HALOPERIDOL ORAL SOLUTION BP 10 MG / 5ML - patient leaflet, side effects, dosage

h. 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.

see, hear, feel or smell things that are not there (hallucinations) feel unusually suspicious (paranoia)

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.

b. 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.

h/Varnings 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 Iwhile 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

kA 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 halofantnne)

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:

calming you down or helping you to sleep (tranquillisers) severe allergic reactions (adrenaline)

thinning theolood (phenindione)

lowering blood pressure (such as guanethidine and methyldopa)

h 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 prink.

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 ftrimester):

muscle tremors, stiff or weak muscles 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 Iwhile you are taking Haloperidol.

Fertility - Haloperidol may increase your levels of a hormone called ‘prolactin’, which may affect fertility in men and women.

alk to your doctor if you have any questions about this.

4. POSSIBLE SIDE EFFECTS

Look out for serious side effects

Prob ems with the heart:

extra heart beats

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.

Elderly people

Elderly people will normally start on 0.5 mg each day or half the lowest adult dose.

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

Taking Haloperidol Haloperidol is for oral use. An oral syringe is included in the pack to help you take the correct dose.

Shake we before use

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

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:

Driving and using machines

Haloperidol can ayour 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

3. HOW TO TAKE HALOPERIDOL

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

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 or search for MHRA Yellow Card in the

5. HOW TO STORE HALOPERIDOL

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.

Haloperidol contains methylhydroxybenzoate and propylhydroxybenzoate Methylhydroxybenzoate

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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:

what conditions you are being treated for other medicines you are taking.

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.

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.

hospital casualty department straight away.

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

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

Tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.

abnormal heart rhythm – this stops the heart working normally and may cause loss of consciousness

abnormally fast heart beat

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),

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

Severe allergic reaction that may include: swollen face, lips, mouth, tongue or throat

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 leas (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

Tell your doctor straight away if you notice any of the serious side effects above.

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

Common (may affect up to 1 in 10 people):

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 difficulty getting and keeping an erection (impotence)

changes that show up in blood tests of the liver.

Uncommon (may affect up to 1 in 100 people): muscle spasms, twitching or contractions that you cannot control, including a spasm in the neck causing the head to twist to one side inflamed liver, or liver problem that causes yellowing of the skin or eyes (jaundice)

increased sensitivity of the skin to sunlight excessive sweating

changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods

breast pain or discomfort

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

difficulty or being unable to open the mouth

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 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

inflamed small blood vessels, leading to a skin rash with small red or purple bumps

Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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