HALOPERIDOL TABLETS BP 20MG

Active substance: HALOPERIDOL

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Ref:

231-30-85109-Y LEA HALOPERIDOL A/S TAB TUK

Version:

1

210001

Trackwise Parent:

09 July 2013
Child:

210002

PL Number(s),
MA Holder & Packer:
Reason for revision:

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

231-10-11022, 110032, 110042, 110052

555 (000101100)

N/A
Variants of Univers.
7.5 Pt

Dimensions:
L:
W:

323 mm
200 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

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 any of the side effects get 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 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

1

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
movements)
• restlessness and agitation in the elderly
• behavioural disorders in children, especially those associated with
hyperactivity and aggression.

2

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
the body)
• 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
attacks
• 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
slower.
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 clots
• 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).

Taking other medicines
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.
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,
rifampicin
• levodopa, for Parkinson’s disease
• certain other medicines called antidyskinetic drugs often used for
treatment of Parkinson’s disease e.g. procyclidine, trihexyphenidyl and
benztropine
• 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
reactions
• 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
prescription.
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
reactions.
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
your doctor.
• 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.

3

HOW TO TAKE HALOPERIDOL

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
Haloperidol tablets.

Always take Haloperidol exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

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.

The tablets should be swallowed preferably with a drink of water. The
usual dose is:

Blood tests
Your doctor may want to check the levels of minerals (electrolytes) in
your blood.
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.
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
available.

You may not feel better for several weeks after you start to take your
tablets.

Adults:
• 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.
• 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.
The Elderly
If you are elderly, your doctor will probably give you half the doses
mentioned above.

Top of page cut-off to middle of registration mark: 44 mm.

HALOPERIDOL 1.5 mg, 5 mg,
10 mg AND 20 mg TABLETS

Ref:

231-30-85109-Y LEA HALOPERIDOL A/S TAB TUK

Version:

1

Trackwise Parent:

210001

09 July 2013
Child:

210002

PL Number(s),
MA Holder & Packer:
Reason for revision:

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

231-10-11022, 110032, 110042, 110052

555 (000101100)

N/A
Variants of Univers.
7.5 Pt

Dimensions:
L:
W:

323 mm
200 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Children
Your doctor will work out the dose depending on your child’s weight. The
usual dose is 25 to 50 micrograms for each kilogram (kg) of body weight up
to a maximum of 10 mg. Teenagers may be given up to
30 mg a day.

• 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
• feeling too warm (hyperthermia)
• fluid may build up in your body causing swollen feet or ankles.

If you take more Haloperidol than you should
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
nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause muscle weakness, muscle stiffness, shaking,
low blood pressure, drowsiness.
Please take this leaflet, any remaining tablets, and the container with you
to the hospital or doctor so that they know which tablets were consumed.

Rare
• if you are a woman, your body may make too much of the hormone
prolactin
• getting excited, symptoms of psychosis such as abnormal thoughts or
vision, or hearing abnormal sounds
• difficulty breathing or wheezing
• unable to open your mouth (Trismus)
• abnormal heavy and prolonged menstrual periods at regular intervals
• abnormal heart rhythms.

If you forget to take Haloperidol
If you forget to take a tablet, take one as soon as you remember, unless it
is nearly time to take the next one. DO NOT take a double dose to make up
for a forgotten dose. If it is nearly time to take the next dose, wait until
then and then carry on as before.

Other side effects
• bleeding or bruising more easily than normal. This can be caused by a
fall in the number of small blood cells called platelets.
• Feeling unwell, confused or weak, feeling sick (nausea), loss of
appetite, feeling irritable. This could be an illness called ‘syndrome of
If you stop taking Haloperidol
inappropriate anti-diuretic hormone secretion’ (SIADH).
DO NOT stop taking Haloperidol without talking to your doctor first even if
• low level of blood glucose (hypoglycaemia)
you feel better.
• excitement
When you stop taking Haloperidol, your doctor will reduce the dose
gradually to avoid the possibility of withdrawal symptoms, such as feeling • feeling drowsy and mentally dulled
and being sick and being unable to sleep, or the recurrence of your original • blue discolouration of skin, breathing difficulties, gagging
• heart problems causing symptoms such as palpitations, abnormal
condition.
heart rhythms, fainting, blackouts or rarely heart attacks. These occur
If you have any further questions on the use of this product, ask your
more frequently at high doses and in patients who are at greater risk of
doctor or pharmacist.
heart problems.
• swelling of the voice box or contraction of the muscle in the voice box
POSSIBLE SIDE EFFECTS
• loss of appetite, feeling sick, indigestion, stomach upsets
• acute liver failure
• inflammation of blood vessels
Like all medicines, Haloperidol can cause side effects, although not
• flaking or peeling of the skin
everybody gets them.
• inflamed skin (red, hot to the touch and tender)
Stop taking the tablets and tell your doctor immediately or go to the
• sudden unexplained death has occurred in rare cases but it is not
casualty department at your nearest hospital if the following happens:
known if this was due to the medicine
• an allergic reaction causing swelling of the lips, face or neck leading to
• swelling of face
severe difficulty in breathing, severe skin rash or hives.
• feeling too cold.
This is a very serious but rare side effect. You may need urgent medical
You may also experience difficulties with sex such as: erectile
attention or hospitalisation.
dysfunction (inability to develop or maintain an erection of the penis,
See your doctor immediately if you suffer from any of the following, as
decreased sexual desire, and some men may experience swelling of the
your treatment will need to be reviewed:
breasts or painful and prolonged erection.
• uncontrolled movements, especially in your limbs and face, mouth and
If you are concerned about any of these side effects, or if you notice any
jaw, tremors, tics and muscle spasm in your shoulders, neck, body and
side effects not listed in this leaflet, please tell your doctor or pharmacist.
arms. These are very common side effects. However, rarely this can be
severe enough to cause breathing difficulties. The first signs may be
HOW TO STORE HALOPERIDOL
uncontrolled movements of your tongue.
• changes in muscle tone, slowness of movement or an abnormal
Keep out of the reach and sight of children.
increase in muscular activity which are very common side effects
Store below 25º C. Store in the original package and protect from light.
• your muscles begin to feel rigid; body adopts rigid posture or a mask
Do not use Haloperidol after the expiry date that is stated on the outer
like face. These are common side effects
packaging. The expiry date refers to the last day of that month.
• extreme restlessness, loss of normal muscle control, difficulty in
Medicines should not be disposed of via wastewater or household waste.
moving, shakiness and loss of movement, which are uncommon side
Ask your pharmacist how to dispose of medicines no longer required.
effects
These measures will help to protect the environment.
• you feel feverish and become less alert than usual, or you feel hot, you
start sweating and your heartbeat speeds up
FURTHER INFORMATION
• blood clots in the veins especially in the legs (symptoms include
swelling, pain and redness in the leg), which may travel through blood
What Haloperidol tablets contain:
vessels to the lungs causing chest pain and difficulty in breathing
• The active ingredient is haloperidol, either 1.5 mg, 5 mg, 10 mg or
• in elderly people with dementia, a small increase in the number of
20 mg
deaths has been reported for patients taking antipsychotics compared
• The other ingredients are lactose, povidone, maize starch, magnesium
with those not receiving antipsychotics
stearate (E572), and stearic acid
• a serious problem called “Neuroleptic malignant syndrome”The signs
.
• The 5 mg tablet also contains the colours acid brilliant green BS
may include:
(E142), tartrazine (E102), patent blue V (E131) and azorubine,
• Fast heart beat, changing blood pressure and sweating followed by
carmoisine (E122)
fever
• The 10 mg tablet also contains colloidal anhydrous silica and the
• Faster breathing, muscle stiffness, reduced consciousness and coma
colour ponceau 4R (E124).
• Raised levels of a protein in your blood (an enzyme called creatine
phosphokinase).
What Haloperidol tablets look like and contents of the pack:
• The 1.5 mg tablet is white biconvex marked 3S2 on one side
If you notice any of these symptoms seek medical advice immediately.
• The 5 mg tablet is light green biconvex marked 4S2 on one side
The following side effects have also been reported:
• The 10 mg tablet is pink biconvex marked 5S2 on one side
Very common
• The 20 mg tablet is white biconvex marked 6S2 on one side
• feeling agitated or having difficulty sleeping
• The product is available in pack sizes of 25, 28, 50, 56, 84, 100, 250, 500
• headache.
or 1000 tablets.
Common
Not all pack sizes may be marketed.
• depression, mental illness
Marketing Authorisation Holder and Manufacturer
• rolling of the eyes
Marketing Authorisation holder and company responsible for
• problems with sight
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
• a fall in blood pressure on standing up which causes dizziness,
This leaflet was last revised: June 2013
light-headedness or fainting
• constipation, dry mouth, mouth watering excessively, nausea, vomiting PL 00289/0305-0308
• abnormal liver function (which may be detected by blood tests)
• rash
• unable to pass urine
• weight changes (increase or decrease)
• dizziness or sleepiness.

4

5

6

Uncommon
• a fall in the number of white blood cells which can cause frequent
infections
• confusional state
• seizures (convulsion)
• blurred vision
• 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
skin
• itching, sweating more than usual

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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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