HALDOL® DECANOATE decanoate injection

Consumer Medicine Information

What is in this leaflet • See, hear, feel or smell things • have a type of dementia called that are not there 'Lewy body dementia' This leaflet answers some common (hallucinations) • have progressive supranuclear questions about Haldol injection. It • Believe things that are not true palsy (PSP). does not contain all the available (delusions) • have an allergy to Haldol or any information. It does not take the • Feel unusually suspicious of the ingredients. place of talking to your doctor or (paranoia) See Product Description at the pharmacist. • Feel very excited, agitated, end of this leaflet for a list of All medicines have risks and enthusiastic, impulsive or ingredients. Signs of allergy benefits. Your doctor has weighed hyperactive may include skin rash, itching, the risks of treating you with Haldol • Feel very aggressive, hostile or shortness of breath, and/or against the benefits this medicine is violent. swollen face that may lead to difficulty breathing or expected to have for you. Your doctor may have prescribed swallowing. If you have any concerns about Haldol for another use. being treated with Haldol, ask If you think you are having an Ask your doctor or healthcare your doctor or pharmacist. allergic reaction, tell your professional if you have any doctor immediately or go to Keep this leaflet with your questions about why this the Accident and Emergency medicine. You may need to read it medicine has been prescribed for department at the nearest again. you. hospital. Haldol is not addictive. Do not give Haldol if the packaging is torn or shows signs What Haldol is used for of tampering and if it is beyond the expiry date (month and year) Haldol contains the active substance Before you are given printed on the pack. haloperidol (as haloperidol Haldol decanoate). This belongs to a group Before you are given it: of medicines called When you must not be given You must tell your doctor if you: it: ‘’. • are pregnant or planning to Haldol is a long-acting Do not give Haldol to anyone who become pregnant. . It works by is unconscious or in a coma. Like most antipsychotic correcting the chemical imbalances You must not be given Haldol if medicines, Haldol is not in the brain, which may cause you: recommended for use during mental illness. • have severe drowsiness and pregnancy. Discuss with your Haldol is used in adults whose slowness due to illness or the doctor the risks and benefits condition has previously been use of or medicine involved in using it. treated with haloperidol taken by • feel unusually confused, dizzy • are breast feeding or wish to mouth. It is used for illnesses or sleepy breastfeed. Small amounts of the medicine affecting the way you think, feel or • suffer from severe depression behave. These include mental health may pass into the mother's milk • have or have ever had muscle problems (such as ). and on to the baby. Discuss with stiffness, restricted or your doctor the risks and These illnesses may make you: uncontrollable movement due to benefits involved in using it. • Feel confused (delirium) certain medical conditions, such • suffer from loss of contact with as Parkinson's disease reality and inability to think and

HALDOL® DECANOATE Published by MIMS August 2019 1 judge clearly, or from a general may cause an imbalance of your reactions, such as sleeping decline mental ability (e.g. potassium levels in your blood tablets, tranquillisers or strong dementia related psychosis) • you suffer from an imbalance of painkillers • have ever had bleeding in the electrolytes (naturally occurring • medicines used to lower high brain, or your doctor has told chemicals present in body blood pressure and heart you that you are more likely fluids, that are needed for conditions (such as , than other people to have a normal body functions). bepridil, tablets) stroke If you have not told your doctor or • medicines used to treat fast or • have or have ever had a heart pharmacist about any of the above, irregular heartbeats (arrhythmia) problem or a family history of tell them before you are given such as , amiodarone, heart problems, such as an Haldol. dofetilide, disopyramide, unusual heart beat or a fast Your doctor will advise you on dronedarone, ibutilide, heartbeat, or are taking a heart whether you should receive Haldol • Certain cough and cold medication or whether to adjust the dose or preparations and weight • have or have ever had low blood alter your treatment. reduction medicines containing pressure substances such as • have or have ever had a rare Taking other medicines: (epinephrine) heart disorder known as QT- • medicines that prevent Tell your doctor or pharmacist if prolongation which sometimes you are taking any other adrenaline (epinephrine) runs in families medicines, including medicines working, such as guanethidine • have or have ever had you can buy without a • antibiotics such as rifampicin, uncontrolled movements of the prescription from a pharmacy, erythromycin, levofloxacin, tongue, mouth, cheeks or jaws supermarket or health food shop. moxifloxacinmedicines used to which may progress to the arms In particular, tell your doctor or prevent travel sickness, treat and legs (also known as tardive pharmacist if you are taking any of Parkinson's Disease or relieve dyskinesia) the following: stomach cramps or spasms (anticholinergics) • have or have ever had a sudden • medicines used to control increase in body temperature, depression or mood swings • medicines used to treat extremely high blood pressure (such as , , Parkinson's disease, such as and severe convulsions (also , , levodopa (Levodopa) known as neuroleptic malignant , paroxetine, • medicines used to treat epilepsy syndrome) , lithium, alprazolam, (such as carbamazapine, • have or have ever had epileptic , , phenobarbital (phenobarbitone)) fits or convulsions (seizures) , St John's Wort • medicines used to slow or • have depression () and prevent blood clotting • have or have ever had kidney or ' ') (anticoagulants, blood thinners liver disease • antipsychotic medicines, used to such as phenindione). • have a very active thyroid gland treat mental illness • (a pain killer or to (hyperthyroidism) • medicines for nausea and treat drug addiction). • have had blood clots, or a family vomiting (such as , • medicines used for malaria history of blood clots. Blood chlorpromazine, ) (such as halofantrine) clots in the lungs and legs have • antiviral medicines (such as • medicines used for cancer (such been seen in patients taking ritonavir for HIV) as toremifene and vandetanib) antipsychotic medicines • antifungal medication (such as These medicines may be affected by • experience a significant increase ketoconazole, itraconazole and Haldol or may affect how well in weight while taking other ) Haldol works. Your doctor or antipsychotic medications. • medicines known to cause pharmacist can tell you what to do Clinically significant weight electrolyte imbalance or if you are taking any of these gain has also been reported in imbalance of naturally occurring medicines. patients using this medicine. chemicals present in body Lithium Tell your doctor if: fluids, that are needed for Special monitoring may be needed normal body functions. • you are taking medicines or if you are using lithium and Haldol have medical conditions which • alcohol or medicines which at the same time. make you feel drowsy or slow

HALDOL® DECANOATE Published by MIMS August 2019 2 Tell your doctor straightaway and controls your symptoms. Follow While you are given stop using both medicines if you your doctor's instructions. Haldol get: If you are elderly or physically • fever you can't explain or unwell, you may need less Haldol. Things you must do: movements you can't control Your doctor may adjust your dose if • Always follow your doctor's • Confused, disoriented necessary. instructions carefully. • a headache Haldol should not be used in • Be sure to keep all of your • balance problems children and adolescents under 18 doctor’s appointments so that years of age. This is because it has • sleepiness your progress can be checked. not been studied in this age group. These are signs of a serious For example, your doctor may condition. If you do not understand the want to take an instructions provided with this electrocardiogram (ECG) to medicine, ask your doctor or Effects on driving and measure the electrical activity of pharmacist for help. operating machinery your heart. Seek your doctor's advice before changing or Haldol can affect your alertness and If you forget to use it: stopping Haldol treatment. ability to drive and operate If you have missed your next • If you are about to start taking a machinery, particularly when you injection, contact your doctor as new medicine, tell your doctor first start using it, or after a high soon as possible and make a new and pharmacist that you are dose. appointment. being given Haldol. Do not drive or operate any tools You should not stop this medicine or machinery until your doctor unless told to do so as your Tell your doctor if you become says it is safe. symptoms may return. pregnant while using Haldol. Do not drink alcohol. The following problems may occur Haldol can increase the effects of If you are given too much in newborn babies of mothers that alcohol, and might make you feel (overdose): use Haldol in the last 3 months of their pregnancy (the last trimester): sleepy and less alert. This means Immediately telephone your you should be careful how much doctor or the Poisons Information • Muscle tremors, stiff or weak alcohol you drink Centre for advice, or go to muscles Accident and Emergency at your • Being sleepy or agitated nearest hospital. • Problems breathing or feeding. You may need urgent medical • Medicine craving (withdrawal) Using Haldol attention. Poisons Information Centre Things you must not do: How it is given: telephone numbers: • Do not use Haldol to treat any Australia: 13 11 26 Haldol will be given as an injection other complaint unless your by your doctor or nurse into a New Zealand: 0800 POISON or doctor says so muscle in the buttocks. 0800 764 766 • Do not give this medicine to Haldol should not be given into a Keep these telephone numbers anyone else, even if their vein. handy symptoms seem similar to It is usually given every four weeks, As this medicine will be given to yours. however your doctor may lengthen you by your doctor or nurse, it is or shorten this time. unlikely that you will be given too Your doctor will decide how much much. If you are worried, tell the Haldol you will be given. This will doctor or nurse. Side Effects depend on your physical conditions Signs of overdose of Haldol may All medicines can have side effects. such as your age, body weight, your include severe tremor, fainting or Sometimes they are serious, most of medical history and conditions. drowsiness. the time they are not. You may need Your doctor will monitor you medical treatment if you get some closely when you start receiving side effects. Do not be alarmed by Haldol injection. Your dose and this list of possible side effects. You how often the injection is given may not experience any of them. may be altered, until the medicine

HALDOL® DECANOATE Published by MIMS August 2019 3 Ask your doctor or pharmacist to • abnormal hormone levels in blood pressure, stiff muscles, answer any questions you may blood such as prolactin, decreased mental alertness or have. antidiuretic hormone fits (seizures). Tell your doctor if you experience • being unable to pass urine or • abnormal heart rhythm (in any of the following: empty the bladder completely ECG), fast or unusual heartbeat. • drowsiness or sleepiness • swelling caused by fluid build- Other side effects not listed above • restlessness or difficulty sitting up in the body may also occur in some people. Tell still • low level of sugar in the blood your doctor if you notice any other effects. • difficulty sleeping • problems with liver such as • constipation jaundice, abnormal blood tests of the liver, liver failure • dry mouth • shaking or tremors • increased salivation After using Haldol • difficulty speaking • nausea or vomiting • uncontrollable twitching or • low body temperature Storage jerking movements of the arms • problems with skin such as and legs; worm-like movements Keep Haldol Injection in the pack flaking or peeling of skin, of the tongue or other until it is time to use them. itching, rash, hives, sensitivity uncontrolled movements of the Keep Haldol Injection in a cool to sunlight mouth, tongue, cheeks or jaws dry place where the temperature • excessive sweating which may progress to the arms is below 25°C. Do not freeze or • changes in sex drive in both men and legs refrigerate it. Protect it from and women, problems having • being unable to move, difficulty light. sex opening the mouth Keep your medicines where children cannot reach them. A • difficulty getting and keeping an • uncontrollable muscle spasms locked cupboard at least one-and-a- erection (impotence), painful affecting the eyes, head, neck half metres (1.5 m) above the and persistent erection and body ground is a good place to store • enlarged breasts in men • feeling agitated, confused or medicines. • problems with menstrual period depressed Do not use this medicine after the such as having no periods, • Serious mental health problem, expiry date which is stated on the painful period, long and heavy such as believing things that are label or carton. The expiry date periods or changes in menstrual not true (delusions) or seeing, refers to the last day of that month. cycles feeling, hearing or smelling • unexpected production of breast things that are not there Do not store Haldol, or any other milk (hallucinations) medicine, in the bathroom or near a • breast pain, discomfort • disease of the brain affecting sink. Do not leave medicines in the car or on window sills. Heat and • weight gain or weight loss movement, resulting in dampness can destroy some • muscle stiffness or weakness, trembling, rigid posture, slow medicines. abnormal muscle tension, joint movements and a shuffling, unbalanced walk (parkinsonism) stiffness Disposal • breakdown of muscle tissue Tell your doctor immediately if (rhabdomyolysis) you notice any of the following as If your doctor tells you to stop using you may need urgent medical Haldol Injection, or your medicine • lack of normal facial care: has passed its expiry date, ask your expressions that sometimes pharmacist what to do with any looks like a mask • difficulty in breathing, or deeper and faster breathing. medicine which may be left over. • redness, burning or pain at the site Haldol is given including • allergic reactions with signs collection of pus at the site such as skin rash, itching, shortness of breath, and/or • vision problems such as blurred swelling of the face, lips or Product Description vision throat that may lead to difficulty • low blood pressure which may breathing or swallowing. What it looks like cause dizziness or headache • a sudden increase in body • low blood cell counts such as Haldol Injection is a slightly amber temperature, extremely high white blood cells, platelets solution and comes in 1 mL or 3

HALDOL® DECANOATE Published by MIMS August 2019 4 mL amber glass ampoules. Each pack contains 5 ampoules.

Ingredients Each mL of Haldol Injection contains • 50 mg haloperidol (as decanoate) as the active ingredient • other ingredients: sesame vehicle,

Sponsor JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road Macquarie Park NSW 2113 Australia Telephone: 1800 226 334 NZ Office: Auckland New Zealand Telephone: 0800 800 806

Registration number The Australian Registration Numbers are: Haldol Decanoate 50 mg/1 mL Injection - AUST R 13302 Haldol Decanoate 150 mg/3 mL Injection - AUST R 46901 This leaflet was prepared in June 2019.

HALDOL® DECANOATE Published by MIMS August 2019 5