ABILIFY™ 5mg, 10mg, 15mg, 20mg & 30mg tablet Aripiprazole Consumer Medicine Information

What is in this leaflet patients experience episodes of  shortness of breath, wheezing or overactivity, elation or irritability. difficulty breathing This leaflet answers some common Schizophrenia is a mental illness  swelling of the face, lips, tongue, questions about ABILIFY. It does with disturbances in thinking, throat or other parts of the body not contain all the available feelings and behaviour. Do not take ABILIFY after the information. Some of the information Bipolar disorder is a condition with expiry or use by date printed on contained in this leaflet may not symptoms such as feeling "high", the pack. apply to you. having excessive amounts of energy, If you take this medicine after this It does not take the place of talking to needing much less sleep than usual, date has passed, it may not work as your doctor or pharmacist. talking very quickly with racing well. All medicines have risks and ideas and sometimes severe irritability. Do not take ABILIFY if the benefits. Your doctor has weighed packaging is torn or shows signs of the risks of you taking ABILIFY Your doctor may have prescribed tampering. against the benefits it is expected to ABILIFY for another reason. Ask If this is the case, return it to your have for you. your doctor if you have any questions pharmacist. If you have any concerns about about why ABILIFY has been If you are not sure whether you taking this medicine, ask your prescribed for you. should start taking ABILIFY, talk doctor or pharmacist. There is no evidence that ABILIFY to your doctor or pharmacist. Keep this leaflet with the medicine. is addictive. You may need to read it again. This medicine is available only with Before you start to take it a doctor's prescription. Tell your doctor or pharmacist if ABILIFY is not recommended for you have allergies to: use in children under the age of 18, What ABILIFY is used as safety and efficacy have not been  any other medicines for established in this age group.  any other substances such as foods, preservatives or dyes ABILIFY is a trade name Tell your doctor if you are (manufacturer's name) for the pregnant or intend to become medicine aripiprazole (Ari-pip-rah- Before you take pregnant. zol). ABILIFY ABILIFY is not recommended for ABILIFY belongs to a group of use during pregnancy. If you need to medicines called antipsychotic agents When you must not take it take ABILIFY during your which improve the symptoms of Do not take ABILIFY if you have pregnancy, your doctor will discuss certain types of mental illness. an allergy to: with you the benefits and risks of ABILIFY is used to treat symptoms taking it. Babies exposed to  aripiprazole of schizophrenia. antipsychotics (including ABILIFY)  any of the ingredients listed at the during the third trimester of ABILIFY may be given to treat acute end of this leaflet pregnancy are at risk of experiencing episodes of sustained upward mood swings (mania) in adult patients with Symptoms of an allergic reaction shaking, muscle stiffness, difficulty in feeding and/or withdrawal Bipolar 1 Disorder. During mania, include: symptoms. These symptoms may  rash, itching or hives on the skin

ABILIFY™ 1 resolve spontaneously or require Tell your doctor if you have past Eating grapefruit or drinking additional medical treatment. experience of excessive gambling. grapefruit juice may affect how Tell your doctor or pharmacist if Tell your doctor if you drink ABILIFY works. you are breast-feeding or plan to alcohol. Your doctor or pharmacist may have breast-feed. Your doctor may advise you to avoid more information on medicines to be It is recommended that you do not alcohol as it can magnify the side- careful with or avoid while taking breast-feed while taking ABILIFY, effects of this medicine. ABILIFY. as it may pass into breast milk and Aripiprazole may cause sleepiness, therefore there is a possibility that the fall in blood pressure when breast-fed baby may be affected. standing up, dizziness and changes in your ability to move and How to take ABILIFY Tell your doctor if you have, or balance, which may lead to falls. have had any medical conditions, Caution should be taken. Follow all directions given to you especially the following: by your doctor or pharmacist  a reaction to some medicines with If you have not told your doctor or carefully. a sudden increase in body pharmacist about any of the above, They may differ from the temperature, sweating, fast heart tell them before you start taking information contained in this leaflet. beat, muscle stiffness and ABILIFY. fluctuating blood pressure, which Your doctor or pharmacist will tell you how much you will need to take may lead to coma. This reaction Taking other medicines is called neuroleptic malignant each day. This will depend on your syndrome. Tell your doctor or pharmacist if condition and whether you are taking you are taking any other any other medicines.  a reaction to some medicines with medicines, including any that you abnormal movements of the The label put on the carton by the buy without a prescription from tongue, or other uncontrolled pharmacist will tell you how much your pharmacy, supermarket or movements of the mouth, tongue, you should take. health food shop. cheeks or jaw which may If you do not understand the progress to the arms and legs. Some medicines and ABILIFY may instructions on the carton, ask This reaction is called tardive interfere with each other. These your doctor or pharmacist for dyskinesia. include: help.  low blood pressure  medicines used to treat brain disorders such as, anxiety, How to take it  problems with your heart or blood depression, mood swings, vessels ABILIFY tablets should be epilepsy or seizures, Parkinson's swallowed whole and washed down  epilepsy, seizures or fits disease or insomnia with a glass of water.  problems with your oesophagus  medicines used to treat high Take ABILIFY at about the same (food pipe) such as difficulty in blood pressure time each day. swallowing.  medicines used to treat fungal Unless your doctor gives you other  high blood sugar or diabetes infections directions, you should take ABILIFY mellitus  medicines used to treat heart only once a day.  Alzheimer's disease or dementia rhythm disturbances Taking the medicine at the same time  alcohol or drug abuse or  medicines used to treat bacterial each day will have the best effect. It dependence or a history of one of or viral infections will also help you remember when to these  a medicine called cyclosporin take it.  venous thromboembolism or are (Neoral®; Sandimmun®) It does not matter whether you take at risk of venous  a medicine called cimetidine ABILIFY with or without food. thromboembolism (Tagamet®; Magicul®)  have a history of or are at risk of If you forget to take it These medicines may be affected by sleep apnea (a sleep disorder ABILIFY, or may affect how well it If it is almost time for your next where your breathing is works. Your doctor may need to dose, skip the dose you missed and interrupted during sleep) adjust your dose of Abilify or of the take your next dose when you are  lactose intolerance other medicine. meant to.

ABILIFY™ 2 Otherwise, take it as soon as you Things you must not do  wear light clothing remember, and then go back to Do not give ABILIFY to anyone  spend time in air-conditioned taking your medicine as you would else, even if their symptoms seem environments (or keep windows normally. similar or they have the same open and use electric fans) Do not take a double dose to make condition as you.  drink plenty of water up for the dose that you missed. Do not take ABILIFY to treat any  take cool baths or showers and This may increase the chance of you other complaints unless your avoid hot baths and saunas getting an unwanted side effect. doctor or pharmacist tells you to.  try to restrict exercise or heavy If you are not sure what to do, ask Do not stop taking ABILIFY or work to cool parts of the day your doctor or pharmacist. lower the dosage, even if you are If you have trouble remembering feeling better, without checking to take your medicine, ask your with your doctor. pharmacist for some hints. If you stop taking ABILIFY In case of overdose suddenly your condition may worsen. How long to take it Do not take more of this medicine If you take too much Continue taking ABILIFY for as and do not take it more often than (overdose) long as your doctor tells you. your doctor has ordered. Immediately telephone your doctor ABILIFY helps to control your or pharmacist or the Poisons Things to be careful of condition but does not cure it. Information Centre (telephone Therefore you must take ABILIFY Make sure that you know how you 131126), or go to the Accident every day. Improvement in react to ABILIFY before you drive Emergency Centre at your nearest symptoms may take several days to a car, operate machinery or do hospital, if you or anyone else may some weeks to occur. Even if you anything else that could be have taken too much ABILIFY. Do feel better do not stop taking dangerous if you are dizzy or light this even if there are no signs of ABILIFY unless your doctor tells headed or not alert. discomfort or poisoning. you to. ABILIFY may cause some people to You may need urgent medical become drowsy or less alert than they attention. are normally or cause light- headedness, dizziness or tiredness. If While you are taking this occurs do not undertake the ABILIFY activity. Side-Effects If ABILIFY makes you feel light- Things you must do headed, dizzy or faint, be careful Tell your doctor or pharmacist as soon as possible if you do not feel Tell any doctors, dentists or when getting up from a sitting or pharmacists who are treating you lying position. well while you are taking ABILIFY. that you are taking ABILIFY. Getting up slowly may help. Like other medicines ABILIFY may If you are about to be started on Be careful when drinking alcohol cause some unwanted side effects. any new medicine, tell your doctor, while taking ABILIFY. These are likely to vary from patient dentist and pharmacist that you Your doctor may suggest you avoid are taking ABILIFY. to patient. ABILIFY is generally alcohol while you are being treated well-tolerated and the side effects are If you plan to have any kind of with ABILIFY. often hard to distinguish from disease surgery that needs a general Make sure you keep cool in hot symptoms. It is important that you anaesthetic, tell your doctor or weather and keep warm in cool tell your doctor as soon as possible dentist that you are taking weather. about any unwanted effects. ABILIFY. ABILIFY may affect the way your Ask your doctor or pharmacist to If you become pregnant while body reacts to temperature changes. answer any questions you may taking ABILIFY, tell your doctor It may prevent sweating, even during have. immediately. heatwaves. You may feel dizzy or Tell your doctor if you notice any Be sure to keep all of your doctor's faint if you are too hot. To stay cool of the following side effects and appointments so that your progress in hot weather, try to do the they worry you: can be checked. following:  headache

ABILIFY™ 3  indigestion behaviours or trouble controlling chest pain and blood streaked impulsive urges or while taking phlegm  nausea ABILIFY.  vomiting  thoughts or talk about death or Obsessive compulsive behaviours suicide; thoughts or talk about  insomnia (feeling the need to check things self-harm or doing harm to  constipation repeatedly or having certain thoughts others; any recent attempts at  light-headedness repeatedly), gambling urges, sexual self-harm; an increase in urges, compulsive spending, binge or aggressive behaviour, irritability  drowsiness compulsive eating and other urges or agitation. If you or someone  agitation have occurred in some patients. you know is showing these signs contact your doctor or a mental  anxiety Tell your doctor immediately or go health advisor right away or go to  inability to sit or stand still; to Accident and Emergency at the nearest hospital for treatment restless movement of the arms your nearest hospital if you notice and legs such as tapping, any of the following: These are very serious side effects. marching in places, rocking,  seizure, fits or convulsions You may need urgent medical crossing and uncrossing the legs. attention or hospitalisation.  fainting These are the more common side All of these side effects are very rare.  abnormal movements of the effects of ABILIFY tongue, or other uncontrolled Other side effects not listed above Tell your doctor if you notice the movements of the tongue, mouth, may occur in some patients. following side effects: cheeks, eyes or jaw which may Also, while taking ABILIFY, some  feeling dizzy especially when progress to the arms and legs elderly patients with dementia have getting up from a lying or sitting  sudden increase in body suffered serious side effects such as a position temperature, sweating, fast heart "mini" stroke, stroke, pneumonia or  altered or increased sexual beat, muscle stiffness, high blood heart problems. These serious side interest pressure and convulsions effects can be life threatening. These side effects are uncommon.  rash Tell your doctor or pharmacist if you notice anything that is making  high blood sugar (excessive thirst,  allergic reaction (rash, itching or you feel unwell. hunger and weakness) or the hives on the skin; shortness of onset or worsening of diabetes breath, wheezing or difficulty Do not be alarmed by this list of possible side effects. This side effect is rare. breathing; swelling of the face, lips, tongue, throat or other parts You may not experience any or only  weight gain of the body) with or without fever some of them.  weight loss  muscle pain, muscle weakness or  loss of appetite muscle stiffness  excessive sweating  inflammation of the pancreas, After using ABILIFY  drowsiness severe upper stomach pain often with nausea and vomiting  high blood pressure  disorder of body temperature Storage  chest pain regulation resulting in low body Store ABILIFY in a cool place  frequent infections such as fever, temperature or high body where the temperature stays below severe chills, sore throat or mouth temperature 30°C. ulcers  painful irreversible erection Do not store it or any other  bleeding or bruising more easily  difficulty in passing urine medicine in the bathroom. Do not than normal leave it in the car or on window  yellowing of the skin and/or eyes,  speech disorder sills. also called jaundice with or  urinary incontinence without nausea, vomiting, loss of Heat and dampness can destroy some medicines.  difficulty swallowing appetite, feeling generally unwell, fever, itching and dark coloured  hiccups Keep it where young children urine cannot reach it. These side effects are very rare.  serious lung infection with fever, A locked cupboard at least one-and- Tell your doctor if you have chills, shortness of breath, cough, a-half metres above the ground is a obsessive (recurring) thoughts or

ABILIFY™ 4 good place to store medicines. Do colorants are also present in the not keep outdated medicine or tablets: medicine no longer needed.  5mg tablets - indigo carmine CI73015 aluminium lake (not Disposal available in New Zealand) If your doctor tells you to stop  10mg tablets - iron oxide red taking ABILIFY or the medicine CI77491 has passed its expiry date, ask your  15mg tablets - iron oxide yellow pharmacist what to do with any CI77492 leftover medicine.  20mg tablets - no colourants Be sure that any discarded medicine is out of the reach of  30mg tablets - iron oxide red children. CI77491 ABILIFY does not contain sucrose, gluten, tartrazine or any other azo dyes. Product Description

What it looks like Sponsor Details

5mg ABILIFY tablets are blue, ABILIFY is supplied in New rectangular with a bevel edge and are Zealand by: marked on one side with "A-007" Pharmacy Retailing (NZ) Ltd trading and "5" (Not available in New Zealand) as Healthcare Logistics 10mg ABILIFY tablets are pink, 58 Richard Pearse Drive rectangular with a bevel edge and are Airport Oaks marked on one side with "A-008" Mangere and "10". Auckland 2022 15mg ABILIFY tablets are yellow, round with a bevel edge and are NEW ZEALAND marked on one side with "A-009" and "15". Tel: Toll free 0800 602 200 20mg ABILIFY tablets are white to pale yellowish white, round with a bevel edge and are marked on one side with "A-010" and "20". Date of Preparation 30mg ABILIFY tablets are pink, This leaflet was revised on 30 March round with a bevel edge and are 2021. marked on one side with "A-011" and "30". ABILIFY tablets are packed in ABILIFY is a trademark of Otsuka aluminium blisters in a carton. Each Pharmaceutical Co., Ltd. carton contains 30 tablets.

Ingredients Active ingredients: aripiprazole Other ingredients: lactose, starch - maize, cellulose - microcrystalline, hydroxypropylcellulose and magnesium stearate. The following

ABILIFY™ 5