HALOPERIDOL TABLETS BP 5MG

Active substance: HALOPERIDOL

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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.
Take special care with Haloperidol
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).
You may need to be more closely monitored, and 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.

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

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:
Adults:
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or • Mental disorders
The most common dose is between 1.5 mg and 20 mg a day, taken
during your treatment with Haloperidol tablets. The ECG measures
as a single dose or two smaller doses. Your doctor may increase this
the electrical activity of your heart.
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
Blood tests
gradually reduce the dose. This could be as low as 3 mg to 10 mg a day.
Your doctor may want to check the levels of minerals (electrolytes) in
• Tourette’s Syndrome and tics
your blood.
The initial dose is usually 1.5 mg three times a day. Your doctor
If you suffer from a disorder with related memory loss, you should
may increase your dose gradually to between 6 mg and 30 mg a
talk first to your doctor, who will decide if you can be given
day until your symptoms are controlled.
Haloperidol and will explain the possible risks of its use.
The Elderly
Taking other medicines
If you are elderly, your doctor will probably give you half the doses
Special monitoring may be needed if you are taking lithium and
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

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 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.



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.
If you stop taking Haloperidol
DO NOT stop taking Haloperidol without talking to your doctor first
even if you feel better.
When you stop taking Haloperidol, your doctor will reduce the dose
gradually to avoid the possibility of withdrawal symptoms, such as
feeling and being sick and being unable to sleep, or the recurrence
of your original condition.
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 can cause side effects, although not
everybody gets them.
Stop taking the tablets and tell your doctor immediately or go to the
casualty department at your nearest hospital if the following happens:
• an allergic reaction causing swelling of the lips, face or neck
leading to severe difficulty in breathing, severe skin rash or hives.
This is a very serious but rare side effect. You may need urgent
medical attention or hospitalisation.
See your doctor immediately if you suffer from any of the following,
as your treatment will need to be reviewed:
• uncontrolled movements, especially in your limbs and face, mouth
and jaw, tremors, tics and muscle spasm in your shoulders, neck,
body and arms. These are very common side effects. However
rarely this can be severe enough to cause breathing difficulties.
The first signs may be uncontrolled movements of your tongue
• changes in muscle tone, slowness of movement or an abnormal
increase in muscular activity which are very common side effects.
• your muscles begin to feel rigid; body adopts rigid posture or a
mask like face. These are common side effects
• extreme restlessness, loss of normal muscle control, difficulty in
moving, shakiness and loss of movement, which are uncommon
side effects
• you feel feverish and become less alert than usual, or you feel hot,
you start sweating and your heartbeat speeds up
• 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
• 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
• 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
• Raised levels of a protein in your blood (an enzyme called
creatine phosphokinase).
If you notice any of these symptoms seek medical advice
immediately.
The following side effects have also been reported:
Very common
• feeling agitated or having difficulty sleeping
• headache.
Common
• depression, mental illness
• rolling of the eyes
• problems with sight
• a fall in blood pressure on standing up which causes dizziness,
light-headedness or fainting
• constipation, dry mouth, mouth watering excessively, nausea,
vomiting
• abnormal liver function (which may be detected by blood tests)
• rash
• unable to pass urine
• weight changes (increase or decrease)
• dizziness or sleepiness.
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, jaundice (your skin and the whites of your
eyes may become yellow) or, 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
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.

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.
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 platelet
• Feeling unwell, confused or weak, feeling sick (nausea), loss of
appetite, feeling irritable. This could be an illness called ‘syndrome
of inappropriate anti-diuretic hormone secretion’ (SIADH)
• low level of blood glucose (hypoglycaemia)
• excitement
• feeling drowsy and mentally dulled
• blue discolouration of skin, breathing difficulties, gagging
• heart problems causing symptoms such as palpitations, abnormal
heart rhythms, fainting, blackouts or rarely heart attacks. These
occur more frequently at high doses and in patients who are a
greater risk of heart problems
• swelling of the voice box or contraction of the muscle in the voice box
• loss of appetite, feeling sick, indigestion, stomach upsets
• acute liver failure
• inflammation of blood vessels
• flaking or peeling of the skin
• inflamed skin (red, hot to the touch and tender)
• sudden unexplained death has occurred in rare cases but it is not
known if this was due to the medicine
• swelling of face
• feeling too cold.
You may also experience difficulties with sex such as: erectile
dysfunction (inability to develop or maintain an erection of the penis,
decreased sexual desire, and some men may experience swelling of
the breasts or painful and prolonged erection.
If you are concerned about any of these side effects, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.

5

HOW TO STORE HALOPERIDOL

Keep out of the reach and sight of children.
Store below 25º C. Store in the original package and protect from light.
Do not use Haloperidol after the expiry date that is stated on the
outer packaging. The expiry date refers to the last day of that month.
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 ingredient is haloperidol, either 1.5 mg, 5 mg, 10 mg or
20 mg
• The other ingredients are lactose, povidone, maize starch,
magnesium stearate (E572), and stearic acid
• 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 4R (E124).
What Haloperidol tablets look like and contents of the pack:
• 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
• The 20 mg tablet is white biconvex marked 6S2 on one side
• 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: November 2011
PL 00289/0305-0308

85109-X
200 x 323

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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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