Haldol Tm 2 Mg/Ml Oral Liquid
PACKAGE LEAFLET: INFORMATION FOR THE USER
Haldol® 2mg/ml oral liquid
Haloperidol
Haldol is a registered trademark
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, 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 side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet
1. What Haldol liquid is and what it is used for
2. Before you use Haldol liquid
3. How to use Haldol liquid
4. Possible side effects
5. How to store Haldol liquid
6. Further information
1. What Haldol liquid is and what it is used for
The name of your medicine is Haldol 2mg/ml oral liquid. It is called ‘Haldol liquid’ in this leaflet.
Haldol liquid contains a medicine called haloperidol. This belongs to a group of medicines called ‘antipsychotics’.
Haldol liquid is used for:
• Schizophrenia, psychoses, mania and behavioural problems in adults and children
These illnesses affect the way you think, feel or behave. They may make you:
• Feel confused
• See, hear or feel things that are not there (hallucinations)
• Believe things that are not true (delusions)
• Feel unusually suspicious (paranoia)
• Feel very excited, agitated, enthusiastic or hyperactive
• Feel very aggressive or violent
Haldol liquid is also used for:
• Gilles de la Tourette syndrome and movements you can’t control (tics)
• Hiccups that won’t go away
2. Before you use Haldol liquid
Do not use Haldol liquid if:
• You are allergic to anything in Haldol liquid (listed in section 6 below)
• You have, or have had, certain types of heart disease which cause your heart to beat with an abnormal rhythm (arrhythmia) or unusually slowly
• You are taking any medicines which affect your heart beat
• Your doctor tells you that the level of potassium in your blood is too low
• You have Parkinson’s disease
• Your doctor tells you that you have a condition that affects part of your brain called the ‘basal ganglia’
• You are less aware of things around you or your reactions become slower Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Haldol liquid.
Take special care with Haldol liquid
If you are elderly, as you may be more sensitive to the effects of Haldol.
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.
Check with your doctor or pharmacist before using Haldol liquid if you have:
• A heart problem or anyone in your close family has died suddenly of heart problems
• Ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke
• Lower than normal levels of minerals (electrolytes) in your blood. Your doctor will advise you
• Not been eating properly for a long time
• Liver or kidney problems
• Epilepsy or have ever had fits (convulsions) as you may need more medicine to control them
• Depression
• Problems with your thyroid gland
• A non-cancerous tumour of the adrenal gland (phaeochromocytoma)
You may need to be more closely monitored, and the amount of Haldol liquid you take may have to be altered. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Haldol liquid.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haldol liquid. The ECG measures the electrical activity of your heart.
Blood tests
Your doctor may want to check the levels of minerals (electrolytes) in your blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Special monitoring may be needed if you are taking lithium and Haldol liquid 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, disoriented, a headache, balance problems and feel sleepy.
These are signs of a serious condition
Haldol liquid 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)
• Illnesses that affect the way you think, feel or behave (antipsychotics or neuroleptics)
• Pain (strong pain killers)
• Changes in your heart beat or are taking medicines that affect your heart beat
• Coughs and colds
• Epilepsy
• Depression, such as ’tricyclic antidepressants’ and 'tetracyclic antidepressants'
• Lowering blood pressure, such as guanethidine and methyldopa
• Severe allergic reactions, such as adrenaline
• Parkinson’s disease, such as levodopa
• Thinning the blood, such as phenindione
Talk to your doctor before taking Haldol liquid if you are taking any of these medicines.
Certain medicines may affect the way that Haldol liquid works
Tell your doctor if you are taking medicines for:
• Depression, such as fluoxetine and paroxetine
• Malaria, such as quinine and mefloquine
• Anxiety, such as buspirone
• Problems with your heart beat, such as quinidine, disopyramide and procainamide, amiodarone, sotalol and dofetilide
• Epilepsy, such as phenobarbital and carbamazepine
• Allergies, such as terfenadine
• Serious infections, such as rifampicin
• Lowering blood pressure, such as water tablets (diuretics)
• Infections such as sparfloxacin, moxifloxacin, erythromycin IV
• A fungal infection, such as ketoconazole
Your doctor may have to change your dose of Haldol liquid.
Taking Haldol liquid with food and alcohol
You can take Haldol liquid with or without food.
Drinking alcohol while you are taking Haldol liquid might make you feel drowsy and less alert. This means you should be careful how much alcohol you drink.
Pregnancy and breast-feeding
Talk to your doctor before using Haldol liquid if you are pregnant, think you may be pregnant or might become pregnant. The following symptoms may occur in newborn babies of mothers that have used Haldol 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.
You may still be able to use Haldol liquid if your doctor thinks you need to.
Do not use this medicine if you are breast-feeding. This is because small amounts may pass into the mother’s milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
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 Haldol and will explain the possible risks of its use.
Driving and using machines
This medicine may affect you being able to drive. Do not drive or use any tools or machines without discussing this with your doctor first.
Important information about some of the ingredients of Haldol liquid
Haldol liquid contains methyl parahydroxybenzoate (E218). This may cause an allergic reaction. This reaction may happen some time after you have taken Haldol liquid.
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.
3. How to use Haldol liquid
Always use Haldol liquid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much should you take
Your doctor will tell you how much Haldol liquid to take and for how long. Your doctor will adjust the dose to suit you. It is very important you take the correct amount.
Your dose will depend on:
• Your age
• How serious your symptoms are
• Whether you have other medical problems
• How you have reacted to similar medicines in the past
Adults
• When used to treat schizophrenia, psychoses or mania your dose will normally be 2mg, but may be increased up to 20mg
• When used to treat agitation and behavioural problems your dose will normally be 1.5 mg to 5mg
• It may be given as a single dose or split into smaller doses and given two to three times a day
• Your doctor may reduce the dose of Haldol liquid when your symptoms begin to improve
Children
• The dose for children depends on their weight and age
• The following doses will be split into smaller doses and given two to three times a day
Children aged 3 to 12 years
• When used to treat childhood schizophrenia, the normal dose will be 1 to 4mg a day but may be increased up to 6 mg a day
• When used to treat agitation and behavioural problems, the normal dose will be 0.5 to 3 mg a day but may be increased up to 3 mg a day
Adolescents aged 13 to 17 years of age
• When used to treat childhood schizophrenia, the normal dose will be 1 to 6 mg a day but may be increased up to 10 mg a day
• When used to treat agitation and behavioural problems, the normal dose will be 2 to 6 mg a day but may be increased up to 6 mg a day
Elderly people
• Elderly people are normally started on half the adult dose
• The amount of Haldol liquid you take will then be adjusted until the doctor finds the dose that suits you best
Using the pipette to take Haldol liquid
You must take Haldol liquid using the pipette.
• 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 A)
• One end of the pipette has a plunger. Place the other end into the liquid in
the bottle
• While holding the lower ring on the pipette, pull the top ring upwards. Do this, until the mark that matches the number of millilitres (ml) or milligrams (mg) is just visible (figure B)
• Holding the lower ring, remove the whole pipette from the bottle (figure C)
• Empty the contents of the pipette into a cup. Do this by sliding the upper ring down while still holding the lower ring
• Drink the Haldol liquid straight away
• Close the bottle, then rinse the pipette with some water
When to stop using Haldol liquid
Take the medicine for as long as your doctor has told you. It may be some time before you feel the full effect of the medicine.
Unless your doctor tells you otherwise, you should stop taking Haldol liquid gradually. Stopping treatment suddenly may cause effects such as:
• Feeling sick (nausea) or being sick (vomiting)
• Difficulty sleeping
Always follow your doctor’s instructions carefully.
If you take more Haldol liquid than you should
If you take more Haldol liquid than you were told to or if someone else has taken any Haldol liquid, talk to a doctor or go to the nearest hospital casualty department straight away.
If you forget to take Haldol liquid
• 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 have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Haldol liquid can cause side effects, although not everybody
gets them.
Tell your doctor or nurse straight away if you notice or suspect any of the
following. You may need urgent medical treatment.
• 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.
• Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction. This only happens in a small number of people
• A serious problem called ‘neuroleptic malignant syndrome’. The signs 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)
This can occur in fewer than 1 in 1,000 people
• 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 neuroleptics compared with those not receiving neuroleptics. 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 rolling of the eyes. If you get any of these effects, you may be given an additional medicine
Tell your doctor or nurse if you notice or suspect any of the following side
effects:
• Feeling agitated or having difficulty sleeping
• Headache
These can affect more than 1 in 10 people
• Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk
• Feeling restless, low or depressed or sleepy
• Feeling light headed or dizzy, particularly when standing up
• Symptoms of psychosis such as abnormal thoughts or visions, or hearing abnormal sounds
• Problems with sight including blurred vision and rapid eye movements These can occur in fewer than 1 in 10 people
• Liver problems including yellowing of the skin and eyes, pale stools and dark coloured urine
• Feeling confused
• A fall in the number of white blood cells which can cause frequent infections
• Fits or seizures (convulsions)
• Difficulty breathing or wheezing
• Hormone changes which may lead to:
• Changes in weight
• Difficulties with sex such as erection problems
• Some men experiencing swelling of their breast or painful and prolonged erection
• Some people losing interest in sex
• Some women having irregular, painful or heavy periods or no monthly period
• Some women unexpectedly producing breast milk, having painful breasts
These can occur in fewer than 1 in 100 people
• Being unable to open mouth
This can occur in fewer than 1 in 1000 people
• Bleeding or bruising more easily than normal. This can be caused by a fall in the number of small blood cells called platelets
• Fluid retention affecting the brain, resulting in weakness, tiredness or confusion
The precise frequency of how often these occur is not known Other side effects
Common side effects (affects fewer than 1 in 10 people)
• Rash
• Slow movements
• Dry mouth
• Feeling sick, being sick
• Constipation
• Difficulty passing water (urine)
Uncommon side effects (affects fewer than 1 in 100 people)
• Sensitivity of skin to sunlight
• Sweating more than usual
• Fever
• Swelling of the ankles
The following side effects have been reported, however the precise frequency cannot be identified and therefore how often they occur is classed as unknown:
• Flaking or peeling of the skin
• Inflamed skin (red, hot to the touch and tender)
• Low body temperature
• In newborn babies, of mothers that have used Haldol in the last trimester (last three months of 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.
Test results:
• Abnormal test results for liver function
• Low blood sugar levels (hypoglycaemia)
• Abnormal heart traces (electrocardiogram, ‘ECG’)
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 Haldol liquid
Keep out of the reach and sight of children.
Do not store above 25°C. Do not refrigerate or freeze the medicine.
Do not use Haldol liquid after the expiry date which is stated on the carton and bottle label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment. Return any leftover Haldol liquid to your pharmacist.
6. Further information
The active substance in Haldol liquid is haloperidol. The liquid contains 2 mg of haloperidol in each millilitre.
The other ingredients are lactic acid, methyl parahydroxybenzoate and water.
What Haldol liquid looks like and contents of the pack
Haldol liquid is supplied in an amber bottle containing 100 ml of a clear, colourless liquid.
The product licence is held by:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
Haldol liquid is made by:
Janssen-Cilag SA, Campus de Maigremont, 27100 Val de Reuil, France OR
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium OR
McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire, OX16 4RS, UK
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last revised in November 2013
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