Haloperidol 1.5mg Tablets
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Haloperidol
Haloperidol
Haloperidol
Haloperidol
Haloperidol
0.5 mg Tablets 1.5 mg Tablets 5 mg Tablets 10 mg Tablets 20 mg Tablets
Read all of the leaflet carefully before you start taking 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Haloperidol Tablets are and what they are used for
2. Before you take Haloperidol Tablets
3. How to take Haloperidol Tablets
4. Possible side effects
5. How to store Haloperidol Tablets
6. Further Information
A SANDOZ
Haloperidol Tablets belong to a group of drugs known as neuroleptics which act on the central nervous system.
They are used to treat the following conditions in adults:
• schizophrenia and other psychoses particularly paranoia (delusions and feelings of persecution)
• mania (overactive behaviour) and hypomania (elated moods and excitability)
• aggression, hyperactivity and self-harm in patients with mental handicap or brain damage
• to treat moderate to severe excitement, agitation and violent dangerously impulsive behaviour; your doctor may prescribe other medicines at the same time
• uncontrollable hiccups
• restlessness and agitation in the elderly
• control the unwanted movements and noises associated with Tourette's syndrome and severe tics.
In children this medicine is used for the treatment of personality disorders such as hyperactivity and aggression, schizophrenia and to control the symptoms of Tourette's syndrome.
DO NOT TAKE Haloperidol Tablets if you:
• have had any unusual or allergic reactions to haloperidol, other neuroleptics or to any of the other ingredients in the product (see Section 6 ‘Further information’).
• have Parkinson's disease, symptoms of which include tremor (shaking), stiffness and shuffling.
• are breast-feeding.
These tablets must NOT be given to patients who are in an
unconscious state (coma).
Take special care with Haloperidol Tablets
Check with your doctor before taking these tablets if you
have:
• liver disease or liver problems such as jaundice (yellowing of the skin or whites of the eyes).
• kidney failure.
• hyperthyroidism (increased activity of the thyroid gland).
• depression.
• heart disease such as heart failure.
• epilepsy or suffer from convulsions/fits.
• phaeochromocytoma (high blood pressure due to a tumour near the kidney).
• lower than normal levels of minerals (electrolytes) in your blood.
• a condition called angle closure glaucoma caused by increased eye pressure.
• a condition called myasthenia gravis which causes muscle weakness and tiredness.
• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Before you have any kind of surgery, it is important to tell your doctor or dentist in charge that you are taking this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicines, including those obtained without a prescription (which may alter the effects of Haloperidol Tablets) especially:
• hypnotics and drugs which have sedative properties such as phenobarbitone (treats epilepsy), diazepam (treats anxiety), temazepam (sleeping tablets)
• strong painkillers i.e codeine phosphate
• drugs to reduce blood pressure such as guanethidine or methyldopa
• central nervous system stimulants such as adrenaline or amphetamines
• anti-convulsant drugs - the dose may need to be increased
• anti-Parkinson’s drugs such as levodopa, carbidopa as these may interfere with the absorption of Haloperidol Tablets
• blood clotting disorder drugs i.e. phenindione
• tricyclic anti-depressants such as amitriptyline or doxepin
• lithium which is used to treat psychiatric disorders. If you are taking Haloperidol Tablets with lithium, your doctor may want to monitor your heart rate.
Taking Haloperidol Tablets with alcohol
Avoid alcohol if taking these tablets.
Pregnancy and breast-feeding
Haloperidol Tablets should not be taken during pregnancy, unless your doctor considers it absolutely necessary. Do not breast-feed if you have to take these tablets. Ask your doctor or pharmacist for advice before taking any medicine.
The following symptoms may occur in newborn babies, of mothers that have used Haloperidol Tablets 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.
Driving and using machines
Haloperidol Tablets may cause some people, especially elderly patients, to become drowsy, light-headed, clumsy, unsteady or less alert than normal. If you are affected, do not drive or operate dangerous machinery during treatment with the medicine. Alcohol may make these effects worse.
Important information about some of the ingredients of Haloperidol Tablets
Lactose - if you have an intolerance to some sugars, contact your doctor before taking these tablets.
Ponceau 4R red (colouring in the 10 mg tablets only) - may cause allergic reactions.
Always take exactly Haloperidol Tablets as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You will be prescribed the lowest dose needed to control your symptoms. Do not stop taking Haloperidol Tablets or change the dose unless your doctor tells you to.
Continued on the next page >>
Swallow the tablets with water.
For all conditions except those conditions mentioned below Adults: Moderate symptoms: Start with 1.5 mg -3mg
two or three times a day.
Severe symptoms/resistant patient: Start with 3mg -5 mg two or three times a day.
This may be increased gradually to reach an effective dose which is usually 5mg- 10 mg daily, but some patients need up to 30 mg daily. Elderly: Start with half the usual adult dose; this may
gradually be increased by your doctor.
For Tourette's syndrome, severe tics and uncontrollable hiccups
Adults: Start with 1.5 mg, two times a day. This may be
increased gradually to reach an effective dose. A daily dose of 10 mg may be required for patients with Tourette's syndrome.
Elderly: Start with half the usual adult dose; this may
gradually be increased by your doctor.
For restlessness or agitation
Elderly: Start with 1.5 mg - 3 mg, two or three times a
day. This may be increased gradually to reach an effective dose, usually 1.5 mg - 5 mg daily.
For childhood behavioural disorders/schizophrenia and Tourette's syndrome
Children: The total maintenance dose is 0.025 mg -
0.05 mg per kg body weight a day. Half the total dosage should be given in the morning and the other half in the evening, up to a maximum of 10 mg daily.
If you take more Haloperidol Tablets than you should
If you (or someone else) accidentally take too much medicine, contact a doctor or go to your nearest hospital casualty department immediately. Take any remaining tablets in their pack with you so they can be identified. Signs and symptoms of an overdose include severe involuntary movements, low blood pressure, sedation (calm state).
• headache, dizziness, light-headedness, slow thinking, epileptic fits, blurred vision
• excitement, agitation, confusion, difficulty in sleeping
• some women experience discharge of milk from their breasts, changes to their periods (irregular or no period at all)
• some men experience swelling of their breasts, problems with ejaculation and long lasting/painful erections
• blood disorders characterised by fever, sore mouth and throat
• increased sensitivity of skin to sunlight (avoid exposure to sunlight and UV light)
• difficulty in performing voluntary movements may develop during therapy, after therapy or during therapy in conjunction with drugs used to treat Parkinson's disease.
This depends on the dosage and the duration of treatment with Haloperidol Tablets.
Withdrawal effects: If you suddenly stop taking this medicine you may get nausea, vomiting, difficulty in sleeping (insomnia), tremor, jerky body movements or an inability to control movements of the hands and body.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
Keep out of the reach and sight of children.
Do not take Haloperidol Tablets after the expiry date shown on the label.
If you forget to take Haloperidol Tablets
If you forget your dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking Haloperidol Tablets
Withdrawal symptoms can occur after you stop treatment (see Section 4 ‘Withdrawal effects’), so gradual withdrawal is advisable. Do not stop taking the tablets without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Store in the original package below 25°C. Keep the container lid tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Haloperidol Tablets can cause side
effects, although not everybody gets them.
STOP taking these tablets and contact your doctor
immediately if you develop any of the following:
• A severe allergic reaction, signs of which include sudden swelling of the face or throat, difficulty breathing, severe skin rash including inflammation and flaking of skin (exfoliative dermatitis), raised red patches of skin which may blister (erythema multiforme)
• Neuroleptic malignant syndrome symptoms of which may include:
- fast heart beat, changing blood pressure and sweating followed by a fever
- faster breathing, muscle stiffness, reduced consciousness and coma
- increased levels of an enzyme called creatine phosphokinase in your blood
• Irregular heart beat (arrhythmia). An arrhythmia can cause your heart to stop beating (cardiac arrest)
• Muscle rigidity, tremor, jerky movements of the hands and body and inability to control these movements, rolling of the eyes, speech problems
• Yellowing of the skin and whites of the eyes (jaundice). A sign of this may be sudden onset of fever after one to three weeks of treatment, followed by the development of jaundice
• 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. If you notice any of these symptoms seek medical advice immediately.
Other side effects:
• upset stomach, loss of appetite, indigestion, irregular changes in body weight
• a fall in blood pressure (hypotension), fainting (especially in the elderly)
What Haloperidol Tablets contain
The active substance is Haloperidol, 0.5 mg, 1.5 mg, 5 mg, 10mgor 20 mg per tablet.
The other ingredients are lactose, povidone, maize starch, magnesium stearate, stearic acid.
The 5 mg tablets also contain green S (E142), tartrazine (E102), patent blue V (E131) and carmoisine (E122).
The 10 mg tablets also contain colloidal anhydrous silica and ponceau 4R red (E214).
For Lactose and Ponceau Red - See end of Section 2 Important information about some of the ingredients of Haloperidol Tablets’,
What Haloperidol Tablets look like and contents of the pack
The tablets are biconvex or flat and circular with an embossed number on the reverse side:
0.5 mg = White 6.5 mm tablet, plain on one side and “A488” on the other side.
1.5 mg = White 7.0 mm tablet, plain on one side and “A489” on the other side.
5 mg = Light green 8.0 mm tablet, plain on one side and “A490” on the other side.
10 mg = Pink 9.0 mm tablet, plain on one side and “A491” and a breakline on the other side.
20 mg = White 10 mm tablet, plain on one side and “A492” and a breakline on the other side.
They are available in:
• blister packs containing 28 or112 tablets
• plastic containers containing 28 or 1000 tablets.
Not all packs sizes may be marketed.
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Regent GM Laboratories Ltd, Coronation Road, Park Royal, London, NW10 7PT.
This leaflet was last revised in 06/2013.
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