NovoMix 30 Penfill 3mL - Novo Nordisk

NovoMix ® 30 Penfill ® 3mLInsulin aspart (rys)Consumer Medicine InformationWhat is in this leafletWhat NovoMix ® 30 is used for ... 1Before you use NovoMix ® 30Penfill ® .......................................... 1How to use NovoMix ® 30 Penfill ®....................................................... 2While you are using NovoMix ® 30Penfill ® .......................................... 4Things to be careful of................. 5Side effects.................................... 5After using NovoMix ® 30 Penfill ®....................................................... 6Product description ..................... 6Further information.................... 6This leaflet answers some commonquestions about NovoMix ® 30Penfill ® 3mL. It does not contain allthe available information. It doesnot take the place of talking to yourdoctor, diabetes education nurse orpharmacist.All medicines have risks andbenefits. Your doctor has weighedthe risks of you using NovoMix 30Penfill against the benefits theyexpect 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 read itagain.What NovoMix ® 30 isused forThe insulin aspart (rys), or“NovoMix 30”, in NovoMix 30Penfill is a mixture of rapid- andlong-acting insulin used to treatdiabetes mellitus. Diabetes mellitusis a condition where your pancreasdoes not produce enough insulin tocontrol your blood sugar (glucose)level. Extra insulin is thereforeneeded.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 is a pre-mixed neutralsuspension consisting of rapidactinginsulin aspart (rys) (30%) andintermediate-acting protamineinsulin aspart (rys) (70%).NovoMix 30 lowers your bloodsugar level after injection. Wheninjected under your skin, NovoMix30 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 of the insulin you inject willvary according to the dose, injectionsite, blood flow, temperature andlevel of physical activity.Penfill is a glass cartridge designedto be used with Novo Nordiskinsulin delivery systems (such asNovoPen ® ).NovoMix 30 is not addictive.NovoMix 30 Penfill is availableonly with a doctor’s prescription.Ask your doctor, diabeteseducation nurse or pharmacist ifyou have any questions about whyNovoMix 30 Penfill has beenprescribed for you.Before you useNovoMix ® 30 Penfill ®When you must not use itDo not use the medicine if:1 you have an allergy to:• any medicine containing insulin• 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 thebody.2 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 after theexpiry date printed on the pack orif the packaging is torn or showssigns of tampering.If it has expired or is damaged,return it to your pharmacist fordisposal.NovoMix ® Penfill ® 3mL Page 1 of 6NovoMix30Pfcmi8

Leave Penfill in the insulindelivery system until it needs to bereplaced.It is recommended that you eat ameal containing carbohydrate within10 minutes of the injection.How long to use itDo not stop using NovoMix 30Penfill unless your doctor tells youto.If you use too much(overdose) - HypoglycaemiaYour blood sugar level may becometoo low (you may experiencehypoglycaemia or a “hypo”) if you:• accidentally use too much ofthis medicine ,• have too much or unexpectedexercise• delay eating meals or snacks• eat too little food• are illThe first symptoms of mild tomoderate hypos can come onsuddenly. They may include:• cold sweat, cool pale skin• fatigue, drowsiness, unusualtiredness and weakness• nervousness, anxious feeling,tremor, rapid heart beat• confusion, difficultyconcentrating• excessive hunger• vision changes• headache, nauseaAlways carry some sugary food orfruit juice with you.If you experience any of thesesymptoms of a hypo, immediatelyeat some sugary food or have asugary drink, e.g. lollies, biscuits orfruit juice.Tell your relatives, friends, closeworkmates or carers that youhave diabetes. It is important thatthey recognise the signs andsymptoms of a hypo.Make sure they know to give yousome sugary food or fruit juice formild to moderate symptoms of ahypo.If you lose consciousness, makesure they know:• to turn you on your side andget medical help immediately.• not to give you anything to eator drink.This is because you could choke.An injection of the hormoneglucagon may speed up recoveryfrom unconsciousness. This can begiven by a relative, friend, workmateor carer who knows how to give it.If glucagon is used, eat some sugaryfood or have a sugary drink as soonas you are conscious again.If you do not feel better after this,contact your doctor, diabeteseducation nurse, or the closesthospital.If you do not respond to glucagontreatment, you will require medicalattention.See your doctor if you keep havinghypo reactions, or if you have everbecome unconscious after usinginsulin.Your insulin dose may need to bechanged.If a severe hypo is not treated, it cancause brain damage and even death.If you miss a dose –HyperglycaemiaIf you forget your insulin dose,test your blood sugar level as soonas possible.If you are not sure what to do, talkto your doctor, diabetes educationnurse or pharmacist.Do not use a double dose of yourinsulin.If it is almost time for your nextdose, skip the dose you missed anduse your next dose when you aremeant to.Otherwise, use it as soon as youremember – don’t forget to eat somecarbohydrate within 10 minutes ofyour injection – and then go back tousing it as you would normally.Your blood sugar levels maybecome high (hyperglycaemia) ifyou:• miss doses of insulin or use lessinsulin than you need• have uncontrolled diabetes• exercise less than usual• eat more carbohydrates thanusual• are ill or stressedHigh blood sugar levels over a longperiod of time can lead to too muchacid in the blood (diabeticketoacidosis).Contact your doctor immediatelyif your blood sugar level is high oryou recognise any of the followingsymptoms.Symptoms of mild to moderatehyperglycaemia include:• drowsy feeling• flushed face• thirst, loss of appetite• fruity odour on the breath• blurred vision• passing larger amounts of urinethan usual• getting up at night more oftenthan usual to pass urine• high levels of glucose andacetone in the urineSymptoms of severe hyperglycaemiainclude:• heavy breathing• fast pulse• nausea, vomiting• dehydration• loss of consciousnessSevere hyperglycaemia can lead tounconsciousness and in extremecases death if untreated.Discuss any worries you may haveabout this with you doctor,diabetes education nurse orpharmacist.While you are usingNovoMix ® 30 Penfill ®Things you must doMeasure your blood sugar levelregularly.NovoMix ® Penfill ® 3mL Page 4 of 6NovoMix30Pfcmi8

Make sure all friends, relatives,workmates or carers know thatyou have diabetes.If your child has diabetes it isimportant to tell their carers.Keep using your insulin even ifyou feel well.It helps to control your condition,but does not cure it.Tell your doctor if you often havehypos (low blood sugar levels).Your doctor may need to adjust yourinsulin dose.Always carry some sugary food orfruit juice with you.If you experience any of thesymptoms of a hypo, immediatelyeat some sugary food or have adrink, e.g. lollies, biscuits or fruitjuice.Tell your doctor if you havetrouble recognising the symptomsof hypos.Under certain conditions, the earlywarning signs of hypos can bedifferent or less obvious. Yourdoctor may need to adjust yourinsulin dose.Make sure that you tell everydoctor, dentist, pharmacist orother health care professional whois treating you that you havediabetes and are using insulin.Tell your doctor, diabeteseducation nurse or pharmacist ifyou are travelling.Ask them for a letter explaining whyyou are taking injecting devices withyou. Each country you visit willneed to see this letter, so you shouldtake several copies.You may need to inject your insulinand eat your meals at different timesbecause of time differences in andbetween countries.You may not be able to get the sametype of insulin in the country you arevisiting.Your doctor, diabetes educationnurse or pharmacist can provide youwith some helpful information.Things you must not doDo not stop using your medicineunless your doctor tells you to.Do not use the medicine if youthink it has been frozen orexposed to excessive heat.It will not work as well.Do not refill your NovoMix 30Penfill.Do not use this medicine to treatany other complaints unless yourdoctor tells you to.Do not give your medicine toanyone else, even if they have thesame condition as you.Things to be careful ofBe careful driving or operatingmachinery until you know how theinsulin affects you.Tell your doctor if you drinkalcohol.Alcohol may mask the symptoms ofhypos.Tell your doctor if you are ill.Illness, especially with nausea andvomiting, may cause your insulinneeds to change. Even if you are noteating, you still require insulin. Youand your doctor should design aninsulin plan for those times whenyou are sick.Tell your doctor if you areexercising more than usual.Exercise may lower your need forthis medicine. Exercise may alsospeed up the effect of a dose of it ,especially if the exercise involvesthe area of the injection site (e.g. theleg should not be used for injectionprior to jogging or running).Tell your doctor if your dietchanges.Changes in diet may cause yourinsulin needs to change.Side effectsTell your doctor, diabeteseducation nurse or pharmacist assoon as possible if you do not feelwell while you are using NovoMix30 Penfill.This medicine helps most people forwhom it is prescribed, but it mayhave unwanted side effects in a fewpeople. All medicines can have sideeffects. Sometimes they are serious,most of the time they are not. Youmay need medical treatment if youget some of the side effects.Do not be alarmed by the followinglists of side effects. You may notexperience any of them.Ask your doctor, diabeteseducation nurse or pharmacist toanswer any questions you mayhave.The most common side effect whenusing insulin is low blood sugarlevels (a hypo).Tell your doctor if you notice anyof the following and they worryyou:• hypos (mild to moderate)• redness, swelling or itching atthe injection site (local allergy).Usually these symptomsdisappear within a few weeksduring continued use.• a depression or thickening of theskin around the injection site(lipodystrophy)• when you first start your insulintreatment you may get visualproblems or swollen hands andfeetThis list includes the more commonside effects of your medicine. Theyare usually mild and short-lived.If any of the following happen, tellyour doctor immediately or go toAccident and Emergency at yournearest hospital:More severe symptoms of low bloodsugar levels, including:• disorientation• seizures, fits or convulsions• loss of consciousness.If a severe hypo is not treated, it cancause brain damage and death.Tell your doctor immediately orgo to Accident and Emergency atNovoMix ® Penfill ® 3mL Page 5 of 6NovoMix30Pfcmi8

your nearest hospital if you noticeany of the following:• skin rashes over a large part ofthe body• shortness of breath, wheezing• swelling of the face, lips ortongue• fast pulse• sweatingThis list includes very serious sideeffects. You may need urgentmedical attention or hospitalisation.These side effects are very rare.Tell your doctor if you noticeanything that is making you feelunwell.Other side effects not listed abovemay also occur in some people.Ask your doctor, diabeteseducation nurse or pharmacist toanswer any questions you have.After using NovoMix ®30 Penfill ®StorageStore NovoMix 30 Penfillcartridges that are not being usedbetween 2°C and 8°C in arefrigerator (not in or too near thefreezer section or coolingelement).Resuspend the insulin in yourNovoMix 30 Penfill – whether it isto be used in your insulin deliverysystem immediately, or whether itis to be carried as a spare – uponremoving it from the refrigerator.Do not keep the NovoMix 30Penfill that you are using in yourinsulin delivery system, or that youare carrying as a spare, in arefrigerator. You can use it up to 4weeks at or below 30°C after takingit out of the refrigerator. Discardyour NovoMix 30 Penfill after 4weeks even if there is still somemedicine left in it.The medicine in your NovoMix 30Penfill must not be frozen, orexposed to heat or direct sunlight.Protect the medicine in NovoMix30 Penfill from light by keepingthe cartridges in the carton whennot in use.Never use NovoMix 30 Penfillafter the expiry date printed onthe label and carton.Never use NovoMix 30 Penfill ifthe insulin does not appear whiteand uniformly cloudy aftershaking.Keep out of the reach of children.DisposalDispose of used needles safely intoa yellow plastic sharps container.If your doctor tells you to stop usingthis medicine or the expiry date haspassed, ask your pharmacist what todo with any medicine that is leftover.Product descriptionWhat it looks likeNovoMix 30 is a white, cloudysuspension for subcutaneousinjection. NovoMix 30 Penfill 3mLis a pre-filled glass cartridgedesigned to be used with NovoNordisk insulin delivery systems.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” indicates themethod of genetic engineering usedto manufacture the insulin aspart.NovoMix 30 Penfill also contain thefollowing inactive ingredients:mannitol, phenol, meta-cresol, zincchloride, sodium chloride, dibasicsodium phosphate dihydrate,protamine sulphate, sodiumhydroxide, hydrochloric acid andwater for injections.SponsorNovoMix 30 Penfill is supplied inAustralia by:Novo Nordisk Pharmaceuticals PtyLtdA.B.N. 40 002 879 996Level 321 Solent CircuitBaulkham Hills NSW 2153NovoMix 30 Penfill is supplied inNew Zealand by:Novo Nordisk PharmaceuticalsLtd.58 Richard Pearse DriveAirport OaksMangereNew Zealand.Australian Registration Number:NovoMix 30 Penfill:AUST R 81759This leaflet was prepared on 23March 2006.NovoMix ® , Penfill ® , NovoFine ® ,NovoPen ® and NovoCare ® areregistered trademarks of NovoNordisk A/S.© March 2006Further 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.nzNovoMix ® Penfill ® 3mL Page 6 of 6NovoMix30Pfcmi8