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LANOXIN™ Digoxin tablets 62.5μg, 250μg; paediatric elixir 50 μg/mL

Consumer Information

What is in this leaflet of breath and may get tired has passed it may not work as easily after light physical well. If the pharmacist has activity, such as walking. Some repacked the medicine for you, Please read this leaflet carefully patients may wake up short of there may not be an expiry date before you start using LANOXIN breath at night. Fluid may collect on the packaging. tablets or paediatric elixir. in different parts of the body, . often first noticed as swollen • Do not take LANOXIN tablets ankles and feet. or give LANOXIN paediatric This leaflet answers some elixir, if the packaging is common questions about LANOXIN contains the active torn or shows signs of LANOXIN. It does not contain all ingredient digoxin, which tampering, if the tablets look of the available information. belongs to a group of discoloured or damaged, or if called cardiac . the paediatric elixir looks cloudy It does not take the place of or discoloured. talking to your doctor or LANOXIN works by slowing pharmacist. down the rate of the so • Do not use LANOXIN if you that each heartbeat is more have any of the following heart All medicines have risks and effective at pumping blood. In problems: benefits. Your doctor has people with , it also weighed the expected benefits of helps to control the symptoms of • Irregular heart rhythms you taking LANOXIN against the tiredness, breathlessness and () caused by risks this medicine could have fluid retention. cardiac glycosides (drugs for you. used to treat heart problems) Use in children and the If you have any concerns about elderly • Certain types of taking this medicine, ask your supraventricular arrhythmias doctor or pharmacist. LANOXIN may be used in • or premature and full term babies, fibrillation Keep this leaflet with your infants and children. • Second degree or intermittent medicine. You may need to read complete heart block it again. It can also be used in elderly • Hypertrophic obstructive people, but because the elderly cardiomyopathy (an enlarged What LANOXIN is are more prone to the side heart muscle). effects of LANOXIN, it is usually used for used in smaller doses than in If you’re not sure whether you younger adults. should be using LANOXIN, talk to your doctor. LANOXIN is used in the treatment of chronic heart failure Before you take and/or and flutter LANOXIN Before you start to (irregular heart rhythms caused use LANOXIN by an electrical problem in the upper chambers of the heart). When you must not take Heart failure is a disease of the It You must tell your doctor if: heart which develops when the heart muscle cannot pump blood • Do not use LANOXIN, if you • You are pregnant or are strongly enough to supply all the have ever had an allergic planning to become pregnant. blood needed throughout the (hypersensitivity) reaction to body. digoxin or to any of the other LANOXIN may be used to treat ingredients in the LANOXIN heart failure and/or irregular Heart failure is not the same as formulations listed at the end of heart beats in pregnant women a heart attack and does not this leaflet. and babies. If you are prescribed mean that the heart stops. Heart LANOXIN during , failure may start off with no • Do not use LANOXIN after the your doctor will have weighed up symptoms but, as the condition expiry date (EXP) on the the expected benefits to you progresses, you may feel short packaging. If you use this and/or your baby against the medicine after the expiry date possible risks. 1

• You are breastfeeding or are Eryacne™, Eryc™, • Metoclopramide (Maxolon™, planning to breastfeed. Stiemycin™, Eromycin™, Metamide™, Paramax™), used EES™, E-Mycin™, ERA™), for (feeling sick) and Only a very small amount of (Doryx™, vomiting LANOXIN passes into Doxine™, Doxy-50™, Doxy- • (Asmol™, milk, so it may be possible for 100™, Minomycin™, Minotab Respolin™, Respox™, you to breastfeed, if your doctor 50™, Panmycin™, Helidac™) Salbuvent™, Salbuvent says it is all right to do so. • gentamicin (Gentamicin™) Forte™, Ventodisk™, • trimethoprim (TMP™, Ventolin™, Ventolin Forte™, • You have other illnesses, Triprim™, Apo-Sulfatrim™, Volmax™), used mainly to especially: Apo-Sulfatrim DS™, treat asthma and other breathing • Electrical problems in the Bactrim™, Septrin™, difficulties heart causing a slow heart Trimel™, Trisul™). • (Dilantin™), used to beat and/or absence of some • neomycin (Neosulf™) treat epilepsy heart beats • Anti-arrhythmic medicines used • Quinine (Q200, Q300, Quinoc- • A previous heart attack to treat irregular heartbeats, F, Quinoc-S), used to treat • problems including: malaria • Severe lung disease • (Cordarone™, • Adrenaline (Medihaler Epi™) • Low levels in Aratac™), used to treat breathing problems your blood (hypokalaemia) (Tambocor™), • Lithium (Lithicarb™, • Low magnesium levels in (Rytmonorm™), Priadel™), used to treat some your blood (Kinidin™) mental illnesses (hypomagnesaemia) • channel blockers, • Cholestyramine (Questran™), • High calcium levels in your used used to lower blood cholesterol blood () to treat high levels • Hypoxia (not enough oxygen in (hypertension), coronary artery • Indomethacin (Arthrexin™, your blood) disease (affecting blood vessels Indocid™, Indocid-R™, • An underactive or overactive in the heart muscle) and Rheumacin™, Rheumacin- thyroid gland irregular heart beats, including: R™), a non-steroidal • Digestion problems • (Civicor™, Civicor antiinflammatory Retard™, Isoptin™, Isoptin medicine used to • You are allergic to any foods, SR™, Verpamil™, Verpamil treat pain, inflammation and dyes, preservatives or any other SR™), felodipine (Agon ER™, stiffness medicines. Plendil ER™), nifedipine • Sulphasalazine (Colizine™, (Adalat Oros™, Adalat Colizine E™, Salazopyrin™, Taking other Retard™, Alpha-Nifedipine Salazopyrin-EN™) used to treat Retard™, Nyefax™, Nyefax some bowel problems Medicines Retard™), (Apo- • Alprazolam (Xanax™), used to Diltiazem™, Cardizem™, treat anxiety and depression Dilcard™, Dilzem™, Dilzem • Itraconazole (Sporanox™), Tell your doctor if you are taking LA™, Dilzem SR™), used to treat some types of any other medicines, including (Dynacirc™, fungal infection medicines you buy without a Dynacirc SRO™) • Propantheline (Pro- prescription from a pharmacy, • Alpha blockers, used to treat Banthine™), a muscle relaxant, supermarket or health food hypertension such as prazosin used in people with peptic shop. (Hyprosin™, Pratsiol™) ulcers, irritable bowel syndrome

• Antacids, used to treat and renal colic Tell your doctor if you are taking and heartburn • St John’s wort (also called any of the following medicines: • Bulk laxatives, used to treat ), a

constipation natural remedy for depression • , including • Some medicines used to stop (Aldactone™, diarrhoea, including kaolinpectin Your doctor or pharmacist will be Spirotone™), used to treat high and diphenoxylate with able to tell you more about what blood pressure (Diastop™, to do when taking LANOXIN • Corticosteroids, powerful anti- Lomotil™) tablets or paediatric elixir inflammatory medicines used to • Drugs known as angiotensin while you are taking other relieve inflammation converting enzyme (ACE) medicines. • Some antibacterial (antibiotic) inhibitors, used to treat high medicines used to treat blood pressure infections, including: • Medicines used to treat cancer • (EMU-V™,

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How to take LANOXIN LANOXIN paediatric elixir : The If it is almost time for the next usual is 25μg to dose of LANOXIN tablets or 45μg per kilogram of paediatric elixir, skip the missed Your doctor will tell you how bodyweight for the paediatric dose and take or give the next many LANOXIN tablets or how elixir. dose when you are meant to. much LANOXIN paediatric elixir Otherwise, take or give it as to give and how often. Your doctor will calculate the soon as you remember, then go dose according to the age and back to using it as you would Do not take or give an extra weight of the child. normally. LANOXIN dose. Do not take or give LANOXIN or any medicine If your child has been treated Do not take or give a double more often than you have been with LANOXIN within the past dose to make up for the one that told. two weeks, the doctor will you missed. prescribe amaller dose of Your doctor will calculate your LANOXIN than usual. If you take or give too LANOXIN dose according to much (overdose) your age, body weight and how The maintenance dose of well your kidneys are working. LANOXIN paediatric elixir for premature babies is usually 20% Immediately telephone your How much to take of the loading dose given in the doctor or Poisons Information first 24 hours. For full term Centre (0800 POISON or 0800 For adults and children over babies, infants and children up 764 766) or go to the accident and emergency department at 10 years of age: to 10 years, the maintenance dose is usually 25% of the your nearest hospital, if you think

loading dose given in the first 24 that you or anyone else may LANOXIN tablets and paediatric hours. have taken too much LANOXIN. elixir: Depending on your Do this even if there are no signs condition and how quickly your Your doctor may adjust your of poisoning or discomfort. heart failure and/or irregular child’s dose of LANOXIN Urgent medical attention could heartbeats need to be treated, according to his or her response be needed. you may be given a rapid to treatment, as well as blood or slow loading (bulk) dose of levels of digoxin, the active Keep telephone numbers for LANOXIN: ingredient in LANOXIN. these places handy.

The usual rapid loading dose is How to take it An overdose of LANOXIN may 750μg to 1500μg, taken as one cause symptoms similar to those dose. listed later under “”, LANOXIN tablets should be swallowed with a drink of water. and include abnormal potassium In elderly people and those likely levels in the blood, and slow to be very sensitive to the side LANOXIN paediatric elixir should be swallowed. A measuring and/or irregular heart rhythms. effects of LANOXIN, the total An overdose of LANOXIN can starting dose may be given in syringe or cup should be used, so you can measure the dose sometimes be fatal. smaller amounts six hours apart. correctly. If you are not sure what to do, The usual slow loading dose is contact your doctor or How long to take it 250μg to 750μg daily for one pharmacist. week. The length of time you need to After the loading dose, the usual take LANOXIN will depend on While you are taking maintenance (long term) dose is the reason why it has been LANOXIN 125μg to 750μg of LANOXIN prescribed for you. Many people daily. In elderly people and those need treatment with LANOXIN with poor kidney function, a dose lifelong. Things you must do as low as 62.5μg may be given. Do not stop taking LANOXIN Tell all doctors and pharmacists For newborn babies, infants without first talking to your involved in your health care that and children up to 10 years: doctor, or your underlying you are taking LANOXIN if you condition could worsen. are about to be started on any new medicines. If you forget to take it You must also tell your doctor or

3 pharmacist that you are taking Ask your doctor or pharmacist to sure LANOXIN is working safely LANOXIN before you start taking answer any questions you might for you. any medicines you buy from a have. pharmacy, health food shop or This is not a complete list of side supermarket. Be sure that your doctor knows effects. Ask your doctor or as soon as possible if you do not pharmacist if you have any Tell your doctor if you become feel well while you are taking questions about the side effects pregnant while taking LANOXIN. LANOXIN. of LANOXIN.

If you are taking LANOXIN If you think that LANOXIN is Tell your doctor if you notice tablets or giving the paediatric causing you to have an allergic anything else that is making you elixir, tell your doctor if, for any (hypersensitivity) reaction, TELL feel unwell, even if it is not on reason, you have not used the YOUR DOCTOR this list. medicine exactly as prescribed. IMMEDIATELY. Symptoms Otherwise your doctor may think include: Ask your doctor or pharmacist if that it is not working for you and • Severe skin rash, itching and you don’t understand something change your treatment hives on this list. unnecessarily. • Swelling of the face, lips, mouth or throat Do not be alarmed by this list of Tell your doctor if you feel that • Difficulty breathing or side effects. You may not LANOXIN is not helping your swallowing experience any of them. Your condition. • Fever doctor may reduce your • Low blood pressure (feeling LANOXIN dose if some of these Things you must not do faint or dizzy). side effects occur. The more common ones tend to If you are taking LANOXIN Tell your doctor if you notice any become less troublesome as tablets or giving paediatric elixir of the following: your treatment progresses. If to a child, do not stop using this • Loss of appetite anything worries you, please talk medicine or change the dose, • Nausea (feeling as if you are to your doctor. without first checking with your about to vomit), vomiting doctor. • Diarrhoea After taking LANOXIN • Weakness Do not give this medicine to • Feeling indifferent anyone else, even if their • Tiredness Storage symptoms seem similar to yours. • Headache • Visual disturbances Keep this medicine where young Do not use LANOXIN to treat • Depression children cannot reach it. A any other complaints unless your • Palpitations (irregular heart locked cupboard at least one doctor says to. beats) and a half metres off the ground • Confusion is a good place to store Things to be careful of • A general feeling of medicines. “unwellness” Do not drive or operate • Pains in the lower stomach Keep LANOXIN tablets in a cool, machinery until you know how (caused by lack of blood supply dry place away from light where LANOXIN affects you. As with or damage to the intestines) the temperature stays below many other medicines, • Skin rash 25°C. LANOXIN may cause • Unusual bleeding or bruising headache and tiredness in some • Breast enlargement in men Keep your LANOXIN tablets in people. their pack until it is time to take In both adults and children, them. If you take LANOXIN LANOXIN can cause new tablets out of their pack they Side-Effects irregular heart rhythms of a may not work as well. different type to those caused by atrial fibrillation (which LANOXIN All medicines can have Keep LANOXIN paediatric elixir is often used to treat). Your unwanted side effects. in a cool, dry place away from doctor may perform regular Sometimes they may be serious, light where the temperature checks on your blood levels but often they are not. You may stays below 25°C. of digoxin and body salts, as well need medical treatment if you as your kidney function, to make get some of these side effects. If you are using LANOXIN

4 paediatric elixir, always screw Lime flavour No 1, Purified water the lid on the bottle after taking or giving the medicine, otherwise Manufacturer it may not work as well. Your LANOXIN medicine is Disposal distributed by: Pharmacy Retailing (NZ) Limited If your doctor tells you to stop trading as Healthcare Logistics using LANOXIN tablets or 58 Richard Pearse Drive paediatric elixir, or your medicine Airport Oaks has passed its expiry date, ask Auckland your pharmacist what to do with New Zealand any leftover medicine. Further information Product description This is not all the information that is available on LANOXIN What LANOXIN looks like tablets and oral solution. If you have any more questions or are LANOXIN 62.5μg tablets are not sure about anything, ask blue, round, biconvex tablets your doctor or pharmacist. debossed “DO6”. They are packed in a bottle or blister pack. Your doctor and pharmacist are the best people to give you LANOXIN 250μg tablets are advice on the treatment of your white, round, biconvex tablet condition. You may also be able debossed “DO25”. They are to find general information about packed in a bottle or blister pack. your disease and its treatment from books in public libraries, or LANOXIN paediatric elixir is a on the Internet. clear, yellow, lime-flavoured, sweetened liquid. It comes in a Date of preparation 60ml bottle. Oct 2012 Ingredients

LANOXIN 62.5μg tablets contain Digoxin, Rice starch, Lactose, Maize starch, Maize starch (hydrolysed), Magnesium stearate, Povidone (K90), Indigo Carmine E132, Purified water

LANOXIN 250μg tablets contain Digoxin, Rice starch, Lactose, Maize starch, Maize starch (hydrolysed), Magnesium stearate, Purified water

LANOXIN paediatric elixir contains Digoxin, Methylhydroxybenzoate, Syrup, Anhydrous phosphate, Citric acid monohydrate, Quinoline yellow, Ethanol (96%), Propylene glycol

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