Label: information for the user

Humalog KwikPen 100 units/mL injectable solution in a pre-filled pen

insulin lispro

Each KwikPen administers 1 to 60 units in increments of 1 unit.

Read this label carefully before starting to use this medication, because

it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Humalog KwikPen and how it is used

2. What you need to know before starting to use Humalog KwikPen

3. How to use Humalog KwikPen

4. Possible adverse effects

5. Storage of Humalog KwikPen

6. Contents of the package and additional informationl

Humalog KwikPen is used to treat diabetes. It works faster than regular human insulin because the insulin molecule has been slightly changed.

You have diabetes when your pancreas does not produce enough insulin to control your blood glucose level. Humalog is a substitute for your own insulin and is used to control glucose levels over the long term. It acts very quickly and for a shorter time than soluble insulin (2 to 5 hours). Humalog is usually used within 15 minutes of eating.

Your doctor may recommend using Humalog KwikPen in addition to a longer-acting insulin. Each one comes with its own leaflet with specific information. Do not change your insulin unless your doctor tells you to. Be very careful when changing insulin.

The use of Humalog is suitable for adults and children.

The KwikPen is a pre-filled, disposable pen that contains 3 ml (300 units, 100 units/ml) of insulin lispro. A KwikPen contains multiple doses of insulin. The KwikPen marks 1 unit each time.

The number of units is shown in the dosing window, check it always before your injection.

You can inject from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to administer more than one injection.

Do not use Humalog KwikPen

-If you think you are starting to have ahypoglycemia(low blood sugar level). Further on in this leaflet, it is indicated how to resolve a mild hypoglycemia (see Section 3: If you use more Humalog than you should).

-If you areallergicto insulin lispro or to any of the other components of this medicine (including in Section 6).

Warnings and precautions

-Always check the name and type of insulin that appears on the packaging and the label of the pre-filled pen. Make sure you are taking the Humalog KwikPen that your doctor has prescribed.

-If your blood sugar levels are well controlled with your current insulin therapy, you may not perceive the warning symptoms that alert you that your blood sugar is dropping too low. Further on in this leaflet, these warning symptoms are specified. You must carefully organize when you should eat, when you should exercise, and to what extent you can do it. You also have to closely monitor your blood sugar levels by frequently performing blood glucose tests.

-Determined patients who have experienced hypoglycemia after switching from animal insulin to human insulin, have commented that the first warning symptoms were less evident or different. If you have frequent hypoglycemias or difficulties in recognizing them, please do not hesitate to inform your doctor.

-If you answer AFFIRMATIVELY to any of the following questions, inform your doctor, pharmacist, or diabetes educator

-Have you recently been ill?

-Do you have liver or kidney problems?

-Are you doing more exercise than usual?

-The amount of insulin you need may vary if you drink alcohol.

-If you are planning to travel abroad, inform your doctor, pharmacist, or diabetes educator. The time difference between some countries may force you to adopt a different schedule for injections and meals than the one you are following in your country.

-Some patients with long-standing type 2 diabetes and previous heart disease or stroke, who were treated with pioglitazone and insulin, developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as difficulty breathing, rapid weight gain, or localized inflammation (edema).

-It is not recommended that the blind or people with visual impairments use this pen without the help of a trained person.

Other medicines and Humalog KwikPen

Your insulin needs may change if

•you are using contraceptives,

•steroids,

•thyroid hormone replacement therapy,

•oral hypoglycemics,

•aspirin,

•sulfa antibiotics,

•octreotide,

•beta-2 stimulants (e.g. ritodrine, salbutamol, or terbutaline),

•beta-blockers, or

•some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

•danazol,

• some angiotensin-converting enzyme inhibitors (e.g. captopril, enalapril),

and

• angiotensin II receptor blockers.

Inform your doctor if you are using, have recently used, or may need to use

any other medicine, even those purchased without a prescription (see section “Warnings and precautions”).

Pregnancy and breastfeeding

Are you pregnant or planning to become pregnant? Are you breastfeeding? The amount of insulin you need usually decreases during the first three months of pregnancy and increases during the next six months. If you are breastfeeding, you may need to adjust your insulin dose or diet. If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Your ability to concentrate or react may be reduced if you experience hypoglycemia. Be aware of this possible problem, considering all situations that may pose a risk to you or others (e.g. driving a vehicle or operating machinery). You should consult your doctor

about the advisability of driving if you have:

•frequent episodes of hypoglycemia

•difficulty perceiving hypoglycemia symptoms or not perceiving them

Humalog KwikPen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again. To prevent possible transmission of diseases, each pen must be used only by you, even if the needle is changed.

Dosage

• Humalog should normally be injected within 15 minutes around mealtime. If needed, it can be injected a little after a meal. However, your doctor will have indicated exactly the amount you need to use, when to apply it, and how often.

These instructions are specific to you. Follow them exactly and visit your diabetes clinic frequently.

• If you change the type of insulin you use (for example, from animal or human insulin to a product with Humalog), you may need to use a greater or lesser amount than before. This may only be the case for the first injection or may require a gradual change that lasts several weeks or months.

• Humalog KwikPen is only indicated for injection just below the skin. Consult your doctor if you need to inject insulin by another method.

How to prepare Humalog KwikPen

• Humalog is already dissolved in water, so it does not need to be mixed. However, it should only be used if its appearance is like water. It must be transparent, not have color, and not contain solid particles. Check that this is the case before each injection.

How to prepare the KwikPen (please read the user manual)

• Wash your hands first.

• Read the instructions on how to use your pre-filled insulin pen. Follow the instructions carefully. You will find some reminders below.

• Use a new needle. (Needles are not included).

• Purge your KwikPen before each use. This verifies that the insulin comes out and that air bubbles are eliminated from your KwikPen. There may still be some small air bubbles in your pen, which are harmless. However, if the air bubble is too large, the dose of the injection may be less precise.

How to inject Humalog

• Before injecting, clean the skin as you have been taught. Inject just below the skin, as you have been taught. Do not inject directly into a vein. After the injection, leave the needle in the skin for five seconds to ensure that the full dose has been injected. Do not rub the area where the injection was made. Make sure you have injected at least 1 cm away from where you did it last time and that you "rotate" the places where you inject, as you have been explained. Humalog injection will always act faster than human soluble insulin, regardless of where it is placed (upper arms, thighs, buttocks, or abdomen).

• Do not administer Humalog intravenously. Inject Humalog as your doctor or diabetes educator has taught you. Only your doctor can administer Humalog intravenously. Your doctor will only administer Humalog intravenously in special circumstances such as surgery or if you have been ill and your blood glucose levels are too high.

After the injection

• As soon as you finish injecting, remove the needle from the KwikPen using the external needle shield. This will keep the insulin sterile and prevent losses. It will also prevent air from entering the pen and the needle from becoming clogged. Do not share needles. Do not share your pen. Put the cap back on the pen.

Subsequent injections

• Each time you use the KwikPen, use a new needle. Before each injection, remove all air bubbles. You can see the remaining insulin by holding the pen with the needle pointing up. The scale on the cartridge shows approximately the number of units remaining.

• Do not mix any other insulin with the disposable pen. When the KwikPen is empty, it cannot be used again. Dispose of the pen responsibly; your pharmacist or diabetes educator will tell you how to do it.

Use of Humalog in an insulin pump

• Humalog KwikPen is only indicated for injection just below the skin. Do not use the pen to administer Humalog by another route. If this is necessary, there are other presentations of Humalog 100 units/ml available. Consult your doctor if you need to inject insulin by another method.

If you use more Humalog than you need

If you use more Humalog than you need or are unsure of how much you have injected, you may have low blood sugar. Check your blood sugar.

If your blood sugar is low(mild hypoglycemia), take glucose tablets, sugar, or a sweet drink. Then eat fruit, cookies, or a snack, as your doctor has instructed you, and rest afterwards. This usually helps to overcome mild hypoglycemia or a small overdose of insulin. If you get worse and your breathing is shallow and your skin is pale, call your doctor immediately. Severe hypoglycemia can be treated with a glucagon injection. After the glucagon injection, take glucose or sugar. If you do not respond to glucagon, you should go to the hospital. Ask your doctor to inform you about glucagon.

If you forget to use Humalog

If you use less Humalog than you need or are unsure of how much you have injected, you may have high blood sugar. Check your blood sugar.

If not treated properly, hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) can be very serious and cause headaches, nausea, vomiting, dehydration, loss of consciousness, coma, and even death (see A and B in section 4 "Possible side effects").

Three simple measures to prevent hypoglycemia or hyperglycemiaare:

• Always have extra syringes and vials of Humalog, or extra pens and cartridges, in case you lose your KwikPen or it breaks.

• Always carry a badge that indicates your diabetes condition.

• Always carry some sugar.

If you interrupt treatment with Humalog

If you use less Humalog than you need, you may have high blood sugar. Do not change insulin unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Systemic allergy israre (≥1/10,000 to <1

•body rash•low blood pressure

•difficulty breathing•rapid heartbeat

•high-pitched breathing•sweating

If you think you are experiencing this type of allergy with Humalog, speak immediately with your doctor.

Localized allergyis common (≥ 1/100 to <1where the insulin has been injected, the skin becomes red, swollen, or itchy. This situation usually disappears in a few days or weeks. If it happens, tell your doctor.

Lipodystrophy (the skin becomes thickeror a kind of hole forms) is infrequent

(≥1/1,000 to <1

Cases of edema (forexample swelling in the arms, legs; fluid retention), especially at the beginning of insulin treatment or during a change in treatment to improve blood sugar control, have been reported.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Common problems of diabetes

A. Hypoglycemia

Hypoglycemia (low blood sugar) means that you do not have enough sugar in your blood. It can be caused by:

• having taken too much Humalog or any other type of insulin;

• skipping a meal, delaying it, or changing your diet;

• having worked a lot or done too much exercise immediately before or after a

meal;

• having an infection or being ill (especially diarrhea or vomiting);

• having changes in your insulin needs; or

• having a worsening of a kidney or liver disease.

Alcohol and certain medications can affect your blood sugar levels.

The first symptoms of low blood sugar usually appear suddenly and are

accompanied by:

•fatigue•palpitations

•nervousness and tremors•nausea

•headache•chills

Until you are sure of recognizing the alarm symptoms, avoid situations (e.g. driving a car) in which you or others may be put in danger if hypoglycemia occurs.

B. Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (too much sugar in the blood) means that the body does not have enough insulin. Hyperglycemia can be caused by:

• not taking Humalog or any other type of insulin;

• having taken less insulin than prescribed by your doctor;

• having eaten much more than your diet allows; or

• having a fever, some infection, or emotional stress.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms appear

slowly, over many hours or several days. Among these symptoms are the following:

•drowsiness•loss of appetite

•facial flushing•breath with a fruity odor

•thirst•nausea or vomiting

The severe symptoms are deep breathing and rapid pulse.Get medical help

immediately.

C. Diseases

If you are ill, especially if you have nausea or vomiting, the amount of insulin you need may vary.Although you are not eating as usual, you still need to receive insulin.Get urine or blood tests, follow the instructions you have been given for when you are ill, and call your doctor.

Before first use, store Humalog KwikPen in the refrigerator (between 2°C and 8°C). Do not freeze.

Conserve your Humalog KwikPen in use at room temperature (below 30°C) and discard after 28 days. Do not leave it near any heat source or in the sun. Do not store the KwikPen in use in the refrigerator. The KwikPen should not be stored with the needle attached.

Maintain this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and in the

container. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that it has changed color or if it contains solid particles.It should only be used if its appearance is like water.Check this before each injection.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Humalog KwikPen 100 units/mL injectable solution

-The active ingredient is insulin lispro. Insulin lispro is manufactured in the laboratory by a DNA recombinant technology process. It is a modified form of human insulin and, therefore, differs from the rest of human insulins and animal insulins. Insulin lispro is closely related to human insulin, which is a natural hormone produced by the pancreas.

-The other components are m-cresol, glycerol, dibasic sodium phosphate.7H2O, zinc oxide, and water for injectable preparations. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

Appearance of the product and contents of the package

Humalog KwikPen 100 units/mL injectable solution is a sterile, transparent, colorless, aqueous solution containing 100 units of insulin lispro in each milliliter of injectable solution (100 units/mL). Each Humalog KwikPen contains 300 units (3 milliliters). Humalog KwikPen is presented in a package of 5 pre-filled pens or in a multiple package formed by 2 packages of 5 pre-filled pens. Not all presentations may be marketed. The Humalog 100 units/mL contained in your pre-filled pen is the same as the Humalog 100 units/mL presented in Humalog 100 units/mL cartridges. The KwikPen simply contains a cartridge inside. When the pre-filled pen is empty, it cannot be reused.

Holder of the marketing authorization and responsible manufacturer

Humalog KwikPen 100 units/mL injectable solution is manufactured by:

•Lilly France, S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

•Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The holder of the marketing authorization is Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Belgium/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tel/Tel: + 32-(0)2 548 84 84

Lithuania

Eli Lilly Lietuva

Tel. +370 (5) 2649600

...

...

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Czech Republic

ELI LILLY CR, s.r.o.

Tel: + 420 234 664 111

Hungary

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Denmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de GiorgioLtd.

Tel: + 356 25600 500

Germany

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Netherlands

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

162

Estonia

Eli Lilly Nederland B.V.

Tel:+372 6817 280

Norway

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Greece

PHARMASERVO-LILLY A.E.B.E.

Tel: +30 210 629 4600

Austria

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

Spain

Lilly S.A.

Tel: + 34-91 663 50 00

Poland

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 4934 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Croatia

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

Romania

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenia

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Iceland

Icepharma hf.

Sími + 354 540 8000

Slovakia

Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111

Italy

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Cyprus

Phadisco Ltd

Τηλ: +357 22 715000

Sweden

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Lithuania

Eli Lilly(Suisse) S.A Parstavnieciba Latvija

Tel:+371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

Date of the last review of this leaflet:

USER MANUAL

The user manual text is included at the end.

More detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.