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HALOPERIDOL ORAL SOLUTION BP 10MG/5ML

Active substance(s): HALOPERIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Haloperidol Oral Solution BP 10 mg/5 ml
Haloperidol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 you get any side effects and they become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
This includes any possible side effects not listed in this leaflet. See section 4.
The name of this product is Haloperidol Oral Solution BP 10 mg/5 ml, but it will be referred to as Haloperidol throughout the leaflet.
What is in this leaflet
1. What Haloperidol is and what it is used for
2. What you need to know before you take Haloperidol
3. How to take Haloperidol
4. Possible side effects
5. How to store Haloperidol
6. Contents of the pack and other information

1. WHAT HALOPERIDOL IS AND WHAT IT IS USED FOR
The name of your medicine is Haloperidol Oral Solution BP 10 mg/5 ml (“Haloperidol”).
Haloperidol contains the active substance haloperidol. This belongs to a group of medicines called ‘antipsychotics’.
Haloperidol is used in adults, adolescents and children for illnesses affecting the way you think, feel or behave. These include mental
health problems (such as schizophrenia and bipolar disorder) and behavioural problems.
These illnesses may make you:
• feel confused (delirium)
• see, hear, feel or smell things that are not there (hallucinations)
• believe things that are not true (delusions)
• feel unusually suspicious (paranoia)
• feel very aggressive, hostile or violent
• feel very excited, agitated, enthusiastic, impulsive or hyperactive.
In adolescents and children, Haloperidol is used to treat schizophrenia in patients aged 13 to 17 years, and to treat behavioural
problems in patients aged 6 to 17 years.
Haloperidol is also used:
• in adolescents and children aged 10 to 17 years and in adults for movements or sounds you can’t control (tics), for example in
severe Tourette’s syndrome
• in adults to help control movements in Huntington’s disease.
Haloperidol is sometimes used when other medicines or treatments have not worked or caused unacceptable side effects.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HALOPERIDOL
Do NOT take Haloperidol:
• if you are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6).
• if you are less aware of things around you or your reactions become unusually slow
• if you have Parkinson’s disease
• if you have a type of dementia called ‘Lewy body dementia’
• if you have progressive supranuclear palsy (PSP)
• if you have a heart condition called ‘prolonged QT interval’, or any other problems with your heart rhythm that shows as an abnormal
tracing on an ECG (electrocardiogram)
• if you have heart failure or recently had a heart attack
• if you have a low level of potassium in your blood, which has not been treated
• if you take any of the medicines listed under ‘Other medicines and Haloperidol – Do not take Haloperidol if you are taking certain
medicines for’.
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 taking Haloperidol.
Warnings and precautions
Serious side effects
Haloperidol can cause problems with the heart, problems controlling body or limb movements and a serious side effect called
‘neuroleptic malignant syndrome’. It can also cause severe allergic reactions and blood clots. You must be aware of serious side effects
while you are taking Haloperidol because you may need urgent medical treatment. See ‘Look out for serious side effects’ in section 4.
Elderly people and people with dementia
A small increase in deaths and strokes has been reported for elderly people with dementia who are taking antipsychotic medicines.
Talk to your doctor or pharmacist before taking Haloperidol if you are elderly, particularly if you have dementia.
Talk to your doctor or pharmacist if you have:
• a slow heartbeat, heart disease or anyone in your close family has died suddenly of heart problems
• low blood pressure, or feel dizzy upon sitting up or standing up
• a low level of potassium or magnesium (or other ‘electrolyte’) in your blood. Your doctor will decide how to treat this
• ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke
• epilepsy or have ever had fits (convulsions)
• problems with your kidneys, liver or thyroid gland
• a high level of the hormone ‘prolactin’ in your blood, or cancer that may be caused by high prolactin levels (such as breast cancer)
• a history of blood clots, or someone else in your family has a history of blood clots
• depression, or you have bipolar disorder and start to feel depressed.
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 applies 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 potassium and magnesium (or other ‘electrolyte’) in your blood before or during your
treatment with Haloperidol.
Children below 6 years of age
Haloperidol should not be used in children below 6 years of age. This is because it has not been studied adequately in this age group.
Other medicines and Haloperidol
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Haloperidol if you are taking certain medicines for:
• problems with your heart beat (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine and sotalol)
• depression (such as citalopram and escitalopram)
• psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole,
thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
• bacterial infections (such as azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin and telithromycin)
• fungal infections (such as pentamidine)
• malaria (such as halofantrine)
• nausea and vomiting (such as dolasetron)
• cancer (such as toremifene and vandetanib)
Also tell your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a pain killer or to treat drug
addiction). These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not take
Haloperidol (see ‘Do not take Haloperidol if’)
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, disorientated, a headache, balance problems and feel sleepy.
Certain medicines may affect the way that Haloperidol works or may make heart problems more likely
Tell your doctor if you are taking:
• duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St John’s Wort (Hypericum perforatum) or
venlafaxine (for depression)
• alprazolam or buspirone (for anxiety)
• bupropion (for depression or to help you stop smoking)
• carbamazepine, phenobarbital or phenytoin (for epilepsy)
• ketoconazole tablets (to treat Cushing’s syndrome)
• rifampicin (for bacterial infections)
• chlorpromazine or promethazine (for nausea and vomiting)
• verapamil (for blood pressure or heart problems)
• itraconazole, posaconazole or voriconazole (for fungal infections)
• indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV).
Also tell your doctor if you are taking any other medicines to lower blood pressure, such as water tablets (diuretics).
Your doctor may have to change your dose of Haloperidol if you are taking any of these medicines.
Haloperidol can affect the way the following types of medicine work
Tell your doctor if you are taking medicines for:
• pain (strong pain killers)
• calming you down or helping you to sleep (tranquillisers)
• depression (‘tricyclic antidepressants’)
• severe allergic reactions (adrenaline)
• Parkinson’s disease (such as levodopa)
• thinning the blood (phenindione)
• lowering blood pressure (such as guanethidine and methyldopa)
• attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as ‘stimulants’).
Talk to your doctor before taking Haloperidol if you are taking any of these medicines.
Haloperidol and alcohol
Drinking alcohol while you are taking Haloperidol might make you feel sleepy and less alert. This means you should be careful how
much alcohol you drink. Talk to your doctor about drinking alcohol while taking Haloperidol, and let your doctor know how much you
drink.
Pregnancy, breast-feeding and fertility
Pregnancy - if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice. Your doctor
may advise you not to take Haloperidol while you are pregnant.
The following problems may occur in newborn babies of mothers that take Haloperidol in the last 3 months of their pregnancy (the last
trimester):
• muscle tremors, stiff or weak muscles
• being sleepy or agitated
• problems breathing or feeding.
The exact frequency of these problems is unknown. If you took Haloperidol while pregnant and your baby develops any of these side
effects, contact your doctor.
Breast-feeding – talk to your doctor if you are breast-feeding or planning to breast-feed. This is because small amounts of the
medicine may pass into the mother’s milk and on to the baby. Your doctor will discuss the risks and benefits of breast-feeding
while you are taking Haloperidol.
Fertility – Haloperidol may increase your levels of a hormone called ‘prolactin’, which may affect fertility in men and women.
Talk to your doctor if you have any questions about this.
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Driving and using machines
Haloperidol can affect your ability to drive and use tools or machines. Side effects, such as feeling sleepy, may affect your alertness,
particularly when you first start taking it or after a high dose. Do not drive or use any tools or machines without discussing this with your
doctor first.
Haloperidol contains methylhydroxybenzoate and propylhydroxybenzoate
• Methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216): may cause allergic reactions (possibly delayed).

3. HOW TO TAKE HALOPERIDOL
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much should you take
Your doctor will tell you how much Haloperidol to take and for how long. Your doctor will also tell you whether to take Haloperidol one or
more times a day. It may be some time before you feel the full effect of the medicine. Your doctor will normally give you a low dose to
start, and then adjust the dose to suit you. It is very important you take the correct amount.
Your dose of haloperidol will depend on:
• your age
• what conditions you are being treated for
• whether you have problems with your kidneys or liver
• other medicines you are taking.
Adults
• Your dose will normally be between 0.5 mg and 10 mg each day.
• Your doctor may adjust this to find the dose that suits you best.
• The highest dose adults should take depends on the condition you are being treated for and varies between 5 mg and 20 mg each day.
Elderly people
• Elderly people will normally start on 0.5 mg each day or half the lowest adult dose.
• The amount of Haloperidol you take will then be adjusted until the doctor finds the dose that suits you best.
• The highest dose elderly people should take is 5 mg each day unless your doctor decides a higher dose is needed.
Children and adolescents 6 to 17 years of age
• Your dose will normally be between 0.5 mg and 3 mg each day.
• Adolescents up to 17 years of age being treated for schizophrenia or behavioural problems may have a higher dose, up to 5 mg
each day.
Taking Haloperidol
• Haloperidol is for oral use.
• Shake well before use.
• An oral syringe is included in the pack to help you take the correct dose.
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.
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 to make up for a forgotten dose.
If you stop taking Haloperidol
Unless your doctor tells you otherwise, you should stop taking Haloperidol gradually. Stopping treatment suddenly may cause effects
such as:
• Nausea and vomiting
• Difficulty sleeping.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Look out for serious side effects
Tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.
Problems with the heart:
• abnormal heart rhythm – this stops the heart working normally and may cause loss of consciousness
• abnormally fast heart beat
• extra heart beats.
Heart problems are uncommon in people taking Haloperidol (may affect up to 1 in 100 people). Sudden deaths have occurred in
patients taking this medicine, but the exact frequency of these deaths is unknown. Cardiac arrest (the heart stops beating) has also
occurred in people taking antipsychotic medicines.
A serious problem called ‘neuroleptic malignant syndrome’. This causes a high fever, severe muscle stiffness, confusion and
loss of consciousness. It is rare in people taking Haloperidol (may affect up to 1 in 1,000 people).
Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
• movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
• feeling restless or difficulty sitting still, increased body movements
• slow or reduced body movements, jerking or twisting movements
• muscle tremors or stiffness, a shuffling walk
• being unable to move
• lack of normal facial expression that sometimes looks like a mask.
These are very common in people taking Haloperidol (may affect more than 1 in 10 people). If you get any of these effects, you may
be given an additional medicine.
Severe allergic reaction that may include:

a swollen face, lips, mouth, tongue or throat
• difficulty swallowing or breathing

itchy rash (hives).
An allergic reaction is uncommon in people taking Haloperidol (may affect up to 1 in 100 people).
Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These have been reported in people taking
antipsychotic medicines. The signs of a DVT in the leg include swelling, pain and redness in the leg, but the clot may move to the
lungs causing chest pain and difficulty in breathing. Blood clots can be very serious, so tell your doctor straight away if you notice
any of these problems.
Tell your doctor straight away if you notice any of the serious side effects above.
Other side effects
Tell your doctor if you notice or suspect any of the following side effects.
Very common (may affect more than 1 in 10 people):
• feeling agitated
• difficulty sleeping
• headache.
Common (may affect up to 1 in 10 people):
• serious mental health problem, such as believing things that are not true (delusions) or seeing, feeling, hearing or smelling things
that are not there (hallucinations)
• depression
• abnormal muscle tension
• feeling dizzy, including upon sitting up or standing up
• feeling sleepy
• upward movement of the eyes or fast eye movements that you cannot control
• problems with vision, such as blurred vision
• low blood pressure
• nausea, vomiting
• constipation
• dry mouth or increased saliva
• skin rash
• being unable to pass urine or empty the bladder completely
• difficulty getting and keeping an erection (impotence)
• weight gain or loss
• changes that show up in blood tests of the liver.
Uncommon (may affect up to 1 in 100 people):
• effects on blood cells – low number of all types of blood cells, including severe decreases in white blood cells and low number of
‘platelets’ (cells that help blood to clot)
• feeling confused
• loss of sex drive or decreased sex drive
• fits (seizures)
• stiff muscles and joints
• muscle spasms, twitching or contractions that you cannot control, including a spasm in the neck causing the head to twist to one side
• problems walking
• being short of breath
• inflamed liver, or liver problem that causes yellowing of the skin or eyes (jaundice)
• increased sensitivity of the skin to sunlight
• itching
• excessive sweating
• unexpected production of breast milk
• changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
• breast pain or discomfort
• high body temperature
• swelling caused by fluid build up in the body.
Rare (may affect up to 1 in 1,000 people):
• narrowed airways in the lungs, causing difficulty breathing
• high level of the hormone ‘prolactin’ in the blood
• difficulty or being unable to open the mouth
• problems having sex.
The following side effects have also been reported, but their exact frequency is unknown:
• high level of ‘antidiuretic hormone’ in the blood (syndrome of inappropriate antidiuretic hormone secretion)
• low level of sugar in the blood
• sudden liver failure
• swelling around the voice box or brief spasm of the vocal cords, which may cause difficulty speaking or breathing
• decreased bile flow in the bile duct
• flaking or peeling skin
• inflamed small blood vessels, leading to a skin rash with small red or purple bumps
• breakdown of muscle tissue (rhabdomyolysis)
• persistent and painful erection of the penis
• enlarged breasts in men
• low body temperature.
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 or search for MHRA Yellow Card in the
Google Play or Apple App Store. 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. Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What this product contains:
• the active ingredient is haloperidol; each 5 ml of solution contains 10 mg haloperidol
• the other ingredients are: 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Manufacturer: CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF or
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland
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PL 04917/0024
This leaflet was last updated in 10/2017

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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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