Microsoft word - haldol tablets pil~c14-21nov11.doc
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 tablets are and what they are used for 2. Before you take Haldol tablets 3. How to take Haldol tablets 4. Possible side effects 5. How to store Haldol tablets 6. Further information 1. What Haldol tablets are and what they are used for
The name of your medicine is Haldol tablets.
Haldol tablets contain a medicine called haloperidol. This belongs to a group of medicines called ‘neuroleptics’.
Haldol tablets are used for illnesses affecting the way you think, feel or behave. These illnesses may make you: • Feel
• 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
Haldol tablets are also used for: • Gilles de la Tourette syndrome and movements you can’t control (tics) • Hiccups that won’t go away 2. Before you take Haldol tablets Do not take Haldol tablets if:
• You are allergic to anything in Haldol tablets (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
• Your doctor tells you that you have a condition that affects part of your brain
• You are less aware of things around you or your reactions become slower 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 using Haldol tablets.
Take special care with Haldol tablets 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 taking Haldol tablets if you have: • A heart problem or anyone in your close family has died suddenly of heart
• 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
• Not been eating properly for a long time
• Epilepsy or have ever had fits (convulsions) as you may need more
• A non-cancerous tumour of the adrenal gland (phaeochromocytoma) You may need to be more closely monitored, and the amount of Haldol tablets 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 tablets.
Medical check ups Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haldol tablets. 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 monitoringmay be needed if you are taking lithiumand Haldol tablets 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. Haldol tablets 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
• Pain (strong pain killers) • Changes in your heart beat or are taking medicines that affect your heart
• Coughs and colds • Epilepsy • Depression, such as ’tricyclic antidepressants’ and 'tetracyclic
• 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 tablets if you are taking any of these medicines.
Certain medicines may affect the way that Haldol tablets work 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 tablets.
Taking Haldol tablets with food and alcohol You can take Haldol tablets with or without food. Swallow the tablets with some water.
Drinking alcohol while you are taking Haldol tablets 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 taking Haldol tablets 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 take Haldol tablets if your doctor thinks you need to.
Do not take 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 5 mg tablets Haldol 5 mg tablets contain lactose. If your doctor has told you that you are intolerant of some sugars, discuss it with them before taking this medicine 3. How to take Haldol tablets
Always take Haldol tablets 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 many Haldol tablets 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
• Your starting dose will normally be between 1.5 mg and 5 mg. You will
• Your doctor may reduce the dose of Haldol tablets when your symptoms
Children • The dose for children depends on their weight
• Children will normally be given 0.025 to 0.05 mg per kilogram each day
• Half the dose should be taken in the morning and the other half in the
• The most children should take each day is 10 mg
• Elderly people are normally started on a lower dose
• The amount of Haldol tablets you take will then be adjusted until the doctor
Taking Haldol tablets • Haldol tablets should be taken by mouth • Swallow the tablets with some water When to stop using Haldol tablets 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 tablets 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 tablets than you should If you take more Haldol tablets than you were told to or if someone else has taken any Haldol tablets, talk to a doctor or go to the nearest hospital casualty department straight away. If you forget to take Haldol tablets • If you forget to take a dose, take your next dose as usual. Then keep taking
your medicine as your doctor has told you
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 tablets 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
• Fast heart beat, changing blood pressure and sweating followed by
• Faster breathing, muscle stiffness, reduced consciousness and coma
• Raised levels of a protein in your blood (an enzyme called creatine
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:
• Difficulties with sex such as erection problems
• Some men experiencing swelling of their breast or painful and
• Some people losing interest in sex • Some women having irregular, painful or heavy periods or no monthly
• Some women unexpectedly producing breast milk, having painful
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’)
If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or nurse . 5. How to store Haldol tablets
Keep out of the reach and sight of children.
Do not use Haldol tablets after the expiry date which is stated on the 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 tablets to your pharmacist. 6. Further information The active substance in Haldol tablets is haloperidol. The tablets contain 5 mg or 10 mg of haloperidol. The other ingredients are different for the 5 mg and 10 mg tablets. They are listed below. Haldol 5 mg tablets: lactose monohydrate, maize starch, talc, cottonseed oil- hydrogenated and indigotindisulphonate sodium (E132). Haldol 10 mg tablets: calcium hydrogen phosphate dihydrate, maize starch, calcium stearate and quinoline yellow (E104). What Haldol tablets look like and contents of the pack Haldol 5 mg tablets are pale blue. They are marked “Janssen” on one side and “X” on the other.
Haldol 10 mg tablets are yellow. They are marked “Janssen” on one side and “H/10” on the other.
Haldol tablets are supplied in blister packs of 100 tablets per pack.
The product licence is held by: JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK Haldol tablets are made by: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Lusomedicamenta-Sociedade Tecnica Farmaceutica SA, Estrada Consiglieri Pedroso 69-B, Queluz de Baixo, 2730-055 Barcarena, Portugal
McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire, UK OX16 4RS
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last approved in Nov 2011
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