MercuryPharma

PATIENT INFORMATION LEAFLET

Haloperidol 5mg/ml Solution for Injection

The product is known by the name above but will be referred to as Haloperidol Injection throughout the rest of this leaflet.

In this leaflet:

1.    What Haloperidol Injection is and what it is used for

2.    Before you are given Haloperidol Injection

3.    How Haloperidol Injection is given to you

4.    Possible side effects

5.    How to store Haloperidol Injection

6.    Further information

1. WHAT HALOPERIDOL INJECTION IS AND WHAT IT IS USED FOR

Haloperidol Injection contains the active ingredient haloperidol, which belongs to a class of drugs called butyrophenone neuroleptics. It improves the symptoms of various major mental disorders, like symptoms of schizophrenia, such as hostility, aggression, hyperactivity, disruptive and violent behaviour, confusion, emotional withdrawal, hallucination and delusions, mania (extreme excitement) and hypomania (less excitement), organic brain syndrome (brain disorders associated with structural changes in the brain). It is also used to treat nausea (feeling sick) and vomiting (being sick).

2. BEFORE YOU ARE GIVEN HALOPERIDOL INJECTION

You SHOULD NOT be given Haloperidol Injection if:

•    you know that you are allergic to haloperidol or any of the other ingredients of Haloperidol Injection (see section 6 of this leaflet).

•    you suffer from a lesion that affects a specific part of the brain (called the basal ganglia)

•    you are suffering from CNS depression (depression of the central nervous system, which can result in decreased rate of breathing, decreased pulse rate, decreased alertness to loss of consciousness)

•    you have a brain disorder causing tremors, rigidity and slowing of movement (Parkinson's disease)

•    you have certain types of heart disease which cause your heart to beat with an abnormal rhythm (arrhythmia) or unusually slowly

•    you are taking medicines that affect your heart beat

•    your doctor tells you that the level of potassium in your blood is too low

•    you have recently had a heart attack or heart failure Haloperidol should not be given to patients in a coma.

Before you are given Haloperidol Injection, your doctor will take special care if any of the following situations apply to you. Make sure your doctor is aware of any of the following if it is not immediately obvious:

•    you have a liver or kidney problem

•    you suffer from high blood pressure due to a tumour near the kidney (a condition known as phaeochromocytoma)

•    you have problems with your thyroid gland

•    you suffer from alcohol abuse

•    you have a problem with your heart or family history of cardiovascular disease

•    you suffer from fits (epilepsy) or you have a condition that might lead to an epileptic attack (such as brain damage or alcohol withdrawal)

•    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

•    you have lower than normal levels of mineral (electrolytes) in your blood

•    you are an elderly patient with dementia

•    you ever had bleeding in the brain

•    you have not been eating properly

•    you suffer from a mental disorder (schizophrenia) or depression.

Medical check ups

Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haloperidol injection. 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, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following:

•    Antiarrhythmic drugs for irregular heart beats (e.g. quinidine, disopyramide, procainamide, amiodarone, sotalol, bretylium and dofetilide)

•    Antimicrobials for treatment of infection (e.g. sparfloxacin, moxifloxacin, erythromycin)

•    Tricyclic antidepressants (e.g. amitriptyline), maprotiline, venlafaxine, fluvoxamine, fluoxetine, sertraline, paroxetine for treatment of depression

•    Antipsychotic drugs (e.g. phenothiazines, chlorpromazine, pimozide and sertindole)

•    Antihistamines for allergic reactions (e.g. terfenadine, promethazine)

•    Cisapride used for treatment of constipation

•    Anti-malarial drugs (e.g. quinine and mefloquine)

•    Diuretics (water pills)

•    Antifungals (e.g. itraconazole and ketoconazole)

•    Anti-anxiety drugs (e.g. Buspirone, alprazolam)

•    Anticonvulsants (e.g. carbamazepine, phenobarbital, sodium valproate)

•    Rifampicin (anti-tuberculosis drug)

•    Hypnotics, sedatives or pain killers

•    Blood pressure lowering drugs (e.g. methyldopa, guanethidine)

•    Levodopa (anti-parkinson drug)

•    Phenindione (anti-coagulant)

•    Lithium (used to treat depression)

•    Adrenaline (used to increase heart rate).

Taking Haloperidol Injection with food and drink

You should not drink alcohol whilst you are taking this medicine.

Pregnancy and breast feeding

Do not take Haloperidol Injection if you are pregnant, think you may be pregnant or are planning to become pregnant, or while breast feeding, unless your doctor decides that treatment is essential.

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 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 Injection may make you feel drowsy or dizzy or give you blurred vision. You should not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.

Important information about some of the ingredients of Haloperidol Injection

This medicine contains less than 1 mmol sodium (23mg) per dose, i.e. is essentially sodium free.

3. HOW HALOPERIDOL INJECTION IS GIVEN TO YOU

Haloperidol Injection is only given in the hospital by a doctor.

Haloperidol is usually given by injection into a muscle. Your doctor will decide on a suitable dose depending on your age, severity of the symptoms and previous responses to similar medicines. Adults:

The way that the initial dose (2 to 10mg injected into a muscle) is calculated will depend on your age, the severity of your illness and how your body has responded to similar medicines. Following that, further injections may be given every 4 to 8 hours until your symptoms are controlled.

However, you will not be given more than 18mg per day. Thereafter, your doctor may keep you on a smaller dose that keeps you illness free and eventually your doctor will give you tablets instead of injections. They will keep you on the equivalent amount of haloperidol.

Elderly, weak patients and those who had reactions after taking similar medications:

Lower initial doses are recommended. Half of the normal doses recommended for adults are likely to be useful. The dose will be increased slowly and at a slower pace.

Haloperidol Injection is not for use in children.

For mood disorders and schizophrenia, it may take several weeks for you to feel the full benefit of this medicine. If you stop taking this medicine suddenly, your symptoms may come back.

During treatment your doctor should regularly check you for physical side effects, changes in your blood counts or liver function, and any heart problem, especially if you are also taking other medicines.

If you stop taking Haloperidol Injection

•    Continue to take Haloperidol Injection even if you no longer feel ill. Do not stop taking this medicine without talking with your doctor first, especially if you have taken large doses for a long time.

•    When the time comes to stop receiving this medicine, your doctor will probably decrease your dose gradually as stopping the haloperidol suddenly may cause with withdrawal ill-effects such as nausea (feeling sick), vomiting (being sick), sweating and difficulty in sleeping.

If you are given more Haloperidol Injection than you should:

This will make you very sleepy, indifferent, with a low blood pressure and uncontrolled body movements. You may also have an abnormal heartbeat. There is no specific treatment to deal with high levels of haloperidol in your blood. You will be treated in a hospital and appropriate measures will be taken to control your heart and breathing.

As Haloperidol Injection is administered by a healthcare professional it is unlikely that you will be given too much. If you are at all concerned, speak to your doctor.

In this event, you will be treated in the hospital and you will be given the necessary treatment.

If you miss a dose of Haloperidol Injection

This is unlikely as the injection is given by a healthcare professional but if you are concerned about missing a dose, speak to your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Haloperidol Injection can sometimes 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.

•    Sudden swelling of the face or throat, swallowing or breathing problems. 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.

•    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.

•    Rarely patients may develop Neuroleptic Malignant Syndrome. This causes a high temperature, rigid muscles, drowsiness, occasional loss of consciousness and requires emergency admission to hospital for treatment.

•    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 has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

Tell your doctor straight away if you notice any of the following side effects:

Very common - (affects more than 1 in 10 people)

•    Agitation, difficulty in sleeping

•    Headache, repetitive, involuntary muscle movements Common - (affects less than 1 in 10 people)

•    Depression

•    Spasmodic movement of the eyeballs

•    Sustained muscle contractions causing twisting movements or abnormal postures

•    Repetitive body movements and the presence of involuntary movements

•    Inability to sit still, slow ability to start and continue movements

•    Decreased body movements

•    Diminished facial expressions

•    Increased tone of muscles, tremors, dizziness

•    Fall in blood pressure, visual disturbances

•    Drowsiness, constipation, dry mouth

•    Secretion of excess saliva, feeling sick (nausea), being sick (vomiting)

•    Abnormal liver function tests

•    Rash, redness or swelling at the site of injection

•    Difficulty in passing urine, problems with erection

•    Increase or decrease in weight.

Uncommon - (affects less than 1 in 100 people)

•    Decrease in the number of white blood cells

•    Confusion, decreased or loss of sexual drive, restlessness

•    Convulsions (fits), impaired body movement, sedation

•    Parkinsonism (characterized by tremor, rigidity or postural instability)

•    Involuntary muscle contractions

•    Blurred vision, increased heart rate

•    Difficulty in breathing, reaction to sunlight, itching, skin rash causing red patches, sweating

•    Enlarged liver, jaundice (yellow discoloration of the eye or skin)

•    Muscle Spasms, muscle stiffness, abnormal neck movements

•    Lack of menstrual periods, painful periods, breast discomfort or pain, spontaneous flow of milk from the breast

•    Fever, difficulty in walking, accumulation of fluid (oedema)

Rare - (affects less than 1 in 1,000 people)

•    Raised prolactin (hormone) levels in the blood

•    Muscle twitching, movement disorder, involuntary eye movements

•    Spasm of the airways, inability to normally open the mouth

•    Heavy periods, menstrual disorder, sexual dysfunction

•    ECG abnormalities.

Other side effects include:

•    Reduction in the number of red and white blood cells and platelets

•    Low blood sugar levels, inappropriate antidiuretic hormone secretion

•    Rapid or irregular heart beats

•    Accumulation of fluid in the throat or spasm of the throat

•    Liver failure, biliary disorders

•    Inflammation of the blood vessels characterized by fever, pain in the joints and muscles

•    Scaling of skin rash, enlarged breasts in males, painful erection

•    Decreased body temperature.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

5. HOW TO STORE HALOPERIDOL INJECTION

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

Do not use Haloperidol Injection after the expiry date which is stated on the ampoule carton and ampoule. Do not store above 25°C. Store in the original package to protect from light.

If only part of the solution is used, the rest should be discarded.

6. FURTHER INFORMATION

Each ml of haloperidol injection contains 5mg of the active substance, haloperidol.

Haloperidol Injection also contains lactic acid, sodium hydroxide and water for injections.

What Haloperidol Injection looks like and contents of the pack

Haloperidol Injection is a clear, colourless sterile solution in 1ml and 2ml clear glass ampoules. Each carton contains 10 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. Manufacturer

B.Braun Melsungen AG, Mistelweg 2/6, D-12357, Berlin, Germany This leaflet was last revised in January 2014.

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