TEVA UK Ref: 231-30-85109- HALOPERIDOL A/S TAB TUK Version: 1    08 May 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

HALOPERIDOL 1.5 mg, 5 mg, 10 mg AND 20 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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 any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

6.    Further information

^ WHAT HALOPERIDOL IS AND WHAT IT IS USED FOR

Haloperidol belongs to a group of drugs known as antipsychotics. Haloperidol is used to treat:

•    schizophrenia and other similar mental disorders such as mania (feeling elated or over-excited, which causes unusual behaviour) and paranoia as well as violent or dangerous impulsive behaviour

•    aggression, overactivity, and self-mutilation in patients who are mentally ill and are likely to behave dangerously

•    Tourette's syndrome and tics (repeated and largely involuntary movements)

•    restlessness and agitation in the elderly

5 • behavioural disorders in children, especially those associated with hyperactivity and aggression.

⁼ 2 BEFORE you take haloperidol

DO NOT take Haloperidol and talk to your doctor if you:

•    are allergic (hypersensitive) to haloperidol or any of the other ingredients of this medicine

•    are breast-feeding

•    suffer from Parkinson's disease

•    have been told by your doctor that you have a condition that affects part of your brain called the "basal ganglia"

•    suffer from uncorrected hypokalaemia (low levels of potassium in the body)

•    have severe heart problems e.g. recent heart attack, heart failure, irregular heart beat for which you need to take medicine

•    have a family history of unexplained fainting, blackouts or heart attacks

•    are taking certain other medicines which can affect the heart (see 'Taking other medicines')

•    have a rare hereditary problem of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption

•    are less aware of things around you or your reactions become slower.

Haloperidol should not be given to patients if they are in a coma. Warnings and precautions

Talk to your doctor before you start to take this medicine if you:

•    are elderly as you may be more sensitive to the effects of Haloperidol

•    are at risk of blood clot in the vein (deep vein thrombosis)

•    have or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

•    suffer from epilepsy or conditions that might cause epilepsy such as alcohol withdrawal or brain damage

•    have diseased arteries

•    suffer from dementia

•    suffer from depression

•    have low blood pressure, calcium or magnesium levels or have not eaten for a prolonged length of time

•    have problems with alcohol abuse or alcoholism

•    have ever had any problems with your liver, kidneys or heart, or there is a history in your family of heart problems or sudden death

•    have previously had a stroke, transient ischaemic attack (TIA) or have a family history of strokes

•    have ever had a growth in your adrenal gland (phaeochromocytoma) or trouble with your thyroid gland, which caused too much thyroid hormone to be made (thyrotoxicosis).

You may need to be more closely monitored, and the amount of Haloperidol tablets you take may have to be altered. If you are not sure if any of the above apply to you, talk to your pharmacist before taking Haloperidol tablets.

Medical check ups

Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haloperidol 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.

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 Haloperidol and will explain the possible risks of its use.

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

Taking other medicines

Special monitoring may be needed if you are taking lithium and Haloperidol tablets at the same time. Tell your doctor straight away and stop taking both medicines if you get:

•    confused, disoriented, a headache, balance problems and feel sleepy. These are signs of serious conditions.

DO NOT take Haloperidol if you are taking: certain other medicines which can affect the heart e.g. quinidine, bretylium, disopyramide, procainamide, amiodarone, sotalol, dofetilide.

Talk to your doctor if you are taking any of the following:

•    any other medicine similar to haloperidol known as a neuroleptic e.g. sertindole, pimozide, promazine, amisulpride

•    certain medicines for the treatment of depression e.g. fluoxetine, amitriptyline, maprotiline, trazodone, lithium, phenothiazines, chlorpromazine, sertraline, fluvoxamine, venlafaxine

•    sleeping tablets, sedatives or strong pain killers

•    medicines which can affect the chemicals in your bloodstream known as electrolytes, such as diuretics, e.g. furosemide

•    medicines for changes in your heart beat or are taking medicines that affect your heart beat

•    certain antibiotics e.g. moxifloxacin, sparfloxacin, erythromycin, rifampicin

•    levodopa, for Parkinson's disease

•    certain other medicines called antidyskinetic drugs often used for treatment of Parkinson's disease e.g. procyclidine, trihexyphenidyl and benztropine

•    bromocriptine, used for a number of conditions including absence of menstrual periods, infertility, abnormal discharge of milk from the breast, Parkinson's disease

•    quinine and mefloquine, for malaria

•    guanethidine, medicine used for high blood pressure

•    cisapride, medicine for some types of indigestion

•    indomethacin, for rheumatoid arthritis

•    methyldopa, to lower your blood pressure

•    carbamazepine and phenobarbital, for epilepsy

•    any antihistamine, for an allergy or hay-fever e.g. promethazine

•    medicine for anxiety, e.g. buspirone, alprazolam

•    any antimuscarinic drug e.g. ipratropium, atropine, hyoscine

•    sympathomimetic agents e.g. found in cold and flu remedies - please check with your pharmacist

•    adrenaline, used in emergency situations e.g. to treat severe allergic reactions

•    medicines for fungal infection, such as ketoconazole, itraconazole

•    phenindione, to prevent and treat blood clots.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of Haloperidol

•    Patients who are intolerant to lactose should note that Haloperidol tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

•    Patients should also note that the 5 mg Tablets contain tartrazine (E102) and azorubine, carmoisine (E122), and the 10 mg Tablets contain ponceau 4R red (E124), as colouring agents. These may cause allergic reactions.

Taking Haloperidol with food and drink

•    DO NOT drink alcohol while you are taking Haloperidol.

Pregnancy and breast-feeding

•    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.

•    DO NOT take Haloperidol if you are breast-feeding. This is because small amounts may pass into mother's milk.

•    If you are pregnant or planning to become pregnant, ask your doctor for advice before taking this medicine.

Driving and using machines

•    Haloperidol may cause drowsiness or impaired alertness, especially at the start of your treatment or when taken at higher doses. If you are affected, DO NOT drive or operate machinery without discussing this with your doctor first.

^ HOW TO TAKE HALOPERIDOL

Always take Haloperidol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

You may not feel better for several weeks after you start to take your tablets.

The tablets should be swallowed preferably with a drink of water. The usual dose is:

Adults:

•    Mental disorders

The most common dose is between 1.5 mg and 20 mg a day, taken as a single dose or two smaller doses. Your doctor may increase this dose up to a maximum of 30 mg a day in some cases. When your doctor is happy that you are responding to your treatment, he may gradually reduce the dose. This could be as low as 3 mg to 10 mg a day.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

•    Tourette's Syndrome and tics

The initial dose is usually 1.5 mg three times a day. Your doctor may increase your dose gradually to between 6 mg and 30 mg a day until your symptoms are controlled.

The Elderly

If you are elderly, your doctor will probably give you half the doses mentioned above.

Children

Your doctor will work out the dose depending on your child's weight. The usual dose is 25 to 50 micrograms for each kilogram (kg) of body weight up to a maximum of 10 mg. Teenagers may be given up to 30 mg a day.

If you take more Haloperidol than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause muscle weakness, muscle stiffness, shaking, low blood pressure, drowsiness.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Haloperidol

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose. If it is nearly time to take the next dose, wait until then and then carry on as before.

If you stop taking Haloperidol

DO NOT stop taking Haloperidol without talking to your doctor first even if you feel better.

When you stop taking Haloperidol, your doctor will reduce the dose gradually to avoid the possibility of withdrawal symptoms, such as feeling and being sick and being unable to sleep, or the recurrence of your original condition.

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

^ POSSIBLE SIDE EFFECTS

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

Stop taking the tablets and tell your doctor immediately or go to the

casualty department at your nearest hospital if the following happens:

•    an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, severe skin rash or hives.

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

See your doctor immediately if you suffer from any of the following, as your treatment will need to be reviewed:

•    uncontrolled movements, especially in your limbs and face, mouth and jaw, tremors, tics and muscle spasm in your shoulders, neck, body and arms. These are very common side effects. However, rarely this can be severe enough to cause breathing difficulties. The first signs may be uncontrolled movements of your tongue.

•    changes in muscle tone, slowness of movement or an abnormal increase in muscular activity which are very common side effects

•    your muscles begin to feel rigid; body adopts rigid posture or a mask like face. These are common side effects

•    extreme restlessness, loss of normal muscle control, difficulty in moving, shakiness and loss of movement, which are uncommon side effects.

•    you feel feverish and become less alert than usual, or you feel hot, you start sweating and your heartbeat speeds up

•    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

•    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

•    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).

If you notice any of these symptoms seek medical advice immediately.

The following side effects have also been reported:

Very common

•    feeling agitated or having difficulty sleeping

•    headache.

Common

•    depression, mental illness

•    rolling of the eyes

•    problems with sight

•    a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting

•    constipation, dry mouth, mouth watering excessively, nausea, vomiting

•    abnormal liver function (which may be detected by blood tests)

•    rash

•    unable to pass urine

•    weight changes (increase or decrease)

•    dizziness or sleepiness.

Uncommon

•    a fall in the number of white blood cells which can cause frequent infections

•    confusional state

•    seizures (convulsion)

•    blurred vision

•    rapid heart beat

•    shortness of breath

•    inflammation of the liver or jaundice (your skin and the whites of your eyes may become yellow) due to a change in the way your liver works

•    skin reactions (for example red, flaky skin), your skin may become sensitive to the sun and severe inflamed patches may appear on your skin

•    itching, sweating more than usual

•    if you are a woman, you may unexpectedly produce milk, have painful breasts and your periods may become infrequent or stop

•    shuffling, unbalanced walk, tilted neck

•    feeling too warm (hyperthermia)

•    fluid may build up in your body causing swollen feet or ankles.

Rare

•    if you are a woman, your body may make too much of the hormone prolactin

•    getting excited, symptoms of psychosis such as abnormal thoughts or vision, or hearing abnormal sounds

•    difficulty breathing or wheezing

•    unable to open your mouth (Trismus)

•    abnormal heavy and prolonged menstrual periods at regular intervals

•    abnormal heart rhythms.

Other side effects

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

•    Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called 'syndrome of inappropriate anti-diuretic hormone secretion' (SIADH).

•    low level of blood glucose (hypoglycaemia)

•    excitement

•    feeling drowsy and mentally dulled

•    blue discolouration of skin, breathing difficulties, gagging

•    heart problems causing symptoms such as palpitations, abnormal heart rhythms, fainting, blackouts or rarely heart attacks. These occur more frequently at high doses and in patients who are at greater risk of heart problems.

•    swelling of the voice box or contraction of the muscle in the voice box

•    loss of appetite, feeling sick, indigestion, stomach upsets

•    acute liver failure

•    inflammation of blood vessels

•    flaking or peeling of the skin

•    inflamed skin (red, hot to the touch and tender)

•    sudden unexplained death has occurred in rare cases but it is not known if this was due to the medicine

•    swelling of face

•    feeling too cold.

You may also experience difficulties with sex such as: erectile dysfunction (inability to develop or maintain an erection of the penis, decreased sexual desire, and some men may experience swelling of the breasts or painful and prolonged erection.

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 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

Keep out of the reach and sight of children.

Store below 25° C. Store in the original package and protect from light.

Do not use Haloperidol after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

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.

^ FURTHER INFORMATION

What Haloperidol tablets contain:

•    The active ingredient is haloperidol, either 1.5 mg, 5 mg, 10 mg or 20 mg

•    The other ingredients are lactose, povidone, maize starch, magnesium stearate (E572), and stearic acid

•    The 5 mg tablet also contains the colours acid brilliant green BS (E142), tartrazine (E102), patent blue V (E131) and azorubine, carmoisine (E122)

•    The 10 mg tablet also contains colloidal anhydrous silica and the colour ponceau 4R (E124).

What Haloperidol tablets look like and contents of the pack:

•    The 1.5 mg tablet is white biconvex marked 3S2 on one side

•    The 5 mg tablet is light green biconvex marked 4S2 on one side

•    The 10 mg tablet is pink biconvex marked 5S2 on one side

•    The 20 mg tablet is white biconvex marked 6S2 on one side

•    The product is available in pack sizes of 25, 28, 50, 56, 84, 100, 250, 500 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: May 2015

PL 00289/0305-0308

■iTWTl

Teva Pharmaceuticals Europe B.V 1.3.2

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20mg-tabletsName removed

Approvals

Regulatory Affairs Approval

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