HUMALOG 100 U/ml INJECTABLE SOLUTION IN VIALS

Introduction

Package Leaflet: Information for the User

Humalog 100 units/ml solution for injection in vial

insulin lispro

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 is and what it is used for
2. What you need to know before you use Humalog

1. How to use Humalog
2. Possible side effects

1. Storage of Humalog
2. Contents of the pack and other information

1. What Humalog is and what it is used for

Humalog is used to treat diabetes. Humalog 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 your glucose levels on a long-term basis. It acts quickly and its effects do not last as long as those of a soluble insulin (between 2 to 5 hours). Normally, Humalog is used shortly before a meal.

Your doctor may prescribe Humalog in addition to a longer-acting insulin. Each of these has its own patient information leaflet with specific instructions. Do not change your insulin unless your doctor has told you to do so. Be very careful if you change your insulin.

Use of Humalog is suitable for adults and children.

2. What you need to know before you use Humalog

Do not use Humalog

• If you think you are experiencing a hypoglycaemic episode(low blood sugar). Later in this leaflet, it is explained how to deal with a mild hypoglycaemic episode (see Section 3: If you use more Humalog than you should).

• If you are allergicto insulin lispro or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• At the pharmacy, always check the name and type of insulin on the label of the vial and the carton. Make sure you have been given the correct Humalog.

• 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. Later in this leaflet, these warning symptoms are listed.

You should plan your meals, physical activity and administration of Humalog in advance. You should also monitor your blood sugar levels regularly by performing blood glucose tests.

• Certain patients who have had hypoglycaemia after switching from an animal insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different. If you have frequent hypoglycaemic episodes or have difficulty recognising the warning symptoms, please 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 liver or kidney problems?
• Are you doing more exercise than usual?

• The amount of insulin you need may change if you drink alcohol.

• If you are going abroad, inform your doctor, pharmacist or diabetes educator. Time differences between countries may mean that you have to adjust your insulin injection schedule and diet.
• Some patients with type 2 diabetes and long-standing diabetes and heart disease or previous 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 shortness of breath, rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog

Your insulin needs may change if you are taking

• oral contraceptives,

• corticosteroids,

• thyroid hormone replacement therapy,

• oral hypoglycaemics,

• aspirin,

• sulfa antibiotics,

• octreotide,

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

• beta-blockers, or

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

• danazol,

• certain angiotensin-converting enzyme (ACE) inhibitors (e.g. 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 obtained without a prescription (see section “Warnings and precautions”).

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 next 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 or react may be reduced if you have hypoglycaemia. Be aware of this potential risk in all situations where you might put yourself and others at risk (e.g. 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 a hypoglycaemic episode or do not experience them

Humalog contains sodium

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

3. How to use Humalog

Follow exactly the instructions for administration of this medicine given by your doctor.

In case of doubt, consult your doctor again.

Dose

• Humalog should normally be given shortly before a meal. If necessary, it can be given 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 specific to you and may change over time. Follow them exactly and visit your diabetes clinic regularly.

• If you change the type of insulin you use (e.g. from animal or human insulin to a product with Humalog), you may need to use a higher or lower dose. This may only be for the first injection or it may need to be continued for several weeks or months.

• Inject Humalog under the skin. Only inject into a muscle if your doctor has told you to do so.

Preparing Humalog

• 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 putting each injection.

Injecting Humalog

• Wash your hands.

• Before injecting, clean your skin as you have been taught. Clean the rubber stopper on the vial but do not remove it.

• Use a clean and sterile needle and syringe. Put the needle through the rubber stopper and push the plunger to put the Humalog into the syringe. Your doctor or diabetes nurse will show you how to do this. Do notshareyour needles or syringes.

• Inject the Humalog under the skin, as you have been taught. Do not inject into a vein. After the injection, leave the needle under the skin for 5 seconds to make sure you have taken the whole 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 injection sites as you have been taught. The injection of Humalog will always work more quickly than a soluble human insulin, no matter where you inject it (upper arm, thigh, buttock or abdomen).

• Your doctor will tell you if you need to mix Humalog with any other insulin. If you need to mix Humalog with another insulin, draw the Humalog into the syringe first. Inject the mixture immediately after drawing it into the syringe. Always do it in the same way. Normally, you should not mix Humalog with any other insulin. Never mix Humalog with insulins made by other manufacturers or animal insulins.

• Humalog must not be administered via a vein (intravenously). Inject Humalog as you have been taught by your doctor or diabetes educator. Only your doctor can administer Humalog via a vein. Your doctor will only administer Humalog via a vein under special circumstances such as surgery or if you are ill and your blood sugar levels are too high.

Using Humalog in an insulin infusion pump

• For infusion of insulin lispro, only certain CE-marked infusion pumps can be used. Before infusion of insulin lispro, the instructions for the pump must be studied to ensure that the pump is suitable for this particular type of insulin. Read and follow the instructions that come with the infusion pump.

• Make sure you use the correct reservoir and infusion set for your pump.

• The infusion set (and needle) should be changed in accordance with the information provided with the infusion set.
• If a hypoglycaemic episode occurs, the infusion should be stopped until the episode is resolved. If severe or repeated episodes of hypoglycaemia occur, contact your healthcare professional and consider reducing or suspending the insulin infusion.

• Pump malfunction or infusion set occlusion can lead to a rapid increase in blood glucose levels. If it is suspected that the insulin flow has been interrupted, follow the instructions in the pump user manual and, if necessary, contact your healthcare professional.

• Humalog must not be mixed with any other insulin when used in an insulin infusion pump.

If you use more Humalog than you should

If you use more Humalog than you need, you may experience hypoglycaemia. Check your blood sugar levels.

If your blood sugar levels are low (mild hypoglycaemia), take glucose tablets, sugar or a sugary drink. Then eat fruit, biscuits or a sandwich, as your doctor has advised, and rest. This usually helps to bring your blood sugar levels back up. If you do not feel better soon, contact your doctor.

If you forget to use Humalog

If you use less Humalog than you need, you may experience hyperglycaemia. Check your blood sugar levels.

If you do not treat these situations, hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) can be very serious and even cause unconsciousness or death (see section 4 “Possible side effects”).

Three simple measuresto avoid hypoglycaemia or hyperglycaemia are:

• Always carry extra Humalog and syringes with you.

• Always carry something to show you are diabetic.

• Always carry sugar with you.

If you stop using Humalog

If you use less Humalog than you need, you may experience hyperglycaemia. 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 doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergic reactions are rare (≥1/10,000 to <1>

If you think you are experiencing a systemic allergic reaction with Humalog, contact your doctor immediately.

Local allergic reactions are common (≥1/100 to <1>

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥1/1,000 to <1>

There have been reports of oedema (e.g. swelling of the arms, ankles, face or throat) particularly at the start of insulin lispro therapy or during a change in insulin regimen to improve glucose control.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Common problems of diabetes

1. Hypoglycaemia

Hypoglycaemia (low blood sugar) means that you have too little sugar in your blood.

This can be caused by:

• taking too much Humalog or any other insulin;

• missing a meal or delaying it or changing your diet;

• doing more exercise than usual or doing it soon after a meal;

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

• changes in your insulin needs; or

• getting worse kidney or liver disease.

Alcohol and some medicines can affect your blood sugar levels.

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

Until you are confident that you can recognise the warning signs of a hypoglycaemic episode, avoid situations (e.g. driving a car) where you or others might be put at risk if you experience hypoglycaemia.

1. Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can occur if:

• you do not take your Humalog or any other insulin;

• you take less insulin than your doctor has prescribed;

• you eat more than your diet allows;

• you have an infection or fever or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms of diabetic ketoacidosis usually come on slowly, over a period of hours or days. They include:

Severe symptoms are heavy breathing and a fast pulse. Seek medical help immediately.

1. Illness

If you are ill, especially if you are sick or have diarrhoea, your need for insulin may change. Even if you are not eating much, you still need insulin.Test your urine or blood, follow your doctor’s advice on what to do when you are ill and contact your doctor.

5. Storage of Humalog

Before the first use, store Humalog in the refrigerator (between 2°C and 8°C). Do not freeze. You can keep your vial in use in the refrigerator (between 2°C and 8°C) or at room temperature (below 30°C) and discard it after 28 days. Do not leave it near any heat source or in the sun.

Keep this medicine out of 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. Onlyuse it if its appearance is like that of water. Check that this is the case before administering each injection.

Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Humalog 100 units/ml injectable solution in vial

• 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 components are m-cresol, glycerol, disodium 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 package contents

Humalog 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 vial contains 1,000 units (10 milliliters). Humalog 100 units/ml injectable solution in vial is presented in a package of 1 vial, 2 vials, or in a multiple package consisting of 5 packages of 1 vial. Not all presentations may be marketed.

Marketing authorization holder and manufacturer

Humalog 100 units/ml injectable solution in vial is manufactured by:

• Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

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 leaflet:

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