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Lasix® and Lasix® High Dose

(LAY-six) Furosemide (Frusemide) (fur-o-za-MIDE / froo-za-MIDE)

Consumer Medicine Information (CMI)

What is in this leaflet Lasix may also be used to lower high • no production or no passing of blood pressure (which is also called urine This leaflet answers some common ). • low blood pressure questions about Lasix oral medicines Everyone has blood pressure. This () (tablets, oral solution) and injections. pressure helps move your blood • low levels in your blood It does not contain all the available around your body. Your blood pressure may vary at different times • low levels in your information. It does not take the blood place of talking to your doctor or of the day, depending on how busy or pharmacist. worried you are. You have • hypertension (high blood pressure) All medicines have risks and • jaundice or history of jaundice when your blood pressure stays benefits. Your doctor has weighed in newborns or infants higher than is needed, even when you the risks of you taking this medicine • hepatic coma or precoma are calm and relaxed. against the benefits they expect it Do not take Lasix if you are If high blood pressure is not treated it will have for you. allergic to: can lead to serious health problems, If you have any concerns about including stroke, heart disease and • this medicine or any of the taking this medicine, ask your . ingredients listed at the end of doctor or pharmacist. this leaflet Lasix may be taken alone or in Keep this leaflet with the medicine. combination with other medicines to • medicines called sulfonamides You may need to read it again. treat your condition. (eg. some types of which are also referred to as Your doctor may have prescribed 'sulfur antibiotics') or Lasix for another purpose. sulfonylureas which are What Lasix is used for Ask your doctor if you have any medicines which can be used to questions about why it has been treat diabetes prescribed for you. Lasix contains furosemide Some symptoms of an allergic (frusemide), which belongs to a This medicine is only available with reaction include skin rash, itching, family of drugs called . A a doctor's prescription. shortness of breath or swelling of the helps reduce the amount of This medicine is not addictive. face, lips or tongue, which may cause excess fluid in the body by increasing difficulty in swallowing or breathing. the amount of urine produced. Do not take Lasix if you are Lasix is used to treat swelling of the pregnant. ankles, feet, legs or even the brain or Before you take it Do not take Lasix if you are breast- lungs. This swelling is called oedema feeding or planning to breast-feed. and can occur in some heart, lung, When you must not take it liver or kidney conditions. The active drug, furosemide Do not take Lasix if you have: (frusemide), passes into breast milk Lasix may be used in some patients and there is a possibility your baby with more serious kidney problems • certain liver and kidney may be affected. who may have some fluid retention. problems Do not take it after the expiry date (EXP) printed on the pack.

LASIX® AND LASIX® HIGH DOSE 1 If you take it after the expiry date has • Systemic Lupus Erythematosus • theophylline, a medicine used to passed, it may not work as well. (SLE), a disease affecting the treat asthma Do not take Lasix if the packaging skin, joints and kidneys • certain antibiotics, especially is torn or shows signs of Tell your doctor if you are on a salt and tampering. restricted diet. If you have not told your doctor • amphotericin, a medicine used to Before you start to take it about any of the above, tell them treat fungal infections Tell your doctor if you have before you take Lasix. • , medicine used to allergies to: treat epilepsy, to produce Taking other medicines • any of the ingredients listed at calmness, or to help you sleep the end of this leaflet Tell your doctor or pharmacist if • narcotic/strong pain killers such • any other medicines called you are taking any other as and medicines, including any that you sulfonamides or sulfonylureas • insulin and tablets used to treat buy without a prescription from diabetes • any other substances, such as your pharmacy, supermarket or foods, preservatives or dyes. health food store. • , a medicine used to treat stomach ulcers Tell your doctor if you are Some medicines should not be taken pregnant or intend to become with Lasix. This includes large • medicines such as pregnant. amounts of laxatives. or Like most medicines of this kind, Some medicines may interfere with • corticosteroids such as cortisone, Lasix is not recommended to be used Lasix. These include: prednisone or dexamethasone during pregnancy. If there is a need • medicines used to treat thyroid to consider Lasix during your • certain other fluid tablets or conditions pregnancy, your doctor will discuss diuretic medicines the risks and benefits of taking it if • medicines used to treat high • risperidone, an you are pregnant. blood pressure and some other medication used to schizophrenia Tell your doctor if you are breast- heart conditions, especially ACE • medicines used during scans to feeding or planning to breast-feed. inhibitors or angiotensin see the images of your body antagonists Lasix passes into breast milk and These medicines may be affected by there is a possibility your baby may • and other medicines used Lasix, or may affect how well it be affected. Your doctor will discuss to treat works. You may need to use different the risks and benefits of taking it if • non-steroidal anti-inflammatory amounts of your medicine, or take you are breast-feeding or planning to drugs (NSAIDs) and , different medicines. Your doctor or breast-feed. medicines used to relieve pain, pharmacist will advise you. Tell your doctor if you have or swelling and other symptoms of You should not eat large amounts of have had any medical conditions, inflammation, including arthritis liquorice when you are taking Lasix. especially the following: • methotrexate, a medicine used to Your doctor or pharmacist has more • liver problems treat arthritis and some types of information on medicines to be cancer careful with or to avoid while taking • kidney problems • probenecid, a medicine used to Lasix. • heart problems treat • high levels • medicines used to relax muscles • asthma before or during surgery How to take it • diabetes • , a medicine used to treat mood swings and some types of • gout, a disease with painful, How much to take swollen joints depression Follow the directions given to you • passing less urine than is • medicines used in emergency by your doctor and pharmacist normal for you situations such as adrenaline (epinephrine) and noradrenaline carefully. • difficulty passing urine (norepinephrine) These directions may differ from the • no production or no passing of • cisplatin, a medicine used to treat information contained in this leaflet. urine cancer • prostate problems

LASIX® AND LASIX® HIGH DOSE 2 Ask your doctor or pharmacist if Lasix may increase the amount of If you take too much you are unsure of the correct dose urine you pass, it will also increase (overdose) for you. the number of times you need to go to the toilet. By taking your last dose Immediately telephone your They will tell you exactly how much doctor, or the Poisons Information to take. around 2:00 pm, there may be less chance that your sleep is disturbed. Centre (telephone Australia 13 11 Follow the instructions they give 26 or New Zealand 0800 POISON you. If you take the wrong dose, Injections: or 0800 764766), or go to Accident Lasix may not work as well and Lasix Injections are normally given and Emergency at your nearest your problem may not improve. by doctors or nurses in hospital. hospital, if you think you or If you are not sure when to receive it, anyone else may have taken too How to take it ask your doctor or pharmacist. much Lasix. Tablets or oral solution: Do this even if there are no signs of How long to take it discomfort or poisoning. Take Lasix tablets with a glass of water. Oedema: You may need urgent medical attention. You can take Lasix oral solution with Continue taking your medicine for water. as long as your doctor tells you. If you take too much Lasix, you may feel confused, dehydrated, dizzy or Injections: The medicine helps control your you may pass excessive urine. Lasix injections are normally condition and lowers the fluid build administered to you by doctors or up in your body. nurses in hospital. Hypertension: Continue taking your medicine for While you are using it When to take it as long as your doctor tells you. Tablets or oral solution: The medicine helps control your Things you must do blood pressure, but it does not cure it. Lasix tablets or oral solution are Tell all the doctors, dentists and Continue taking the medicine until usually taken once or twice a day. pharmacists who are treating you your doctor tells you to stop. Take Lasix tablets or oral solution that you are taking Lasix. Ask your doctor or pharmacist if on an empty stomach. For If you are about to be started on you are not sure how long to take example, one hour before food or any new medicine, tell your doctor the medicine for. two hours after food. and pharmacist that you are taking Food can interfere with their Lasix. If you forget to take it absorption. If you plan to have a surgery that Take Lasix tablets or oral solution Do not try to make up for missed needs a general anaesthetic, tell at about the same time each day doses by taking more than one dose your doctor or dentist that you are unless your doctor tells you at a time. taking this medicine. otherwise. This may increase the chance of Your blood pressure may drop Taking your medicine at the same getting an unwanted side effect. suddenly. time each day will have the best If it is almost time for your next If you become pregnant while you effect. It will also help you remember dose, skip the dose you missed and are taking this medicine, tell your when to take the medicine. take the next dose when you are doctor or pharmacist immediately. meant to. If your doctor prescribes Lasix Tell your doctor if you have tablets or oral solution to be taken If there is still a long time to go excessive vomiting or diarrhoea once a day, it is best done in the before your next dose, take it as while taking Lasix or if you morning, for example, before soon as you remember, and then go experience any of the following breakfast. back to taking it as you would symptoms: normally. If you are taking Lasix tablets or • dry mouth or thirst oral solution more than once a day, If you are not sure what to do, ask • fainting take your first dose immediately your doctor or pharmacist. • weakness, tiredness or before breakfast and take your last If you have trouble remembering drowsiness dose around 2:00 pm (on an empty when to take your medicine, ask stomach), unless your doctor tells your pharmacist for hints. • muscle pain or cramps you otherwise. • fast heart beat

LASIX® AND LASIX® HIGH DOSE 3 • passing less urine than normal Be careful driving or operating and fish. Also eat less fat and If you experience these symptoms, machinery until you know how sugar you may be dehydrated because you Lasix affects you. • exercise - regular exercise helps are losing too much water. Diuretic medicines may cause reduce blood pressure and helps Make sure you drink enough water dizziness or light-headedness in some the heart get fitter, but it is during any exercise and during hot people. Make sure you know how important not to overdo it. weather when you are taking you react to your medicine before Walking is a good exercise, but Lasix, especially if you sweat a lot. you drive a car, operate machinery, try to find a route that is fairly or do anything else that could be flat. Before starting any exercise, If you do not drink enough water dangerous if you are dizzy or light- ask your doctor about the best while taking Lasix, you may feel headed. kind of program for you faint or light-headed or sick. This is because your blood pressure is If this occurs do not drive. • salt - if you have high blood dropping suddenly and you are If you drink or take strong pressure, your doctor may advise dehydrating. If you continue to feel painkillers, dizziness or light- you to watch the amount of salt in unwell, tell your doctor. headedness may be worse. your diet. To reduce your salt intake you should avoid using salt If you are about to have any blood The effects of alcohol could be in cooking or at the table tests, tell your doctor that you are made worse while taking Lasix. It taking Lasix. is not recommended that you drink • smoking - your doctor may advise alcohol while taking Lasix. you to stop smoking or at least to There may be some interference with cut it down the results of these tests. There are two Lasix Oral Solution formulations available. • weight - your doctor may suggest If you are taking Lasix to treat that you lose some weight to help Lasix oral solution (not requiring high blood pressure, make sure lower your blood pressure and refrigeration) contains you have your blood pressure help lessen the amount of work (alcohol) 0.5g per 5ml dose, which is checked when your doctor says to your heart has to do. Some people equivalent to 12.7ml of beer or 5.3ml make sure Lasix is working may need a dietician's help to lose of wine per 5ml dose. properly. weight. If you are taking Lasix for a long Talk to your doctor or pharmacist Things you must not do period of time, you should check about these measures and for more with your doctor to determine Do not give this medicine to anyone information. else, even if they have the same whether or not you should eat condition as you. more potassium-containing foods or take potassium supplements. Do not use this medicine to treat However, increasing the amount of any other complaints unless your potassium in your diet may not be Side effects doctor tells you to. necessary and could be harmful. All medicines have some unwanted Do not stop taking Lasix, or Check with your doctor. change the dosage, without side effects. Sometimes they are Lasix may cause your skin to checking with your doctor. serious, but most of the time they are become more sensitive to the sun. not. Your doctor has weighed the If this happens you should take Things to be careful of risks of using this medicine against care to wear protective clothing the benefits they expect it will have If you feel light-headed, dizzy or including a hat and sun block when for you. faint, get up slowly when getting you are outside. Do not be alarmed by this list of out of bed or standing up. possible side effects. You may feel light-headed or dizzy Things that may help your You may not experience any of them. when you begin to take Lasix. This is condition Tell your doctor or pharmacist as because your blood pressure is Some self-help measures suggested soon as possible if you do not feel falling suddenly. Standing up slowly, below may help your condition. especially when you get up from well while you are taking Lasix. • Alcohol - your doctor may advise beds or chairs, will help your body Lasix helps most people with high you to limit your alcohol intake get used to the change in position and blood pressure or fluid retention, but blood pressure. If this problem • diet - eat a healthy diet which it may have unwanted side effects in continues or gets worse, talk to your includes plenty of fresh a few people. doctor. vegetables, fruit, bread, cereals

LASIX® AND LASIX® HIGH DOSE 4 Tell your doctor if you notice any • gout, a disease with painful, information in this leaflet, discuss of the following and they worry swollen joints them with your doctor or you: • deafness or ringing in the ears pharmacist. • very dry mouth or unusual thirst These may be serious side effects of Storage • weight loss Lasix. You may need urgent medical Keep your Lasix tablets or oral • weakness or tiredness attention. Serious side effects are uncommon. solution in the bottle until it is time • numbness or tingling in the hands to take them. and/or feet If any of the following happen, tell your doctor immediately or go to If you store your Lasix tablets or oral • calf muscle spasms Accident and Emergency at your solution out of the container they • muscle pains or cramps nearest hospital: may not keep well. • restlessness • sudden signs of allergy such as Keep your Lasix tablets in a cool • drowsiness or a lack of energy rash, itching or hives (pinkish, dry place where the temperature itchy raised areas) on the skin, stays below 25°C. • dizziness or light-headedness swelling of the face, lips, tongue There are two Lasix Oral Solution • headache or other parts of the body, formulations available. Refer to • fever shortness of breath, wheezing or product label for instructions trouble breathing • vomiting or nausea regarding storage conditions. Do • chest pain not store Lasix or any other • diarrhoea medicine in the bathroom, near a • fainting or having a rapid, weak • blurred or impaired vision sink, or on a windowsill. pulse • unusual bleeding or bruising Do not leave it in the car. • lockjaw under the skin Heat and damp can destroy some • red, often itchy spots similar to • ringing or buzzing in the ears medicines. the rash seen with measles which • confusion starts on the limbs and sometimes Keep it where children cannot These are more common side effects on the face and body. The spots reach it. of Lasix. Mostly they are mild or may blister and may progress to A locked cupboard at least one-and- short-lived. form raised red, pale-centred a-half metres above the ground is a marks. Those affected may have Tell your doctor as soon as possible good place to store medicines. fever, sore throat, headache with if you notice any of the following: Lasix injection is usually stored in or without diarrhoea • irregular or fast heart beat the pharmacy or on the ward. The • yellowing of the skin and/or eyes injection is kept in a cool dry place, • passing less urine than is normal (jaundice) protected from light, where the for you These are serious side effects. You temperature stays below 25°C. • severe stomach pain, often with may need urgent medical attention or nausea or vomiting hospitalisation. These side effects are Disposal • severe dizziness or a spinning very rare. If your doctor tells you to stop sensation Tell your doctor or pharmacist if taking Lasix or the medicine has • increased sensitivity to sunlight you notice anything else that is passed its expiry date, ask your • flaking or peeling of the skin making you feel unwell. pharmacist what to do with any that is left over. • symptoms of anaemia such as Other side effects not listed above tiredness, being short of breath may occur in some people. Return any unused medicine to when exercising, dizziness and Ask your doctor or pharmacist to your pharmacist. looking pale answer any questions you may • frequent infections such as fever, have. severe chills, sore throat or mouth ulcers Product description • bleeding or bruising more easily What it looks like than normal, nose bleeds After using it Lasix M 20 mg tablets: white round • loss of control of your bladder or If you have any queries about any tablets, marked with "DLF" on one bowels (incontinence) aspect of your medicine, or any questions regarding the

LASIX® AND LASIX® HIGH DOSE 5 side. These are supplied in bottles of potassium sorbate, polysorbate 80, Lasix 40 mg/4 mL injection*: AUST 50 tablets. butylated hydroxytoluene, butylated R 76767 Lasix 40 mg tablets: yellow round hydroxyanisole, ethanol, tetrarome Lasix High Dose 250 mg/25 mL tablets, marked with "Lasix®" and orange 987431, yellow, injection: AUST R 12408 purified water. "40" on one side and the Hoechst *Not available in New Zealand logo on the other side. These are Lasix oral solution (not requiring supplied in bottles of 100 tablets. refrigeration) contains ethanol Lasix oral solution: a clear, yellow (alcohol) 0.5g per 5ml dose, which is The following products are available liquid with the odour and taste of equivalent to 12.7ml of beer or 5.3ml in New Zealand : orange. It is supplied in a glass, of wine per 5ml dose. It also contains Lasix oral solution 10 mg/ mL sorbitol, , sodium hydroxide, amber-coloured bottle of 30 mL. Lasix High Dose 250 mg/25 mL methyl hydroxybenzoate, propyl Lasix injection is a clear, colourless injection hydroxybenzoate, ethanol, quinoline liquid presented in a glass, amber- yellow, sunset yellow FCF, orange coloured ampoule. It is supplied in flavour (P.I. No. 106046), purified This leaflet was prepared in packs of 5 ampoules of 2 mL or 4 water. September 2017 mL solution. Lasix injections also contain sodium lasix-ccdsv12-cmiv16-sep17 Lasix High Dose injection is a clear, chloride, sodium hydroxide and colourless liquid presented in a glass, ® Registered Trademark water for injections. Contains 0.16 amber-coloured ampoule. It is mmol/mL of sodium. supplied in packs of 5 or 6 ampoules of 25 mL solution. Lasix High Dose injections also contain , sodium hydroxide Ingredients and water for injections. Contains 0.03 mmol/mL of sodium. Active ingredient: Lasix M 20 mg tablets contain 20 mg Manufacturer/Sponsor furosemide (frusemide) per tablet. Lasix is supplied in Australia by: Lasix 40 mg tablets contain 40 mg -aventis australia pty ltd furosemide (frusemide) per tablet. 12-24 Talavera Road Lasix oral solution contains 10 mg/ mL furosemide (frusemide) (300 mg Macquarie Park NSW 2113 in 30 mL solution). Lasix and Lasix High Dose injections Lasix is supplied in New Zealand by: contain 10 mg/mL furosemide sanofi-aventis new zealand limited (frusemide) (20 mg in 2 mL, 40 mg in 4 mL, or 250 mg in 25 mL Level 8, 56 Cawley Street ampoules) Ellerslie, Auckland Inactive ingredients: Lasix M 20 mg tablets also contain Australian Register Numbers maize starch, lactose monohydrate, The following products are available colloidal anhydrous silica, purified in Australia: talc, stearate. Lasix M 20 mg tablets*: AUST R Lasix 40 mg tablets also contain 12409 maize starch, lactose monohydrate, Lasix 40 mg tablets*: AUST R colloidal anhydrous silica, purified 12406 talc, magnesium stearate, sunset yellow FCF, quinoline yellow Lasix oral solution (refrigerated) 10 aluminium lake. mg/ mL: AUST R 12405 There are two Lasix Oral Solution Lasix oral solution 10 mg/ mL: formulations available. AUST R 232815 Lasix oral solution (refrigerated) also Lasix 20 mg/2 mL injection*: AUST contains sorbitol, glycerol, sodium R 12404 hydroxide, methyl hydroxybenzoate,

LASIX® AND LASIX® HIGH DOSE 6