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STRATTERA® atomoxetine hydrochloride Consumer Medicine Information

What is in this leaflet frequent or severe than others who abnormal or dangerously fast are close in age or development. heart beat, thickening and This leaflet answers some common STRATTERA works by acting on hardening of the walls of the questions about STRATTERA. It brain chemicals called amines which arteries due to cholesterol does not contain all the available are involved in controlling deposits information. It does not take the behaviour. • an uncontrolled overactive place of talking to your doctor or Ask your doctor if you have any thyroid gland which causes pharmacist. questions about why this medicine increased appetite, weight loss, The information in this leaflet was has been prescribed for you. Your intolerance to heat, increased last updated on the date shown on the doctor may have prescribed it for sweating, tremors, and rapid heart final page. More recent information another reason. rate on this medicine may be available. Available evidence suggests that • a tumour of the adrenal gland, Make sure you speak to your STRATTERA does not have a which sits near the kidney. The pharmacist or doctor to obtain the significant potential for abuse. symptoms are bouts of anxiety most up to date information on this and headaches, , This medicine is available only with medicine. You can also download dizziness, a feeling of weakness, a doctor's prescription. the most up to date leaflet from nausea, vomiting, diarrhoea, www.lilly.com.au. The updated dilated pupils and blurring vision, leaflet may contain important stomach pains, and raised blood information about STRATTERA and pressure. Before you take its use that you should be aware of. Do not take STRATTERA if you All medicines have risks and STRATTERA are taking medicine called a benefits. Your doctor has weighed monoamine oxidase inhibitor the risks of you taking STRATTERA When you must not take it (MAOI) for the treatment of against the benefits it may have for Do not take STRATTERA if you or have been taking a you. have an allergy to: MAOI within the last 14 days. If you have any concerns about • any medicine containing Check with your doctor or taking this medicine, ask your atomoxetine hydrochloride (the pharmacist if you are unsure as to doctor or pharmacist. active ingredient in whether or not you are taking a Keep this leaflet with the medicine. STRATTERA) MAOI. • any of the ingredients listed at the If you do take STRATTERA while end of this leaflet. you are taking a MAOI, you may experience shaking (tremor), Some of the symptoms of an allergic shivering, muscle stiffness, fever, What STRATTERA is reaction may include shortness of rapid pulse, rapid breathing or used for breath, wheezing or difficulty confusion. breathing; swelling of the face, lips, STRATTERA is used to treat tongue or other parts of the body; Do not take STRATTERA if you Attention Deficit Hyperactivity rash, itching or hives on the skin. have high pressure in the eye Disorder (ADHD) in children 6 years (), or have a family Do not take STRATTERA if you and older, adolescents and adults. history of glaucoma. ADHD is a behavioural disorder that have any of the following Do not take this medicine after the causes lack of focus and/or conditions: expiry date printed on the pack or hyperactivity that is much more • certain heart diseases such as moderate to severe , strattera-cmi-v6-29aug14 Page 1 of 5 if the packaging is torn or shows • have a family history of • medicines containing the signs of tampering. sudden/cardiac death. decongestants If it has expired or is damaged, return STRATTERA generally should not or it to your pharmacist for disposal. be used in children, adolescents or • asthma reliever medicines such as If you are not sure whether you adults with known structural heart salbutamol, when taken orally as should start taking this medicine, abnormalities. a syrup or as an injection talk to your doctor. Tell your doctor if you are • certain medicines taken for pregnant or plan to become anxiety such as or to Before you start to take it pregnant or are breast-feeding. treat epilepsy such as . Tell your doctor if you have Your doctor can discuss with you the Your doctor and pharmacist have allergies to any other medicines, risks and benefits involved. more information on medicines to be foods, preservatives or dyes. Safety and effectiveness in elderly careful with or avoid while taking STRATTERA. Tell your doctor if you have or patients older than 65 years and have had any of the following children younger than 6 years have medical conditions: not been established. • high blood pressure If you have not told your doctor about any of the above, tell How to take • low blood pressure him/her before you start taking STRATTERA • fast heart beat STRATTERA. Carefully follow all directions • heart disease given to you by your doctor or Taking other medicines • conditions affecting blood flow in pharmacist. the brain, such as Tell your doctor or pharmacist if They may differ from the you are taking any other • disease information contained in this leaflet. medicines, including any that you • kidney disease get without a prescription from If you do not understand the • an overactive thyroid gland your pharmacy, supermarket or instructions on the box, ask your doctor or pharmacist for help. • enlargement or disease of the health food shop. prostate Some medicines may be affected by How much to take • difficulty passing urine STRATTERA or may affect how it works. You may need different For children and adolescents up to 70 • seizures, fits or convulsions amounts of your medicines or you kg body weight, the usual starting • any psychiatric disorder, may need to take different medicines. dose is approximately 0.5 mg/kg including depression or bipolar once a day. These include: disorder. After a minimum of 3 days, if • monoamine oxidase inhibitors Tell your doctor if you or your necessary, the dose may be increased (MAOIs), medicines used to treat child have or have had to approximately 1.2 mg/kg once some types of depression. • thoughts or talk of death or daily in the morning or as evenly You should stop taking MAOIs divided doses in the morning and late at least two weeks before afternoon/early evening. After 2 to 4 • thoughts or talk of self-harm or starting STRATTERA additional weeks, if necessary, the harm to others • certain medicines used to treat dose may be increased to a maximum • any recent attempts at self- depression such as , of 1.4 mg/kg once daily or 100 mg. harm. , , For children and adolescents greater You may wish to see a paediatric , and than 70 kg body weight and adults, psychiatrist for further assessment the usual starting dose is 40 mg once and supervision of your child. • certain medicines used to treat a day. Tell your doctor if you irregular heart beat such as After a minimum of 3 days, if • are involved in strenuous exercise necessary, the dose may be increased or activities • medicines used to treat low blood to approximately 80 mg once daily in pressure or to raise blood pressure the morning or as evenly divided • are using a group of medicines doses in the morning and late called (pressor agents) afternoon/early evening. After 2 to 4

strattera-cmi-v6-29aug14 Page 2 of 5 additional weeks, the dose may be Otherwise, take it as soon as you • attempts to commit suicide increased to a maximum of 100 mg. remember, and then go back to • new or worse depression taking your medicine as you would If therapy is interrupted for more • new or worse anxiety than 1 week, treatment should be normally. Do not take more than • feeling very agitated or restless started at the lowest recommended your total daily dose in a 24 hour dose. period. • panic attacks Your doctor will tell you how much If you are not sure what to do, ask • difficulty sleeping (insomnia) your doctor or pharmacist. STRATTERA you need to take each • new or worse irritability day. If you have trouble remembering • acting on dangerous impulses Your doctor may increase or to take your medicine, ask your • an extreme increase in activity decrease your dose depending on pharmacist for some hints. and talking your condition and any other illness that you may have. If you take too much • other unusual changes in (overdose) behaviour. How to take it If you think that you or anyone else Preventing suicidal thoughts Swallow the capsules whole with a may have taken too much or action: full glass of water. STRATTERA, immediately telephone your doctor or the Poisons STRATTERA can be taken with or To try and prevent suicidal thoughts Information Centre (telephone or actions in your child, talk with and without food. Australia: 13 11 26, NZ: 0800 listen to your child about his or her POISON or 0800 764 766) for When to take it thoughts and feelings and pay close advice, or go to Emergency attention to changes in his or her STRATTERA is usually taken one or Department at the nearest hospital. moods or action, especially if the two times a day (early morning and Do this even if there are no signs of changes occur suddenly. Other late afternoon/early evening). discomfort or poisoning. You may important people in your child's life If you find that you are sleepy need urgent medical attention. can help by paying attention as well during the day or have trouble If you have taken too much (e.g. brothers and sisters, teachers, sleeping at night, talk to your STRATTERA, the most common caregivers and other important doctor about the best time to take signs are sleepiness, agitation, people). Pay close attention to your your medicine. hyperactivity, unusual behaviour and child whenever STRATTERA is started or its dose is changed. (See Take your medicine at about the an upset stomach. In some cases of Side Effects). same time each day. overdose, seizures have been reported. If you notice an increase in Taking it at the same time each day aggression or hostility since taking will have the best effect. It will also this medication, you should call help you remember when to take it. your doctor as soon as possible. It does not matter if you take this While you are taking Tell your doctor if you experience medicine before or after food. STRATTERA a seizure, fit or convulsion. If you already suffer from seizures, fits or How long to take it Things you must do convulsions, tell your doctor if they Continue taking your medicine for seem to increase in frequency. Contact your doctor or a paediatric as long as your doctor tells you. psychiatrist straight away or go to the Tell your doctor if you notice This medicine helps to control your nearest hospital for treatment if you changes in your sexual function condition, but does not cure it. It is notice any sudden change in your while you are taking this medicine. important to keep taking your child's behaviour, if your child is If you are about to be started on medicine even if you feel well. demonstrating any of the following any new medicine, remind your warning signs, if you notice any of doctor and pharmacist that you If you forget to take it the following or if they seem worse. are taking STRATTERA. If it is almost time for your next Signs to watch for: Tell any other doctors, dentists and dose, skip the dose you missed and • thoughts or talk of death or pharmacists who treat you that take your next dose when you are suicide you are taking this medicine. meant to. • thoughts or talk of self-harm or harm to others strattera-cmi-v6-29aug14 Page 3 of 5

If you are going to have surgery, Standing up slowly, especially when • lacking energy, feeling tired tell the surgeon or anaesthetist that you get up from bed or chairs, will Adults you are taking this medicine. help your body get used to the • dry mouth It may affect other medicines used change in position and blood • thirst during surgery. pressure. If this problem continues or gets worse, talk to your doctor. • difficulty urinating, abnormal, If you become pregnant while painful and/or frequent urination taking this medicine, tell your If your doctor advises you to stop doctor immediately. taking STRATTERA, do not take • sexual problems monoamine oxidase inhibitors Keep all of your doctor's • testicular or genital pain in males (MAOIs) within the first two weeks appointments so that your progress after stopping STRATTERA. • painful or irregular menstrual can be checked. periods Your doctor may do some tests • hot flushes (blood pressure and heart rate) from • increased sweating time to time while on therapy. After Side effects starting STRATTERA children may • tickling, tingling, burning, have a reduced rate of growth so Tell your doctor or pharmacist as pricking, or numbness of skin your doctor may also monitor your soon as possible if you do not feel • feeling jittery, tremors height and weight from time to time well while you are taking • agitation when on long term therapy. STRATTERA. • persistent abnormal taste All medicines can have side effects. Things you must not do Sometimes they are serious, most of Tell your doctor immediately or go to the Emergency Department of Do not take STRATTERA to treat the time they are not. You may need your nearest hospital if you notice any other complaints unless your medical attention if you get some of doctor tells you to. the side effects. any of the following in you/your child while taking STRATTERA: Do not give your medicine to Do not be alarmed by the following • anyone else, even if they have the lists of side effects. You may not fast or irregular heart beat same condition as you. experience any of them. Ask your • fainting Do not open your STRATERRA doctor or pharmacist to answer • numbness, tingling and colour capsules as the content is an eye any questions you may have. change (white, blue then red) in irritant. Tell your doctor or pharmacist if fingers and toes when exposed to cold In the event of capsule content you notice any of the following: coming in contact with the eye, flush Children, adolescents and Adults • seizures, fits or convulsions the affected eye immediately with • signs of liver injury such as dark • constipation water and seek medical advice. urine, yellowing of the skin or Hands and any potentially • upset or sore stomach, nausea, eyes, severe cramps of the contaminated surfaces should be vomiting stomach, or unexplained nausea, washed as soon as possible. • diarrhoea fatigue, lethargy, itching or flu- • decreased appetite like symptoms Things to be careful of • • decreased weight episodes of overactivity, elation Be careful driving or operating or irritability machinery until you know how • headache • confusion or hallucinations STRATTERA affects you. • dizziness (seeing or feeling things that are This medicine may cause dizziness, • constant flu like symptoms such not really there) tiredness or drowsiness in some as chills, fever, irritated watery • thoughts of suicide or attempts to people. If you have any of these eyes, sore throat harm yourself. (also see Things symptoms, do not drive, operate • dilated pupils You Must Do if you notice this machinery or do anything else that • mood swings, irritability behaviour in children or could be dangerous. adolescents) • If you feel light-headed, dizzy or skin rash, redness, itching These are serious side effects, which • early morning waking, tiredness, faint when getting out of bed or may require medical attention. standing up, get up slowly. difficulty sleeping Serious side effects are rare or very • unusual weakness rare. Other side effects not listed strattera-cmi-v6-29aug14 Page 4 of 5 above may also occur in some STRATTERA 25 mg capsules are (NZ) Ltd. people. coloured opaque blue and opaque Level 1, 123 Ormiston Rd white and are marked with "Lilly", Tell your doctor or pharmacist if South Botany, AUCKLAND you notice any other effects. "3228" and "25 mg". New Zealand STRATTERA 40 mg capsules are coloured opaque blue and are marked with "Lilly", "3229" and "40 mg". Australian Registration Number: After taking STRATTERA 60 mg capsules are STRATTERA coloured opaque blue and gold and STRATTERA 10 mg capsules - are marked with "Lilly", "3239" and AUST R 90592 "60 mg". Storage STRATTERA 80 mg capsules are Keep your capsules in the pack STRATTERA 18 mg capsules - until it is time to take them. coloured opaque brown and opaque white and are marked with "Lilly", AUST R 90593 If you take the capsules out of the "3250" and "80 mg". pack they may not keep as well. STRATTERA 100 mg capsules are STRATTERA 25 mg capsules - Keep your capsules in a cool dry coloured opaque brown and are AUST R 90594 place where the temperature stays marked with "Lilly", "3251" and below 25°C. "100 mg". Do not store STRATTERA or any STRATTERA 40 mg capsules - other medicine in the bathroom or AUST R 90595 near a sink. Do not leave it on a Ingredients windowsill or in the car. STRATTERA contains 10, 18, 25, Heat and dampness can destroy some STRATTERA 60 mg capsules - 40, 60, 80 or 100 mg of atomoxetine medicines. AUST R 90596 hydrochloride as the active Keep it where children cannot ingredient. It also contains: reach it. • starch (pregelatinised maize) STRATTERA 80 mg capsules - A locked cupboard at least one-and- • dimethicone 350 AUST R 146333 a-half metres above the ground is a good place to store medicines. • gelatin • sodium lauryl sulfate STRATTERA 100 mg capsules - Disposal • edible black ink AUST R 146413 If your doctor tells you to stop • one or more of the following: taking this medicine or the expiry − indigo carmine CI73015 This leaflet was revised in date has passed, ask your pharmacist what to do with any − iron oxide yellow CI77492 August 2014. medicine that is left over. − iron oxide red CI77491 ® = Registered Trademark − titanium dioxide This medicine does not contain Product description lactose, sucrose, gluten, tartrazine or any other azo dyes. What it looks like

STRATTERA 10 mg capsules are Supplier coloured opaque white and are marked with "Lilly", "3227" and "10 Supplied in Australia by mg". Eli Lilly Australia Pty Limited STRATTERA 18 mg capsules are 112 Wharf Road coloured gold and opaque white and WEST RYDE NSW 2114 are marked with "Lilly", "3238" and "18 mg". Supplied in NZ by:

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