
you feel better.
• blue discolouration of skin, breathing difficulties, gagging
When you stop taking Haloperidol, your doctor will reduce the dose
gradually to avoid the possibility of withdrawal symptoms, such as feeling • heart problems causing symptoms such as palpitations, abnormal
heart rhythms, fainting, blackouts or rarely heart attacks. These occur
and being sick and being unable to sleep, or the recurrence of your original
more frequently at high doses and in patients who are at greater risk of
If you have any further questions on the use of this product, ask your
• swelling of the voice box or contraction of the muscle in the voice box
doctor or pharmacist.
• loss of appetite, feeling sick, indigestion, stomach upsets
• acute liver failure
• inflammation of blood vessels
4 POSSIBLE SIDE EFFECTS
• flaking or peeling of the skin
Like all medicines, Haloperidol can cause side effects, although not
• inflamed skin (red, hot to the touch and tender)
everybody gets them.
• sudden unexplained death has occurred in rare cases but it is not
Stop taking the tablets and tell your doctor immediately or go to the
known if this was due to the medicine
casualty department at your nearest hospital if the following happens:
• swelling of face
• an allergic reaction causing swelling of the lips, face or neck leading to
• feeling too cold.
severe difficulty in breathing, severe skin rash or hives.
You may also experience difficulties with sex such as: erectile
This is a very serious but rare side effect. You may need urgent medical
dysfunction (inability to develop or maintain an erection of the penis,
attention or hospitalisation.
decreased sexual desire, and some men may experience swelling of the
See your doctor immediately if you suffer from any of the following, as
breasts or painful and prolonged erection.
your treatment will need to be reviewed:
• uncontrolled movements, especially in your limbs and face, mouth and
Reporting of side effects
jaw, tremors, tics and muscle spasm in your shoulders, neck, body and
If you get any side effects, talk to your doctor or pharmacist. This includes
arms. These are very common side effects. However, rarely this can be
any possible side effects not listed in this leaflet. You can also report side
severe enough to cause breathing difficulties. The first signs may be
effects directly via the Yellow Card Scheme at:
uncontrolled movements of your tongue.
• changes in muscle tone, slowness of movement or an abnormal
By reporting side effects you can help provide more information on the
increase in muscular activity which are very common side effects
safety of this medicine.
• your muscles begin to feel rigid; body adopts rigid posture or a mask
like face. These are common side effects
5 HOW TO STORE HALOPERIDOL
• extreme restlessness, loss of normal muscle control, difficulty in
moving, shakiness and loss of movement, which are uncommon side
Keep out of the reach and sight of children.
Store below 25º C. Store in the original package and protect from light.
• you feel feverish and become less alert than usual, or you feel hot, you
Do not use Haloperidol after the expiry date that is stated on the outer
start sweating and your heartbeat speeds up
packaging. The expiry date refers to the last day of that month.
• blood clots in the veins especially in the legs (symptoms include
Medicines should not be disposed of via wastewater or household waste.
swelling, pain and redness in the leg), which may travel through blood
Ask your pharmacist how to dispose of medicines no longer required.
vessels to the lungs causing chest pain and difficulty in breathing
These measures will help to protect the environment.
• in elderly people with dementia, a small increase in the number of
deaths has been reported for patients taking antipsychotics compared
6 FURTHER INFORMATION
with those not receiving antipsychotics
• a serious problem called “Neuroleptic malignant syndrome”The signs
What Haloperidol tablets contain:
• The active ingredient is haloperidol, either 1.5 mg, 5 mg, 10 mg or
- Fast heart beat, changing blood pressure and sweating followed by
• The other ingredients are lactose, povidone, maize starch, magnesium
- Faster breathing, muscle stiffness, reduced consciousness and coma
stearate (E572), and stearic acid
- Raised levels of a protein in your blood (an enzyme called creatine
• The 5 mg tablet also contains the colours acid brilliant green BS
(E142), tartrazine (E102), patent blue V (E131) and azorubine,
If you notice any of these symptoms seek medical advice immediately.
• The 10 mg tablet also contains colloidal anhydrous silica and the
The following side effects have also been reported:
colour ponceau 4R (E124).
What Haloperidol tablets look like and contents of the pack:
• feeling agitated or having difficulty sleeping
• 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
• The 10 mg tablet is pink biconvex marked 5S2 on one side
• depression, mental illness
• The 20 mg tablet is white biconvex marked 6S2 on one side
• rolling of the eyes
• The product is available in pack sizes of 25, 28, 50, 56, 84, 100, 250, 500
• problems with sight
or 1000 tablets.
• a fall in blood pressure on standing up which causes dizziness,
Not all pack sizes may be marketed.
light-headedness or fainting
• constipation, dry mouth, mouth watering excessively, nausea, vomiting
Marketing Authorisation Holder and Manufacturer
• abnormal liver function (which may be detected by blood tests)
Marketing Authorisation holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
• unable to pass urine
• weight changes (increase or decrease)
This leaflet was last revised: May 2015
• dizziness or sleepiness.
• a fall in the number of white blood cells which can cause frequent
• confusional state
• seizures (convulsion)
• blurred vision
• Tourette’s Syndrome and tics
The initial dose is usually 1.5 mg three times a day. Your doctor may
increase your dose gradually to between 6 mg and 30 mg a day until
your symptoms are controlled.
Page 2 of 3
THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
Meaning of Signature
Regulatory Affairs Approval
10-Jun-2015 01:53:59 PM
Page 3 of 3