PATIENT INFORMATION LEAFLET

i HALOPERIDOL

Tablets 0.5mg, l.5mg, 5mg, I0mg and 20mg

Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again.

If you have any questions or are not sure about anything, 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.

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

This medicine belongs to a group of drugs know as neuroleptics. These medicines treat illnesses that affect the way you think, behave or feel such as schizophrenia.

Haloperidol is used to treat illnesses that can make you: feel confused; see, feel or hear things that are not there (hallucinations); believe things that are not true (delusions); be very suspicious of things (paranoia); feel very excited, restless, agitated or hyperactive; feel very aggressive or violent.

Haloperidol can also be used to treat persistent hiccups, to control the symptoms of Tourette's Syndrome and severe tics (sounds or movements you can't control), and behavioural problems in children.

2.    Before you take Haloperidol Tablets

Do not take these tablets if you:

•    are allergic to Haloperidol or to any of the other ingredients (see section 6)

•    have, or have had, certain types of heart disease which cause abnormal or unusually slow heart beat

•    are taking any medicines which affect your heart beat

•    have low levels of potassium in your blood

•    have Parkinson's disease

•    have a lesion that affects part of your brain called the basal ganglia

•    are less aware of things around you or your reactions become slower. Your doctor will not use this medicine if you are in a coma.

Check with your doctor before taking these tablets 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

•    have a heart problem or anyone in your close family has died suddenly of heart problems

•    have ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke

•    have lower than normal levels of minerals (electrolytes) in your blood

•    have not been eating properly for a long time

•    have liver disease, kidney failure or an overactive thyroid gland

•    have a tumour of the adrenal gland (near the kidney)

•    suffer from depression

•    suffer from epilepsy or convulsions (fits)

•    drink too much alcohol.

You may need to be more closely monitored and the amount of tablets you take may have to be altered.

Taking other medicines:

Tell your doctor or pharmacist if you are taking any other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:

•    lithium (used to treat mental depression) as it can increase the risk of getting serious side effects. Your doctor will monitor lithium levels in your blood. Tell your doctor straightaway and stop taking both medicines if you get a fever, movements you can't control, or if you get confused, disoriented, a headache, balance problems and feel sleepy. These are signs of a serious condition

•    medicines for calming you down or to help you sleep (tranquillisers) or for anxiety (e.g. buspirone, alprazolam)

•    medicines to treat epilepsy (e.g. phenobarbital, carbamazepine)

•    antihistamine medicines for hayfever or other allergies (e.g. terfenadine, promethazine)

•    medicines for coughs and colds

•    strong pain killers

•    medicines to treat illnesses that affect the way you think, feel or behave (antipsychotics or neuroleptics)

•    medicines for depression e.g. amitriptyline, maprotiline, fluoxetine, paroxetine, venlafaxine, fluvoxamine, sertraline

•    medicines used to treat Parkinson's disease such as levodopa

•    adrenaline (used for severe allergic reactions such as bee stings), drugs used to treat asthma such as salbutamol and terbutaline, and ephedrine for nasal congestion

•    medicines used to treat high blood pressure such as guanethidine and methyldopa and water tablets (diuretics)

•    medicines for changes in your heart beat or that affect your heart beat (e.g. quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, bretylium)

•    medicines for malaria e.g. quinine and mefloquine

•    rifampicin, sparfloxacin, moxifloxacin, erythromycin IV, ketoconazole, itraconazole used to treat infections

•    phenindione (used to treat blood clotting disorders).

Other special warnings:

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

Medical check ups and blood tests:

Your doctor may want to take an electrocardiogram (ECG) to measure the electrical activity of your heart before or during your treatment, and may want to perform blood tests to check the levels of minerals (electrolytes) in your blood.

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 haloperidol and will explain the possible risks of its use.

Pregnancy and breast feeding:

Talk to your doctor before taking this medicine if you are pregnant, think you may be pregnant or might become pregnant. Do not take this medicine if you are 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.

Children:

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 is available.

Effects on driving or operating machinery:

This medicine may cause sedation and make you feel drowsy. Do not drive or operate machinery if the medicine has this effect on you.

Haloperidol Tablets and alcohol:

Haloperidol may increase the effects of alcohol, making you feel drowsy and less alert. You should be careful with how much alcohol you drink.

Important information about some of the ingredients of this medicine:

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Also contains the colourants E102, E122 (5mg tablets) and E124 (10mg tablets) which may cause allergic reactions.

3. How to take Haloperidol Tablets

Swallow the tablets with water.

The usual doses are as given below but your doctor will decide the dose that is best for you depending on the condition being treated and how severe it is. The pharmacist's label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

Adults:

For all indications EXCEPT Tourette’s syndrome, severe tics and uncontrollable hiccups.

Starting dose:

Moderate symptoms: 1.5-3.0 mg two to three times daily.

Severe symptoms / resistant patients: 3.0-5.0 mg two to three times daily.

In resistant schizophrenics, a maximum daily dose of up to 30 mg may be necessary to successfully control symptoms. The same starting dose may be used in adolescents, who may, in certain cases require up to 30 mg per day.

Maintenance dose: 5 mg or 10 mg per day.

For Tourette’s syndrome, severe tics and uncontrollable hiccups. Starting dose:

1.5 mg three times daily.

A daily maintenance dose of 10 mg may be required for Tourette's syndrome.

Elderly:

All indications except restlessness and agitation.

Half the adult dose.

For restlessness or agitation.

Starting dose: 1.5-3.0 mg two to three times daily.

Maintenance dose: 1.5-30 mg daily.

Children:

For childhood behavioural disorders / schizophrenia.

Maintenance dose: Your doctor will work out the correct dose based on the bodyweight of the child. The correct dose is written on the pharmacist's label. 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.

For tourette's syndrome.

Maintenance dose: up to 10 mg per day.

Stopping Haloperidol and withdrawal effects:

This medicine is not to be stopped suddenly; keep taking your medicine until your doctor tells you how to reduce the dose slowly. If you stop taking these tablets suddenly, you may feel or be sick, have difficulty sleeping or your medical condition may get worse.

If you forget to take a dose:

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.

If you have taken too many tablets:

If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the container so the medicine can be identified.

4. Possible side effects

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

Tell your doctor STRAIGHT AWAY if you notice any of the following effects as you may need urgent medical attention:

•    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

•    difficulty breathing or dizziness; hives (raised red weals), severe irritation, reddening or blistering of your skin; sudden swelling of the face, throat or lips. These may be signs of a serious allergic reaction. This only happens in a small number of people

•    a serious condition called “neuroleptic malignant syndrome” which can occur in less than 1 in 1,000 people. Symptoms 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)

•    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 antipsychotics compared with those not receiving antipsychotics. 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 rapid blinking of the eyes.

Tell your doctor if you notice any of the following effects:

Very common effects that may happen to more than 1 in 10 people:

•    agitation, difficulty sleeping

•    headache.

common effects that may happen to less than 1 in 10 people:

•    symptoms of psychosis such as abnormal thoughts or visions, or hearing abnormal sounds

•    feeling low or depressed or sleepy

•    inability to sit still, trembling, rigid posture, mask-like face, slow movements

•    feeling light headed or dizzy, particularly when standing up

•    problems with sight, rolling of the eyes

•    problems getting an erection

•    rash

•    changes in weight

•    dry mouth, feeling or being sick, constipation

•    difficulty passing urine.

Uncommon effects that may happen to less than 1 in 100 people:

•    liver problems, signs include yellowing of the skin and eyes, pale stools and dark coloured urine

•    tremor, stiffness and shuffling, unbalanced walk, difficulty moving, involuntary muscle contractions, stiff neck

•    a fall in the number of white blood cells which can cause frequent infections

•    fits or convulsions

•    fluid retention which may cause swelling in your body

•    sensitivity of skin to sunlight, itching, sweating more than usual

•    feeling confused or restless

•    some people losing interest in sex

•    painful periods or no monthly period

•    change in milk flow from the breasts, painful breasts

•    blurred vision

•    breathlessness

•    fever.

Rare effects that may happen to less than 1 in 1000 people:

•    difficulty breathing or wheezing

•    being unable to open the mouth

•    some women unexpectedly producing breast milk

•    irregular or heavy periods

•    difficulties with sex such as problems with ejaculation

•    uncontrolled eye movements.

Other effects:

•    a reduction in the number of blood cells which may cause weakness, or bleeding or bruising more easily than normal and make infections more likely

•    fluid retention affecting the brain, resulting in weakness, tiredness or confusion

•    flaking or peeling of the skin, inflamed skin (red, hot to the touch and tender)

•    red or purple raised spots on the skin which may be painful or itchy

•    puffy face

•    swelling of the throat, temporary inability to breathe or speak

•    low body temperature

•    unpleasant feelings of dullness or slowness

•    excitement

•    swelling of the breasts in men or painful and prolonged erection

•    loss of appetite, indigestion. test results:

Abnormal test results for liver function, low blood sugar levels (hypoglycaemia) and abnormal heart traces (electrocardiogram, ECG) have been observed.

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 Haloperidol Tablets

Keep this medicine in the container provided. Store below 25°C and protect from light and moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Unless your doctor tells you to, do not keep any tablets that you no longer need. Return them to the pharmacist.

Do not take the tablets if the expiry date on the label has passed.

6.    Further information

Ingredients:

Each tablet contains 0.5mg, 1.5mg, 5mg, 10mg or 20mg of the active ingredient Haloperidol.

All the tablets also contain the inactive ingredients: lactose, povidone, maize starch, magnesium stearate and stearic acid. The 5 mg tablets also contain the colourants green S (E142), tartrazine (E102), patent blue V (E131) and carmoisine (E122). The 10 mg tablets also contain the colourant ponceau 4R (E124) and colloidal anhydrous silica.

What the medicine looks like:

All Haloperidol Tablets are round and marked with the company logo on one side.

Haloperidol Tablets 0.5 mg are white and marked with A488 on one side.

Haloperidol Tablets 1.5 mg are white and marked with A489 on one side.

Haloperidol Tablets 5 mg are light green and marked with A490 on one side.

Haloperidol Tablets 10 mg are pink and marked with A491 on one side. Haloperidol Tablets 20 mg are white and marked with A492 on one side. This medicine is available in pack sizes of 28, 30, 42, 56, 60, 84, 90 and 112 tablets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED

Date leaflet revised: June 2013

If you would like this leaflet in a different format please contact the licence holder at the above address.