Inactive ingredients: lactic acid and sodium hydroxide in water for injections.

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1 Patient Information Leaflet Haloperidol Injection BP 5mg in 1ml This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered. The leaflet contains a summary but not all of the information about Haloperidol Injection BP. If you require any further information or if you are unsure about anything, ask your doctor or pharmacist. ABOUT YOUR MEDICINE The active ingredient in Haloperidol Injection BP is haloperidol. Each 1ml ampoule contains 5mg of haloperidol in the form of a clear, colourless, sterile solution for injection. Inactive ingredients: lactic acid and sodium hydroxide in water for injections. Pack sizes: 10 x 1ml clear glass ampoules. Type of medicine Haloperidol belongs to a group of medicines known as butyrophenone neuroleptics. It improves the symptoms of various major mental disorders, including schizophrenia. Haloperidol also helps to relieve anxiety and to control nausea and vomiting. Holder of Product Authorization: Mercury Pharmaceuticals (Ireland) Ltd, Roscrea, County Tipperary, Ireland. Manufacturer: B.Braun Melsungen AG, Mistelweg 2/6, Berlin 47, D Germany. PA 73/101/1. USES Haloperidol Injection BP may be used in the management of anxiety states behavioural disorders major mental disorders (including schizophrenia, mania and hypomania) nausea and vomiting Gilles de la Tourette's syndrome and tic movements alcohol withdrawal BEFORE YOU RECEIVE YOUR MEDICINE Circumstances in which Haloperidol Injection should not be used: you suffer from a lesion that affects a specific part of the brain(called 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).

2 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 Injection BP should not be given to patients who are in a coma. If you suffer from Parkinson's disease, or if you are allergic to haloperidol, or to any butyrophenone medicine, or if you are breast-feeding, tell your doctor, as Haloperidol Injection should not be used in these circumstances. Circumstances in which Haloperidol Injection should be used with special care: Before taking your medicine, tell your doctor if you have any of the following conditions so that your doctor can advise you about any special precautions you may need to take: you suffer from a movement disorder (loss of movement, stiffness or odd movements) you have problems with your thyroid gland you have a problem with your liver or kidneys you suffer from epilepsy or from convulsions you have a heart problem or a disease that affects your blood vessels you suffer from low blood pressure you or any member of your family is suffering from a heart disease causing changes in the Electrocardiogram (QT Prolongation) you are taking other medications to cure mental illnesses or medications known to cause QT prolongation on an electrocardiogram or medications causing changes in electrolytes in the blood 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 are pregnant 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. This medicinal product contains negligible amount of sodium, i.e. essentially sodium-free. Taking other medicines In particular, tell your doctor if you are taking any of the following: Antiarrhythmics drugs for irregular heart beats (e.g. quinidine)

3 Tricyclic antidepressants (e.g. amitriptyline), venlafaxine, fluvoxamine, fluoxetine, sertraline, paroxetine for treatment of depression Antipsychotic drugs (e.g. phenothiazines) Antihistamines for allergic reactions (e.g. terfenadine, promethazine) 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) Alcohol: Use of alcohol during haloperidol treatment may cause drowsiness & reduce your Alertness 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. Driving or operating machinery: Haloperidol may cause drowsiness, or it may make you less alert than usual. These effects could interfere with your ability to drive or to operate machinery. If you wish to drive or to use machines, ask your doctor for advice. HOW YOUR MEDICINE IS ADMINISTERED Your doctor or nurse will administer Haloperidol Injection BP by injecting it into a muscle or into a vein. Dosage for adults For prompt control of acutely agitated patients with moderate to severe symptoms, an initial dose of 2 to 10mg, by injection into a muscle, may be adequate. Up to 30mg by injection into a muscle may be required to control severe agitation. Depending on the response to the initial injection, subsequent doses of 5mg may be injected into a muscle every hour if required, although intervals of 4 to 8 hours may be adequate. To control nausea and vomiting, the usual dose is 1 to 2mg, given by injection into a muscle every 12 hours. To relieve tension before an operation and to reduce the incidence of nausea and vomiting after an operation, a single dose of 1 to 5mg may be given by injection into a vein or into a muscle. For control of anxiety, insomnia, nausea and vomiting in the Alcohol Withdrawal Syndrome, a dose of 2 to 5mg may be injected into a muscle every 4 to 6 hours for up to 24 hours.

4 Children Haloperidol Injection BP is not recommended for use in children. What to do in case of a missed dose or an overdose If you think that you may have missed a dose or that you have been given too much of this injection, tell your doctor. AFTER YOU RECEIVE YOUR MEDICINE As well as having beneficial effects, a medicine may sometimes cause unwanted effects in some patients. If you notice any of the following effects, tell your doctor: 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 Repititive 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

5 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 Accumulationof 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 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. You should also tell your doctor if you notice any unwanted effects that are not mentioned here. 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

6 STORING THIS MEDICINE Do not use after the expiry date printed on the ampoule and carton Do not store above 25 C. Keep the ampoule in the outer carton in order to protect from light. If the solution is cloudy, discoloured or if there are any particles present, it should be returned unused to the pharmacist. Keep out of the reach and sight of children. If only part used, discard the remaining solution. This product should be used immediately after opening. For single use only. Marketing Authorisation Holder Mercury Pharmaceuticals (Ireland) Ltd 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland Date of last revision: June 2015

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