Amizide contains the active ingredients and amiloride hydrochloride CONSUMER MEDICINE INFORMATION

What is in this leaflet whilst retaining . This Some of the symptoms of an allergic helps reduce high blood pressure and reaction may include skin rash, This leaflet answers some common some forms of swelling, while at the itching or hives, swelling of the face, questions about Amizide. same time helping to maintain lips or tongue which may cause normal levels of potassium in your difficulty in swallowing or breathing, It does not contain all of the available blood. wheezing or shortness of breath. information. It does not take the place of talking to your doctor or Amizide may be taken alone or in Do not take Amizide if you have: pharmacist. combination with other medicines to · certain kidney problems treat your condition. All medicines have benefits and · no production of urine Your doctor may have prescribed risks. Your doctor has weighed the · high potassium levels in your risks of you taking Amizide against Amizide for another reason. Ask your doctor if you have any questions blood (hyperkalaemia), possibly the benefits they expect it will have due to a high potassium diet, for you. about why Amizide has been prescribed for you. taking potassium supplements, or If you have any concerns about other potassium-sparing taking this medicine, talk to your Amizide is available only with a medication. doctor or pharmacist. doctor©s prescription. There is no evidence that Amizide is addictive. Amizide helps maintain normal Keep this leaflet with your medicine. levels of potassium in your blood. If You may need to read it again. you are taking potassium tablets or supplements, other potassium- conserving medicines or a potassium Before you take rich diet, your potassium levels may Amizide What Amizide is used increase too much. for Ask your doctor or pharmacist if When you must not take it you are not sure whether you are Amizide is used for: Do not take Amizide if you are taking too much potassium. · oedema, swelling of the ankles, allergic to medicines containing Do not take Amizide if you are feet and legs either amiloride or pregnant or intend to become hydrochlorothiazide or any of the · due to disease pregnant unless you and your ingredients listed at the end of this resulting in fluid accumulation in doctor have discussed the risks and leaflet. the stomach area benefits involved. Do not take Amizide if you are · lower high blood pressure Like most medicines, allergic to medicines which contain (). Amizide is not recommended for use sulfur (sulfonamides). during pregnancy. Amizide contains a combination of Hydrochlorothiazide, one of the two , amiloride Do not take Amizide if you are active ingredients of Amizide, is a hydrochloride and breastfeeding or plan to sulfur containing medicine. hydrochlorothiazide as the active breastfeed. Therefore, if you are allergic to ingredients. It helps reduce the sulfur medicines, such as some Amizide passes into breast milk and amount of excess fluid in the body by antibiotics, you are likely to be may affect your baby. increasing the amount of urine allergic to Amizide. If you are not Do not take Amizide if the expiry produced, while at the same time, sure if you have an allergy to date (Exp.) printed on the pack has minimizing potassium loss. medicines, check with passed. Amizide works by making your your doctor or pharmacist. Do not take Amizide if the kidneys pass more water and salt packaging shows signs of

AMIZIDE 1 tampering or the tablets do not · cyclosporin, tacrolimus, How to take Amizide look quite right. medicines used to suppress the immune system Do not give Amizide to children. How much to take The safety of Amizide in children has · , a medicine used in the The usual dose is one or two tablets not been established. treatment of mood swings and some types of depression daily. Before you start to take it · non-steroidal anti-inflammatory Your doctor may advise you to take a drugs (NSAIDs) such as different dose. This depends on your Tell your doctor if you are allergic , naproxen, diclofenac, condition and whether or not you are to any other medicines, foods, dyes indomethacin, medicines used to taking any other medicines. Your or preservatives. relieve pain, swelling and other initial dose will be maintained or Tell your doctor if you have, or symptoms of inflammation adjusted until a satisfactory response have had, any medical conditions, including arthritis is noted, but should not exceed 4 especially the following: tablets per day. · such as · phenobarbitone, and Your doctor may increase your dose · kidney problems , medicines used to if necessary. No more than four treat epilepsy tablets a day should be taken. · liver problems · strong pain killers such as Follow all directions given to you · heart and lung problems , and by your doctor and pharmacist · asthma carefully. · gout or hyperuricaemia · insulin and tablets used to treat They may differ from the · systemic lupus erythematosus diabetes information contained in this leaflet. · high levels. · steroid-based medicines such as How to take Amizide Your doctor may want to take special prednisone, dexamethasone Swallow the tablets with a glass of care if you have any of these · adrenaline, a medicine used in water. conditions. emergency situations such as an anaphylactic reaction If you have not told your doctor When to take Amizide about any of the above, tell them · cholestyramine, colestipol resins, before you start taking Amizide. medicines used to lower blood If you are taking Amizide once a cholesterol levels day, take it in the morning, for example, at breakfast time. Taking other medicines · medicines used to relax muscles Amizide takes about two hours to Tell your doctor if you are taking before and during surgery start working. any other medicines, including any · medicines used in emergency that you buy without a situations such as adrenaline If you are taking more than one prescription from a pharmacy, dose a day, take the last dose no · supermarket or health food shop. later than 6 p.m, unless your These medicines may be affected Some medicines may be affected by doctor tells you otherwise. by Amizide or may affect how well Amizide, or may affect how well it Amizide may increase the amount of it works. You may need to take works. These include: water (urine) you pass and also the different amounts of your number of times you go to the toilet. · preparations which contain medicine, or may need to take By taking the last dose no later than 6 potassium different medicines. p.m there may be less chance of your · potassium conserving medicines Your doctor can tell you what to do if sleep being disturbed. · converting enzyme you are taking any of these (ACE) inhibitors and angiotensin medicines. If you forget to take Amizide receptor antagonists, a group of If you are not sure whether you are If it is almost time for your next medicines used to treat high taking any of these medicines, dose, skip the dose you missed and blood pressure and some heart check with your doctor or take your next dose when you are conditions pharmacist. meant to. · other medicines to treat high Your doctor and pharmacist have Otherwise, take the missed dose as blood pressure more information on medicines to be soon as you remember, and then go careful with or avoid while taking back to taking your tablets as you Amizide. would normally.

AMIZIDE 2 Do not take a double dose to make · excessive or diarrhoea Be careful getting up from a sitting up for the dose you missed. · dry mouth, thirst or lying position. If you are not sure what to do, ask · weakness, tiredness, drowsiness Dizziness, lightheadedness or your doctor or pharmacist. fainting may occur, especially when · muscle pain or cramps If you have any questions about you get up quickly. Getting up · fast heart beat this, check with your doctor or slowly may help. If this problem gets pharmacist. · passing less urine than normal. worse or continues, talk to your doctor. You may be dehydrated from losing How long to take Amizide for too much water if you experience any Be careful when drinking alcohol or taking strong pain killers while It is important to take Amizide every of these symptoms. taking Amizide. day as it helps control your condition If you plan to have surgery, and lower the fluid build-up in your including dental surgery, which Combining Amizide with alcohol or body. needs a general anaesthetic, tell strong pain killers can make you more dizzy or lightheaded. Keep taking Amizide for as long as your doctor or dentist that you are your doctor recommends. taking Amizide. Be aware of foods or drinks that If you have to have any blood tests, have a high potassium content. If you take too much tell your doctor that you are taking Amizide helps to maintain normal Amizide (overdose) Amizide. potassium levels in your body. However, if you eat foods or have Immediately telephone your Amizide may affect the results of drinks that are high in potassium this doctor, or the Poisons Information some tests. may lead to an increase of potassium Centre (telephone 13 11 26), or go Visit your doctor regularly so they in your body. Too much potassium to Accident and Emergency at the can check on your progress. can be harmful, therefore it is nearest hospital, if you think you Your doctor may want to check your important to discuss your diet with or anyone else may have taken too blood pressure and potassium levels your doctor or pharmacist. much Amizide. Do this even if regularly to make sure Amizide is there are no signs of discomfort or Monitor your blood sugar levels working properly for you. poisoning. carefully if you are a diabetic. You may need urgent medical Things you must not do Amizide may change how well your attention. diabetes is controlled. Your doses of Do not stop taking Amizide, or If you take too much Amizide, you diabetic medicines, including insulin, change the dose, without checking may need to change. may feel thirsty, tired, confused, with your doctor. dizzy, nausea, vomiting, have muscle cramps and a very fast heart rate. Do not use Amizide to treat any Things that would be helpful other conditions unless your doctor for your blood pressure tells you to. Some self-help measures suggested Do not give Amizide to anyone else, below may help your blood pressure. even if they have the same While you are taking Talk to your doctor or pharmacist condition as you. Amizide about these measures and for more information. Things to be careful of Things you must do · Alcohol: your doctor may advise Be careful driving or operating Before starting any new medicine, you to limit your alcohol intake. machinery until you know how tell your doctor or pharmacist that Amizide affects you. · Diet: eat a healthy diet which you are taking Amizide. includes plenty of fresh Amizide may cause drowsiness, Tell all the doctors, dentists and vegetables, fruit, bread, cereals dizziness or lightheadedness in some pharmacists who are treating you and fish. Also eat less fat and people. If any of these occur, do not that you are taking Amizide. sugar. drive, operate machinery or do If you become pregnant while anything else that could be · Exercise: regular exercise helps taking Amizide, tell your doctor dangerous. Make sure you know how to reduce blood pressure. Try immediately. you react to it before you drive a car, regular walking, swimming, cycling or games such as tennis Tell your doctor if you have any of operate machinery or do anything and golf. Before starting any the following dehydration else that could be dangerous if you exercise, ask your doctor about symptoms: are dizzy or lightheaded.

AMIZIDE 3 the best kind of programme for Tell your doctor as soon as possible Other side effects not listed above you. if you notice any of the following: may also occur in some patients. · Salt: your doctor may advise you · very dry mouth or unusual thirst Tell your doctor if you notice anything that is making you feel to watch the amount of salt in · severe dizziness, spinning unwell. your diet. To reduce your salt sensation intake you should avoid using salt in cooking or at the table. · fainting · Smoking: your doctor may advise · muscle pain or cramps, swollen you to stop smoking or at least or painful joints After taking Amizide cut down. · numbness or tingling in the hands Storage · Weight: your doctor may suggest or feet losing some weight to help lower · irregular or very fast heart beat Keep Amizide where children your blood pressure. Some people · chest pain cannot reach it. may need a dietician©s help to lose · mental confusion A locked cupboard at least one-and- weight. a-half metres above the ground is a · pain when passing urine, loss of good place to store medicines. control of your bladder or bowels Keep your tablets in the bottle · yellowing of the skin or eyes until it is time to take them. Side effects (jaundice) If you take the tablets out of the · signs of frequent infections such bottle they may not keep well. Tell your doctor or pharmacist as as fever, severe chills, sore throat soon as possible if you do not feel or mouth ulcers Keep your tablets in a cool dry well while you are taking Amizide. place where the temperature stays · bruising or bleeding more easily Like all other medicines, Amizide below 30°C. than normal, nose bleeds may have unwanted side effects in Do not store Amizide or any other · changes in heart beat some people. Sometimes they are medicine in the bathroom or near a serious, most of the time they are not. Tell your doctor immediately or go sink. You may need medical treatment if to Accident and Emergency at the Do not leave Amizide in the car or you get some of the side effects. nearest hospital if you notice any of on window sills. the following: Do not be alarmed by this list of Heat and dampness can destroy some possible side effects. · rash, itching or hives medicines. You may not experience any of them. · severe skin reactions which starts Ask your doctor or pharmacist to with painful red areas, then large Disposal blisters and ends with peeling of answer any questions you may If your doctor tells you to stop layers of skin. This is have. taking Amizide, or your tablets accompanied by fever and chills, have passed their expiry date, ask Tell your doctor if you notice any aching muscles and generally your pharmacist what to do with of the following and they worry feeling unwell. you: any that are left over. · swelling of the face, lips, tongue · dizziness or light-headedness or other parts of the body, · drowsiness, lack of energy, shortness of breath, wheezing or weakness trouble breathing Product description · restlessness · fits or seizures · nausea, vomiting, change in · vomiting blood or material that What it looks like appetite looks like coffee grounds Amizide is a round, off-white, scored · diarrhoea or constipation · bleeding from the back passage, tablet marked H|A on one side and α · stomach discomfort or fullness black, sticky bowel motions on the reverse. (stools) or bloody diarrhoea. · passing wind Each pack contains 50 tablets. These are serious side effects. You · bad in the mouth, visual may need urgent medical attention disturbances, such as blurred Ingredients or hospitalisation. These side vision or yellow vision Amizide contains two active effects are rare. · passing less urine than normal. ingredients:

AMIZIDE 4 · hydrochlorothiazide 50 mg · amiloride hydrochloride 5 mg. The tablets also contain: · lactose · starch - wheat · povidone · starch glycollate · stearate.

Manufacturer Amizide is made in Australia by:

Alphapharm Pty Limited (ABN 93 002 359 739) Level 1, 30 The Bond 30 - 34 Hickson Road Millers Point NSW 2000 Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers: Amizide - Aust R 17702

This leaflet was prepared on 19 August 2013.

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AMIZIDE 5