Haldol Oral Concentrate
(Haloperidol Lactate)

What Haldol Oral Concentrate is and what it is used for

The name of your medicine is Haldol. Haldol contains the active substance haloperidol. This belongs to a group of medicines called ‘antipsychotics’. Haldol 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 excited, agitated, enthusiastic, impulsive or hyperactive
• Feel very aggressive, hostile or violent. In adolescents and children, Haldol is used to treat schizophrenia in patients aged 13 to 17 years, and to treat behavioural problems in patients aged 6 to 17 years. Haldol 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. Haldol is sometimes used when other medicines or treatments have not worked or caused unacceptable side effects.

How to take Haldol Oral Concentrate

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 Haldol to take and for how long. Your doctor will also tell you whether to take Haldol 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 condition 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 Haldol 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 Haldol
• Haldol is for oral use.
• You can mix Haldol oral solution in some water before you take it, but don’t mix it with any other liquids. You must take the solution using the oral syringe.
• Place the bottle on a flat surface.
• Remove the cap from the bottle by pushing down on the cap while turning it anti-clockwise (figure 1).
• One end of the oral syringe has a plunger. Place the other end into the solution in the bottle.
• While holding the lower ring on the oral syringe, pull the top ring of the plunger upwards. Do this, until the mark that matches. the number of millilitres (ml) is just visible (figure 2).
• Holding the lower ring, remove the whole oral syringe from the bottle (figure 3).
• Empty the contents of the oral syringe onto a spoon or into a cup. Do this by sliding the upper ring down while still holding the lower ring.
• Drink the solution straight away.
• Close the bottle, then rinse the oral syringe with some water. If you take more Haldol than you should If you take more Haldol than you were told to or if someone else has taken any Haldol, talk to a doctor or go to the nearest hospital casualty department straight away. If you forget to take Haldol
• 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 stop taking Haldol Unless your doctor tells you otherwise, you should stop taking Haldol gradually. Stopping treatment suddenly may cause effects such as:
• Nausea and vomiting
• Difficulty sleeping. Always follow your doctor’s instructions carefully. If you have any further questions on the use of this medicine, ask your doctor or pharmacist

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 Haldol (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 Haldol (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 Haldol (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 Haldol (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
• Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
• Unexpected production of breast milk
• 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):
• High level of the hormone ‘prolactin’ in the blood
• Narrowed airways in the lungs, causing difficulty breathing
• 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
• Swelling around the voice box or brief spasm of the vocal cords, which may cause difficulty speaking or breathing
• Sudden liver failure
• 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 or pharmacist. 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

How to Store Haldol Oral Concentrate

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze the medicine. Do not use this medicine after the expiry date which is stated on the bottle label or carton. The expiry date refers to the last day of that month. 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.