C. Illness

If you are ill. especially if you feel sick ct are sick, die amount of insulin you need may change. Even when yon are not eating normally, von still need insulin. Test vour urine or blood, follow your ‘sick rules¹, and tell your diabetes specialist muse 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. Yon can also report sLde effects directly via Ireland: HPRA Phaimacovigtlance, Earlsfort Terrace, IRL - Dublin 2, Teh +353 1 67154971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafetyiiz¹ hpra.te, Malta: ADR Reporting, Website: wwwcmedicinesamhority.gavjnti'adiportal, United Kingdom: Yellow Card Scheme, Website: mvwjnhia.gov.ukiyetlowcaid. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Humuliu S

Keep this medicine out of the sight and reach of children

Before the first use store your Humulin £ in a refrigerator (2°C - 8°C). Do not freeze. Keep your ‘in use¹ pen and cartridge at room temperature (below 30⁼C) for up to 28 days. Do not keep your ‘in use¹ pen or cartridges m the fridge. Do not put them near beat or m the stm.

Do not use this medicine 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 this medicine if yon notice that it is coloured or it has solid particles in it. Yon must use it on tv if it looks like water. Check this each time you inject yourself

Do not throw away any medicines via wastewater or householdwaste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Humulin S 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 mcnimc

-    The other ingredients are metaaesol. glycerol aM water fcr injection. £ odium hydroxide or hydrochloric acid may have been used during manufacture to adjust the acidity.

What Humulin S looks like and contents of the pack

Humulin S (Soluble) 100 IU/ml. solution for injection is a sterile, cleat, coknaiess. aqueous solution and contains 100 units of insulin in each millilitre (100 IUlnl)- Each cartridge contains 300 units (3 millilitres).

The cartridges come in packs of 5 cartridges.

Marketing Authorisation Holder and Manufacturer

Humulin S in cartridge 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 Eh Lilly and Company (Ireland) Limited, Hyde House, 65 Adelaide Road. Dublin 2, Ireland.

This medicinal product is authorised in the Member States of the LEA under the fallowing names:

Huminsnlin ..Lilly' Normal 1001.E.'ml (Austria)

Uinuline Rapide 100 UT'ml (Fiance)

Humulme Regular (Belgium. Luxembourg)

Rnmulme Regular Lilly 100 (The Netherlands)

Huminsulm Normal loo (Germany)

Humulin Regular (Finland. Greece, Portugal. Sweden)

Humulin S (Malta. Ireland. UK)

Humulin R (Bulgaria, Czech Republic. Estonia, Hungary. Latvia, Lithuania, Italy. Poland, Romania, Slovak Republic, Slovenia)

This leaflet was last revised in May 2016

If you would like a large-print version of this leaflet, please phone 01256 315000 (UK) or 01 6614377 (Ireland)

Package leaflet: Information for the user

HUMULIN® S (Soluble) 100 IU/ml

solution for injection in cartridge

(Insulin Inman)

Humnlm S contains 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 S is used to control glucose in the long ienn. Humulin S is a rapidly acting insulin preparation.

Your doctor may tell you to use Humulin S as well as a longer-acting insulin. Each kind of insulin comes with its own patient information leaflet to tell you about it Do not change your insulin unless your doctor tells yon to. Be very careful if you do change insulin. Each type of msulin has a different colour and symbol on the pack and the cartridge so that you can easily tell the difference.

2. What you need to know before you use Humulin S

Do not use Humnlin S:

-    If yon think hypoglvcaetnia (low blood sugar) is starting. Further in this leaflet it tells yon how to deal with mild hypoglycneniia (sea A in Section 4).

-    If you are allergic to human insulin or any of the other ingredients of this medidne (listed in section 6). Waraings and precautions

Talk to your doctor, pharmacist or muse before using Humulin S.

■    If your blood sugar levels axe 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 leafier. You must think carefully about when to have your meals, how often to exercise and how much to do. You most also keep a close watch an your blood sugar levels by testing your blood glucose often.

*    A tew people who have had bypoglvcaemia (low blood sugar) after switching from animal msulm to human insulin have reported that the earl)' wanting symptoms were less obvious or different. If you often have hypo give aemia or have difficult)' recognising the symptoms, please discuss this with your doctor

■    If you answer YES to any of the following questions, tell your diabetes specialist nurse, doctor or pharmacist.

-    Have you recently become ill?

-    Do yon have trouble with your kidneys or liver?

-    Are you exercising more than usual?

*    The amouru of insulin you need may also change if you drink alcohol.

*    Yon should also tell your dateres 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.

' Some patients with long-standing type 2 diabetes meUitus and heart disease or previous stroke who were treated with ptoglirazone and insulin experienced the development of bean failure. Moim your doctor as soon as possible, if you experience signs of bean failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humnlin S

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your in^nlin needs may change if you are taking any of the following:

*    steoids.

*    thyroid hoi metre replacement therapy,

*    oral typogtycaemics (anndubenc medic anon).

*    acetylsahcylK add (aspinn).

*    growth hormone.

*    octreotide, lanreotide,

*    beta, stimulants (for example ritodrine, salbutamol or terbutaline),

*    beta-blockers.

■    thiazides or some antidepressants (monoamine oxidase inhibitors),

* danazoL

■    some angiotensin convening (ACE) inhibitors (for example captopril. enalapril) or angiotensin II receptor blockers.

Pregnancy, breast-feeding and fertility

The amount of instil in 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 mtake or diet.

If you are pregnant or breast-feeding, chink you may be pregnam or are planning to have a baby, ask your doctor or pharmacist far advice before using this medicine.

Driving and using machines

Your ability to concentrate and react may be reduced if yon have hypoglycaemia (low blood sugar). Please remember this iu all situations where you ought put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your diabetes specialist muse or doctor about the advisability of driving if you have:

■    frequent episodes of hypoglycaemia

*    reduced or absent warning signs of hypoglycaemia.

3. How to use Humulin S

The i ml cartridge is only for use in 3ml pens. It is not for use iu 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy. Make sore you get the Humulin that your doctor has told you to use.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle an the delivery device is changed.

Dosage

*    Your doctor has told you which insulin to use, haw much, when and how often to inject. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

*    If sou change vour msulm type (for example from animal to human), sou mav have to take more or less than before. This might just be for the first rmecnou at it may be 1 gradual change over several weeks or months.

*    Inject Humulin S under the skin. You should only inject it into a muscle if your doctor has told you to. Preparing Humulin S

■    Humulin S is already dissolved in water, so you do not need to mix if. But you must use if only if it looks like water. It must be clear, have no colour and no solid particle m it. Check each, tune sou inject yourself.

Getting the pen ready to use

*    First wash your hands. Disinfect the rubber membrane of the cartridge.

*    You must only use Humulin S cartridges in compatible CE marked pens. Please make sure that Humulin S or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 3 ml cartridge only fits, the 3 ml pen.

*    Follow the instructions tliar come with the pen. Put the cartridge ituo the pen.

*    You will set the dose to 1 or 2 units. Then bold the pen with the needle pointing up and tap the side of the pen so that any bubble float to fee top. With the pen still pointing up, pres the injection mechanism. Do this until a drop of Humulin S comes out of fee needle. There may still be some small air bubbles left in fee pen. These ire harmless, but If the air bubble is too big, it may make fee dose of your injection less accurate.

Injecting Humulin S

*    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, lease the needle lathe 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 an) from where you last injected and that you ‘rotate^: the places you inject, as you have been taught.

*    You must not inject Humulin S into a vein. Inject Humulin S as your diabetes specialist nurse or doctor has taught you Only your doctor can inject Humnlm S into a vein. He or she will only do this under special circumstances such as surgery oar if you are ill and your glucose levels are too high.

After injecting

*    As soon as you have done the injection, unscrew fee needle from the pen using the outer needle cap. This will keep fee insulin sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles or your pen. Replace fee cap an your pen.

Further injections

*    Leave fee cartridge iu the pen. Before every injection, dial 1 or 2 units and pres the injection mechanism with the pen poinmg up until a drop of Humulin S comes out of the needle You can see how much Humnlm S is left bv looking at fee gauge on fee side of fee carmdge. The distance betw een each mack on the gauge is about 20 units. If there is not enough for your dose, change fee cartridge.

Do not mix any other insulin in a Humulin S cartridge. Once the cartridge is empty, do not use it again. If you use more Humulin S than you should

If yon use mere Hiutmlin S than you should, your blood sugar may become low. Check your blood sugar, (see A in Section 4).

If you forget to use Humulin S

If you use less Humulin S than you should, your blood sugar levels may increase. Check your blood sugar. Do not inject a double dose to make up for a fotgotten dose.

If you stop using Humulin S

If you use less Humnlm S than you should, your blood sugar levels may become too high. Do not change vour insulin unless your doctor tells you to.

If you have any further quesnoos on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, feds medicine can cause side effects, although not every body 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:

* fall in Wood pressure    • rash over the whole body

* difficulty in bieaitung    * wheezing

*    fast bean beat    ■ sweating

If you think you are hatting this sort of insulin allergy with Humulin S, tell your doctor at once.

Local allergy is common (affects less than 3 person in 10). Some people get redness, swelling or itching around the area of fee insulin injection Ibis usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (affects less than 1 person iu 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 repented, particularly at the start of insulin therapy or during a change iu therapy to improve control of your blood glucose.

Common problems of diabetes

A.    Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in fee blood This can be caused if yon:

*    take too much Humulin S or other insulin:

*    miss or delay meals or change your diet;

*    exercise or work too hard just before or after a meal;

*    have an infection or illness (especially diarrhoea or vomiting);

*    have a change in your need tor insulin; or

*    have trouble wife your kidneys or liver which gets worse.

Alcohol and scone medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

* tiredness    • rapid heartbeat

■    nervousness or shakiness    * feeling side

■ headache    * cold sweat

Until you become confident in recognising your warning symptoms, avoid situations such as driving a cat, in which you or others would he put at risk by hypoglycaemia.

Do not use Humulin S if you think hypoglycaemia (low blood sugar) is starting.

If your blood sugar is low. eat glucose (ablets, sugar or diink 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 you breathing is shallow and you skin gets pale, tell you doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after fee glucagon injection. If you do not respond to glucagon, yon will have to go to hospital. Ask you doctor to tell you about glucagon.

B.    Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means feat you body does not have enough insulin. Hyperglycaemia can be brought about by.

*    not v*terny youx Hunni ir S or other insulin,

*    taking less msulm than your doctor tells you to;

*    eating a lot more than you diet allows; or

*    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:

*    feeling sleepy    • no appetite

* flushed face    ■ fruity smell on the breath

* thirst    • 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 sugar) are not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death.

Three simple steps to avoid hvpogiyaiemia or hypergtycaemia are:

•    Always keep spare syringes and a spare vial of Humuhn S.

•    Always cany something to show you are diabetic.

•    Always cany sugar with you.