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HALOPERIDOL ORAL SOLUTION BP 5MG/5ML

Active substance(s): HALOPERIDOL

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Important information about some of the ingredients of this medicine
• Methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216): may cause allergic reactions (possibly delayed).

PATIENT INFORMATION LEAFLET
Haloperidol Oral Solution BP 5 mg/5 ml
Haloperidol

3. HOW TO TAKE HALOPERIDOL
Always take Haloperidol exactly as your doctor has advised, as the dosage is likely to be adjusted from the initial dose. Check with your doctor
if you are not sure about the dose you should take.
Take Haloperidol only by mouth. Shake well before use. An oral syringe is included in the pack to help you take the correct dose.

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.
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.

Usual doses are:
Adults: For schizophrenia, mania and hypomania, used with other therapies (short term) to manage moderate to severe signs of physical
tension, states of agression, hyperactivity and self harm, excitement, violent or dangerously impulsive behaviour, mental and behavioural
problems, restlessness and agitation in the elderly:

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

Initial dose
Maintenance dose

1. WHAT HALOPERIDOL IS AND WHAT IT IS USED FOR
Haloperidol Oral Solution BP 5 mg/5 ml (“Haloperidol”) belongs to a group of medicines called neuroleptics, and is used to improve thoughts,
feelings and/or behaviour when these are disturbed in certain medical conditions:
• hearing, seeing or sensing things which are not there
• states of aggression, hyperactivity and self-harming
• severe tics (uncontrollable movements)
• behavioural disorders in children, associated with hyperactivity and aggression
• restlessness and agitation in the elderly
• nausea, vomiting and persistent hiccup
• Tourette’s syndrome

Elderly
Adolescents

Initial dose
Maintenance dose

For Tourette’s syndrome - Daily maintenance doses of up to 10 ml are usually recommended; your doctor will advise you.
If you take more Haloperidol than you should
If you take too much Haloperidol, contact your doctor or go to your nearest hospital immediately. Take the bottle with you.

Use of Haloperidol with drugs that cause electrolyte imbalance (such as sodium, potassium, calcium in the body) is not recommended.
Taking Haloperidol with food and drink
If you drink alcohol while taking Haloperidol, the combined effect can make you feel drowsy and less alert than usual. You can take Haloperidol
with or without food.
Pregnancy and breast-feeding
Do not use Haloperidol if you are pregnant, trying to become pregnant or are breast-feeding. Always speak to your doctor before taking any
medicine.
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.

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You should contact your doctor immediately if you experience any of the following:
• blood clots in the vein especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the
blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms seek medical advice
immediately.
• nerve and muscular effects such as quivering, restlessness, jerking movements, tremor, inability to sit still, exaggerated reflexes,
rigidity, unusual posture, involuntary movements of the tongue, face or jaw, disjointed movements
• emotional and behavioural changes, insomnia, depression, confusion, drowsiness, lethargy, stupor, anxiety, euphoria
• worsening of psychotic symptoms such as hallucinations, alteration of sleep patterns
• in women, irregular or absent periods, infertility, spontaneous discharge of milk
• in men, breast development, as well as impotence
• heartburn, nausea, vomiting, weight loss or gain, constipation, diarrhoea
• liver effects including jaundice (maybe a fever, followed by yellowing of the skin and eyes). Your doctor may stop your treatment
• dermatitis (itchy pink or red rash), erythema multiforme (mild itchy pink, red blotches), sensitivity to sunlight
• “neuroleptic malignant syndrome” – feeling hot, muscle rigidity, altered consciousness, coma
• stuffiness in the nose or dry mouth
• urinary retention (not able to pass water), incontinence (loss of control of the bowel or bladder), blurred vision
• fast or irregular heartbeat, drop in blood pressure (light headedness, fainting, slow heartbeat)
• fever, heat stroke, vertigo (dizziness or light headedness), seizures
• 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.
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
Keep this medicine out of the sight and reach of children. Do not store above 25˚C. Keep container in the outer carton. Do not use
Haloperidol after the expiry date which is stated on the label or carton. Take unused medicine to your pharmacist for safe disposal.
6. FURTHER INFORMATION
What this product contains:
• the active ingredient is haloperidol; each 5 ml of solution contains 5 mg haloperidol
• the other ingredients: lactic acid, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), propylene glycol and purified water
(see end of Section 2 for further information).
What Haloperidol looks like and contents of the pack
Haloperidol is a clear colourless oral solution, and is available in amber glass or plastic bottles of 100 ml, 200 ml and 500 ml.
Marketing Authorisation Holder: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Manufacturer: CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF or
Pinewood Labolatories Ltd., Ballymacarbry, Clonmel, Co.Tipperary, Ireland.
PL 04917/0023
This leaflet was last updated in 02/2016

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VENDOR CODE TO BE PRINTED AT THE BOTTOM RIGHT HAND CORNER OF FRONT AND BACK PAGE
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Haloperidol can cause side effects, although not everybody gets them.
You should STOP using Haloperidol and contact your doctor immediately if you experience a rare allergic reaction, including
swelling of the skin, rashes, difficulty breathing, loss of consciousness, fever or shock.

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Driving and using machines
Do not drive or operate machinery until you know how this medicine affects you. Haloperidol can make you less alert and alcohol increases
these effects.
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If you stop taking Haloperidol
Do not stop taking Haloperidol on your own without advice from your doctor. The dose must be decreased gradually, because withdrawal
effects may occur if this medicine is stopped suddenly. These effects are likely to be nausea, vomiting and insomnia (difficulty in sleeping).
Your symptoms may return even after several weeks or months.

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Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription,
but particularly the following:
• drugs to treat heart failure (e.g. atropine or sotalol) must NOT be taken with Haloperidol (see Section “Do not take Haloperidol”)
• sedatives including alcohol, hypnotics (e.g. zolpidem), opiates (e.g. morphine)
• drugs for Parkinson’s disease (e.g. levodopa, bromocriptine, pergolide)
• drugs for convulsions (fits) (e.g. phenobarbital, carbamazepine)
• ephedrine, phenylephrine - ingredients used in cough and cold remedies
• high blood pressure medication (e.g. guanethidine, guanadrel, methyldopa, methoxamine)
• medicines used to treat mental conditions - antidepressants e.g. imipramine (tricyclic antidepressant), monoamine oxidase inhibitors
(MAOIs e.g. selegiline), trazodone, maprotiline, nefazodone
• antipsychotic drugs - used to treat mental conditions like schizophrenia e.g. dopamine
• adrenaline for severe allergic reactions
• lithium used to treat depression
• anticoagulants e.g. warfarin used to thin the blood
• amphetamines - used as a stimulant e.g. dexamphetamine sulphate
• anticholinergic drugs - used as a muscle relaxant e.g. benzatropine mesilate
• hypoglycaemic drugs e.g. insulin to treat diabetes
• diazoxide used to treat very high blood pressure
• methoxamine used to prevent or correct low blood pressure
• amiodarone used to control the rhythm of your heart beat
• conivaptan used to treat low levels of sodium in the blood
• CYP 2D6 inhibitors - e.g. terbinafine used to treat fungal infections of skin and nails
• medicines that may reduce the salt levels in your blood e.g. Cisplatin (to treat cancer), furosemide (water tablets), Ciclosporin (to prevent
organ rejection after transplantation).

If you forget to take Haloperidol
If you miss a dose, take it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double
dose to make up for the forgotten dose.

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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.

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Take special care in very hot or cold weather, since Haloperidol may affect your body’s ability to regulate its temperature.

1.5 ml three times a day, adjusted according to your response
Once your symptoms are controlled, your dose will be gradually reduced to the lowest dose
that is effective for you.

Children: For Childhood behavioural disorders - The dose will be calculated by the doctor and the child should receive what is written on the
pharmacy label.

Take special care
Talk to your doctor before taking Haloperidol if any of the following applies to you:
• liver or kidney disease

tumour of the adrenal gland (phaeochromocytoma)
• enlarged prostate

closed angle glaucoma
• epilepsy or are prone to fits (e.g. during alcohol withdrawal)

heart disease, family history of sudden death
• thyroid gland problems

depression.
If you are elderly, or have had heart problems, your heart rhythm and potassium levels may be monitored and your dose may need to be
adjusted or treatment stopped.

Moderate symptoms
Severe symptoms
1.5 - 3 ml
3 - 5 ml
two or three times a day
two or three times a day
Once your symptoms are controlled, your dose will be gradually reduced to the lowest dose that
is effective for you, usually 1 - 2 ml three to four times a day.
A rapid reduction in dose should be avoided
Half the initial adult dose is usually recommended
As for adults. Doses up to 30 ml daily may be required in exceptional cases.

For Tourette’s syndrome, intractable hiccup and severe tics

2. BEFORE YOU TAKE HALOPERIDOL
Do NOT take Haloperidol if you:
• are allergic (hypersensitive) to haloperidol or any of the other ingredients in the product (see Section 6 and end of Section 2).
• have reduced awareness or slower reactions (due to illness or taking other medication)
• have heart disease which causes abnormal heart rhythm (irregular or slow heartbeat)
• are taking medication for abnormal heart rhythm

low potassium levels in your blood
• are breast-feeding

have Parkinson’s disease.

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.

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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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