HALOPERIDOL 0.5MG TABLETS

Active substance: HALOPERIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Haloperidol 0.5 mg Tablets
Haloperidol 1.5 mg Tablets
Haloperidol 5 mg Tablets
Haloperidol 10 mg Tablets
Haloperidol 20 mg Tablets

Read all of the 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 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.

In this leaflet:
1. What Haloperidol Tablets are and what they are used for
2. Before you take Haloperidol Tablets
3. How to take Haloperidol Tablets
4. Possible side effects
5. How to store Haloperidol Tablets
6. Further Information

1

What Haloperidol Tablets are and what
they are used for

Haloperidol Tablets belong to a group of drugs known as
neuroleptics which act on the central nervous system.

They are used to treat the following conditions in adults:
• schizophrenia and other psychoses particularly
paranoia (delusions and feelings of persecution)
• mania (overactive behaviour) and hypomania (elated
moods and excitability)
• aggression, hyperactivity and self-harm in patients with
mental handicap or brain damage
• to treat moderate to severe excitement, agitation and
violent dangerously impulsive behaviour; your doctor
may prescribe other medicines at the same time
• uncontrollable hiccups
• restlessness and agitation in the elderly
• control the unwanted movements and noises associated
with Tourette's syndrome and severe tics.

In children this medicine is used for the treatment of
personality disorders such as hyperactivity and
aggression, schizophrenia and to control the symptoms of
Tourette's syndrome.

2

Before you take Haloperidol Tablets

DO NOT TAKE Haloperidol Tablets if you:
• have had any unusual or allergic reactions to
haloperidol, other neuroleptics or to any of the other
ingredients in the product (see Section 6 ʻFurther
informationʼ).
• have Parkinson's disease, symptoms of which include
tremor (shaking), stiffness and shuffling.
• are breast-feeding.

These tablets must NOT be given to patients who are in an
unconscious state (coma).

Take special care with Haloperidol Tablets
Check with your doctor before taking these tablets if you
have:
• liver disease or liver problems such as jaundice (yellowing
of the skin or whites of the eyes).
• kidney failure.
• hyperthyroidism (increased activity of the thyroid gland).
• depression.
• heart disease such as heart failure.
• epilepsy or suffer from convulsions/fits.
• phaeochromocytoma (high blood pressure due to a
tumour near the kidney).
• lower than normal levels of minerals (electrolytes) in your
blood.
• a condition called angle closure glaucoma caused by
increased eye pressure.
• a condition called myasthenia gravis which causes
muscle weakness and tiredness.
• or someone else in your family has a history of blood
clots, as medicines like these have been associated with
formation of blood clots.

Before you have any kind of surgery, it is important to tell your
doctor or dentist in charge that you are taking this medicine.

Taking other medicines
Tell your doctor if you are taking any other medicines,
including those obtained without a prescription (which may
alter the effects of Haloperidol Tablets) especially:
• hypnotics and drugs which have sedative properties such
as phenobarbitone (treats epilepsy), diazepam (treats
anxiety), temazepam (sleeping tablets)
• strong painkillers i.e codeine phosphate
• drugs to reduce blood pressure such as guanethidine or
methyldopa
• central nervous system stimulants such as adrenaline or
amphetamines
• anti-convulsant drugs – the dose may need to be
increased
• anti-Parkinsonʼs drugs such as levodopa, carbidopa as
these may interfere with the absorption of Haloperidol
Tablets
• blood clotting disorder drugs i.e. phenindione
• tricyclic anti-depressants such as amitriptyline or doxepin
• lithium which is used to treat psychiatric disorders. If you
are taking Haloperidol Tablets with lithium, your doctor
may want to monitor your heart rate.

Taking Haloperidol Tablets with alcohol
Avoid alcohol if taking these tablets.

Pregnancy and breast-feeding
Haloperidol Tablets should not be taken during pregnancy,
unless your doctor considers it absolutely necessary. Do not
breast-feed if you have to take these tablets. Ask your doctor
or pharmacist for advice before taking any medicine.

The following symptoms may occur in newborn babies, of
mothers that have used Haloperidol Tablets 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
Haloperidol Tablets may cause some people, especially
elderly patients, to become drowsy, light-headed, clumsy,
unsteady or less alert than normal. If you are affected, do not
drive or operate dangerous machinery during treatment with
the medicine. Alcohol may make these effects worse.

Important information about some of the ingredients of
Haloperidol Tablets
Lactose - if you have an intolerance to some sugars, contact
your doctor before taking these tablets.
Ponceau 4R red (colouring in the 10 mg tablets only) - may
cause allergic reactions.

3

How to take Haloperidol Tablets

Always take exactly Haloperidol Tablets as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure. You will be prescribed the lowest dose
needed to control your symptoms. Do not stop taking
Haloperidol Tablets or change the dose unless your doctor
tells you to.

Continued on the next page >>

Swallow the tablets with water.
For all conditions except those conditions mentioned below
Adults:
Moderate symptoms: Start with 1.5 mg - 3 mg
two or three times a day.
Severe symptoms/resistant patient: Start with
3 mg – 5 mg two or three times a day.
This may be increased gradually to reach an
effective dose which is usually 5 mg - 10 mg
daily, but some patients need up to 30 mg daily.
Elderly:
Start with half the usual adult dose; this may
gradually be increased by your doctor.

For Tourette's syndrome, severe tics and uncontrollable
hiccups
Adults:
Start with 1.5 mg, two times a day. This may be
increased gradually to reach an effective dose. A
daily dose of 10 mg may be required for patients
with Tourette's syndrome.
Elderly:
Start with half the usual adult dose; this may
gradually be increased by your doctor.

For restlessness or agitation
Elderly:
Start with 1.5 mg - 3 mg, two or three times a
day. This may be increased gradually to reach an
effective dose, usually 1.5 mg - 5 mg daily.
For childhood behavioural disorders/schizophrenia and
Tourette's syndrome
Children: The total maintenance dose is 0.025 mg 0.05 mg per kg body weight a day. Half the total
dosage should be given in the morning and the
other half in the evening, up to a maximum of
10 mg daily.

If you take more Haloperidol Tablets than you should
If you (or someone else) accidentally take too much
medicine, contact a doctor or go to your nearest hospital
casualty department immediately. Take any remaining tablets
in their pack with you so they can be identified. Signs and
symptoms of an overdose include severe involuntary
movements, low blood pressure, sedation (calm state).
If you forget to take Haloperidol Tablets
If you forget your dose, skip the missed dose and go back to
your regular schedule. Do not take a double dose to make
up for a forgotten dose.

If you stop taking Haloperidol Tablets
Withdrawal symptoms can occur after you stop treatment
(see Section 4 ʻWithdrawal effectsʼ), so gradual withdrawal is
advisable. Do not stop taking the tablets without talking to
your doctor first.

If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Haloperidol Tablets can cause side
effects, although not everybody gets them.

STOP taking these tablets and contact your doctor
immediately if you develop any of the following:
• A severe allergic reaction, signs of which include
sudden swelling of the face or throat, difficulty breathing,
severe skin rash including inflammation and flaking of
skin (exfoliative dermatitis), raised red patches of skin
which may blister (erythema multiforme)
• Neuroleptic malignant syndrome symptoms of which
may include:
- fast heart beat, changing blood pressure and sweating
followed by a fever
- faster breathing, muscle stiffness, reduced
consciousness and coma
- increased levels of an enzyme called creatine
phosphokinase in your blood
• Irregular heart beat (arrhythmia). An arrhythmia can
cause your heart to stop beating (cardiac arrest)
• Muscle rigidity, tremor, jerky movements of the hands
and body and inability to control these movements, rolling
of the eyes, speech problems
• Yellowing of the skin and whites of the eyes (jaundice). A
sign of this may be sudden onset of fever after one to
three weeks of treatment, followed by the development of
jaundice
• 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.

Other side effects:
• upset stomach, loss of appetite, indigestion, irregular
changes in body weight
• a fall in blood pressure (hypotension), fainting (especially
in the elderly)

• headache, dizziness, light-headedness, slow thinking,
epileptic fits, blurred vision
• excitement, agitation, confusion, difficulty in sleeping
• some women experience discharge of milk from their
breasts, changes to their periods (irregular or no period at
all)
• some men experience swelling of their breasts, problems
with ejaculation and long lasting/painful erections
• blood disorders characterised by fever, sore mouth and
throat
• increased sensitivity of skin to sunlight (avoid exposure to
sunlight and UV light)
• difficulty in performing voluntary movements may develop
during therapy, after therapy or during therapy in
conjunction with drugs used to treat Parkinson's disease.
This depends on the dosage and the duration of treatment
with Haloperidol Tablets.
Withdrawal effects: If you suddenly stop taking this
medicine you may get nausea, vomiting, difficulty in sleeping
(insomnia), tremor, jerky body movements or an inability to
control movements of the hands and body.

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.

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.

5

How to store Haloperidol Tablets

Keep out of the reach and sight of children.

Do not take Haloperidol Tablets after the expiry date shown
on the label.

Store in the original package below 25°C. Keep the container
lid tightly closed.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6

Further information

What Haloperidol Tablets contain
The active substance is Haloperidol, 0.5 mg, 1.5 mg, 5 mg,
10 mg or 20 mg per tablet.

The other ingredients are lactose, povidone, maize starch,
magnesium stearate, stearic acid.
The 5 mg tablets also contain green S (E142), tartrazine
(E102), patent blue V (E131) and carmoisine (E122).
The 10 mg tablets also contain colloidal anhydrous silica and
ponceau 4R red (E214).

For Lactose and Ponceau Red - See end of Section 2
Important information about some of the ingredients of
Haloperidol Tabletsʼ.

What Haloperidol Tablets look like and contents of the
pack
The tablets are biconvex or flat and circular with an
embossed number on the reverse side:
0.5 mg = White 6.5 mm tablet, plain on one side and “A488”
on the other side.
1.5 mg = White 7.0 mm tablet, plain on one side and “A489”
on the other side.
5 mg = Light green 8.0 mm tablet, plain on one side and
“A490” on the other side.
10 mg = Pink 9.0 mm tablet, plain on one side and “A491”
and a breakline on the other side.
20 mg = White 10 mm tablet, plain on one side and “A492”
and a breakline on the other side.
They are available in:
• blister packs containing 28 or 112 tablets
• plastic containers containing 28 or 1000 tablets.

Not all packs sizes may be marketed.

Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK.

Manufacturer:
Regent GM Laboratories Ltd, Coronation Road, Park Royal,
London, NW10 7PT.

This leaflet was last revised in 06/2013.

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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.

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