HUMALOG JUNIOR KWIKPEN 100 Units/mL Injectable Solution in Pre-filled Pen

Introduction

Package Leaflet: Information for the User

Humalog KwikPen 100 units/ml solution for injection in a pre-filled pen

insulin lispro

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

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Humalog KwikPen is and what it is used for
2. What you need to know before you use Humalog KwikPen
3. How to use Humalog KwikPen
4. Possible side effects
5. Storing Humalog KwikPen
6. Contents of the pack and other information

1. What Humalog KwikPen is and what it is used for

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

You have diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog is a substitute for your own insulin and is used to control glucose levels in the long term. It acts quickly and has a shorter duration of action (2 to 5 hours) compared to soluble insulin. Normally, Humalog is used within 15 minutes of a meal.

Your doctor may tell you to use Humalog KwikPen as well as a longer-acting insulin. Each of these insulins has its own patient information leaflet to tell you how to use them. Do not change your insulin unless your doctor has told you to. Be very careful if you do change your insulin.

Humalog can be used in adults and children.

The KwikPen is a pre-filled pen that contains 3 ml (300 units, 100 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen measures each dose of insulin in units. The number of units is shown in the dose window, always check this before you inject.You can give yourself one dose of 1 to 60 units of insulin at a time. If your dose is more than 60 units, you will need to give yourself more than one injection.

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

Do not use Humalog KwikPen

• If you think you are experiencing hypoglycaemia(low blood sugar levels). Later in this leaflet, it tells you how to deal with mild hypoglycaemia (see Section 3: If you use more Humalog than you need).
• If you are allergicto insulin lispro or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

• Always check the name and type of insulin you use to make sure you are using the correct medicine.
• If your blood sugar levels are well controlled with your current insulin therapy, you may not feel the warning symptoms of a low blood sugar. You must be careful to check your blood sugar levels regularly and to follow your doctor’s advice on diet and exercise and other medications you are taking.
• Some patients who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different. If you are experiencing frequent hypoglycaemia or have difficulty recognising the warning signs, you should talk to your doctor.
• If you answer YESto any of the following questions, tell your doctor, pharmacist or diabetes educator
• • Have you recently become ill?
  • Do you have problems with your liver or kidneys?
  • Are you doing more exercise than usual?
• The amount of insulin you need may change if you drink alcohol.
• If you are going abroad, you should talk to your doctor, pharmacist or diabetes educator. The time difference between countries may mean that you have to adjust your insulin routine.
• Some patients with type 2 diabetes and long-standing disease, or heart disease or previous stroke, who were treated with pioglitazone and insulin, developed heart failure.

Tell your doctor as soon as possible if you experience signs of heart failure such as difficulty breathing, rapid weight gain or localised swelling (oedema).

• It is not recommended that blind or visually impaired patients use this pen without assistance from a trained person.

Skin changes at the injection site

You should rotate your injection sites to avoid getting lumps under the skin. Insulin may not work properly if you inject it into a lumpy area (see How to use Humalog KwikPen). If you are currently injecting in a lumpy area, talk to your doctor before you start injecting in a different area. Your doctor may tell you to check your blood sugar levels more often and to adjust your insulin dose or the dose of your other diabetes medications.

Other medicines and Humalog KwikPen

Your insulin needs may change if you are taking

• oral contraceptives,
• corticosteroids,
• thyroid replacement therapy,
• medicines for the treatment of high blood pressure,
• aspirin,
• sulfa antibiotics,
• octreotide,
• beta-2 stimulants (such as ritodrine, salbutamol or terbutaline),
• beta-blockers, or
• certain antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
• danazol,
• certain angiotensin-converting enzyme (ACE) inhibitors (such as captopril, enalapril), and
• angiotensin II receptor blockers.

Tell your doctor if you are using, have recently used or might use any other medicines, including those not prescribed.

Pregnancy and breast-feeding

Are you pregnant or breast-feeding, or thinking of becoming pregnant? The amount of insulin you need usually decreases during the first three months of pregnancy and increases during the last six months. If you are breast-feeding, you may need to adjust your insulin dose or diet. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Discuss this with your doctor in any situations where you may put yourself and others at risk (such as driving a car or operating machinery). You should contact your doctor for advice on driving if you

• have frequent episodes of hypoglycaemia
• have difficulty recognising the warning signs of hypoglycaemia

Humalog KwikPen contains sodium

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

3. How to use Humalog KwikPen

Follow the instructions for using Humalog KwikPen exactly as your doctor has told you. If you are not sure about anything, ask your doctor. To prevent possible transmission of disease, each pen must be used by only one person, even if the needle is changed.

Dose

• Humalog should normally be given shortly before a meal. If you need to, you can give yourself a dose shortly after a meal. However, your doctor will tell you exactly how much to use, when to use it and how often. These instructions are only for you.
• 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 larger or smaller dose. This may only be for the first injection or it may need to be continued for several weeks or months.
• Humalog KwikPen is only intended for injection under the skin. If you need to inject insulin by another method, talk to your doctor.

Preparing Humalog KwikPen

• Humalog is already dissolved in water, so you do not need to mix it. However, onlyuse it if it looks like water. It must be clear, have no colour and not contain any solid particles. Check this before you inject each dose.

Preparing the KwikPen (please read the user manual)

• Wash your hands.
• Read the instructions on how to use your pre-filled pen. Follow the instructions carefully. The following are some reminders.
• Use a new needle. (Needles are not included).
• Prime your KwikPen before each use. This checks that insulin comes out and that air bubbles are removed from the pen. You may still see small air bubbles. These are harmless, but if the air bubble is too large, the dose of insulin may be slightly less accurate.

Injecting Humalog

• Before you inject, clean your skin as you have been taught. Inject under the skin, as you have been taught. Do not inject directly into a vein. After injecting, leave the needle in the skin for 5 seconds to make sure you have taken the full dose. Do not rub the area where you have just injected. Make sure you inject at least 1 cm away from where you last injected and rotate the sites as you have been taught. The injection of Humalog will always work more quickly than soluble human insulin, no matter where you inject it (upper arm, thigh, buttock or abdomen).
• Do not inject Humalog into a vein. Inject Humalog as your doctor has taught you. Only your doctor can give you Humalog by injection into a vein. Your doctor will only do this in special circumstances, such as severe dehydration or diabetic ketoacidosis.

After the injection

• When you have finished injecting, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and prevent contamination. It will also prevent air entering the pen and the needle clogging. Do not share needles.Do not share your pen. Put the cap back on the pen.

Further injections

• Every time you use the KwikPen, use a new needle. Before each injection, remove any air bubbles. You can see how much insulin is left by looking at the scale on the side of the pen.
• Do not mix any other insulin with the insulin in the KwikPen. When the KwikPen is empty, it must not be used again. Dispose of it carefully, following any local guidelines and advice from your doctor or pharmacist.

Using Humalog in an insulin infusion pump

• Humalog KwikPen is only intended for injection under the skin. Do not use it in an infusion pump. If you need to use an infusion pump, talk to your doctor.

If you use more Humalog than you need

If you use more Humalog than you need, you may get low blood sugar. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or a sweet snack (such as biscuits or sweets). Then eat a long-acting carbohydrate (such as bread or fruit) and rest. This usually gets better after 10 to 15 minutes. If you do not feel better after 10 to 15 minutes, contact your doctor or hospital.

If you forget to use Humalog

If you use less Humalog than you need, you may get high blood sugar. Check your blood sugar.

If you are not sure how much insulin you have taken, or think you have missed a dose, contact your doctor or pharmacist for advice.

Three simple measuresto prevent hypoglycaemia or hyperglycaemia are:

• Always carry some spare syringes and needles or a spare pen and cartridges with you, in case you lose or damage the ones you are using.
• Always carry something to show you are diabetic.
• Always carry some sugar with you.

If you stop using Humalog

If you use less Humalog than you need, you may get high blood sugar. Do not stop using Humalog without talking to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

If you think you are suffering from this type of allergy with Humalog, talk to your doctor immediately.

Localized allergy is frequent (≥1/100 to <1>

Lipodystrophy is infrequent (≥1/1,000 to <1>

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

Reporting of Adverse Effects

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

Common Diabetes Problems

1. Hypoglycemia

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

• you have taken too much Humalog or any other type of insulin;
• you have skipped a meal, delayed it, or changed your diet;
• you have worked too much or exercised too much immediately before or after a meal;
• you have an infection or are sick (especially diarrhea or vomiting);
• there have been changes in your insulin needs; or
• you have a worsening kidney or liver condition.

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 you can recognize the warning symptoms, avoid situations (e.g., driving a car) where you or others could be in danger if hypoglycemia occurs.

1. Hyperglycemia and Diabetic Ketoacidosis

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

• you have not taken Humalog or any other type of insulin;
• you have taken less insulin than prescribed by your doctor;
• you have eaten much more than your diet allows; or
• you have a fever, an 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:

Severe symptoms are heavy breathing and rapid pulse. Get medical help immediately.

1. Illnesses

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

5. Storage of Humalog KwikPen

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

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the label and packaging. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Humalog KwikPen 100 units/ml injectable solution

• The active ingredient is insulin lispro. Insulin lispro is manufactured in the laboratory by a process of "recombinant DNA technology". It is a modified form of human insulin and, therefore, differs from other human insulins and animal-derived insulins. Insulin lispro is closely related to human insulin, which is a natural hormone produced by the pancreas.
• The other ingredients are m-cresol, glycerol, disodium phosphate heptahydrate, 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 Package Contents

Humalog KwikPen 100 units/ml injectable solution is a sterile, transparent, colorless, aqueous solution and contains 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 contained in your pre-filled pen is the same as the Humalog 100 units/ml presented in individual 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 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.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Prospectus:

USER MANUAL

The text of the user manual is included at the end.

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