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PATIENT INFORMATION LEAFLET

Haloperidol Oral Solution BP 5 mg/5 ml Haloperidol

Read all of this 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.

This medicine nas 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.

In this leaflet:

1.    What Haloperidol is and what it is used for

2.    Before you take Haloperidol

3.    How to take Haloperidol

4.    Possible side effects

5.    How to store Haloperidol

3.    Further information

1.    WHAT HALOPERIDOL IS AND WHAT IT IS USED FOR

Haloperidol Oral Solution BP 5 mg/5 ml (“Haloperidol”) belongs to a group of medicines called neuroleptics, and is used to improve thoughts, feelings and/or behaviour when these are disturbed in certain medical conditions:

•    hearing, seeing or sensing things which are not there

•    states of aggression, hyperactivity and self-harming

•    severe tics (uncontrollable movements)

•    behavioural disorders in children, associated with hyperactivity and aggression

•    restlessness and agitation in the elderly

•    nausea, vomiting and persistent hiccup

•    Tourette’s syndrome

2.    BEFORE YOU TAKE HALOPERIDOL Do NOT take Haloperidol if you:

are allergic (hypersensitive) to haloperidol or any of the other ingredients in the product (see Section 6 and end of Section 2). have reduced awareness or slower reactions (due to illness or taking other medication) have heart disease which causes abnormal heart rhythm (irregular or slow heartbeat)

are taking medication for abnormal heart rhythm    •    low potassium levels in your blood

are breast-feeding    •    have Parkinson’s disease.

Take special care

Falk to your doctor before taking Haloperidol if any of the following applies to you:

•    liver or kidney disease

•    enlarged prostate

•    epilepsy or are prone to fits (e.g. during alcohol withdrawal)

•    thyroid gland problems

tumour of the adrenal gland (phaeochromocytoma)

closed angle glaucoma

heart disease, family history of sudden death

depression.

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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.

If you are elderly, or have had heart problems, your heart rhythm and potassium levels may be monitored and your dose may need to be adjusted or treatment stopped.

Fake special care in very hot or cold weather, since Haloperidol may affect your body’s ability to regulate its temperature.

Available safety data in the paediatric population indicate a risk of extrapyramidal symptoms, including tardive dyskinesia (involuntary, 'epetitive body movements), and sedation. No long-term safety data are available.

Faking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, out particularly the following:

drugs to treat heart failure (e.g. atropine or sotalol) must NOT be taken with Haloperidol (see Section “Do not take Haloperidol”) sedatives including alcohol, hypnotics (e.g. zolpidem), opiates (e.g. morphine) drugs for Parkinson’s disease (e.g. levodopa, bromocriptine, pergolide) drugs for convulsions (fits) (e.g. pnenobarbital, carbamazepine) ephedrine, phenylephrine - ingredients used in cough and cold remedies high blood pressure medication (e.g. guanethidine, guanadrel, methyldopa, methoxamine)

medicines used to treat mental conditions - antidepressants e.g. imipramine (tricyclic antidepressant), monoamine oxidase inhibitors (MAOIs e.g. selegiline), trazodone, maprotiline, nefazodone

antipsychotic drugs - used to treat mental conditions like schizophrenia e.g. dopamine adrenaline for severe allergic reactions lithium used to treat depression anticoagulants e.g. warfarin used to thin the blood amphetamines - used as a stimulant e.g. dexamphetamine sulphate anticholinergic drugs - used as a muscle relaxant e.g. benzatropine mesilate hypoglycaemic drugs e.g. insulin to treat diabetes diazoxide used to treat very high blood pressure methoxamine used to prevent or correct low blood pressure amiodarone used to control the rhythm of your heart beat conivaptan used to treat low levels of sodium in the blood

CYP 2D6 inhibitors - e.g. terbinafine used to treat fungal infections of skin and nails

medicines that may reduce the salt levels in your blood e.g. Cisplatin (to treat cancer), furosemide (water tablets), Ciclosporin (to prevent organ rejection after transplantation).

Use of Haloperidol with drugs that cause electrolyte imbalance (such as sodium, potassium, calcium in the body) is not recommended.

Faking Haloperidol with food and drink

If you drink alcohol while taking Haloperidol, the combined effect can make you feel drowsy and less alert than usual. You can take Haloperidol with or without food.

Pregnancy and breast-feeding

Do not use Haloperidol if you are pregnant, trying to become pregnant or are breast-feeding. Always speak to your doctor before taking any medicine.

Fhe following symptoms may occur in newborn babies, of mothers that have used Haloperidol in the last trimester (last three months of their oregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of tf ese symptoms you may need to contact your doctor.

Driving and usin j machines

Do not drive or op these effects

irate machinery until you know how this medicine affects you. Haloperidol can make you less alert and alcohol increases

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VENDOR CODE TO BE PRINTED AT THE BOTTOM RIGHT HAND CORNER OF FRONT AND BACK PAGE PRINT FREE AREA

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Important information about some of the ingredients of this medicine

• Methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216): may cause allergic reactions (possibly delayed).

3. HOW TO TAKE HALOPERIDOL

Always take Haloperidol exactly as your doctor has advised, as the dosage is likely to be adjusted from the initial dose. Check with your doctor f you are not sure about the dose you should take.

Fake Haloperidol only by mouth. Snake well before use. An oral syringe is included in the pack to help you take the correct dose.

Usual doses are:

Adults: For schizophrenia, mania and hypomania, used with other therapies (short term) to manage moderate to severe signs of physical tension, states of agression, hyperactivity and self harm, excitement, violent or dangerously impulsive behaviour, mental and behavioural orobiems, restlessness and agitation in the elderly:

For Tourette’s syndrome, intractable hiccup and severe tics

Children: For Childhood behavioural disorders ■ oharmacy label.

The dose will be calculated by the doctor and the child should receive what is written on the

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For Tourette’s syndrome - Daily maintenance doses of up to 10 ml are usually recommended; your doctor will advise you.

If you take more Haloperidol than you should

If you take too much Haloperidol, contact your doctor or go to your nearest hospital immediately. Take the bottle with you.

If you forget to take Haloperidol

If you miss a dose, take it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up for the forgotten dose.

If you stop taking Haloperidol

Do not stop taking Haloperidol on your own without advice from your doctor. The dose must be decreased gradually, because withdrawal effects may occur if this medicine is stopped suddenly. These effects are likely to be nausea, vomiting and insomnia (difficulty in sleeping). Your symptoms may return even after several weeks or months.

4. POSSIBLE SIDE EFFECTS

Jke all medicines, Haloperidol can cause side effects, although not everybody gets them.

You should STOP using Haloperidol and contact your doctor immediately if you experience a rare allergic reaction, including swelling of the skin, rashes, difficulty breathing, loss of consciousness, fever or shock.

You should contact your doctor immediately if you experience any of the following:

blood clots in the vein especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the blood vessels to the lungs causing chest pain ana difficulty breathing, ft you notice any of these symptoms seek medical advice immediately.

nerve and muscular effects such as quivering, restlessness, jerking movements, tremor, inability to sit still, exaggerated reflexes, rigidity, unusual posture, involuntary movements of the tongue, face or jaw, disjointed movements emotional and behavioural changes, insomnia, depression, confusion, drowsiness, lethargy, stupor, anxiety, euphoria worsening of psychotic symptoms such as hallucinations, alteration of sleep patterns in women, irregular or absent periods, infertility, spontaneous discharge of milk in men, breast development, as well as impotence heartburn, nausea, vomiting, weight loss or gain, constipation diarrhoea

liver effects including jaundice (maybe a fever, followed by yellowing of the skin and eyes). Your doctor may stop your treatment dermatitis (itchy pink or red rash), erythema multiforme (mild itchy pink, red blotches), sensitivity to sunlight “neuroleptic malignant syndrome” - feeling hot, muscle rigidity, altered consciousness, coma stuffiness in the nose or ary mouth

urinary retention (not able to pass water), incontinence (loss of control of the bowel or bladder), blurred vision fast or irregular heartbeat, drop in blood pressure (light headedness, fainting, slow heartbeat) fever heat stroke, vertigo (dizziness or light headedness), seizures

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, 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.

HOW TO STORE HALOPERIDOL

<eep this medicine out of the sight and reach of children. Do not store above 25°C. Keep container in the outer carton. Do not use Haloperidol after the expiry date which is stated on the label or carton. Take unused medicine to your pharmacist for safe disposal.

6. FURTHER INFORMATION What this product contains:

the active ingredient is haloperidol; each 5 ml of solution contains 5 mg haloperidol

the other ingredients: lactic acid, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), propylene glycol and purified water (see end of Section 2 for further information).

What Haloperidol looks like and contents of the pack

Haloperidof is a clear colourless oral solution, and is available in amber glass or plastic bottles of 100 ml, 200 ml and 500 ml.

Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

<ham, LL13 9UF or

Marketing Autho Manufacturer: ~

Pinewood Labolat PL 04917/0023

isation Holder: Pinewood Laboratories Ltd., Pharmaceuticals Ltd., Ash Road North, Wrexham,

Dries Ltd., Ballymacarbry, Clonmel Co.Tipperary, Ireland.

This leaflet was last updated in 02/2016

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