Humalog KwikPen 200 units/ml solution for injection in pre-filled pen

Patient Information Leaflet

Introduction

Patient Information Leaflet

Humalog KwikPen 100 units/ml solution for injection in a prefilled pen

insulin lispro

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

Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Humalog KwikPen is and what it is used for
2. What you need to know before using Humalog KwikPen
3. How to use Humalog KwikPen
4. Possible side effects
5. How to store 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 regular human insulin because the insulin molecule has been slightly modified.

You have diabetes when your pancreas does not produce enough insulin to control your blood glucose level. Humalog acts as a replacement for your own insulin and is used to control blood glucose over the long term. It acts very rapidly and for a shorter duration than soluble insulin (from 2 to 5 hours). Humalog is usually taken within 15 minutes around mealtime.

Your doctor may recommend that you use Humalog KwikPen in addition to a longer-acting insulin. Each of these comes with its own package leaflet containing specific information. Do not change your insulin unless your doctor tells you to. Be very careful when switching from one insulin to another.

Humalog is suitable for use in adults and children.

The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen displays the dose in 1-unit increments. The number of units is shown in the dose window; always check it before injecting. You can inject from 1 to 60 units in a single injection. If your dose is greater than 60 units, you will need to administer more than one injection.

2. What you need to know before using Humalog KwikPen

DO NOT use Humalog KwikPen

• If you think you are experiencing hypoglycaemia (low blood sugar). How to manage mild hypoglycaemia is explained later in this leaflet (see Section 3: If you use more Humalog than you should).
• If you are allergic to insulin lispro or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

• Always check at the pharmacy the name and type of insulin shown on the packaging and label of the pre-filled pen. Make sure you are taking the Humalog KwikPen prescribed by your doctor.
• If your blood sugar levels are well controlled with your current insulin therapy, you may not notice the warning symptoms that alert you that your blood sugar is dropping too low. These warning symptoms are described later in this leaflet. You must carefully plan your meal times, when to exercise, and how much exercise you can do. You must also monitor your blood sugar levels closely by frequently testing your blood glucose.
• Some patients who have experienced hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less noticeable or different. If you experience frequent hypoglycaemic episodes or have difficulty recognizing them, please inform your doctor.
• If you answer YES to any of the following questions, please discuss this with your doctor, pharmacist, or diabetes educator:
• Have you recently become ill?
• Do you have liver or kidney problems?
• Are you exercising more than usual?
• The amount of insulin you need may change if you consume alcohol.
• If you are planning to travel abroad, inform your doctor, pharmacist, or diabetes educator. Time differences between countries may require you to follow a different schedule for injections and meals than you normally follow at home.
• Some patients with long-standing type 2 diabetes mellitus and prior heart disease or stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as difficulty breathing, rapid weight gain, or localized swelling (oedema).
• It is not recommended that blind individuals or those with visual impairments use this pen without the assistance of a person trained in its use.

Other medicines and Humalog KwikPen

Your insulin requirements may change if you are using

• contraceptives,
• steroids,
• thyroid hormone replacement therapy,
• oral hypoglycaemics,
• acetylsalicylic acid,
• sulfa antibiotics,
• octreotide,
• beta2 stimulants (e.g. ritodrine, salbutamol, or terbutaline),
• beta-blockers, or
• certain 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 taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breastfeeding

Are you pregnant or planning to become pregnant? Are you breastfeeding? Your insulin requirement generally decreases during the first three months of pregnancy and increases during the following six months. If you are breastfeeding, you may need to adjust your insulin dose or diet. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Your ability to concentrate or react may be reduced if you experience hypoglycaemia. Be aware of this potential problem, considering all situations that could pose a risk to yourself or others (e.g. driving a vehicle or operating machinery). You should consult your doctor about whether it is safe for you to drive if you:

• have frequent episodes of hypoglycaemia
• have difficulty perceiving the symptoms of hypoglycaemia or do not perceive them at all

Humalog KwikPen contains sodium

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

3. How to use Humalog KwikPen

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again. To prevent the 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 necessary, it may be injected shortly after a meal. However, your doctor will have told you exactly how much to use, when to take it, and how often. These instructions are specific to you. Follow them precisely and attend your diabetes clinic regularly.

• If you change the type of insulin you use (for example, from animal or human insulin to a product containing Humalog), you may need to use a larger or smaller amount than before. This may apply only for the first injection or may require a gradual adjustment lasting several weeks or months.

• Humalog KwikPen is intended only for subcutaneous injection. Consult your doctor if you need to administer insulin by another method.

How to prepare Humalog KwikPen

• Humalog comes already dissolved in water, so it does not need to be mixed. However, you should only use it if its appearance is like that of water—clear, colorless, and free of solid particles. Check this 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 prefilled insulin 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 ensures that insulin flows properly and removes air bubbles from your KwikPen. Small air bubbles may still remain in your pen; these are harmless. However, if the air bubble is too large, the injection dose may be less accurate.

How to inject Humalog

• Before injecting, clean the skin as you have been taught. Inject under the skin as instructed. Do not inject directly into a vein. After injection, leave the needle in the skin for five seconds to ensure the full dose has been delivered. Do not rub the injection site. Make sure to inject at least 1 cm away from your last injection site and rotate injection sites as instructed. Humalog will always act faster than soluble human insulin, regardless of the injection site (upper arms, thighs, buttocks, or abdomen).
• Humalog must not be administered into a vein (intravenous). Inject Humalog as taught by your doctor or diabetes educator. Only your doctor may administer Humalog intravenously. Your doctor will administer Humalog intravenously only under special circumstances, such as during surgery or if you have been ill and your glucose levels are too high.

After the injection

• Immediately after completing the injection, unscrew the needle from the KwikPen using the outer needle cap. This keeps the insulin sterile and prevents leakage. It also prevents air from entering the pen and avoids needle blockage. 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 upward. The scale on the cartridge shows approximately the number of units remaining.
• Do not mix any other insulin into the disposable pen. When the KwikPen is empty, it cannot be reused. Dispose of the pen responsibly; your pharmacist or diabetes educator will advise you how to do this.

Use of Humalog in an insulin infusion pump

• Humalog KwikPen is intended only for subcutaneous injection. Do not use the pen to administer Humalog by any other route. If needed, other presentations of Humalog 100 units/mL are available. Consult your doctor if you need to administer insulin by another method.

If you use more Humalog than you should

If you use more Humalog than needed or are unsure of the amount injected, you may experience low blood sugar. Check your blood glucose.

If your blood sugar is low (mild hypoglycemia), take glucose tablets, sugar, or a sugary drink. Then eat fruit, biscuits, or a snack as instructed by your doctor, and rest afterward. This usually helps overcome mild hypoglycemia or a small insulin overdose. If your condition worsens and your breathing becomes shallow and your skin pale, call your doctor immediately. Severe hypoglycemia can be treated with a glucagon injection. After a glucagon injection, glucose or sugar should be taken. If there is no response to glucagon, hospitalization is required. Ask your doctor for information about glucagon.

If you forget to use Humalog

If you use less Humalog than needed or are unsure of the amount injected, you may experience high blood sugar. Check your blood glucose.

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

Three simple measures to avoid hypoglycemia or hyperglycemia are:

• Always keep spare syringes and vials of Humalog, or extra pens and cartridges, in case you lose your KwikPen or it becomes damaged.

• Always wear a medical identification tag indicating you are diabetic.

• Always carry some sugar with you.

If you stop using Humalog

If you use less Humalog than needed, you may experience high blood sugar. Do not switch insulin unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Systemic allergy is rare (≥1/10,000 to <1/1,000). It presents the following symptoms:

• rash all over the body • drop in blood pressure
• difficulty breathing • rapid heartbeat
• wheezing • sweating

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

Localized allergy is common (≥1/100 to <1/10). In some people, the area where insulin has been injected becomes red, swollen, or itchy. This condition usually resolves within a few days or weeks. If this occurs, inform your doctor.

Lipodystrophy (skin thickening or formation of a pit-like depression) is uncommon (≥1/1,000 to <1/100). If you notice that the skin at your injection sites becomes thicker or develops a pit-like appearance, inform your doctor.

Cases of edema (e.g., swelling in arms, ankles; fluid retention) have been reported, especially at the beginning of insulin treatment or during a change in treatment aimed at improving blood glucose control.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

Common diabetes-related problems

• Hypoglycemia

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

• administering too much Humalog or any other type of insulin;
• skipping a meal, delaying it, or changing your diet;
• excessive physical work or exercise performed just before or after a meal;
• having an infection or being ill (especially diarrhea or vomiting);
• changes in your insulin requirements; or
• worsening of kidney or liver disease.

Alcohol and certain medicines can affect your blood sugar levels.

Early symptoms of low blood sugar usually appear suddenly and include:

• fatigue • palpitations
• nervousness and trembling • nausea
• headache • cold sweats

Until you are confident in recognizing these warning symptoms, avoid situations (e.g., driving a car) in which you or others could be endangered if hypoglycemia occurs.

• Hyperglycemia and diabetic ketoacidosis

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

• not administering Humalog or any other type of insulin;
• administering less insulin than prescribed by your doctor;
• eating significantly more than allowed by your diet; or
• having a fever, infection, or emotional stress.

Hyperglycemia may progress to diabetic ketoacidosis. Early symptoms develop slowly over several hours or days. These symptoms include:

• drowsiness • loss of appetite
• flushed face • fruity-smelling breath
• thirst • nausea or vomiting

Severe symptoms include labored breathing and rapid pulse. Seek medical help immediately.

• Illness

If you are ill, especially if you have nausea or vomiting, the amount of insulin you need may change. Even if you are not eating as usual, you still need insulin. Perform urine or blood tests, follow the instructions you have been given for managing illness, and contact your doctor.

5. Storage of Humalog KwikPen

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

Keep the Humalog KwikPen in use at room temperature (below 30°C) and discard it after 28 days. Do not place it near any heat source or expose it to direct sunlight. Do not store the KwikPen you are currently using in the refrigerator. Never store the KwikPen with the needle attached.

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

Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice it has changed colour or contains solid particles. Only use it if it appears clear and colourless, like water. Check this before each injection.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and additional information

Composition of Humalog KwikPen 100 units/ml solution for injection

• The active substance is insulin lispro. Insulin lispro is produced in the laboratory using "recombinant DNA technology". It is a modified form of human insulin and therefore differs from other human insulins and from animal-source insulins. Insulin lispro is closely related to human insulin, a natural hormone produced by the pancreas.
• The other components are m-cresol, glycerol, dibasic sodium phosphate·7H₂O, zinc oxide, and water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the pH.

Description of the product and contents of the pack

Humalog KwikPen 100 units/ml solution for injection is a sterile, clear, colourless, aqueous solution containing 100 units of insulin lispro per millilitre of injectable solution (100 units/ml). Each Humalog KwikPen contains 300 units (3 millilitres). Humalog KwikPen is available in a pack of 5 pre-filled pens or in a multipack consisting of 2 packs of 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog 100 units/ml contained in your pre-filled pen is identical to the Humalog 100 units/ml available in individual cartridges for Humalog 100 units/ml. The KwikPen device 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 solution for injection 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, The Netherlands.

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Belgique/België/Belgien

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

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Lietuva

Tel. +370 (5) 2649600

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???. + 359 2 491 41 40

Luxembourg/Luxemburg

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

Tél/Tel: + 32-(0)2 548 84 84

Ceská republika

ELI LILLY CR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

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

162

Eesti

Eli Lilly Nederland B.V.

Tel: +372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

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

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly (Suisse) S.A. Parstāvniecība Latvijā

Tel: +371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

Date of the most recent review of this leaflet:

USER MANUAL

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

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