NovoRapid Penfill, Solution for injection
Contents
1. Do not be alarmed by the following lists of side effects You may not experience any of them Ask your doctor diabetes education nurse or pharmacist to answer any questions you may have The most common side effect when using insulin is low blood sugar levels a hypo Tell your doctor if you notice any of the following and they worry you e hypos mild to moderate e pain redness hives bruising swelling or itching at the injection site Usually these symptoms disappear within a few weeks during continued use If you have serious or continuing reactions you may need to stop using NovoRapid and use another insulin e a depression or thickening of the skin around the injection site lipodystrophy e when you first start your insulin treatment you may get visual problems or swollen hands and feet This list includes the more common side effects of your medicine They are usually mild and short lived If any of the following happen tell your doctor immediately or go to Accident and Emergency at your nearest hospital More severe symptoms of low blood sugar levels including e disorientation e seizures fits or convulsions e loss of consciousness If a severe hypo is not treated it can cause brain damage and death Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following e skin rashes over a large part of the body e shortness of breath wheezing e swelling of2. Ingredients section of this leaflet Some of the symptoms of an allergic reaction may include e redness swelling rash and itching at the injection site e rash itching or hives on the skin e shortness of breath e wheezing or difficulty breathing e swelling of the face lips tongue or other parts of the body 2 you are experiencing a low blood sugar level a hypo when the dose is due If you have a lot of hypos discuss appropriate treatment with your doctor If you are not sure whether you should start using this medicine talk to your doctor Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering If it has expired or is damaged return it to your pharmacist for disposal 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 medical conditions especially the following e kidney problems e liver problems e adrenal pituitary or thyroid gland problems Tell your doctor if you are pregnant or plan to become pregnant NovoRapid can be used during pregnancy Pregnancy may make managing your diabetes more difficult Insulin needs usually decrease during the first three months of pregnancy and increase during the last six months Your doctor can discuss with you the risks and benefits involved Tell your doctor if you are breast feeding or plan to brea
3. Type 2 diabetes also called maturity onset diabetes Patients with type 1 diabetes always require insulin to control their blood sugar levels Some patients with type 2 diabetes may also require insulin after initial treatment with diet exercise and tablets NovoRapid lowers your blood sugar level after injection When injected under your skin NovoRapid has a faster onset of action than soluble human insulin It takes effect within 10 to 20 minutes Usually the maximum effect will occur between 1 3 hours after injection and the effect may last for up to 5 hours As with all insulins the duration of action will vary according to the dose injection site blood flow temperature and level of physical activity Due to its shorter duration of action NovoRapid has a lower risk of causing nocturnal hypoglycaemic episodes Penfill is a pre filled 3mL glass cartridge designed to be used with Novo Nordisk insulin delivery systems such as NovoPen NovoRapid is not addictive NovoRapid Penfill is available only with a doctor s prescription Ask your doctor diabetes education nurse or pharmacist if you have any questions about why NovoRapid Penfill has been prescribed for you NovoRapid Penfill Page 1 of 6 NovoRapidPfcmil4 Before you use NovoRapid Penfill When you must not use it Do not use NovoRapid if 1 you have an allergy to any medicine containing insulin e any of the ingredients listed in the
4. amounts of urine than usual e getting up at night more often than usual to pass urine e high levels of glucose and acetone in the urine Symptoms of severe hyperglycaemia include e heavy breathing e fast pulse e nausea vomiting e dehydration e loss of consciousness Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated Discuss any worries you may have about this with you doctor diabetes education nurse or pharmacist While you are using NovoRapid Penfill Things you must do Measure your blood sugar level regularly Make sure all friends relatives workmates or carers know that you have diabetes If your child has diabetes it is important to tell their carers NovoRapid Penfill Page 6 of 6 NovoRapidPfcmil4 Keep using your insulin even if you feel well It helps to control your condition but does not cure it Tell your doctor if you often have hypos low blood sugar levels Your doctor may need to adjust your insulin dose Always carry some sugary food or fruit juice with you If you experience any of the symptoms of a hypo 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 hypos Under certain conditions the early warning signs of hypos can be different or less obvious Your doctor may need to adjust your insulin dose Make sure that you tell every doctor de
5. NovoRapid Penfill Insulin aspart rys Consumer Medicine Information What is in this leaflet What NovoRapid is used for 1 Before you use NovoRapid Penfill 2 How to use NovoRapid Penfill 3 While you are using NovoRapid Penfill 6 Things to be careful of 7 Side effects cccscsccessssssseees 8 After using NovoRapid Penfill 8 Product Description 9 Further Information 0 10 This leaflet answers some common questions about NovoRapid Penfill It does not contain all the available information It does not take the place of talking to your doctor diabetes education nurse or pharmacist All medicines have risks and benefits Your doctor has weighed the risks of you using NovoRapid Penfill against the benefits they expect it will have for you If you have any concerns about using this medicine ask your doctor diabetes education nurse or pharmacist Keep this leaflet with the medicine You may need to read it again What NovoRapid is used for The insulin aspart or NovoRapid in NovoRapid Penfill is a rapid acting insulin used to treat diabetes mellitus in adults and children Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar glucose level Extra insulin is therefore needed There are two types of diabetes mellitus Type 1 diabetes also called juvenile onset diabetes
6. ctor or diabetes education nurse NovoRapid Penfill Page 4 of 6 NovoRapidPfcmi1l4 Insert the needle into the skin and inject the full dose of insulin under the skin Keep the needle under the skin for at least 6 seconds Keep the push button fully depressed until the needle has been withdrawn from the skin Apply gentle pressure over the injection site for several seconds Do not rub the area After injecting Dispose of your used needle safely into a yellow plastic sharps container after each injection If you do not remove it temperature changes may cause insulin to leak out of the needle Health care professionals relatives and other carers should follow general precautionary measures for removal and disposal of needles to eliminate the risk of needlestick injury It is recommended that you eat a meal or a snack containing carbohydrate within 10 minutes of the injection Do not share needles cartridges or insulin delivery systems Leave Penfill in the insulin delivery system until it needs to be replaced How long to use it Do not stop using NovoRapid Penfill unless your doctor tells you to If you use too much overdose Hypoglycaemia Your blood sugar level may become too low you may experience hypoglycaemia or a hypo if you e accidentally use too much of this medicine e have too much or unexpected exercise e delay eating meals or snacks e eat too little food e are ill The first symptoms of m
7. drive a car e if you have frequent hypos e if you find it hard to recognise hypoglycaemia Tell your doctor if you drink alcohol Alcohol may mask the symptoms of hypos If you drink alcohol your need for insulin may change as your blood sugar level may either rise or fall Careful monitoring is recommended Tell your doctor if you are ill Illness especially with nausea and vomiting may cause your insulin needs to change Even if you are not eating you still require insulin You and your doctor should design an insulin plan for those times when you are sick Tell your doctor if you are exercising more than usual Exercise may lower your need for this medicine Exercise may also speed up the effect of a dose of it especially if the exercise involves the area of the injection site e g the leg should not be used for injection prior to jogging or running Tell your doctor if your diet changes NovoRapid Penfill Page 7 of 6 NovoRapidPfcmi1l4 Changes in diet may cause your insulin needs to change Side effects Tell your doctor diabetes education nurse or pharmacist as soon as possible if you do not feel well while you are using NovoRapid Penfill This medicine helps most people for whom it is prescribed but it may have unwanted side effects in a few people All medicines can have side effects Sometimes they are serious most of the time they are not You may need medical treatment if you get some of the side effects
8. he above return your Penfill to your pharmacist do not use your Penfill Preparing a dose 1 Wash your hands 2 If your NovoRapid Penfill is already inside your insulin delivery system check the amount of insulin remaining If there is insufficient insulin for your dose follow the relevant instructions in the system user manual 3 Alternatively or if your insulin delivery system does not already carry a Penfill cartridge load a new NovoRapid Penfill 4 Disinfect the rubber membrane of Penfill with an alcohol swab 5 Attach a NovoFine or NovoTwist needle Checking for insulin flow priming Always check your Novo Nordisk insulin delivery system for insulin flow priming before each injection as described in the system user manual The priming procedure may highlight a malfunction with your insulin delivery system Priming also removes any air bubbles and helps indicate whether or not a needle is broken Only dial up your required dose after you see a drop of insulin at the needle tip After priming if you need to put the insulin delivery system down make sure the needle does not touch anything Injecting a dose Choose a site for injection Inject NovoRapid under the skin subcutaneous injection as shown by your doctor or diabetes education nurse NovoRapid may be injected into the abdomen thighs buttocks or upper arms Remember to change your injection site regularly as shown to you by your do
9. ild to moderate hypos can come on suddenly They may include e cold sweat cool pale skin e fatigue drowsiness unusual tiredness and weakness e nervousness anxious feeling tremor rapid heart beat e confusion difficulty concentrating e excessive hunger e vision changes e headache nausea Always carry some sugary food or fruit juice with you If you experience any of these symptoms of a hypo immediately eat some sugary food or have a sugary drink e g lollies biscuits or fruit juice and measure your blood sugar level Tell your relatives friends close workmates or carers that you have diabetes It is important that they recognise the signs and symptoms of a hypo Make sure they know to give you some sugary food or fruit juice for mild to moderate symptoms of a hypo If you lose consciousness make sure they know e to turn you on your side and get medical help immediately e not to give you anything to eat or drink This is because you could choke An injection of the hormone glucagon may speed up recovery from unconsciousness This can be given by a relative friend workmate or carer who knows how to give it If glucagon is used eat some sugary food or have a sugary drink as soon as you are conscious again NovoRapid Penfill Page 5 of 6 NovoRapidPfcmil4 If you do not feel better after this contact your doctor diabetes education nurse or the closest hospital If you do not respond to glucagon treatment
10. ll advise you if it is all right to keep taking them or if you should stop taking them Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine How to use NovoRapid Penfill Your doctor diabetes education nurse or pharmacist will have given you advice on how to use your medicine Carefully follow all the directions They may differ from the information contained in this leaflet Your doctor may also want you to use another insulin such as Protaphane or Levemir Any change in dose or type of insulin should be made cautiously and only under medical supervision If you change the type of insulin that you use you may have to use more or less than before This may happen with the first dose or over a period of time If you do not understand the instructions ask your doctor diabetes education nurse or pharmacist for help How much to use Your doctor or diabetes education nurse will tell you how much of this medicine you need to use It is very important that you manage your diabetes carefully Too much or too little insulin can cause serious effects NovoRapid Penfill Page 3 of 6 NovoRapidPfcmi1l4 When to use it NovoRapid should normally be used immediately up to 10 minutes before your meal or carbohydrate snack When necessary NovoRapid may be used immediately after the meal How to use it e NovoRapid Penfill is designed to be used with Novo Nordi
11. ly into a yellow plastic sharps container If your doctor tells you to stop using this medicine or the expiry date has passed ask your pharmacist what to do with any medicine that is left over Product Description What it looks like NovoRapid is a clear colourless solution for subcutaneous injection NovoRapid Penfill is a pre filled 3mL glass cartridge designed to be used with Novo Nordisk insulin delivery systems Ingredients NovoRapid contains insulin aspart rys 100 units per mL 100 U mL as the active ingredient The abbreviation rys indicates the method of genetic engineering used to manufacture this insulin NovoRapid also contains the following inactive ingredients glycerol phenol meta cresol zinc chloride sodium chloride dibasic sodium phosphate dihydrate sodium hydroxide hydrochloric acid and water for injections Sponsor NovoRapid Penfill is supplied in Australia by Novo Nordisk Pharmaceuticals Pty Ltd Level 3 21 Solent Circuit Baulkham Hills NSW 2153 NovoRapid Penfill is supplied in New Zealand by Novo Nordisk Pharmaceuticals Ltd 58 Richard Pearse Drive Airport Oaks Mangere New Zealand NovoRapid Penfill NovoFine NovoTwist Protaphane and Levemir are registered trademarks of Novo Nordisk A S This leaflet was prepared on 12 August 2011 Australian Registration Number AUST R 133444 2011 NovoRapid Penfill Page 9 of 6 NovoRapidPfcmil4 F
12. ntist pharmacist or other health care professional who is treating you that you have diabetes and are using insulin Tell your doctor diabetes education nurse or pharmacist if you are travelling Ask them 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 You may need to inject your insulin and eat your meals at different times because of time differences in and between countries You may not be able to get the same type of insulin in the country you are visiting 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 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 well Do not refill your NovoRapid Penfill 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 Be careful driving or operating machinery until you know how the insulin affects you If your blood sugar is low or high your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine Bear in mind that you could endanger yourself or others Please ask your doctor whether you can
13. sk insulin delivery systems and NovoFine or NovoTwist needles e Carefully follow the instructions on how to use your Novo Nordisk insulin delivery system e Do not use the insulin level indicator on the insulin delivery system to measure your dose of NovoRapid e If you use more than one type of Penfill more than one type of insulin you must use a separate insulin delivery system for each type of Penfill e Take care not to drop or knock the insulin delivery system that contains NovoRapid Penfill e As a precautionary measure always carry a spare Penfill in case your in use Penfill is lost or damaged e Inject NovoRapid under the skin subcutaneous injection as shown to you by your doctor or diabetes education nurse e In an emergency the insulin contained within NovoRapid Penfill is suitable for intravenous administration under medical supervision only For emergency use the insulin must first be withdrawn from Penfill into a syringe Discard your Penfill after emergency use Checking your NovoRapid Penfill Check your NovoRapid Penfill before each preparation and injection Make sure you are using the correct type of insulin Do not use this medicine if it is thickened coloured or has solid bits in it Always check the cartridge including the rubber plunger stopper Do not use it if any damage is seen or if there is a gap between the plunger and the white label band If you note any of t
14. st feed Your doctor or pharmacist can discuss with you the risks and benefits involved Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling oedema Some patients with long standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure If you have not told your doctor about any of the above tell them before you use NovoRapid Taking other medicines Your dose of insulin may need to change if you take other medicines Tell your doctor if you are currently taking any medicines especially the following e oral hypoglycaemic agents used for the treatment of type 2 diabetes e monoamine oxidase inhibitors MAOTI used for the treatment of depression e alpha blocking agents used for the treatment of high blood pressure and to relieve difficulty in passing urine caused by an enlarged prostate e non selective beta blocking agents used for the treatment of certain heart conditions and high blood pressure NovoRapid Penfill Page 2 of 6 NovoRapidPfcmil4 e angiotensin converting enzyme ACE inhibitors used for the treatment of certain heart conditions high blood pressure or elevated protein albumin in the urine e salicylates e g aspirin used to relieve pain and lower fever e anabolic steroids used to promo
15. te growth e glucocorticoids except when applied locally used to treat inflammatory conditions e oral contraceptives the pill used for birth control e thiazides frusemide or ethacrynic acid used for the treatment of high blood pressure or fluid retention oedema e thyroid hormones used for the treatment of malfunction of the thyroid gland e sympathomimetics used for the treatment of asthma e sulphonamides used to treat bacterial infections Or other specific medicines including e danazol used to treat endometriosis menorrhagia fibrocystic breast disease and hereditary angioedema e oxymetholone used to treat certain blood disorders e octreotide used to treat gastrointestinal endocrine tumours and enlargement of parts of the body e g hands feet head caused by abnormal growth hormone levels e Janreotide used to treat enlargement of parts of the body e g hands feet head caused by abnormal hormone levels e diazoxide used for the treatment of high blood pressure e nicotinic acid used for the treatment of high cholesterol levels in the blood e asparaginase used to treat leukaemia and lymph gland tumours e quinine used for the prevention of malaria and the relief of muscle cramps e quinidine used for the control of heart problems e growth hormone used to treat growth hormone disorders Tell your doctor about any other medicines that you are taking This is very important Your doctor wi
16. the face lips or tongue e fast pulse e sweating This list includes very serious side effects You may need urgent medical attention or hospitalisation These side effects are very rare 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 Ask your doctor diabetes education nurse or pharmacist to answer any questions you have After using NovoRapid Penfill Storage Store NovoRapid Penfill cartridges that are not being used between 2 C and 8 C in a refrigerator not in or too near the freezer section or cooling element NovoRapid Penfill Page 8 of 6 NovoRapidPfcmi1l4 Do not keep the NovoRapid Penfill that you are using in your insulin delivery system or that you are carrying as a spare in a refrigerator You can use it up to 4 weeks below 30 C after taking it out of the refrigerator Discard NovoRapid Penfill after 4 weeks even if there is still some NovoRapid left in it The NovoRapid in NovoRapid Penfill must not be frozen or exposed to excessive heat or light Protect the NovoRapid in NovoRapid Penfill from light by keeping the cartridges in the carton when not in use Never use NovoRapid Penfill after the expiry date printed on the label and carton Never use NovoRapid Penfill if the solution is not clear and colourless Keep out of the reach of children Disposal Dispose of used needles safe
17. urther Information For further information call the NovoCare Customer Care Centre on 1800 668 626 Australia or 0800 733 737 NZ www novonordisk com au www novonordisk co nz You can also get more information about diabetes and insulin from Diabetes Australia and Diabetes New Zealand e freecall helpline 1300 136 588 Australia e www diabetesaustralia com au e www diabetes org nz NovoRapid Penfill Page 10 of 6 NovoRapidPfcmil4
18. you will require medical attention See your doctor if you keep having hypo reactions or if you have ever become unconscious after using insulin Your insulin dose may need to be changed If a severe hypo is not treated it can cause brain damage and even death If you miss a dose Hyperglycaemia If you forget your insulin dose test your blood sugar level as soon as possible If you are not sure what to do talk to your doctor diabetes education nurse or pharmacist Do not use a double dose of your insulin If it is almost time for your next dose skip the dose you missed and use your next dose when you are meant to Otherwise use it as soon as you remember don t forget to eat some carbohydrate within 10 minutes of your injection and then go back to using it as you would normally Your blood sugar levels may become high hyperglycaemia if you e miss doses of insulin or use less insulin than you need e have uncontrolled diabetes e exercise less than usual e eat more carbohydrates than usual e are ill or stressed High blood sugar levels over a long period of time can lead to too much acid in the blood diabetic ketoacidosis Contact your doctor immediately if your blood sugar level is high or you recognise any of the following symptoms Symptoms of mild to moderate hyperglycaemia include e drowsy feeling e flushed face e thirst loss of appetite e fruity odour on the breath e blurred vision e passing larger
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