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 the entire label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to 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 you need to know before starting to use Humalog KwikPen
2. How to use Humalog KwikPen

1. Possible adverse effects
2. Storage of Humalog KwikPen
3. Contents of the package and additional information

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 an insulin substitute and is used to control glucose levels in 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 havehypoglycemia(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 in the pharmacy. 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.

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

• • 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 in the use of the pen.

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 (for example ritodrine, salbutamol, or terbutaline),

• beta-blockers, or

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

• danazol,

• some angiotensin-converting enzyme inhibitors (for example captopril, enalapril), and

• angiotensin II receptor blockers.

Inform your doctor if you are using, have used recently, or may need to use any other medicine, even those acquired 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, or think you may be pregnant, 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 the symptoms of a hypoglycemia 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.

Dose

• Normally, Humalog should be injected within 15 minutes around a meal. 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. It may only be so 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,onlyuse it 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)

• First, wash your hands.

• Read the instructions on how to use your preloaded 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. You may still see some small air bubbles in your KwikPen, 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 you have injected the full dose. Do not rub the area where the injection was made. Make sure you have injected at least 1 cm away from where you last injected and that you "rotate" the injection sites, 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 outer needle cap. This will keep the insulin sterile and prevent losses. It will also prevent air from entering the pen and clogging the needle.Do not share needles.Do not share your pen.Replace the cap 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 KwikPen 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 reused. 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, and rest afterwards. This usually helps you recover from 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 glucagon injection. After 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 measuresto avoid hypoglycemia or hyperglycemia are:

• 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 distinctive sign indicating your diabetes condition.

• Always carry some sugar.

If you interrupt Humalog treatment

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 using this medication, ask your doctor or pharmacist.

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

Systemic allergy is rare (≥1/10,000 to <1

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

Localized allergy is common (≥ 1/100 to <1

Lipodystrophy (the skin becomes thicker ora depression forms) is infrequent

(≥ 1/1,000 to <1

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

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 thenational 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

1. 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;

• having missed a meal, delayed it or changed your diet;

• having worked too hard or done too much exercise immediately before or after a meal;

• being ill or having an infection (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:

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

1. Hyperglycemia and diabetic ketoacidosis

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

• not having taken 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:

The severe symptoms are deep breathing and rapid pulse.Seek medical assistance immediately.

1. 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 insulin.Get urine or blood tests, follow the instructions you have been given 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.

Store 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.

Keep 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 packaging. 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.Onlyuse it if its appearance is like water. Check this before each injection.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging 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 other 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 consisting of 2 packages of 5 pre-filled pens. Not all presentations may be marketed. The Humalog 100 units/mL containing the 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.

Marketing authorization holder 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 marketing authorization holder 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:

Last review date 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.