leaflet MAH BRAND_PL 00006-0338
Contents
1. Ss MF i UMOUS Suun UIYS Wo1 lD U 5 SHUN GE CFU payoene lp u v UM uad y 310 S 104 OG DUHE 3y JO 110 1e d 0 401291 1 Jaye lD U OU 910N DUlAOUI Sd01S qouy 9900 du un ysnd pue qouy 9900 3y UO Qulunu 19 JNoA Aq papuswwose anbiuyoe uon lul Huisn UIYS lp u LaSu MMO S G 0 1Un09 pue Ul qouy asoq plou asop IIN y OL UMOUS S lun 01 Spuemyoeg Huljep Aq sop au 199109 UP NOA syun AUeW 00 noA 4 10211 0 NOA silun JO 0 qouy soq WN 19 Jesyyeay Kg se eme MOU pue 2 y maisun 196 D N 13 Nn0 ay pid i 2 Y soq no bun lul uad y luld pue lp u y buPu2 NIIP 3o S Uad 3U pue dil lp u au W014 UlinSul JO amp 89S JOU OP NOA Jj 10 Keme MoI do e Hp PUL IPIN JUU HO lind ae mo n 1991102 0 DLHEO dey qouy feme you urul 27 J 7 10U dn uad 1102 soq au uruan Aq spun 2 eld 00 PI IUS p N 19N0 HO lind S 0p UI NSU JO WENS E J di lp u v WOU SJeadde uljnsul 102. KwikPen Insulin delivery device PLEASE READ THESE INSTRUCTIONS BEFORE USE Introduction The KwikPen js designed for ease of use It is a disposable pen containing 3 mL 300 units of U 100 insulin You can inject from 1 to 60 units of insulin in one injection You can dial your dose one unit at a time If you dial too many units you can correct the dose without wasting any insulin Before using KwikPen read the entire manual completely and follow the directions carefully If you do not follow these directions completely you may get too much or too little insulin Your KwikPen must be used only for your injections Do not share your pen or your needles as this may risk transmission of infectious agents Use a new needle for each injection DO NOT USE your pen if any part appears broken or damaged Always carry an extra pen in case yours is lost or damaged This pen is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the product Preparing KwikPen Important Notes e Read and follow the directions provided in the insulin package leaflet e Check the label on your pen before each injection for the expiration date and to make sure you are using the correct type of insulin Do not remove the pen label Note The colour of your KwikPen Dose Knob matches the insulin specific colour band shown on the Pen Label In this
3. F u ymM l ld ul02 SI HUI 6 15 0 UN09 fsi d pue ul qouy osod D OH 09 021 081 MOpUIM 8SOq 8 Ul UBS SI Q pue 50019 w S 1 un ul qouy soq ysnd dn p lulod YM 9 0299 1 q Y Ullnsul 3N 00 10 YONW 00 396 Aew noA uon lul weans e JOU Op NOA Jj UddyIMy urud ad Ul NSU 1291409 3U bulsn ase no 9 0 f qE7 094 ay pea SAPM V UONDE y UO P S 13qqNY 3U LET adim 0 Gems 0110012 Ue SN 01 ulinsul INOA 2909 91 9 ag SALXIM 6 77 yoo a QE7 U d l BAOW JOU ua d y 0 U0 v SOD 1U L y 106 no auns 8 00 ded 3y 19 JOU OG jybiens qp u 2 usnd lp u b 10 9 0 que vod s BUKIN 5 0 40 1u IES den uad Ind 9911 uad li H AU NV 9901 0 H d 3y 0 Anuay Aquo uljnsuy 2 104 Ge seli g Y buupd lq uon lul JO SUO ONASUI s v MOO s S Ullunu C N Ulihumu Kay 2 02 qouy soq bl tus 491n0 bl rtus pUMEQ lp N JOUU i I x 081 021 09 b un m MOPUIM 9500 jeas seqqny lD N ANE qe Jaded JoyeaIpu asoq Jaqe 94 pb pnroul JON s lp N SMEd U dAIMY urum SMEd lp N U d sue
4. for example captopril enalapril or angiotensin receptor blockers Pregnancy and breast feeding Ask your doctor or diabetes specialist nurse for advice before taking any medicine The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months If you are breast feeding you may need to alter your insulin intake or diet Driving and using machines Your ability to concentrate and react may be reduced if you have hypoglycaemia low blood sugar Please remember this in all situations where you might put yourself and others at risk e g driving a car or operating machinery You should contact your diabetes specialist nurse or doctor about the advisability of driving if you have e frequent episodes of hypoglycaemia e reduced or absent warning signs of hypoglycaemia 3 HOW TO USE HUMULIN I KWIKPEN Always check the pack and the label of the pre filled pen for the name and type of the insulin when you get it from your pharmacy Make sure you get the Humulin I KwikPen that your doctor has told you to use Always use Humulin I KwikPen exactly as your doctor has told you You should check with your doctor if you are not sure Dosage e You should normally inject Humulin I as your basal insulin Your doctor has told you which insulin to use how much when and how often to inject These instructions are only for you Follow them exactly and visit your diabetes clinic re
5. needle will make it easier to push the Dose Knob during your injection See your healthcare professional to determine which needle size is best for you 4 Ifthe Dose Knob continues to be difficult to push after following the steps above you may need a new pen What should do if my KwikPen is jammed Your pen is jammed if it is difficult to inject a dose or dial a dose To clear the jam 1 Attach a new needle When you do this you may see insulin come out of the needle 2 Prime the pen 3 Dial your dose and inject Do not attempt to lubricate your pen as this may damage the mechanism The Dose Knob may become harder to push if foreign material dirt dust food insulin or other liquids get inside the pen Avoid getting foreign material inside the pen e Why is insulin leaking from the needle after finished my dose You may have removed the needle from your skin too quickly 1 Make sure you see a 0 in the Dose Window 2 Por the next dose push and hold the Dose Knob in and count to 5 slowly before removing the needle e What should 1 do if my dose is dialled and the Dose Knob is accidentally pushed in without a needle attached 1 Dial back to zero 2 Attach a new needle 3 Prime the pen 4 Dial your dose and inject e What should 1 do if 1 dial a wrong dose too high or too low Turn the Dose Knob backward or forward to correct the dose What should I do if see insulin leaking from the pen needle while diall
6. user manual the Dose Knob is shown in grey The Pen Body is beige to indicate that it contains a Humulin family of products Dose Knob Colour code key Humulin Humulin M3 Humulin S e Your healthcare professional has prescribed the most appropriate type of insulin for you Any changes in insulin therapy should be made only under medical supervision KwikPen is recommended for use with Becton Dickinson and Company BD pen needles e Be sure the needle is completely attached to the pen before use e Keep these directions for future reference Frequently Asked Questions about Preparing KwikPen e What should my insulin look like Some insulins are cloudy while others are clear be sure to refer to your insulin package leaflet for the appearance of your specific insulin What do I do if my dose is higher than 60 units If your dose is higher than 60 units of insulin multiple injections will be required or you may contact your healthcare professional Why should I use a new needle for each injection If needles are reused you may get the wrong amount of insulin a clogged needle a jammed pen or an infection because Sterility is not ensured e What should do if I am not sure how much insulin remains in my cartridge Hold the pen with the needle end pointing down The scale on the clear Cartridge Holder shows an estimate of the number of units remaining These numbers should NOT be used for measuring an insulin dose
7. will tell you how to do this If you take more Humulin I than you need If you take more Humulin 1 than you need your blood sugar may become low Check your blood sugar see A in Section 4 If you forget to use Humulin I KwikPen If you take less Humulin I than you need your blood sugar levels may increase Check your blood sugar If you stop using Humulin I KwikPen If you take less Humulin I than you need your blood sugar levels may become too high Do not change your insulin unless your doctor tells you to If you have any further questions on the use of this product ask your diabetes specialist nurse doctor or pharmacist 4 POSSIBLE SIDE EFFECTS Like all medicines Humulin I can cause side effects although not everybody gets them Human insulin may cause hypoglycaemia low blood sugar See more information on hypoglycaemia below in the subsection Common problems of diabetes Possible side effects Systemic allergy is very rare affects less than 1 person in 10 000 The symptoms are as follows e fall in blood pressure e rash over the whole body e difficulty in breathing e wheezing e fast heart beat e sweating If you think you are having this sort of insulin allergy with Humulin I tell your doctor at once Local allergy is common affects less than 1 person in 10 Some people get redness swelling or itching around the area of the insulin injection This usually clears up in anything from a few days to a few
8. 100 IU ml Each Humulin I KwikPen contains 300 units 3 millilitres The Humulin I KwikPen comes in a pack of 5 The Humulin I in your KwikPen is the same as the Humulin I which comes in separate Humulin I cartridges The KwikPen simply has a built in cartridge When the KwikPen is empty you cannot use it again Marketing Authorisation Holder and Manufacturer Humulin I KwikPen is made by Lilly France S A S Rue du Colonel Lilly 67640 Fegersheim France The marketing authorisation is held by Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL U K It is distributed in the Republic of Ireland by Eli Lilly and Company Ireland Limited Hyde House 65 Adelaide Road Dublin 2 Ireland This medicinal product is authorised in the Member States of the EEA under the following names Huminsulin Lilly Basal 100 I E ml KwikPen Austria Humuline KwikPen NPH Belgium Luxembourg The Netherlands Humulin N KwikPen Estonia Latvia Lithuania Poland Romania Huminsulin Basal NPH 100 KwikPen Germany Humulin NPH KwikPen Denmark Finland Iceland Norway Slovenia Sweden Humulin NPH KwikPen Greece Humulina NPH KwikPen 100 Spain Humulin I KwikPen Ireland UK Umuline NPH KwikPen France This leaflet was last approved in March 2015 If you would like a large print version of this leaflet please phone 01256 315000 UK or 01 661 4377 Ireland RA040FSAA02 USER MANUAL
9. PACKAGE LEAFLET INFORMATION FOR THE USER HUMULIN I Isophane KwikPen 100 U ml suspension for injection insulin human Read all of this leaflet carefully before you start using this medicine Keep this leaflet You may need to read it again If you have any further questions ask your diabetes specialist nurse doctor or pharmacist This medicine has been prescribed for you Do not pass it on to others It may harm them even if their symptoms are the same as yours If any of the side effects gets serious or if you notice any side effects not listed in this leaflet please tell your diabetes specialist nurse doctor or pharmacist In this leaflet What Humulin I KwikPen is and what it is used for Before you use Humulin I KwikPen How to use Humulin I KwikPen Possible side effects How to store Humulin I KwikPen Further information Nm BW NR 1 WHAT HUMULIN I KWIKPEN IS AND WHAT IT IS USED FOR Humulin I KwikPen is a pre filled pen containing the active substance human insulin which is used to treat diabetes You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood blood sugar Humulin I is used to control glucose in the long term Its action is prolonged by the inclusion of protamine sulfate in the suspension Your doctor may tell you to use Humulin I KwikPen as well as a fast acting insulin Each kind of insulin comes with its own patient information lea
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11. e pen in the fridge Do not put it near heat or in the sun Do not use Humulin I KwikPen after the expiry date which is stated on the label and the carton The expiry date refers to the last day of that month Do not use Humulin I KwikPen if clumps of material are present or if solid white particles stick to the bottom or sides of the cartridge giving it a frosted appearance Check this each time you inject yourself Medicines should not be disposed of via wastewater or household waste Ask your pharmacist how to dispose of medicines no longer required These measures will help to protect the environment 6 FURTHER INFORMATION What Humulin I KwikPen contains The active substance is human insulin Human insulin is made in the laboratory by a recombinant DNA technology process It has the same structure as the natural hormone made by the pancreas It is therefore different from animal insulins The human insulin in Humulin I is available in a suspension together with protamine sulfate The other ingredients are protamine sulfate metacresol phenol glycerol dibasic sodium phosphate 7H O zinc oxide and water for injection Sodium hydroxide or hydrochloric acid may have been used during manufacture to adjust the acidity What Humulin I KwikPen looks like and contents of the pack Humulin I Isophane KwikPen 100 IU ml suspension for injection is a white sterile suspension and contains 100 units of insulin in each millilitre
12. e What should do if can t remove the Pen Cap Pull the cap straight off If you are having difficulty removing the cap gently twist the cap back and forth to realign and then pull the cap straight off Priming KwikPen Important Notes e Prime every time The pen must be primed to a stream of insulin before each injection to make sure the pen is ready to dose If you do not prime to a stream you may get too much or too little insulin Frequently Asked Questions about Priming e Why should prime my pen before each dose 1 Ensures that the pen is ready to dose 2 Confirms that a stream of insulin comes out of the tip of the needle when you push the Dose Knob in 3 Removes air that may collect in the needle or insulin cartridge during normal use What should I do if cannot completely push in the Dose Knob when priming KwikPen 1 Attach a new needle 2 Prime the pen What should 1 do if I see an air bubble in the cartridge You need to prime the pen Remember do not store the pen with the needle attached as this may cause air bubbles to collect in the insulin cartridge A small air bubble will not affect your dose and you can continue to take your dose as usual Injecting Your Dose Important Notes e Follow the instructions for sanitary injection technique recommended by your healthcare professional e Make sure you receive your complete dose by pushing and holding the dose knob in and count to 5 slowly befor
13. e cartridge e Refer to the package leaflet for complete insulin storage instructions e After first use the pen should not be used beyond the time specified in the insulin package leaflet e Dispose of used needles in a closable puncture resistant container or as directed by your healthcare professional e Dispose of used pens as instructed by your healthcare professional and without the needle attached e Do not recycle the filled sharps container e Ask your healthcare professional about options available in your area to throw away the sharps container properly e The directions regarding needle handling are not intended to replace local healthcare professional or institutional policies e Keep the pen out of the reach of children If you have any questions or problems with your KwikPen contact your healthcare professional for assistance UO ypres Pulusnd pue MOPUIM SOQ a4 YM dil deg y bulub lp Aq deg uad pid v SOD Y JOU Op ISOP J N JNOA paniadas NOA Yury JOU NOA SOD 9 9 CW09 QU D N Q 1 NOA ULHUO 0 MOpuIM SOQ l 0 no 1 9 0 Y99349 910N uad AU Ul 191 SHUN 10 y uey erp 0 NOA MO JOU Jim uad BUY a 0N c VVS 0rY VMH 2102 UO S A EDUP N s lli lini SE UMOUS ul Jaye 9 ppo y PIP au UO p luld aJe SJBQLUNU BU
14. e removing the needle If insulin is leaking from the pen you may not have held it in your skin long enough A drop of insulin at the needle tip is normal It will not affect your dose e The pen will not allow you to dial more than the number of units left in the pen If you do not think you received your full dose do not take another dose Call your healthcare professional for assistance e f your dose is greater than the number of units left in the pen you may either inject the amount remaining in your current pen and then use a new pen to complete your dose OR inject the full dose with a new pen e Do not attempt to inject your insulin by turning the Dose Knob You will NOT receive your insulin by turning the Dose Knob You must PUSH the Dose Knob straight in for the dose to be delivered e Do not attempt to change the dose while injecting e The directions regarding needle handling are not intended to replace local healthcare professional and or institutional policies e Remove the needle after completing each injection Frequently Asked Questions about Injecting Your Dose e Why is it difficult to push the Dose Knob when try to inject 1 Your needle may be clogged Try attaching a new needle When you do this you may see insulin come out of the needle Then prime the pen 2 Pressing the Dose Knob quickly may make the Dose Knob harder to push Pressing the Dose Knob more slowly may make it easier 3 Using a larger diameter
15. flet to tell you about it Do not change your insulin unless your doctor tells you to Be very careful if you do change insulin Each type of insulin has a different colour and symbol on the pack and the pen so that you can easily tell the difference 2 BEFORE YOU USE HUMULIN I KWIKPEN Do not use Humulin I KwikPen if you think hypoglycaemia low blood sugar is starting Further in this leaflet it tells you how to deal with mild hypoglycaemia see A in Section 4 are allergic hypersensitive to human insulin or any of the other ingredients of Humulin I KwikPen see Section 6 Take special care with Humulin I KwikPen e If your blood sugar levels are well controlled by your current insulin therapy you may not feel the warning symptoms when your blood sugar is falling too low Warning signs are listed later in this leaflet You must think carefully about when to have your meals how often to exercise and how much to do You must also keep a close watch on your blood sugar levels by testing your blood glucose often e Afew people who have had hypoglycaemia low blood sugar after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different If you often have hypoglycaemia or have difficulty recognising the symptoms please discuss this with your doctor e If you answer YES to any of the following questions tell your diabetes specialist nurse doctor or pharmacist Have
16. gar are not treated they can be very serious and cause headaches nausea vomiting dehydration unconsciousness coma or even death Three simple steps to avoid hypoglycaemia or hyperglycaemia are e Always keep spare syringes and a spare vial of Humulin I e Always carry something to show you are diabetic e Always carry sugar with you C Illness If you are ill especially if you feel sick or are sick the amount of insulin you need may change Even when you are not eating normally you still need insulin Test your urine or blood follow your sick rules and tell your diabetes specialist nurse or doctor Reporting of side effects If you get any side effects talk to your doctor pharmacist or nurse This includes any possible side effects not listed in this leaflet You can also report side effects directly via Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL Dublin 2 Tel 353 1 6764971 Fax 353 1 6762517 Website www hpra ie e mail medsafety hpra ie United Kingdom Yellow Card Scheme Website www mhra gov uk yellowcard By reporting side effects you can help provide more information on the safety of this medicine 5 HOW TO STORE HUMULIN I KWIKPEN Keep out of the reach and sight of children Before the first use store your Humulin I KwikPen in a refrigerator 2 C 8 C Do not freeze Keep your in use Humulin I KwikPen at room temperature below 30 C for up to 28 days Do not keep your in us
17. gularly e If you change your insulin type for example from animal to human you may have to take more or less than before This might just be for the first injection or it may be a gradual change over several weeks or months e Inject Humulin I under the skin You should not administer it using a different administration route Under no circumstances should Humulin I be given into a vein Preparing Humulin I KwikPen e The KwikPen should be rotated in the palms of the hands 10 times and inverted 10 times immediately before use to resuspend insulin until it appears uniformly cloudy or milky If not repeat the above procedure until contents are mixed Cartridges in the pen contain a small glass bead to assist mixing Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose The cartridges in the pen should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or sides of the cartridge giving it a frosted appearance Check each time you inject yourself Getting the KwikPen ready to use Please see user manual e First wash your hands e Read the instructions on how to use your pre filled insulin pen Please follow the instructions carefully Here are some reminders Use a clean needle Needles are not included Prime your KwikPen before each use This checks that insulin comes out and clears the air bubbles f
18. ing the dose or correcting the dose Do not inject the dose because you may not get your complete dose Dial the pen down to zero and prime the pen again see Routine Use section Priming KwikPen steps 2B through 2D Dial your dose and inject What should I do if my full dose cannot be dialled The pen will not allow you to dial a dose greater than the number of insulin units remaining in the cartridge For example if you need 31 units and only 25 units remain in the cartridge you will not be able to dial past 25 Do not attempt to dial past this point If a partial dose remains in the pen you may either 1 Give the partial dose and then give the remaining dose using a new pen or 2 Give the full dose with a new pen Why can I not dial the dose to use the small amount of insulin that remains in my cartridge The pen is designed to deliver at least 300 units of insulin The pen design prevents the cartridge from being completely emptied because the small amount of insulin that remains cannot be delivered accurately Storage and Disposal Important Notes e Before the first use store your pen in a refrigerator 2 C 8 C Do not use a pen if it has been frozen e Keep your pen in use at room temperature and away from heat and light e Do not store the pen with the needle attached If the needle is left on insulin may leak from the pen insulin may dry inside the needle causing the needle to clog or air bubbles may form in th
19. ld be put at risk by hypoglycaemia Do not use Humulin I if you think hypoglycaemia low blood sugar is starting If your blood sugar is low eat glucose tablets sugar or drink a sugary drink Then eat fruit biscuits or a sandwich as your doctor has advised you and have some rest This will often get you over mild hypoglycaemia or a minor insulin overdose If you get worse and your breathing is shallow and your skin gets pale tell your doctor at once A glucagon injection can treat quite severe hypoglycaemia Eat glucose or sugar after the glucagon injection If you do not respond to glucagon you will have to go to hospital Ask your doctor to tell you about glucagon B Hyperglycaemia and diabetic ketoacidosis Hyperglycaemia too much sugar in the blood means that your body does not have enough insulin Hyperglycaemia can be brought about by e not taking your Humulin 1 or other insulin e taking less insulin than your doctor tells you to e eating a lot more than your diet allows or e fever infection or emotional stress Hyperglycaemia can lead to diabetic ketoacidosis The first symptoms come on slowly over many hours or days The symptoms include the following e feeling sleepy no appetite e flushed face e fruity smell on the breath e thirst e feeling or being sick Severe symptoms are heavy breathing and a rapid pulse Get medical help immediately If hypoglycaemia low blood sugar or hyperglycaemia high blood su
20. rom your KwikPen There may still be some small air bubbles left in the KwikPen these are harmless but if the air bubble is too big it may make the dose of your injection less accurate Injecting Humulin I e Before you make an injection clean your skin as you have been instructed Inject under the skin as you were taught Do not inject directly into a vein After your injection leave the needle in the skin for 5 seconds to make sure you have taken the whole dose Do not rub the area you have just injected Make sure you inject at least half an inch 1 cm from where you last injected and that you rotate the places you inject as you have been taught After injecting e As soon as you have done the injection unscrew the needle from the KwikPen using the outer needle cap This will keep the insulin sterile and prevent leaking It will also stop air going back into the KwikPen and the needle clogging up Do not share your needles or your KwikPen Replace the cap on the KwikPen Further injections e Every time you use a KwikPen you must use a new needle Before every injection clear any air bubbles You can see how much insulin is left by holding the KwikPen with the needle pointing down The scale on the cartridge shows about how many units you have left e Do not mix any other insulin in your disposable pen Once the KwikPen is empty do not use it again Please get rid of it carefully your diabetes specialist nurse or pharmacist
21. weeks If this happens to you tell your doctor Lipodystrophy thickening or pitting of the skin is uncommon affects less than 1 person in 100 If you notice your skin thickening or pitting at the injection site change your injection site and tell your doctor Oedema e g swelling in arms ankles fluid retention has been reported particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose If any of the side effects gets serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist Common problems of diabetes A Hypoglycaemia Hypoglycaemia low blood sugar means there is not enough sugar in the blood This can be caused if you e take too much Humulin 1 or other insulin e miss or delay meals or change your diet e exercise or vvork too hard fust before or after a meal e have an infection or illness especially diarrhoea or vomiting have a change in your need for insulin or e have trouble with your kidneys or liver which gets worse Alcohol and some medicines can affect your blood sugar levels The first symptoms of low blood sugar usually come on quickly and include the following e tiredness e rapid heartbeat e nervousness or shakiness e feeling sick e headache e cold sweat Until you become confident in recognising your warning symptoms avoid situations such as driving a car in which you or others wou
22. you recently become ill Do you have trouble with your kidneys or liver Are you exercising more than usual e The amount of insulin you need may also change if you drink alcohol e You should also tell your diabetes specialist nurse doctor or pharmacist if you are planning to go abroad The time difference between countries may mean that you have to have your injections and meals at different times to when you are at home e Some patients with long standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure 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 Using other medicines Please tell your doctor or diabetes specialist nurse if you are taking or have recently taken any other medicines including medicines obtained without a prescription Your insulin needs may change if you are taking any of the following e steroids e thyroid hormone replacement therapy e oral hypoglycaemics antidiabetic medication e acetylsalicylic acid aspirin e growth hormone e octreotide lanreotide e beta stimulants for example ritodrine salbutamol or terbutaline e beta blockers e t hiazides or some antidepressants monoamine oxidase inhibitors e danazol e some angiotensin converting ACE inhibitors
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