ZYPREXA® and ZYPREXA®Zydis® olanzapine Consumer Medicine Information

What is in this leaflet What ZYPREXA is information on its effects in this age used for group. This leaflet is designed to provide you with answers to some common ZYPREXA belongs to a group of questions about this medicine. It medicines called antipsychotics. It does not contain all the available helps to correct chemical imbalances Before taking information and does not take the in the brain, which may cause mental ZYPREXA place of talking with your doctor. illness. Tell your doctor if you have any of The information in this leaflet was ZYPREXA is used to treat symptoms the following conditions or if you last updated on the date shown on the of schizophrenia and related have ever experienced any of these final page. More recent information psychoses. Schizophrenia is a mental conditions. about this medicine may be available. illness with disturbances in thinking, Make sure you speak to your feelings and behaviour. When you must not take it pharmacist or doctor to obtain the ZYPREXA alone, or in combination most up to date information on this Do not take ZYPREXA: with lithium or valproate, is used for medicine. You can also download the short-term treatment of acute • if you have had an allergic the most up to date leaflet from manic episodes associated with reaction to any type of www.lilly.co.nz. The updated leaflet Bipolar I Disorder. ZYPREXA is ZYPREXA or to any of the may contain important information also a mood stabiliser that prevents ingredients listed at the end of about ZYPREXA and its use that you further occurrences of the disabling this leaflet (see 'Product should be aware of. high and low (depressed) extremes of Description'). All medicines have risks and mood associated with Bipolar I Signs of an allergic reaction may benefits. Disorder. include a skin rash, itching, Your doctor has more information Bipolar I Disorder is a mental illness shortness of breath or swelling of about this medicine than is contained with symptoms such as feeling the face, lips or tongue. in this leaflet. Also, your doctor has "high", having excessive amounts of • if the packaging is torn or had the benefit of taking a full and energy, needing much less sleep than shows signs of tampering or the detailed history from you and is in usual, talking very quickly with tablets or wafers do not look the best position to make an expert racing ideas and sometimes severe quite right. judgement to meet your individual irritability. needs. • if the expiry date on the pack Your doctor may have prescribed has passed. If you have any concerns about ZYPREXA for another reason. taking this medicine, talk to your If you take this medicine after the Ask your doctor if you have any expiry date has passed it may not doctor or pharmacist. questions about why ZYPREXA work as well. Keep this leaflet with this has been prescribed for you. If you are not sure whether you medicine. This medicine is available only with should start taking ZYPREXA, You may need to read it again. a doctor's prescription. talk to your doctor or pharmacist. ZYPREXA is not recommended for use in children under the age of 18 years as there is not enough

NZ ZYPREXA® & ZYPREXA Zydis v7.0 1 Before you start to take it Like most antipsychotic medicines, • medicines used for Parkinson's ZYPREXA is not recommended for disease Tell your doctor if you have had an use during pregnancy. If there is a allergic reaction to any medicine • medicines that can change the need to consider ZYPREXA during which you have taken previously to heart's electrical activity or make your pregnancy, your doctor will treat your current condition. it more likely to change. discuss with you the benefits and Your doctor or pharmacist has more Tell your doctor if you have or risks of using it. have had any medical conditions, information on medicines to be Tell your doctor if you are breast- especially the following: careful with or avoid while taking feeding or plan to breast-feed. ZYPREXA. • tumour of the pituitary gland (a It is recommended that you do not small gland at the base of the Tell your doctor about these things breast-feed while taking ZYPREXA. brain) before you take ZYPREXA. Tell your doctor if you suffer from • disease of the blood with a lactose intolerance (because reduced number of white or red ZYPREXA tablets contain lactose). blood cells Tell your doctor if you suffer from How to take ZYPREXA • disease of the blood vessels of the phenylketonuria (because brain, including stroke ZYPREXA Zydis wafers contain Follow all directions given to you • prostate problems aspartame). by your doctor or pharmacist carefully. • kidney or liver disease Tell your doctor if you will be in a These may differ from the • high blood sugar, diabetes or a hot environment or do a lot of information contained in this leaflet. family history of diabetes vigorous exercise. • breast cancer or a family history ZYPREXA may make you sweat How much to take of breast cancer less, causing your body to overheat. ZYPREXA tablets or wafers: • paralytic ileus, a condition where Tell your doctor if you smoke. the small bowel does not work Smoking may affect ZYPREXA or Your doctor will tell you how many ZYPREXA tablets or wafers you properly may affect how it works. should take. The dose your doctor • epilepsy (seizures or fits) Taking other medicines will prescribe for you will usually be • glaucoma, a condition in which in the range 5 mg to 20 mg per day. there is usually a build up of fluid Tell your doctor if you are taking Your doctor may increase or in the eye any other medicines, including any decrease your dose in order to find that you buy without a • heart disease, including irregular the appropriate dose for your prescription from your pharmacy, heart rhythm condition. supermarket or health food shop. • neuroleptic malignant syndrome, A lower starting dose may be Some medicines may be affected by a reaction to some medicines with prescribed for elderly patients over ZYPREXA or may affect how it a sudden increase in body the age of 65 years. temperature, extremely high works. These include: blood pressure and severe • medicines used to treat a fast or How to take it convulsions irregular heart beat (arrhythmia) ZYPREXA tablets: • tardive dyskinesia, a reaction to • medicines taken for anxiety or to ZYPREXA tablets should be some medicines with help you sleep swallowed whole with a glass of uncontrollable twitching or • medicines taken for depression water. jerking movements of the arms and legs. • carbamazepine, a medicine used ZYPREXA Zydis wafers: for mood stabilisation and to treat Do not handle the wafers with wet • sleep apnoea, a sleep disorder epilepsy where a person has pauses in hands as the wafers may break up. • other centrally acting medicines breathing or periods of shallow ZYPREXA Zydis wafers break (eg. tranquillisers) breathing during sleep. easily, so you should handle them • ciprofloxacin, a medicine used to carefully. treat bacterial infections Tell your doctor if you are The wafers can be taken two ways: • medicines that lower blood pregnant or intend to become • Directly into your mouth pressure pregnant. • In a drink

NZ ZYPREXA® & ZYPREXA Zydis v7.0 2 To take a wafer directly into your Do not take a double dose to make developing diabetes should have mouth: up for the dose that you missed. their blood sugar checked often. 1. Hold the blister strip at the If you are not sure what to do, ask • If you are over 65, your doctor edges and separate one blister your doctor or pharmacist. may measure your blood pressure cell from the rest of the strip by from time to time. gently tearing along the If you take too much Tell your doctor if you are female perforations around it. Immediately telephone your doctor and your monthly periods are 2. Carefully peel off the coloured or the Australian Poisons absent for six months or more. backing. Information Centre (telephone 13 Talk to your doctor or mental 3. Gently push the wafer out. 11 26) or the New Zealand health professional if you have National Poisons Centre (0800 4. Put the wafer in your mouth. It thoughts or talk about death or POISON or 0800 764 766), or go to will dissolve directly in your suicide; or thoughts or talk about Accident and Emergency at your mouth, so that it can be easily self-harm or doing harm to others. nearest hospital, if you think that swallowed. These may be signs of changes or you or anyone else has taken too worsening in your mental illness. To take a wafer in a drink: much ZYPREXA. Do this even if there are no signs of discomfort or You can also place the wafer in a full Things you must not do glass or cup of water, orange juice, poisoning. apple juice, milk or coffee, and stir. If you have taken too much Do not stop taking ZYPREXA, or lower the dosage, even if you are Drink it straight away. ZYPREXA, the most common signs feeling better, without checking are fast heart beat, With some drinks, the mixture may with your doctor. agitation/aggression, difficulty change colour and possibly become speaking, uncontrollable movements Do not give ZYPREXA to anyone cloudy. and sedation. else, even if their symptoms seem Do not place the wafer in cola similar or they have the same drinks. condition as you. Your doctor has prescribed When to take it While you are taking ZYPREXA for you and your ZYPREXA tablets or wafers ZYPREXA condition. should be taken once a day as advised by your doctor. Things you must do Things to be careful of Take your prescribed dose at the It is important that you remember Be careful driving or operating same time each day. to take ZYPREXA daily and at the machinery until you know how ZYPREXA tablets or wafers can be dose prescribed by your doctor. ZYPREXA affects you. taken with or without food. Tell all doctors, dentists and ZYPREXA may cause drowsiness in pharmacists who are treating you some people. How long do I take it that you are taking ZYPREXA. Be careful when drinking alcohol Do not stop taking ZYPREXA just While you are taking ZYPREXA, while taking ZYPREXA. because you feel better. It is tell your doctor or pharmacist The effects of alcohol could be made important that you do NOT stop before you start any new medicine. worse while taking ZYPREXA. taking ZYPREXA unless your If you become pregnant while doctor tells you. Your doctor may suggest you avoid taking ZYPREXA, tell your alcohol while you are being treated If you forget to take it doctor. with ZYPREXA. Keep all of your doctor's If ZYPREXA makes you feel light- If it is almost time for your next appointments so that your progress headed, dizzy or faint, be careful dose skip the dose you missed and can be checked. when getting up from a sitting or take your next dose when you are lying position. meant to. • Your doctor should monitor your weight while you are taking Getting up slowly may help. Otherwise, take it as soon as you ZYPREXA. remember then go back to taking If outdoors, wear protective your medicine as you would • Patients with diabetes or who clothing and use at least a 30+ normally. have a higher chance of sunscreen.

NZ ZYPREXA® & ZYPREXA Zydis v7.0 3 ZYPREXA may cause your skin to • dizziness, confusion, your nearest hospital if you notice be much more sensitive to sunlight forgetfulness. any of the following: than it is normally. Some people may feel dizzy in the • Sudden signs of an allergic Exposure to sunlight may cause a early stages of treatment, especially reaction such as a skin rash, skin rash, itching, redness, or severe when getting up from a lying or itching, shortness of breath or sunburn. sitting position. This side effect swelling of the face, lips or If your skin does appear to be usually passes after taking tongue. burning, tell your doctor. ZYPREXA for a few days. • frequent infections such as fever, Make sure you keep cool in hot Tell your doctor if you notice any severe chills, sore throat or mouth weather and keep warm in cool of the above side effects and they ulcers weather. worry you. • bleeding or bruising more easily ZYPREXA may affect the way your These are the more common side than normal body reacts to temperature changes effects of ZYPREXA. • seizures, fits or convulsions Tell your doctor as soon as possible • yellowing of the skin and/or eyes if you notice any of the following • nausea, vomiting, loss of appetite, side effects: Side effects generally feeling unwell, fever, • symptoms of sunburn (such as itching, yellowing of the skin redness, itching, swelling or and/or eyes All medicines may have some blistering of the skin) which • severe upper stomach pain often unwanted side effects. Sometimes occur more quickly than normal they are serious, but most of the time with nausea and vomiting • rash or allergic reaction they are not. Your doctor has (inflammation of the pancreas) weighed the risks of using this • slow heart beat • worm-like movements of the medicine against the benefits they • changes in sexual functioning or tongue, or other uncontrolled expect it will have for you. sex drive in men or women movements of the tongue, mouth, Like other medicines, ZYPREXA • prolonged and/or painful erection cheeks, or jaw which may may cause some unwanted side progress to the arms and legs • unusual secretion of breast milk effects. These are likely to vary from • sudden increase in body • breast enlargement in men or patient to patient. Some side effects temperature, sweating, fast heart women may be related to the dose of beat, muscle stiffness, high blood ZYPREXA. Accordingly, it is • symptoms of high sugar levels in pressure and convulsions important that you tell your doctor as the blood (including passing large • sharp chest pain, coughing of soon as possible about any unwanted amounts of urine, excessive thirst, blood, or sudden shortness of effects. Your doctor may then decide having a dry mouth and skin and breath to adjust the dose of ZYPREXA you weakness). These may indicate are taking. the onset or worsening of diabetes • pain/tenderness in the calf muscle area Tell your doctor if you notice any • reaction following abrupt of the following side effects and discontinuation (profuse • muscle pain, muscle weakness they worry you: sweating, nausea or vomiting) and brown urine • drowsiness • absence of menstrual periods and • heart palpitations and dizziness, which may lead to collapse. • unusual tiredness or weakness changes in the regularity of menstrual periods These are very serious side effects. • fever • involuntary passing of urine or You may need urgent medical • restlessness or difficulty sitting difficulty in initiating urination attention or hospitalisation. still • unusual hair loss or thinning. All of these side effects are very rare. • increased appetite, weight gain • excessive saliva in the mouth. The following additional side effects • constipation, bloating may occur in some groups of people

• dry mouth taking ZYPREXA: These side effects are uncommon but • swelling of your hands, feet and may require medical attention. ankles Tell your doctor immediately or go • aching joints to Accident and Emergency at • nose bleeds

NZ ZYPREXA® & ZYPREXA Zydis v7.0 4 Elderly patients with Other side effects not listed above Product Description dementia-related psychosis may also occur in some patients. Elderly patients with dementia- Tell your doctor if you notice What it looks like related psychosis may notice the anything else that is making you ZYPREXA tablets are white and are following side effects: feel unwell. available in the following strengths: • unusual manner of walking • 2.5 mg tablet • falls • 5 mg tablet • pneumonia After taking ZYPREXA • 7.5 mg tablet (Australia only) • involuntary passing of urine. Storage • 10 mg tablet. Each ZYPREXA tablet has "Lilly" Parkinson's disease Keep your tablets and wafers in and an identicode number printed on psychosis the blister pack until it is time to it. The identicode number for: Some patients with Parkinson's take them. • 2.5 mg tablet is 4112 disease may hallucinate (see, feel or Keep your tablets and wafers in a hear things that are not there) or cool, dry place where the • 5 mg tablet is 4115 develop worsening symptoms of temperature stays below 25°C. • 7.5 mg tablet is 4116 Parkinson's disease. ZYPREXA Zydis wafers should be • 10 mg tablet is 4117. kept out of direct light. Zyprexa in combination with ZYPREXA tablets come in blister lithium or valproate Do not store ZYPREXA or any packs in the following pack sizes: other medicine in the bathroom or • 2.5 mg tablet- 28 tablets Patients with bipolar mania taking near a sink. ZYPREXA in combination with • 5 mg tablet- 7 or 28 tablets Do not leave your tablets and lithium or valproate may notice the wafers in the car on hot days or on • 7.5 mg tablet- 28 tablets following additional side effects: window sills. • 10 mg tablet- 7 or 28 tablets. • tremors Heat and dampness can destroy some ZYPREXA Zydis wafers are yellow • speech disorder. medicines. and are available in the following All medicines should be kept where strengths: Zyprexa IM injection young children cannot reach them. • 5 mg wafer Additional side effects seen with A locked cupboard at least one and a • 10 mg wafer ZYPREXA IM Injection are: half metres above the ground is a • 15 mg wafer (Australia only) • low blood pressure good place to store medicines. • 20 mg wafer (Australia only). • slow heart beat There will be an expiry date (month, year) on your ZYPREXA container. ZYPREXA Zydis wafers come in • fast heart beat. blister packs in the following pack Tell your doctor if you notice The medicine should not be taken sizes: after this date because it may have anything unusual or if you are 5 mg wafer - 7 or 28 wafers concerned about any aspect of lost some of its strength. your health, even if you think the 10 mg wafer - 7 or 28 wafers problems are not connected with Disposal 15 mg wafer - 28 wafers this medicine and are not referred If your doctor tells you to stop taking 20 mg wafer - 28 wafers to in this leaflet. ZYPREXA or you find that the Also, some side effects, such as tablets or wafers have passed their Ingredients changes to liver function, cholesterol expiry date, please return any left ZYPREXA tablets: or triglycerides can occur. These can over tablets or wafers to your only be found when your doctor does pharmacist. Active Ingredient: tests from time to time to check your • 2.5 mg tablet - 2.5 mg olanzapine progress. per tablet Do not be alarmed by this list of • 5 mg tablet - 5 mg olanzapine per side effects. tablet You may not experience any of them. • 7.5 mg tablet - 7.5 mg olanzapine per tablet

NZ ZYPREXA® & ZYPREXA Zydis v7.0 5 • 10 mg tablet - 10 mg olanzapine 10 mg tablet - AUST R 56606 per tablet. ZYPREXA Zydis wafers: Inactive Ingredients - lactose, 5 mg wafer - AUST R 73388 hydroxypropylcellulose, crospovidone, microcrystalline 10 mg wafer - AUST R 73389 cellulose, magnesium stearate, 15 mg wafer - AUST R 73390 hypromellose and carnauba wax, 20 mg wafer - AUST R 73391 Colour Mixture White YS-1-18027-

A and Edible Blue Ink. This leaflet was revised in ZYPREXA Zydis wafers: November 2019. Active Ingredient: • 5 mg wafer - 5 mg olanzapine per wafer • 10 mg wafer - 10 mg olanzapine per wafer • 15 mg wafer - 15 mg olanzapine per wafer • 20 mg wafer - 20 mg olanzapine per wafer. Inactive ingredients - gelatin, mannitol, aspartame, sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate.

Supplier ZYPREXA is a product of: Eli Lilly Australia Pty Limited 112 Wharf Road WEST RYDE NSW 2114 AUSTRALIA ZYPREXA is distributed in New Zealand by: Eli Lilly and Company (NZ) Ltd. Level 1, 123 Ormiston Road Botany South Auckland 2016 NEW ZEALAND Telephone 0800 500 056

®= Registered Trademark

Australian Registration Numbers ZYPREXA tablets: 2.5 mg tablet - AUST R 56603 5 mg tablet - AUST R 56604 7.5 mg tablet - AUST R 56605

NZ ZYPREXA® & ZYPREXA Zydis v7.0 6