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MODURETIC® amiloride hydrochloride 5 mg/ 50 mg Consumer Medicine information (CMI)

What is in this leaflet around your body. Your blood pressure may be different at different times of the day, depending on how This leaflet answers some common Before you take it questions about MODURETIC. It busy or worried you are. You have does not contain all the available or high blood pressure information. when your blood pressure stays When you must not take it higher than is needed, even when you Do not take MODURETIC if you It does not take the place of talking to are calm and relaxed. your doctor or pharmacist. have ever had an allergic reaction There are usually no symptoms of to: All medicines have risks and hypertension. The only way of benefits. Your doctor has weighed  amiloride hydrochloride knowing that you have hypertension the risks of you taking is to have your blood pressure  hydrochlorothiazide, MODURETIC against the benefits checked on a regular basis. If high or sulfur medicines they expect it will have for you. blood pressure is not treated it can Hydrochlorothiazide is a sulfur- If you have any concerns about lead to serious health problems. You containing medicine (a taking this medicine, ask your may feel fine and have no symptoms, sulfonamide). Therefore, if you doctor or pharmacist. but eventually hypertension can are allergic to sulfur medicines, Keep this leaflet with the medicine. cause stroke, heart disease and such as some antibiotics, you are . likely to be allergic to You may need to read it again. The combination of active MODURETIC. ingredients in MODURETIC work Check with your doctor or by making your kidneys pass more pharmacist if you are not sure What MODURETIC is water and salt whilst minimizing whether you are allergic to used for loss. This helps reduce sulfur medicines. high blood pressure and some forms  any of the ingredients listed at the of swelling, while at the same time MODURETIC contains a end of this leaflet. helping to maintain normal levels of combination of two , Symptoms of an allergic reaction amiloride hydrochloride and potassium in your blood. may include shortness of breath, Ask your doctor if you have any hydrochlorothiazide as the active wheezing or difficulty in breathing; ingredients. questions about why this medicine swelling of the face, lips, tongue or has been prescribed for you. MODURETIC is used to help reduce any other parts of the body; rash, the amount of excess fluid in the Your doctor may have prescribed it itching or hives on the skin. body for people who have: for another purpose. Do not take MODURETIC if you  oedema, swelling of the ankles, This medicine is only available with are pregnant or intend to become feet and legs a doctor's prescription. pregnant unless you and your  due to disease There is no evidence that it is doctor have discussed the risks and resulting in fluid accumulation in addictive. benefits involved. the stomach area. It may affect your developing baby if MODURETIC is also used to help you take it during pregnancy. people with hypertension or high Do not take MODURETIC if you blood pressure. are breast-feeding or intend to Everyone has blood pressure. This breast-feed. pressure helps get your blood all

MODURETIC® 1 This medicine can pass into breast Taking other medicines Your doctor or pharmacist has more milk and therefore may harm the information on medicines to be Tell your doctor if you are taking baby. careful with or to avoid while taking any other medicines, including MODURETIC. Do not take MODURETIC if: medicines that you buy without a  you have kidney disease prescription from your pharmacy, supermarket or health food shop.  your doctor advises you that you have too much potassium in your Some medicines and MODURETIC How to take it blood may interfere with each other. These include:  you are taking medicines which How much to take can increase the amount of  potassium tablets or other Your doctor will tell you how many potassium in the blood or you are potassium-conserving medicines tablets you need to take each day. eating a potassium-rich diet.  ACE inhibitors, medicines used This depends on your condition and MODURETIC helps maintain to treat high blood pressure whether you are taking other normal levels of potassium in  other medicines used to treat high medicines. Your initial dose will be your blood. If you are taking blood pressure maintained or adjusted until a potassium tablets or supplements,  other fluid tablets (diuretics) other potassium-conserving satisfactory response is noted, but should not exceed 4 tablets per day. medicines or a potassium-rich  , used to treat diet, your potassium levels may  , used to treat severe mood Follow all directions given to you increase too much. swings and some types of by your doctor and pharmacist carefully. Ask your doctor or pharmacist depression if you are not sure whether you  non-steroidal anti-inflammatory They may differ from the are taking any of these. medicines (NSAIDs), used to information contained in this leaflet. Do not give MODURETIC to a treat inflammation, pain and When to take it child. arthritis The safety of MODURETIC in  steroid medicines such as If you are taking a single dose a children has not been established. cortisone, prednisone day, take it in the morning. If you are taking more than one dose a Do not take MODURETIC if the  insulin and tablets used to treat day, take the last dose in the early packaging is torn or shows signs of evening, unless your doctor tells tampering.  cyclosporin and tacrolimus, you otherwise. Do not take this medicine after the medicines used to suppress the MODURETIC may increase the expiry date printed on the pack. immune system amount of urine you pass and the  , used to treat number of times you go to the toilet. Before you start to take it epilepsy, such as phenobarbitone By taking the last dose in the early Tell your doctor if you are allergic  strong pain killers such as evening there may be less chance of to any other medicines or any , , your sleep being disturbed. foods, dyes or preservatives. dextroproxyphene Take MODURETIC at about the Tell your doctor if you have or  cholestyramine and colestipol, same time each day, unless your have had any of the following used to treat high doctor tells you otherwise. medical conditions:  medicines used to relax muscles This will help you remember when to  high potassium levels in the blood before and during surgery take the tablets.  diabetes  medicines used in emergency How long to take it  liver disease situations such as adrenaline Continue taking MODURETIC for  kidney disease  . as long as your doctor tells you.  heart and lung disease These medicines may be affected by MODURETIC or may affect how If you have high blood pressure, this  high cholesterol well it works. You may need to take medicine helps to control this  gout different amounts of your medicine, condition but does not cure it.  asthma or you may need to take different Therefore MODURETIC must be medicines. taken every day.  lupus erythematosus.

MODURETIC® 2 If you have oedema or ascites, your dentist that you are taking Talk to your doctor or pharmacist doctor will tell you how long to take MODURETIC. about these measures and for more it. Tell any other doctor, dentist of information. pharmacist who is treating you  Alcohol If you forget to take it that you are taking MODURETIC, your doctor may advise you to If it is almost time for your next especially if you are about to be limit your alcohol intake. dose, skip the dose you missed and started on any new medicines.  Diet take your next dose when you are Tell your doctor if you become eat a healthy diet which includes meant to. Otherwise, take it as pregnant while taking plenty of fresh vegetables, fruit, soon as you remember and then go MODURETIC. back to taking your medicine as bread, cereals and fish. Also eat you would normally. Things to be careful of less fat and sugar.  Exercise Do not take a double dose to make Be careful driving or operating up for the dose that you missed. machinery until you know how this regular exercise helps to reduce medicine affects you. blood pressure. Try regular If you take too much walking, swimming, cycling or MODURETIC may cause dizziness (overdose) games such as tennis and golf. or light-headedness in some people, Before starting any exercise, ask Immediately telephone your doctor especially after the first few doses or your doctor about the best kind of or Poisons Information Centre on if the dose is increased. Make sure programme for you. 13 11 26 (Australia) or 0800 you know how you react to it before POISON or 0800 764 766 (New you drive a car, operate machinery or  Salt Zealand) for advice, or go to do anything else that could be your doctor may advise you to Accident and Emergency at your dangerous if you are dizzy or light- watch the amount of salt in your nearest hospital, if you think that headed. diet. To reduce your salt intake you or anyone else may have taken If you drink alcohol, or take strong you should avoid using salt in too much MODURETIC. Do this pain killers or barbiturates, dizziness cooking or at the table. even if there are no signs of and light-headedness may be worse.  Smoking discomfort or poisoning. Talk to your doctor about foods or your doctor may advise you to You may need medical attention. drinks that have a high potassium stop smoking or at least cut down. content.  Weight MODURETIC helps to maintain your doctor may suggest losing While you are taking it normal potassium levels in your some weight to help lower your body. However, if you eat foods or blood pressure. Some people have drinks that are high in Things you must do may need a dietician's help to lose potassium this may lead to an weight. Visit your doctor regularly for a increase of potassium in your body. blood pressure test so they can Too much potassium can be harmful, make sure that MODURETIC is therefore it is important to discuss working properly and to check for your diet with your doctor. Side Effects any unwanted side effects. Tell your doctor if you are being If you feel light-headed, dizzy or treated for diabetes. Tell your doctor as soon as possible faint when getting out of bed or MODURETIC may change how well if you do not feel well while you are standing up, get up slowly. your diabetes is controlled. Your taking MODURETIC. You may feel light-headed or dizzy doses of diabetic medicines, MODURETIC helps most people when you begin to take including insulin, may need to with high blood pressure or some MODURETIC. This is because your change. forms of swelling, but it may have blood pressure is falling suddenly. Things that would be helpful for unwanted side-effects in a few If this problem gets worse or your blood pressure people. All medicines can have side effects. Sometimes they are serious, continues, talk to your doctor. Some self-help measures suggested most of the time they are not. You below may help your blood pressure. If you plan to have surgery (even may need medical treatment if you at the dentist) that needs a general get some of the side effects. anaesthetic, tell your doctor or

MODURETIC® 3 Ask your doctor or pharmacist to  shortness of breath A locked cupboard at least one-and- answer any questions you may  pinkish, itchy swellings on the a-half metres above the ground is a have. skin, also called hives or good place to store medicines. Tell your doctor if you notice any nettlerash Disposal of the following and they worry  severe skin reaction which starts you: with painful red areas, then large If your doctor tells you to stop  nausea, , loss of appetite blisters and ends with peeling of taking MODURETIC or the tablets have passed their expiry  diarrhoea, constipation, stomach layers of skin. This is date, ask your pharmacist what to pain, wind accompanied by fever and chills, aching muscles and generally do with any that are left over.  dry mouth, thirst feeling unwell  dizziness or lightheadedness  vomiting blood or material that  weakness, drowsiness looks like coffee grounds Product description  restlessness  bleeding from the back passage, black, sticky bowel motions  transient blurred vision or yellow What it looks like vision (stools) or bloody diarrhoea MODURETIC is a peach diamond-  passing less urine than normal.  chest pain or tightness. shaped compressed tablet. Tell your doctor immediately if These are serious side effects. You Available in packs of 50 tablets. you notice any of the following: may need urgent medical attention or hospitalisation. These side effects are  muscle cramps rare. Ingredients  severe dizziness, spinning Tell your doctor if you notice Active ingredients: sensation anything else that is making you Each MODURETIC tablet contains  fainting feel unwell, even if you think the amiloride hydrochloride 5 mg and  signs of frequent infections such problems are not connected with hydrochlorothiazide 50 mg. this medicine and are not referred as fever, severe chills, sore throat Inactive ingredients: or mouth ulcers to in this leaflet.  calcium phosphate  bruising or bleeding more easily Other side effects not listed above than normal, nose bleeds may also occur in some patients.  lactose  tiredness, headaches, being short Do not be alarmed by this list of  starch-pregelatinised maize of breath when exercising, possible side effects.  starch-maize looking pale You may not experience any of them.  guar gum  yellowing of the skin and/or eyes,  stearate also called jaundice  sunset yellow FCF CI15985.  numbness or tingling in the hands or feet After taking it MODURETIC tablets do not contain sucrose, gluten or tartrazine.  skin rash, itchiness Storage  changes in the way your heart beats. Keep your tablets in the blister pack until it is time to take them. These may be serious side effects. Sponsor You may need urgent medical Keep it in a cool dry place where attention. the temperature stays below 30°C. In Australia: Serious side effects are rare. Do not store it or any other Aspen Pharmacare Australia Pty Ltd medicine in the bathroom or near a If any of the following happen, stop 34-36 Chandos St sink. Do not leave it in the car or taking MODURETIC and tell your St Leonards NSW 2065 on window sills. doctor immediately or go to

Accident and Emergency at your Heat and dampness can destroy some nearest hospital: medicines. In New Zealand:  swelling of the face, lips, mouth, Keep it where children cannot Pharmacy Retailing (NZ) Limited throat or tongue which may cause reach it. t/a Healthcare Logistics difficulty swallowing or breathing

MODURETIC® 4 58 Richard Pearse Drive Airport Oaks Auckland

Australian Registration Number: AUST R 10499

This leaflet was revised in January 2012

MODURETIC® 5