RdSEmmnt^ Package leaflet: Information for the user

Haloperidol 10mg/5ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine - because it contains important information for you.

■    Keep this leaflet. You may need to read it again.

■    If you have any further questions, ask your doctor or your pharmacist.

■    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

■    If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Haloperidol Oral Solution is and what it is used for

2.    What you need to know before you take Haloperidol Oral Solution

3.    How to take Haloperidol Oral Solution

4.    Possible side effects

5.    How to store Haloperidol Oral Solution

6.    Contents of the pack and other information

1. What Haloperidol Oral Solution is and what it is used for

The full name of your medicine is Haloperidol 10mg/5ml Oral Solution. In this leaflet the shorter name Haloperidol is used. Haloperidol belongs to a group of medicines called neuroleptics.

Haloperidol acts on the brain to calm your emotions.

Haloperidol can be used to treat:

■    schizophrenia

^■    feeling and being sick

^■    problems with behaviour in adults and children

^■    persistent hiccups or severe tics

■    Gilles de la Tourette syndrome in adults and children

■    or to calm your emotions particularly if you feel agitated and restless if you are an older person, over-excited or aggressive.

2. What you need to know before you take Haloperidol Oral Solution

Do not take Haloperidol and tell your doctor if:

■    you are allergic (hypersensitive) to haloperidol or any other ingredients in this liquid (listed in section 6). The signs of allergic reaction can include a rash, itching or shortness of breath

■    you have a history of blood problems

■    you have or are at the risk of having an irregular or unusually slow heart beat, heart block or other heart problems

■    you are taking medicines that affect the beating of your heart such as verapamil and sotalol

■    you have dulled senses

■    you have Parkinson's Disease

■    you have damage to the part of the brain known as the basal ganglia

■    you have been told by your doctor that you have low potassium levels in your blood (hypokalaemia).

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.

Warnings and precautions

Talk to your doctor before taking Haloperidol if:

■    you have a heart problem or anyone in your close family has died suddenly from heart problems

■    you are pregnant or breast-feeding

■    you have kidney or liver problems

■    you have epilepsy or other problems that may cause fits such as brain damage or alcohol withdrawal

■    you have thyroid problems

■    you have a tumour of your adrenal gland that causes high blood pressure (phaeochromocytoma)

^■    you are feeling depressed

^■    you have been told by your doctor that you metabolise some drugs slower than other people

^■    you have had a stroke or brain haemorrhage

■    you have been told you have low levels of potassium, calcium or magnesium in your blood

■    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

■    you are an elderly patient with dementia

■    you suffer from a disorder with related memory loss

■    you have not been eating properly for a long time.

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.

Other important information to take into account before you take this medicine:

■    if you or members of your family have heart problems (including heart failure, heart attack or uneven heart beats) or you have low potassium or magnesium in your blood, your doctor may do some tests on your heart (ECG)

■    your doctor may also want to give you regular blood tests to check the levels of minerals (electrolytes) in your blood. This is particularly true for patients taking water tablets (diuretics) or who have other related illnesses.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Haloperidol.

Other medicines and Haloperidol:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because haloperidol can affect the way some other medicines work. Also some medicines can affect the way haloperidol works.

Special monitoring may be needed if you are taking lithium and haloperidol 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, disorientated, a headache, balance problems and feel sleepy. These are signs of a serious condition.

Haloperidol can affect the way medicines work.

Tell your doctor if you are taking:

■    medicines to treat high blood pressure such as guanethidine, methyldopa and water tablets (diuretics)

■    heart medicines to control your heart beat such as quinidine, amiodarone, disopyramide, procainamide, sotalol, dofetilide and bretylium

■    medicines that control your emotions such as thioridazine, lithium, sertindole, pimozide and chlorpromazine

■    medicines for depression and anxiety such as fluvoxamine, fluoxetine, buspirone, venlafaxine, sertraline, paroxetine and also 'tricyclic antidepressants' that include amitriptyline, and 'tetracyclic antidepressants' that include maprotiline

■    medicines that help you sleep such as sedatives or hypnotics such as temazepam and alprazolam

■    medicines to treat epilepsy such as phenobarbital and carbamazepine

■    medicines used to treat Parkinson's Disease such as levodopa

■    adrenaline, used for severe allergies and other medicines that mimic the actions of natural substances in the body. These are normally found in cough and cold medicines

■    phenindione, used to treat thrombosis

■    strong painkillers such as codeine

■    medicines to treat stomach problems such as cisapride

Certain medicines may affect the way that Haloperidol works. Tell your doctor if you are taking:

■    medicines to treat high blood pressure such as guanethidine, methyldopa and water tablets (diuretics)

■    heart medicines to control the heart beat such as quinidine, amiodarone, disopyramide, procainamide, sotalol, dofetilide and bretylium

■    medicines for depression and anxiety such as amitriptyline, fluvoxamine, maprotiline, fluoxetine, buspirone, venlafaxine, sertraline and paroxetine

■    medicines to treat epilepsy such as phenobarbital and carbamazepine

■    medicines used to treat malaria such as quinine, mefloquine and halofantrine

■    antibiotics such as moxifloxacin, sparfloxacin and erythromycin IV

■    medicines used to treat fungal infections such as itraconazole and ketoconazole

■    other medicines to treat allergies (antihistamines) such as terfenadine and promethazine

■    rifampicin used to treat serious infections

■    arsenic mesilate, given for leukaemia

■    dolasetron, used to treat nausea (feeling sick) and vomiting

Haloperidol with food, drink and alcohol

You must not drink alcohol whilst taking this medicine. This is because this medicine may make you feel drowsy and drinking alcohol will make you even more drowsy. Drinking alcohol may also affect the condition you are suffering from.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not use this medicine unless your doctor feels it is absolutely necessary if you are pregnant, or if you are breast-feeding as small amounts may pass into the mother's milk.

The following symptoms may occur in newborn babies, of mothers that have used haloperidol 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

Do not drive or use tools or machines if this medicine makes you drowsy or gives you blurred vision.

If you drink alcohol whilst taking Haloperidol, it may further affect your ability to drive and use machinery.

Important information about what is in this medicine:

Haloperidol Oral Solution contains:

■    methyl and propyl parahydroxybenzoates. These may cause an allergic reaction.

This allergy may happen some time after starting the medicine.

3. How to take Haloperidol Oral Solution

Always take this medicine exactly as your doctor or pharmacist has told you. Look on the label and check with your doctor or pharmacist if you are not sure.

Taking this medicine

■    this medicine contains 10mg of haloperidol in each 5ml

■    take this medicine by mouth

■    if you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to your doctor or pharmacist.

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 Haloperidol when your symptoms begin to improve

■    The maximum dose for all treatments is 20mg a day.

Children

■    Your doctor will work out the dose for your child according to their age and weight

■    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

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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 Haloperidol you take will then be adjusted until the doctor finds the dose that suits you best

If you take more Haloperidol than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken. Signs of an overdose may include low or high blood pressure, extreme sleepiness, muscle spasms, fits, quick and shallow breaths and coma.

If you forget to take Haloperidol

■    Do not take a double dose (two doses at the same time) to make up for forgotten doses.

■    Skip the missed dose then go on as before.

If you stop taking Haloperidol

Keep taking Haloperidol until your doctor tells you to stop. The doctor will lower your dose gradually.

If you stop taking the medicine suddenly you may get withdrawal symptoms.

Signs include:

■    feeling or being sick, sweating and difficulty sleeping (insomnia)

■    your original symptoms becoming worse

■    movements that you can't control.

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

4. Possible side effects

Like all medicines, haloperidol 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.

■    if you have an allergic reaction to Haloperidol. An allergic reaction may include sudden swelling of the face or throat, sudden wheezing, fluttering or tightness of the chest or collapse. Any kind of skin rash such as hives (also known as nettle rash or uticaria), itching, severe irritation, reddening, blistering or faking of your skin, boils or sore lips and mouth.

■    a severe skin rash that causes blistering, particularly the mouth and tongue. These may be signs of a condition known as Stevens-Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN). If this happens seek medical advice immediately. Your doctor may have to stop your treatment.

■    if you have any of the following symptoms:

-    unusually fast heart beat, unstable blood pressure (feeling dizzy, light-headed or faint) and sweating

-    very high body temperature, faster breathing, muscle stiffness or a change in consciousness leading to coma

-    these are early warning signs of a disorder called 'neuroleptic malignant syndrome' caused by the type of medicine you are taking.

■    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

■    heart changes including fast heart beats, unusual heart beats, heart attack. Symptoms of a heart attack are chest pain which may spread to the shoulders, neck or arms and shortness of breath. If you get these see a doctor straight away. Unexplained deaths have been reported but it is not proven that they were caused by haloperidol

■    blood problems. You may notice signs such as high temperature or chills, sore throat, ulcers in your mouth or throat and unusual tiredness.

If you get any of the following side effects, see your doctor as soon as possible:

Very Common side effects (affects more than 1 in 10 people)

■    feeling agitated

■    difficulty sleeping

■    headache

^■    repetitive, involuntary muscle movements.

Common side effects (affects fewer than 1 in 10 people)

■    twitching often of the mouth, jaws, lips, eyes, tongue and throat

■    vision disturbance rapid eye movements and rolling of the eyes

■    feeling depressed or sleepy

■    symptoms of psychosis such as abnormal thoughts or visions, or hearing abnormal sounds

■    repetitive body movements and the presence of involuntary movements

■    sustained muscle contractions causing twisting of the body or a rigid or abnormal posture

■    decreased body movements, slow ability to start and continue movements

■    unable to sit still

■    increased tone of muscles and tremors. This can include trembling and shaking of the hands and feet

^■    mask-like face

■    low blood pressure. You may feel dizzy when standing up

^■    problems with erection

^■    increase or decrease in weight

^■    abnormal test results for liver function.

Uncommon side effects (affects fewer than 1 in 100 people)

■    jerky movements and muscle problems such as spasms, stiffness and involuntary contractions

■    enlarged liver, yellowing of the skin and whites of your eyes (jaundice) with fever

■    feeling confused

■    feeling restless

■    increased heart rate

■    abnormal neck movements

■    fits or seizures (convulsions)

■    parkinsonism (characterised by tremor, rigidity, or instability when standing)

■    difficulty breathing or wheezing

■    blurred vision

■    frequent infections. This can be caused by a fall in the number of white blood cells

■    decrease or loss of sexual drive

■    irregular, painful or no monthly period

■    women unexpectedly producing breast milk, breast discomfort or pain.

Rare side effects (affects fewer than 1 in 1000 people)

■    raised prolactin (hormone) levels in the blood

■    being unable to open mouth

■    muscle twitching, movement disorder, involuntary eye movements

■    spasm of the airways

^■    heavy periods, menstrual disorder, sexual dysfunction

■    abnormal heart traces (electrocardiogram, 'ECG').

The following side effects have also been reported (frequency unknown)

^■    high blood pressure

■    fluid retention affecting the brain, resulting in weakness, tiredness or confusion

■    bleeding or bruising more easily than normal. This can be caused by a fall in the number of small blood cells called platelets

■    liver failure or biliary disorders

^■    men experiencing painful or prolonged erection.

Other side effects:

Common side effects (affects fewer than 1 in 10 people)

^■    feeling dizzy

^■    feeling sick (nausea) or being sick (vomiting)

^■    dry mouth or more saliva in the mouth than normal

^■    skin rashes

^■    constipation

■    water retention or difficulty in passing water (urine).

Uncommon side effects (affects fewer than 1 in 100 people)

■    skin reaction to direct sunlight

■    excessive sweating, itching or skin rash causing red patches

^■    fever

■    difficulty walking, shuffling

■    build up of fluid (oedema).

The following side effects have also been reported (frequency unknown)

■    loss of appetite, upset stomach or indigestion

■    swelling of the breasts (particularly in men)

■    build up of fluid in the throat or spasm in the throat

■    low blood sugar levels (hypoglycaemia). The symptoms of this are hunger, shakiness, sweating, dizziness, confusion, anxiety and weakness

■    inappropriate antidiuretic hormone secretion (where the body produces too much antidiuretic hormone)

■    feeling of dizziness or spinning (vertigo)

■    rapid or irregular heart beats

■    swelling of the face

^■    faking or peeling of the skin

■ inflamed skin (red, hot to the touch and tender) or inflammation of the blood vessels characterised by fever, pain in the joints and muscles

■    low body temperature

^■    feeling drowsy

■    in newborn babies, of mothers that have used haloperidol in the last trimester (last three months of their pregnancy), side effects can occur. See section 2: Pregnancy and breast feeding.

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.

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. Website: 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 Haloperidol Oral Solution

■    Keep this medicine out of the sight and reach of children

■    Store below 25°C. Protect from light

■    Do not use this medicine after the expiry date which is stated on the label and carton (exp: month, year)

■    The expiry date refers to the last day of that month

■    Do not use this medicine if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist

■    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.

6. Contents of the pack and other information

What Haloperidol Oral Solution contains

■    The active ingredient is haloperidol

■    The other ingredients are propylene glycol (E1520), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), lactic acid (E270) and purified water.

What Haloperidol Oral Solution looks like and contents of the pack

A colourless solution.

It comes in a brown glass bottle holding 100ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This leaflet was last revised in 09/2015.    P0797

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Signature:

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Name:

Regulatory Sign-off

Date:

-I—l-

Artwork produced by: