NovoMix 30 FlexPen - Novo Nordisk Australasia

NovoMix ® 30 FlexPen ®30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamineConsumer Medicine InformationWhat is in this leafletBefore you use NovoMix ® 30FlexPen ® ..................................... 1How to use NovoMix ® 30FlexPen ® ..................................... 2While you are using NovoMix ®30 FlexPen ® ................................ 4Things to be careful of .............. 4Side effects ................................. 5After using NovoMix ® 30FlexPen ® ..................................... 5Product description .................. 6Further information ................. 6Instructions For Use ................. 7This leaflet answers some commonquestions about NovoMix ® 30FlexPen ® . It does not contain allthe available information. It doesnot take the place of talking toyour doctor, diabetes educationnurse or pharmacist.All medicines have risks andbenefits. Your doctor has weighedthe risks of you using NovoMix ®30 FlexPen ® against the benefitsthey expect it will have for you.If you have any concerns aboutusing this medicine, ask yourdoctor, diabetes education nurseor pharmacist.Keep this leaflet with themedicine. You may need to readit again.What NovoMix ® 30 isused forThe insulin aspart (rys), or“NovoMix ® 30”, in NovoMix ® 30FlexPen ® is a mixture of rapidandlonger-acting insulin used totreat diabetes mellitus. Diabetesmellitus is a condition where yourpancreas does not produce enoughinsulin to control your blood sugar(glucose) level. Extra insulin istherefore needed.There are two types of diabetesmellitus:Type 1 diabetes – also calledjuvenile onset diabetesType 2 diabetes – also calledmaturity onset diabetesPatients with type 1 diabetes alwaysrequire insulin to control their bloodsugar levels.Some patients with type 2 diabetesmay also require insulin after initialtreatment with diet, exercise andtablets.NovoMix ® 30 lowers your bloodsugar level after injection. Wheninjected under your skin, NovoMix ®30 has a faster onset of action thansoluble human insulin. It takeseffect within 10 to 20 minutes. Themaximum effect will occur between1-4 hours after injection and theeffect may last for up to 24 hours.As with all insulins, the duration ofaction will vary according to thedose, injection site, blood flow,temperature and level of physicalactivity.NovoMix ® 30 is a pre-mixed neutralsuspension consisting of rapidactinginsulin aspart (rys) (30%) andlonger-acting protamine insulinaspart (rys) (70%).FlexPen ® is a pre-filled dial-a-doseinsulin pen able to deliver from 1 to60 units in increments of 1 unit.NovoMix ® 30 FlexPen ® can be usedalone, or together with othermedicines, for treating diabetes.NovoMix ® 30 is not addictive.NovoMix ® 30 FlexPen ® is availableonly with a doctor’s prescription.Ask your doctor, diabeteseducation nurse or pharmacist ifyou have any questions aboutwhy NovoMix ® 30 FlexPen ® hasbeen prescribed for you.Before you useNovoMix ® 30 FlexPen ®When you must not use itDo not use the medicine if:1 you have an allergy to: any medicine containinginsulin any of the ingredients listed inthe ‘Ingredients’ section of thisleaflet.Some of the symptoms of anallergic reaction may include: redness, swelling, rash anditching at the injection site rash, itching or hives on theskin shortness of breath wheezing or difficultybreathing swelling of the face, lips,tongue or other parts of thebody2 you are experiencing a lowblood sugar level (a “hypo”)when the dose is due.If you have a lot of hyposdiscuss appropriate treatmentwith your doctor.If you are not sure whether youshould start using this medicine,talk to your doctor.Do not use this medicine afterthe expiry date printed on thepack or if the packaging is tornor shows signs of tampering.If it has expired or is damaged,return it to your pharmacist fordisposal.NovoMix ® 30 FlexPen ® Page 1 of 12NovoMix30FlexPencmi12.doc

Before you start to use itTell your doctor if you haveallergies to any other medicines,foods, preservatives or dyes.Tell your doctor if you have orhave had any medicalconditions, especially thefollowing: kidney problems liver problemsadrenal, pituitary or thyroidgland problemsTell your doctor if you arepregnant or plan to becomepregnant.Pregnancy may make managingyour diabetes more difficult.Insulin needs usually decreaseduring the first three months ofpregnancy and increase during thelast six months. Your doctor candiscuss with you the risks andbenefits involved.Tell your doctor if you arebreast-feeding or plan to breastfeed.Your doctor or pharmacist candiscuss with you the risks andbenefits involved.Inform your doctor as soon aspossible if you experience signsof heart failure such as unusualshortness of breath or rapidincrease in weight or localisedswelling (oedema).Some patients with long-standingtype 2 diabetes mellitus and heartdisease or previous stroke who aretreated with thiazolidinediones incombination with insulin maydevelop heart failure.If you have not told your doctorabout any of the above, tell thembefore you start using thismedicine.Taking other medicinesTell your doctor if you aretaking any other medicines,including any that you getwithout a prescription from yourpharmacy, supermarket orhealth food shop.Some medicines and NovoMix ® 30may interfere with each other.These include: oral hypoglycaemic medicines -used to treat type 2 diabetes monoamine oxidase inhibitors(MAOI) - used for the treatmentof depression alpha blockers - used to treathigh blood pressure and torelieve difficulty in passingurine caused by an enlargedprostate non-selective beta blockers -used to treat high blood pressureand certain heart conditionsACE inhibitors - used to treathigh blood pressure, certainheart conditions or elevatedprotein/albumin in the urinesalicylates e.g. aspirin - used torelieve pain and lower feveranabolic steroids – used topromote growth glucocorticoids (except whenapplied locally) – used to treatinflammatory conditions oral contraceptives (“the pill”) -used for birth controlthiazides - used to treat highblood pressure or fluid retention(oedema) thyroid hormones - used to treatmalfunction of the thyroid gland sympathomimetics such assalbutamol or terbutaline - usedto treat asthma sulphonamides – used to treatbacterial infectionsOr other specific medicinesincluding: danazol - used to treatendometriosis, menorrhagia,fibrocystic breast disease andhereditary angioedema oxymetholone – used to treatcertain blood disorders octreotide - used to treatgastrointestinal endocrinetumours and enlargement ofparts of the body (e.g. hands,feet, head) caused by abnormalgrowth hormone levelslanreotide – used to treatenlargement of parts of thebody (e.g. hands, feet, head)caused by abnormal hormonelevelsdiazoxide - used to treat highblood pressurenicotinic acid - used to treathigh cholesterol levels in thebloodasparaginase - used to treatleukaemia and lymph glandtumoursquinine – used to treat malariaand relieve muscle crampsquinidine – used to treat heartproblemsgrowth hormone – used totreat growth disordersTell your doctor about any othermedicines that you are taking.This is very important. Yourdoctor will advise you if it is allright to keep taking them or if youshould stop taking them.Your doctor and pharmacisthave more information onmedicines to be careful with oravoid while using this medicine.How to useNovoMix ® 30 FlexPen ®Your doctor, diabetes educationnurse or pharmacist will haveshown you how to use yourmedicine.Carefully follow all thedirections.They may differ from theinformation contained in thisleaflet.Any change in dose or type ofinsulin should be madecautiously and only undermedical supervision.If you change the type of insulinthat you use, you may have to usemore or less than before. Thismay happen with the first dose orover a period of time.If you do not understand theinstructions, ask your doctor,NovoMix ® 30 FlexPen ® Page 2 of 12NovoMix30FlexPencmi12.doc

Product descriptionWhat it looks likeNovoMix ® 30 is a white, cloudysuspension for subcutaneousinjection. NovoMix ® 30 FlexPen ®is a 3mL pre-filled glass cartridgecontained in a dial-a-dose insulinpen.IngredientsNovoMix ® 30 contains solubleinsulin aspart (rys) and protaminecrystallisedinsulin aspart (rys) 100units per mL (100 U/mL) as theactive ingredient, in the ratio of30:70.The abbreviation “rys” indicatesthe method of genetic engineeringused to manufacture the insulinaspart.NovoMix ® 30 FlexPen ® alsocontains the following inactiveingredients: glycerol, phenol,meta-cresol, zinc chloride, sodiumchloride, dibasic sodium phosphatedihydrate, protamine sulfate,sodium hydroxide, hydrochloricacid and water for injections.AUST R 143166© 2012Further informationFor further information call theNovoCare ® Customer Care Centreon 1800 668 626 (Australia) or 0800733 737 (NZ).www.novonordisk.com.auwww.novonordisk.co.nzYou can also get more informationabout diabetes and insulin fromDiabetes Australia and DiabetesNew Zealand: freecall helpline 1300 136 588(Australia) www.diabetesaustralia.com.au www.diabetes.org.nzSponsorNovoMix ® 30 FlexPen ® issupplied in Australia by:Novo Nordisk PharmaceuticalsPty. Ltd.Level 321 Solent CircuitBaulkham Hills NSW 2153NovoMix ® 30 FlexPen ® issupplied in New Zealand by:Novo Nordisk PharmaceuticalsLtd.58 Richard Pearse DriveAirport OaksMangereNew ZealandNovoMix ® , FlexPen ® , NovoFine ® ,NovoTwist ® and NovoCare ® areregistered trademarks of NovoNordisk A/S.This leaflet was prepared on 05September 2012.Australian Registration Number:NovoMix ® 30 FlexPen ® Page 6 of 12NovoMix30FlexPencmi12.doc

NovoMix ® 30 FlexPen ®30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamineInstructions For UseIntroductionPlease read the following instructions carefully before using your NovoMix ® 30 FlexPen ® .Your NovoMix ® 30 FlexPen ® is a unique, dial-a-dose insulin pen. You can select doses from 1 to 60units in increments of 1 unit. FlexPen ® is designed to be used with NovoFine ® or NovoTwist ®disposable needles up to a length of 8mm.As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen ® is lostor damaged.MaintenanceYour FlexPen ® is designed to work accurately and safely. It must be handled with care. If it is droppedor crushed, there is a risk of damage and leakage of insulin.You can clean the exterior of your FlexPen ® by wiping it with an alcohol swab. Do not soak it, wash orlubricate it as this may damage the pen.Do not refill your FlexPen ® .Preparing your NovoMix ® 30 FlexPen ®Check the label to make sure that your FlexPen ® contains the correct type of insulin. Beforeevery injection with a FlexPen ® you must resuspend the insulin.A The first use of a new NovoMix ® 30 FlexPen ® :Let the insulin reach room temperature before you use it.This makes it easier to resuspend.Pull off the pen cap.NovoMix ® 30 FlexPen ® Page 7 of 12NovoMix30FlexPencmi12.doc

B Roll the pen between your palms ten times – it is important that the pen is kept horizontal.C Move the pen up and down ten times between the two positions as shown, so the glass ball movesfrom one end of the cartridge to the other.Repeat rolling and moving the pen until the NovoMix ®(resuspended).30 appears uniformly white and cloudyFor every subsequent injection:Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If thereare fewer than 12 units left, use a new FlexPen ® .Move the pen up and down between the two positions - as shown in Figure C - at least ten times untilthe NovoMix ® 30 appears uniformly white and cloudy.After you have resuspended the insulin, complete all the following steps of injection without delay.Attaching a needleDisinfect the rubber membrane with an alcohol swab.D Remove the paper tab from a NovoFine ® or NovoTwist ® disposable needle.If using a NovoFine ® needle screw the needle onto your FlexPen ® so that it is straight and secure. Ifusing a NovoTwist ® needle, twist the needle onto your FlexPen ® until a "click" is heard.NovoMix ® 30 FlexPen ® Page 8 of 12NovoMix30FlexPencmi12.doc

E Pull off the big outer needle cap and keep it for later.F Pull off the inner needle cap and dispose of it.Always use a new needle for each injection.Be careful not to bend or damage the needle before use.To reduce the risk of needlestick injury, never put the inner needle cap back on once youhave removed it from the needle.Checking the insulin flowIt is important to prime your FlexPen ® prior to every injection. The priming procedure mayhighlight a malfunction with FlexPen ® . Priming also removes any air bubbles and would help indicatewhether or not a needle is blocked. If problems are encountered during priming, use an alternativeinsulin delivery system, DO NOT USE YOUR FLEXPEN ® , and contact your diabetes education nurseand/or Novo Nordisk.NovoMix ® 30 FlexPen ® Page 9 of 12NovoMix30FlexPencmi12.doc

To prime your FlexPen ® :G Turn the dose selector to select 2 units.H Hold your FlexPen ® with the needle pointing upwards and tap the cartridge gently with your finger afew times to make any air bubbles collect at the top of the cartridge.I Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedureno more than six times.If a drop of insulin still does not appear, your FlexPen ® has failed to prime, and you must use a newone.NovoMix ® 30 FlexPen ® Page 10 of 12NovoMix30FlexPencmi12.doc

Selecting your doseCheck that the dose selector is set at 0.J Turn the dose selector to select the number of units you need to inject. Do not use the residual scaleto measure your dose of insulin.The dose can be corrected either up or down by turning the dose selector in either direction until thecorrect dose lines up with the pointer. When turning the dose selector, be careful not to push thepush-button as insulin will come out.You cannot select a dose larger than the number of units left in the cartridge.Injecting the insulinInsert the needle into your skin. Use the injection technique shown by your doctor or diabeteseducation nurse.K Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be carefulonly to push the push-button when injecting. Turning the dose selector will not inject insulin.L Keep the push-button fully depressed after the injection until the needle has been withdrawn fromthe skin. The needle must remain under the skin for at least six seconds. This will ensure that the fulldose has been injected.NovoMix ® 30 FlexPen ® Page 11 of 12NovoMix30FlexPencmi12.doc

M Guide the needle into the big outer needle cap without touching the big outer needle cap, as shown.When the needle is covered, carefully push the big outer needle cap completely on and then removethe needle by unscrewing it (for NovoFine ® needles) or with a twist (for NovoTwist ® needles).Dispose of it carefully and put the pen cap back on.Always remove the needle after each injection and store your FlexPen ® without the needleattached. Otherwise, the insulin may leak out which can cause inaccurate dosing.Health care professionals, relatives and other carers should follow general precautionarymeasures for removal and disposal of needles, to eliminate the risk of needlestick injury.Dispose of your used FlexPen ® carefully without the needle attached.Do not share your FlexPen ® or needles with anyone else.NovoMix ® 30 FlexPen ® Page 12 of 12NovoMix30FlexPencmi12.doc