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HALDOL 10MG TABLETS / HALOPERIDOL 10MG TABLETS

Active substance(s): HALOPERIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Haldol® 10mg tablets
(haloperidol)
Read all of this leaflet carefully before you start using 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 side effects and they become serious or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist
The name of your medicine is Haldol 10mg tablets but will be referred to as
Haldol throughout this leaflet. Please note that the leaflet also contains
information about other strengths such as Haldol 5mg tablets.
In this leaflet
1. What Haldol is and what it is used for
2. Before you take Haldol
3. How to take Haldol
4. Possible side effects
5. How to store Haldol
6. Further information

1. What Haldol is and what it is used for
The name of your medicine is Haldol.
Haldol contains a medicine called haloperidol. This belongs to a group of
medicines called `antipsychotics'.
Haldol is used for:
Schizophrenia, psychoses, mania and behavioural problems in adults
and children
These illnesses affect the way you think, feel or behave. They may make
you:
Feel confused
See, hear or feel things that are not there (hallucinations)
Believe things that are not true (delusions)
Feel unusually suspicious (paranoia)
Feel very excited, agitated, enthusiastic or hyperactive
Feel very aggressive or violent
Haldol is also used for:
Gilles de la Tourette syndrome and movements you can't control (tics)
Hiccups that won't go away

2. Before you take Haldol
Do not take Haldol if:
You are allergic to anything in Haldol (listed in section 6 overleaf)
You have, or have had, certain types of heart disease which cause your
heart to beat with an abnormal rhythm (arrhythmia) or unusually slowly
You are taking any medicines which affect your heart beat
Your doctor tells you that the level of potassium in your blood is too low
You have Parkinson's disease
Your doctor tells you that you have a condition that affects part of your
brain called the 'basal ganglia'
You are less aware of things around you or your reactions become
slower
Do not take this medicine if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before using Haldol.
Take special care with Haldol
If you are elderly, as you may be more sensitive to the effects of Haldol.
If you or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood clots.
Check with your doctor or pharmacist before taking Haldol if you have:
A heart problem or anyone in your close family has died suddenly of
heart problems
Ever had bleeding in the brain, or your doctor has told you that you are
more likely than other people to have a stroke
Lower than normal levels of minerals (electrolytes) in your blood. Your
doctor will advise you
Not been eating properly for a long time
Liver or kidney problems
Epilepsy or have ever had fits (convulsions) as you may need more
medicine to control them.
Depression
Problems with your thyroid gland
A non-cancerous tumour of the adrenal gland (phaeochromocytoma)
You may need to be more closely monitored, and the amount of Haldol you
take may have to be altered. If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before taking Haldol.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or during
your treatment with Haldol. The ECG measures the electrical activity of your
heart.
Blood tests
Your doctor may want to check the levels of minerals (electrolytes) in your
blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines that you buy without a
prescription or herbal medicines.
Special monitoring may be needed if you are taking lithium and Haldol
at the same time. Tell your doctor straight away and stop taking both
medicines if you get:
Fever you can't explain or movements you can't control
Confused, disoriented, a headache, balance problems and feel sleepy.
These are signs of a serious condition
Haldol can affect the way the following types of medicine work
Tell your doctor if you are taking medicines for:
Calming you down or helping you to sleep (tranquillisers)
Illnesses that affect the way you think, feel or behave (antipsychotics or
neuroleptics)
Pain (strong pain killers)
Changes in your heart beat or are taking medicines that affect your
heart beat
Coughs and colds
Epilepsy
Depression, such as 'tricyclic antidepressants' and 'tetracyclic
antidepressants'
Lowering blood pressure, such as guanethidine and methyldopa

Severe allergic reactions, such as adrenaline
Parkinson's disease, such as levodopa
Thinning the blood, such as phenindione
Talk to your doctor before taking Haldol if you are taking any of these
medicines.
Certain medicines may affect the way that Haldol work
Tell your doctor if you are taking medicines for:
Depression, such as fluoxetine and paroxetine
Malaria, such as quinine and mefloquine
Anxiety, such as buspirone
Problems with your heart beat, such as quinidine, disopyramide and
procainamide, amiodarone, sotalol and dofetilide
Epilepsy, such as phenobarbital and carbamazepine
Allergies, such as terfenadine
Serious infections, such as rifampicin
Lowering blood pressure, such as water tablets (diuretics)
Infections such as sparfloxacin, moxifloxacin, erythromycin IV
A fungal infection, such as ketoconazole
Your doctor may have to change your dose of Haldol.
Taking Haldol with food and alcohol
You can take Haldol with or without food. Swallow the tablets with some
water.
Drinking alcohol while you are taking Haldol might make you feel drowsy
and less alert. This means you should be careful how much alcohol you
drink.
Pregnancy and breast-feeding
Talk to your doctor before taking Haldol if you are pregnant, think you may
be pregnant or might become pregnant. The following symptoms may occur
in newborn babies of mothers that have used Haldol 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.
You may still be able to take HaIdol if your doctor thinks you need to.
Do not take this medicine if you are breast-feeding. This is because small
amounts may pass into the mother's milk.
Ask your doctor or pharmacist for advice before taking any medicine if you
are pregnant or breast-feeding.
Elderly
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 HaIdol and will explain the
possible risks of its use.
Driving and using machines
This medicine may affect you being able to drive. Do not drive or use any
tools or machines without discussing this with your doctor first.
Important information about some of the ingredients of HaIdol 5mg
tablets
HaIdol 5mg tablets contain lactose. If your doctor has told you that you are
intolerant of some sugars, discuss it with them before taking this medicine.
Available safety data in the paediatric population indicate a risk of
extrapyramidal symptoms, including tardive dyskinesia (involuntary,
repetitive body movements), and sedation. No long-term safety data are
available.

3. How to take Haldol
Always take HaIdol exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
How much should you take
Your doctor will tell you how many tablets to take and for how long. Your
doctor will adjust the dose to suit you. It is very important you take the
correct amount.
Your dose will depend on:
Your age
How serious your symptoms are
Whether you have other medical problems
How you have reacted to similar medicines in the past
Adults
When used to treat schizophrenia, psychoses or mania your dose will
normally be 2mg, but may be increased up to 20mg
When used to treat agitation and behavioural problems your dose will
normally be 1.5mg to 5mg
It may be given as a single dose or split into smaller doses and given
two to three times a day
Your doctor may reduce the dose of HaIdol when your symptoms begin
to improve
Children
The dose for children depends on their weight and age
The following doses will be split into smaller doses and given two to
three times a day
Children aged 3 to 12 years
When used to treat childhood schizophrenia, the normal dose will be
1 to 4mg a day but may be increased up to 6mg a day
When used to treat agitation and behavioural problems, the normal
dose will be 0.5 to 3mg a day but may be increased up to 3mg a day
Adolescents aged 13 to 17 years of age
When used to treat childhood schizophrenia, the normal dose will be 1
to 6mg a day but may be increased up to 10mg a day
When used to treat agitation and behavioural problems, the normal dose
will be 2 to 6mg a day but may be increased up to 6mg a day
Elderly people
Elderly people are normally started on half the adult dose
The amount of HaIdol you take will then be adjusted until the doctor
finds the dose that suits you best
Taking HaIdol
HaIdol should be taken by mouth
Swallow the tablets with some water
When to stop taking HaIdol
Take the medicine for as long as your doctor has told you. It may be some
time before you feel the full effect of the medicine.
Unless your doctor tells you otherwise, you should stop taking HaIdol
gradually. Stopping treatment suddenly may cause effects such as:
Feeling sick (nausea) or being sick (vomiting)
Difficulty sleeping
Always follow your doctor's instructions carefully.

If you take more HaIdol than you should
If you take more HaIdol than you were told to or if someone else has taken
any HaIdol, talk to a doctor or go to the nearest hospital casualty
department straight away.
If you forget to take HaIdol
If you forget to take a dose, take your next dose as usual. Then keep taking
your medicine as your doctor has told you
Do not take a double dose
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, HaIdol can cause side effects, although not everybody
gets them.
Tell your doctor or nurse straight away if you notice or suspect any of
the following. You may need urgent medical treatment.
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.
Sudden swelling of the face or throat. Hives (also known as nettle rash
or urticaria), severe irritation, reddening or blistering of your skin. These
may be signs of a severe allergic reaction. This only happens in a small
number of people
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)
This can occur in fewer than 1 in 1,000 people
Your heart may beat abnormally (arrhythmia). An arrhythmia can cause
your heart to stop beating (cardiac arrest). In elderly people with
dementia, a small increase in the number of deaths have been reported
for patients taking neuroleptics compared with those not receiving
neuroleptics. The precise frequency of how often this occurs is not
known.
Jerky movements and problems such as slowness, muscle stiffness,
trembling and feeling restless. More saliva than normal, twitching or
unusual movements of the tongue, face, mouth, jaw or throat, or rolling
of the eyes. If you get any of these effects, you may be given an
additional medicine
Tell your doctor or nurse if you notice or suspect any of the following
side effects:
Feeling agitated or having difficulty sleeping
Headache
These can affect more than 1 in 10 people
Trembling, rigid posture, mask-like face, slow movements and a
shuffling, unbalanced walk
Feeling restless, low or depressed or sleepy
Feeling light headed or dizzy, particularly when standing up
Symptoms of psychosis such as abnormal thoughts or visions, or
hearing abnormal sounds
Problems with sight including blurred vision and rapid eye movements
These can occur in fewer than 1 in 10 people
Liver problems including yellowing of the skin and eyes, pale stools and
dark coloured urine
Feeling confused
A fall in the number of white blood cells which can cause frequent
infections
Fits or seizures (convulsions)
Difficulty breathing or wheezing
Hormone changes which may lead to:
Changes in weight
Difficulties with sex such as erection problems
Some men experiencing swelling of their breast or painful and
prolonged erection
Some people losing interest in sex
Some women having irregular, painful or heavy periods or no monthly
period
Some women unexpectedly producing breast milk, having painful
breasts These can occur in fewer than 1 in 100 people
Being unable to open mouth
This can occur in fewer than 1 in 1000 people
Bleeding or bruising more easily than normal. This can be caused by a
fall in the number of small blood cells called platelets
Fluid retention affecting the brain, resulting in weakness, tiredness or
confusion
The precise frequency of how often these occur is not known
Other side effects
Common side effects (affects fewer than 1 in 10 people)
Rash
Slow movements
Dry mouth
Feeling sick, being sick
Constipation
Difficulty passing water (urine)
Uncommon side effects (affects fewer than 1 in 100 people)
Sensitivity of skin to sunlight
Sweating more than usual
Fever
Swelling of the ankles
The following side effects have been reported, however the precise
frequency cannot be identified and therefore how often they occur is classed
as
Unknown:
Flaking or peeling of the skin
Inflamed skin (red, hot to the touch and tender)
Low body temperature
In newborn babies of mothers that have used Haldol in the last trimester
(last three months of 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.
Test results:
Abnormal test results for liver function
Low blood sugar levels (hypoglycaemia)
Abnormal heart traces (electrocardiogram, 'ECG')

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Haldol
Keep out of the sight and reach of children.
Do not take your tablet after the expiry date which is stated on the carton/
blister label after ‘Exp’. The expiry date refers to the last day of that month.
Do not store above 25°C. Protect from light.
Medicines should not be disposed of via wastewater or household waste.
These measures will help protect the environment. Return any leftover
HaIdol to your pharmacist.

6. Further information
What Haldol contains
The active substance is haloperidol.
Each tablet contains 10mg of haloperidol.
The other ingredients are: Calcium hydrogen phosphate dihydrate, maize
starch, calcium stearate and quinoline yellow.
What Haldol looks like and contents of the pack.
Haldol is yellow, round, biconvex tablet with 'JANSSEN’ on one side and 'H'
above the break line and '10' below the break line.
Haldol is available in blister packs of 20 tablets.
Manufactured by: FAMAR ABE (Lab. B), Av. Anthoussa, 153 44
Anthoussa, Greece.
Procured from within the EU and repacked by the Product Licence
Holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Haldol® 10mg tablets, PL 18799/2438
Leaflet date: 30.04.2015
Haldol is a registered trademark of Janssen-Cilag Ltd.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Haloperidol 10mg tablets
Read all of this leaflet carefully before you start using 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 side effects and they become serious or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist
The name of your medicine is Haloperidol 10mg tablets but will be referred
to as Haloperidol throughout this leaflet. Please note that the leaflet also
contains information about other strengths such as Haloperidol 5mg tablets.
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
The name of your medicine is Haloperidol.
Haloperidol contains a medicine called haloperidol. This belongs to a group
of medicines called `antipsychotics'.
Haloperidol is used for:
Schizophrenia, psychoses, mania and behavioural problems in adults
and children
These illnesses affect the way you think, feel or behave. They may make
you:
Feel confused
See, hear or feel things that are not there (hallucinations)
Believe things that are not true (delusions)
Feel unusually suspicious (paranoia)
Feel very excited, agitated, enthusiastic or hyperactive
Feel very aggressive or violent
Haloperidol is also used for:
Gilles de la Tourette syndrome and movements you can't control (tics)
Hiccups that won't go away

2. Before you take Haloperidol
Do not take Haloperidol if:
You are allergic to anything in Haloperidol (listed in section 6 overleaf)
You have, or have had, certain types of heart disease which cause your
heart to beat with an abnormal rhythm (arrhythmia) or unusually slowly
You are taking any medicines which affect your heart beat
Your doctor tells you that the level of potassium in your blood is too low
You have Parkinson's disease
Your doctor tells you that you have a condition that affects part of your
brain called the 'basal ganglia'
You are less aware of things around you or your reactions become
slower
Do not take this medicine if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before using Haloperidol.
Take special care with Haloperidol
If you are elderly, as you may be more sensitive to the effects of
Haloperidol.
If you or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood clots.
Check with your doctor or pharmacist before taking Haloperidol if you have:
A heart problem or anyone in your close family has died suddenly of
heart problems
Ever had bleeding in the brain, or your doctor has told you that you are
more likely than other people to have a stroke
Lower than normal levels of minerals (electrolytes) in your blood. Your
doctor will advise you
Not been eating properly for a long time
Liver or kidney problems
Epilepsy or have ever had fits (convulsions) as you may need more
medicine to control them.
Depression
Problems with your thyroid gland
A non-cancerous tumour of the adrenal gland (phaeochromocytoma)
You may need to be more closely monitored, and the amount of Haloperidol
you take may have to be altered. If you are not sure if any of the above
apply to you, talk to your doctor or pharmacist before taking Haloperidol.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or during
your treatment with Haloperidol. The ECG measures the electrical activity of
your heart.
Blood tests
Your doctor may want to check the levels of minerals (electrolytes) in your
blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines that you buy without a
prescription or herbal medicines.
Special monitoring may be needed if you are taking lithium and
Haloperidol at the same time. Tell your doctor straight away and stop
taking both medicines if you get:
Fever you can't explain or movements you can't control
Confused, disoriented, a headache, balance problems and feel sleepy.
These are signs of a serious condition
Haloperidol can affect the way the following types of medicine work
Tell your doctor if you are taking medicines for:
Calming you down or helping you to sleep (tranquillisers)
Illnesses that affect the way you think, feel or behave (antipsychotics or
neuroleptics)
Pain (strong pain killers)
Changes in your heart beat or are taking medicines that affect your
heart beat
Coughs and colds
Epilepsy
Depression, such as 'tricyclic antidepressants' and 'tetracyclic
antidepressants'
Lowering blood pressure, such as guanethidine and methyldopa

Severe allergic reactions, such as adrenaline
Parkinson's disease, such as levodopa
Thinning the blood, such as phenindione
Talk to your doctor before taking Haloperidol if you are taking any of these
medicines.
Certain medicines may affect the way that Haloperidol work
Tell your doctor if you are taking medicines for:
Depression, such as fluoxetine and paroxetine
Malaria, such as quinine and mefloquine
Anxiety, such as buspirone
Problems with your heart beat, such as quinidine, disopyramide and
procainamide, amiodarone, sotalol and dofetilide
Epilepsy, such as phenobarbital and carbamazepine
Allergies, such as terfenadine
Serious infections, such as rifampicin
Lowering blood pressure, such as water tablets (diuretics)
Infections such as sparfloxacin, moxifloxacin, erythromycin IV
A fungal infection, such as ketoconazole
Your doctor may have to change your dose of Haloperidol.
Taking Haloperidol with food and alcohol
You can take Haloperidol with or without food. Swallow the tablets with
some water.
Drinking alcohol while you are taking Haloperidol might make you feel
drowsy and less alert. This means you should be careful how much alcohol
you drink.
Pregnancy and breast-feeding
Talk to your doctor before taking Haloperidol if you are pregnant, think you
may be pregnant or might become pregnant. 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.
You may still be able to take Haloperidol if your doctor thinks you need to.
Do not take this medicine if you are breast-feeding. This is because small
amounts may pass into the mother's milk.
Ask your doctor or pharmacist for advice before taking any medicine if you
are pregnant or breast-feeding.
Elderly
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 HaIdol and will explain the
possible risks of its use.
Driving and using machines
This medicine may affect you being able to drive. Do not drive or use any
tools or machines without discussing this with your doctor first.
Important information about some of the ingredients of Haloperidol
5mg tablets
HaIoperidol 5mg tablets contain lactose. If your doctor has told you that you
are intolerant of some sugars, discuss it with them before taking this
medicine.
Available safety data in the paediatric population indicate a risk of
extrapyramidal symptoms, including tardive dyskinesia (involuntary,
repetitive body movements), and sedation. No long-term safety data are
available.

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.
How much should you take
Your doctor will tell you how many tablets to take and for how long. Your
doctor will adjust the dose to suit you. It is very important you take the
correct amount.
Your dose will depend on:
Your age
How serious your symptoms are
Whether you have other medical problems
How you have reacted to similar medicines in the past
Adults
When used to treat schizophrenia, psychoses or mania your dose will
normally be 2mg, but may be increased up to 20mg
When used to treat agitation and behavioural problems your dose will
normally be 1.5mg to 5mg
It may be given as a single dose or split into smaller doses and given
two to three times a day
Your doctor may reduce the dose of Haloperidol when your symptoms
begin to improve
Children
The dose for children depends on their weight and age
The following doses will be split into smaller doses and given two to
three times a day
Children aged 3 to 12 years
When used to treat childhood schizophrenia, the normal dose will be
1 to 4mg a day but may be increased up to 6mg a day
When used to treat agitation and behavioural problems, the normal
dose will be 0.5 to 3mg a day but may be increased up to 3mg a day
Adolescents aged 13 to 17 years of age
When used to treat childhood schizophrenia, the normal dose will be 1
to 6mg a day but may be increased up to 10mg a day
When used to treat agitation and behavioural problems, the normal dose
will be 2 to 6mg a day but may be increased up to 6mg a day
Elderly people
Elderly people are normally started on half the adult dose
The amount of Haloperidol you take will then be adjusted until the doctor
finds the dose that suits you best
Taking Haloperidol
Haloperidol should be taken by mouth
Swallow the tablets with some water
When to stop taking Haloperidol
Take the medicine for as long as your doctor has told you. It may be some
time before you feel the full effect of the medicine.
Unless your doctor tells you otherwise, you should stop taking HaIdol tablets
gradually. Stopping treatment suddenly may cause effects such as:
Feeling sick (nausea) or being sick (vomiting)
Difficulty sleeping
Always follow your doctor's instructions carefully.

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 Haloperidol, talk to a doctor or go to the nearest hospital casualty
department straight away.

Test results:
Abnormal test results for liver function
Low blood sugar levels (hypoglycaemia)
Abnormal heart traces (electrocardiogram, 'ECG')

If you forget to take Haloperidol
If you forget to take a dose, take your next dose as usual. Then keep taking
your medicine as your doctor has told you
Do not take a double dose

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

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

By reporting side effects, you can help provide more information on the
safety of this medicine.

4. Possible side effects

5. How to store Haloperidol

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

Keep out of the sight and reach of children.
Do not take your tablet after the expiry date which is stated on the carton/
blister label after ‘Exp’. The expiry date refers to the last day of that month.
Do not store above 25°C. Protect from light.
Medicines should not be disposed of via wastewater or household waste.
These measures will help protect the environment. Return any leftover
HaIdol tablets to your pharmacist.

Tell your doctor or nurse straight away if you notice or suspect any of
the following. You may need urgent medical treatment.
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.
Sudden swelling of the face or throat. Hives (also known as nettle rash
or urticaria), severe irritation, reddening or blistering of your skin. These
may be signs of a severe allergic reaction. This only happens in a small
number of people
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)
This can occur in fewer than 1 in 1,000 people
Your heart may beat abnormally (arrhythmia). An arrhythmia can cause
your heart to stop beating (cardiac arrest). In elderly people with
dementia, a small increase in the number of deaths have been reported
for patients taking neuroleptics compared with those not receiving
neuroleptics. The precise frequency of how often this occurs is not
known.
Jerky movements and problems such as slowness, muscle stiffness,
trembling and feeling restless. More saliva than normal, twitching or
unusual movements of the tongue, face, mouth, jaw or throat, or rolling
of the eyes. If you get any of these effects, you may be given an
additional medicine
Tell your doctor or nurse if you notice or suspect any of the following
side effects:
Feeling agitated or having difficulty sleeping
Headache
These can affect more than 1 in 10 people
Trembling, rigid posture, mask-like face, slow movements and a
shuffling, unbalanced walk
Feeling restless, low or depressed or sleepy
Feeling light headed or dizzy, particularly when standing up
Symptoms of psychosis such as abnormal thoughts or visions, or
hearing abnormal sounds
Problems with sight including blurred vision and rapid eye movements
These can occur in fewer than 1 in 10 people
Liver problems including yellowing of the skin and eyes, pale stools and
dark coloured urine
Feeling confused
A fall in the number of white blood cells which can cause frequent
infections
Fits or seizures (convulsions)
Difficulty breathing or wheezing
Hormone changes which may lead to:
Changes in weight
Difficulties with sex such as erection problems
Some men experiencing swelling of their breast or painful and
prolonged erection
Some people losing interest in sex
Some women having irregular, painful or heavy periods or no monthly
period
Some women unexpectedly producing breast milk, having painful
breasts These can occur in fewer than 1 in 100 people
Being unable to open mouth
This can occur in fewer than 1 in 1000 people
Bleeding or bruising more easily than normal. This can be caused by a
fall in the number of small blood cells called platelets
Fluid retention affecting the brain, resulting in weakness, tiredness or
confusion
The precise frequency of how often these occur is not known
Other side effects
Common side effects (affects fewer than 1 in 10 people)
Rash
Slow movements
Dry mouth
Feeling sick, being sick
Constipation
Difficulty passing water (urine)
Uncommon side effects (affects fewer than 1 in 100 people)
Sensitivity of skin to sunlight
Sweating more than usual
Fever
Swelling of the ankles
The following side effects have been reported, however the precise
frequency cannot be identified and therefore how often they occur is classed
as
Unknown:
Flaking or peeling of the skin
Inflamed skin (red, hot to the touch and tender)
Low body temperature
In newborn babies of mothers that have used Haloperidol in the last
trimester (last three months of 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.

6. Further information
What Haloperidol contains
The active substance is haloperidol.
Each tablet contains 10mg of haloperidol.
The other ingredients are: Calcium hydrogen phosphate dihydrate, maize
starch, calcium stearate and quinoline yellow.
What Haloperidol looks like and contents of the pack.
Haloperidol is yellow, round, biconvex tablet with 'JANSSEN’ on one side
and 'H' above the break line and '10' below the break line.
It is available in blister packs of 20.
Manufactured by: FAMAR ABE (Lab. B), Av. Anthoussa, 153 44
Anthoussa, Greece.
Procured from within the EU and repacked by the Product Licence
Holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Haloperidol 10mg tablets, PL 18799/2438
Leaflet date: 30.04.2015

POM

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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