Bydureon® - Better Health Channel
Contents
1. kit before beginning therapy Read the User Manual each time you get a new kit in case something has changed Refer to the User Manual each time you inject this medicine Use a new injection needle for each injection and dispose of it after each use This medicine is for you never share BYDUREON with others If you do not understand the User Manual ask your doctor or health care professional for help How much to use Each BYDUREON kit contains a single 2 mg dose The whole dose should be mixed with the diluent for each injection BY DUREON needs to be injected only once per week Use BYDUREON exactly as prescribed by your doctor When to use it Inject BYDUREON once a week at any time of the day with or without meals You may wish to choose a specific day of the week that will be your BYDUREON injection day How long to use it Do not stop using BY DUREON unless your doctor tells you to If you forget to use it If you miss a dose of BYDUREON you should take it as soon as you notice The next weekly dose can be taken on the preferred day of the week as long as it is at least one day after the last dose taken Do not take an extra dose or increase the amount of your next dose to make up for the one you missed If you are not sure if you have taken your entire dose do not inject another dose of BYDUREON Wait until your next weekly dose is due Ask your healthcare professional if you a2. Bydureon exenatide Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about BYDUREON It does not contain all the available information It does not take the place of talking to your doctor or pharmacist The information in this leaflet was last updated on the date shown on the final page More recent information on this medicine may be available Make sure you speak to your pharmacist nurse or doctor to obtain the most up to date information on this medicine All medicines have risks and benefits Your doctor has weighed the risks of you taking BY DUREON against the benefits they expect it will have for you If you have any concerns about taking this medicine consult your doctor or pharmacist Keep this leaflet with the medicine You may need to read it again What BYDUREON is used for BYDUREON is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus It is used with metformin or sulfonylureas It may also be used with a combination of metformin and sulfonylureas Bydureon Ask your doctor or healthcare professional if you are not sure whether your antidiabetic medicine contains sulfonylurea Diabetes mellitus is a condition in which your pancreas does not produce enough insulin to control your blood sugar level BY DUREON helps your body to increase production of insulin when your blood sugar is hi
3. N may reduce your appetite Nausea and vomiting were very commonly reported in patients using BY DUREON Mostly these were mild to moderate and short lived In most patients who initially experienced nausea the frequency and severity decreased with continued therapy You may experience dehydration as a result of nausea vomiting and or diarrhoea Some symptoms of mild to moderate dehydration are e dry mouth e decreased frequency of urination and concentrated urine e headache e muscle weakness e dizziness or light headedness Drink plenty of fluids if you are experiencing any of these symptoms Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you continue to experience these symptoms Tell your doctor immediately if you notice any of the following e passing little or no urine e taste disturbance or loss of taste e sleepiness or drowsiness e swelling of the face lips mouth tongue or throat which may cause difficulty in swallowing or breathing e stomach discomfort relieved by belching or passing wind e constipation e itching e hives pinkish itchy swellings on the skin itchy rash Bydureon e red raised skin rash e bleeding more easily than normal if you are taking warfarin These are rare or very rare side effects of BYDUREON The above list includes serious side effects which may require medical attention Tell your doctor immediately if you ar
4. ate has passed ask your pharmacist what to do with any medicine that is left over Product description What it looks like BYDUREON powder is white to off white The diluent is a clear colourless to pale yellow to pale brown liquid When mixed together the solution is white to off white and cloudy It is supplied in a kit containing a vial of exenatide powder a syringe of diluent solvent an adapter and 2 needles 1 spare Each kit contains dosing for 1 week of treatment as a single dose BYDUREON is available in packs of 4 single dose kits Ingredients The vial of BYDUREON contains 2 mg of exenatide as the active ingredient It also contains lactic glycolic copolymer and sucrose The syringe of diluent contains e carmellose sodium e sodium chloride e polysorbate 20 e sodium phosphate monobasic e sodium phosphate dibasic e water for injection Published by MIMS September 2014 4 Suppliers Supplied in Australia by AstraZeneca Pty Ltd ABN 54 009 682 311 Alma Road NORTH RYDE NSW 2113 Supplied in New Zealand by AstraZeneca Limited Auckland For all enquiries contact AstraZeneca by calling 1800 805 342 Australia or 09 306 5650 New Zealand Australian Registration Number The Australian Registration Number for BYDUREON 2 mg is AUST R 175504 Further information Your food and exercise plan along with your periodic blood sugar testing and scheduled A1C also known as HbA1C checks w
5. e experiencing any of the following e severe abdominal pain and e vomiting and or e diarrhoea and or e nausea These can be symptoms of acute pancreatitis which has been reported rarely in patients taking BYDUREON Do not be alarmed by this list of possible side effects You may not experience any of them Tell your doctor if you notice anything that is making you feel unwell Other side effects not listed above may also occur in some people After using BYDUREON Storage Keep your BYDUREON kits in the refrigerator where the temperature stays between 2 8 C Do not freeze Do not use BYDUREON if it has been frozen Keep this medicine where children cannot reach it Each BYDUREON kit contains one dose you should use the full dose each time you inject Use a new kit for each injection BYDUREON kits can be kept out of the refrigerator below 30 C for a total of 4 weeks Discard the used components including the needle of the BYDUREON kit immediately after use Ask your pharmacist how to discard the kit BYDUREON kits are for use in a single patient only Disposal Dispose of your syringe with the needle still attached into a yellow plastic sharps container or similar puncture proof container composed of hard plastic or glass Ask your doctor nurse or pharmacist where you can dispose of the container when it is full If your doctor tells you to stop using this medicine or the expiry d
6. gh BYDUREON is not a substitute for insulin in patients who require insulin treatments for their diabetes This medicine has not been studied in children This medicine is only available with a doctor s prescription Ask your doctor if you have any questions about why this medicine has been prescribed for you Before you use BYDUREON When you must not use it Do not use BYDUREON if e you have type 1 diabetes or diabetic ketoacidosis often caused by very high blood glucose levels e you are allergic to exenatide or any of the ingredients listed at the end of this leaflet e you have severe kidney problems or you are on dialysis Do not use BYDUREON after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering Return the product to your pharmacist if it has expired or is damaged Talk to your doctor if you are not sure whether you should start using BYDUREON Before you start to use it Tell your doctor if you have allergies to any other medicines foods preservatives or dyes Tell your doctor if you have or have had any of the following medical conditions e kidney problems e high blood pressure or other heart problems e high cholesterol and triglycerides a lipid disorder involving too many fatty acids in the blood stream e pancreatitis e gall stones e inflammation of the gall bladder cholecystitis e alcohol abuse Tell your doctor if you have
7. ia are e drowsiness Bydureon e weakness e confusion e irritability e hunger e fast heartbeat e sweating If you are experiencing any of these symptoms of hypoglycaemia immediately eat some sugary food or have a drink e g lollies biscuits or fruit juice Tell your doctor if you have trouble recognising the symptoms of hypoglycaemia Under certain conditions the early warning signs of hypoglycaemia can be different or less obvious Tell your doctor diabetes education nurse or pharmacist if you are travelling You may not be able to get BYDUREON in the country you are visiting Ask your doctor for a letter explaining why you are taking injecting devices with you Each country you visit will need to see this letter so you should take several copies Your doctor diabetes education nurse or pharmacist can provide you with some helpful information Things you must not do Do not stop using your medicine or change your dosage unless your doctor tells you to Do not use the medicine if you think it has been frozen or exposed to excessive heat It will not work as it should Do not use this medicine to treat any other complaints unless your doctor tells you to Do not give your medicine to anyone else even if they have the same condition as you Things to be careful of Tell your doctor if you drink alcohol Alcohol may mask the symptoms of hypoglycaemia or make it worse Be caref
8. icines may affect your kidneys e orlistat a weight loss medicine e opioids a narcotic commonly used as a pain killer e anticholinergics a type of medicine used to relieve stomach cramps or spasms to treat travel sickness and to treat Parkinson s disease e when using BYDUREON in combination with sulfonylureas you may need to adjust the dose of the sulfonylurea to avoid hypoglycaemia Bydureon e use of BYDUREON with insulins or other GLP 1 agonists e g BYETTA is not recommended Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine How to use BYDUREON Carefully follow all the directions given to you by your doctor or health care professional They may differ from the information contained in this leaflet The BYDUREON kit includes a vial of powder a syringe of diluent an adaptor and 2 needles 1 spare How to use it BYDUREAON is a powder that must be mixed with a diluent solvent before use Only mix BYDUREON with the diluent if the diluent is clear and free of particles Once you have mixed BYDUREON with the diluent the mixture should be white to off white and cloudy BYDUREON must be injected immediately after mixing with the diluent BYDUREON comes as kit containing a vial and syringe Your health care professional should teach you how to use the BYDUREON kit Read the User Manual for information on how to use the BYDUREON
9. ill continue to be important in managing your diabetes while you are taking BYDUREON You can get more information about diabetes from Diabetes Australia e free call helpline 1300 136 588 e www diabetesaustralia com au Diabetes New Zealand e toll free helpline 0800 342 238 e www diabetes org nz This leaflet was prepared in May 2014 BYDUREON is a registered trademark of the AstraZeneca group of companies Bydureon Published by MIMS September 2014 5
10. re not sure what to do If you have trouble remembering to use your medicine ask your doctor or healthcare professional for some hints Published by MIMS September 2014 2 If you take too much overdose If you take too much BYDUREON immediately call your doctor or the Poisons Information Centre telephone AU 13 11 26 NZ 0800 764 766 for advice or go to Accident and Emergency at the nearest hospital Symptoms of an overdose may include nausea vomiting dizziness or symptoms of low blood sugar You may need urgent medical attention While you are using BYDUREON Things you must do If you are about to be started on any new medicine remind your doctor and pharmacist that you are using BYDUREON Tell any other doctors dentists and health care professionals who treat you that you are using this medication If you are going to have surgery tell the surgeon or anaesthetist that you are using this medicine It may affect other medicines used during surgery If you become pregnant while using this medicine tell your doctor immediately Make sure all friends relatives workmates or carers know that you have diabetes Tell your doctor if you experience hypoglycaemia low blood sugar levels When BYDUREON is used with a medicine that contains sulfonylurea hypoglycaemia can occur The dose of your sulfonylurea medicine may need to be reduced while you use BYDUREON Some symptoms of hypoglycaem
11. severe problems with your stomach or food digestion BYDUREON slows stomach emptying so food passes more slowly through your stomach Tell your doctor if you are pregnant or plan to become pregnant Use of this medicine in pregnancy is limited Your doctor can discuss with you the risks and benefits involved Published by MIMS September 2014 1 Tell your doctor if you are breast feeding or plan to breast feed It is not known if this medicine passes into your breast milk Your doctor can discuss with you the risks and benefits involved If you have not told your doctor about any of the above tell them before you start using this medicine Taking other medicines Tell your doctor if you are taking any other medicines including any that you get without a prescription from your pharmacy supermarket or health food shop Some medicines may be affected by BYDUREON or may affect how it works You may need different amounts of your medicines or you may need to take different medicines These include e warfarin a medicine used to prevent blood clots Taking BYDUREON while you are taking warfarin may cause you to bleed more easily e angiotensin converting enzyme inhibitors medicines used to treat high blood pressure and other heart conditions e nonsteroidal anti inflammatory medicines e diuretics medicines used to treat fluid retention and high blood pressure Taking BYDUREON while you are taking these med
12. ul driving or operating machinery If you use BYDUREON in combination with sulfonylureas hypoglycaemia can occur Hypoglycaemia may reduce your ability to concentrate Side effects Tell your doctor or healthcare professional as soon as possible if you do not feel well while you are using BYDUREON BYDUREON helps most people with type 2 diabetes but it may have unwanted side effects in some people All medicines can have side effects Sometimes they are serious most of the time they are not You may need medical attention if you get some of the side effects Ask your doctor or healthcare professional to answer any questions you may have When BYDUREON is used with a medicine that contains sulfonylurea hypoglycaemia can occur Tell your doctor if you experience hypoglycaemia Tell your doctor if you notice any of the following e nausea e vomiting e diarrhoea e constipation e dizziness or light headedness e headache e feeling jittery e acid stomach e abdominal pain or distension e loss of energy and strength e redness swelling or itching at the injection site local allergy Published by MIMS September 2014 3 e a lump or hardening under the skin at the injection site e indigestion dyspepsia e excessive sweating hyperhidrosis e mood changes e flu like symptoms e bone or muscle pain These are the more common side effects of BYDUREON Mostly these are mild and short lived BYDUREO
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