Humalog Mix25 KwikPen 100 U/ml injection suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Humalog Mix25 KwikPen 100 units/ml injectable suspension in a pre-filled pen insulin lispro

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

Read this entire 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 others, 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.

Package leaflet

1. What Humalog Mix25 KwikPen is and what it is used for
2. What you need to know before using Humalog Mix25 KwikPen
3. How to use Humalog Mix25 KwikPen
4. Possible side effects
5. How to store Humalog Mix25 KwikPen
6. Contents of the pack and other information

1. What Humalog Mix25 KwikPen is and what it is used for

Humalog Mix25 KwikPen is used to treat diabetes. It is a premixed suspension. Its active substance is insulin lispro. In Humalog Mix25 KwikPen, 25% of insulin lispro is dissolved in water and works more rapidly than regular human insulin because the insulin molecule has been slightly modified. In Humalog Mix25 KwikPen, 75% of insulin lispro is combined as a suspension with protamine sulfate to prolong its action.

You have diabetes when your pancreas does not produce enough insulin to control the level of glucose in your blood. Humalog Mix25 is a replacement for your own insulin and is used to control blood glucose over the long term. It acts more rapidly and for a longer duration than soluble insulin.

Usually, Humalog Mix25 should be used within 15 minutes around mealtime.

Your doctor may recommend that you use Humalog Mix25 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. Exercise great care when switching from one insulin to another.

The KwikPen is a disposable, pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro. One KwikPen contains multiple insulin doses. The KwikPen delivers insulin in 1-unit increments. The number of units is displayed in the dose window; always check it before your injection. 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 you start using Humalog Mix25 KwikPen

DO NOT use Humalog Mix25 KwikPen

• If you think you are experiencing hypoglycaemia (low blood sugar). Later in this leaflet, instructions are provided on how to manage mild hypoglycaemia (see Section 3: If you use more Humalog Mix25 than you should).
• If you are allergic to 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 shown on the packaging and label of the pre-filled pen. Make sure you take home the Humalog Mix25 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 signal your blood sugar is dropping too low. These warning symptoms are specified later in this leaflet. You must carefully plan your meal times, when and how much physical activity you do. You must also monitor your blood sugar levels closely by frequently testing your blood glucose.
• Some patients who experienced hypoglycemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less noticeable or different. If you experience frequent hypoglycemia or have difficulty recognizing its symptoms, 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 doing more physical exercise than usual?
• The amount of insulin you need may change if you drink 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 the one you follow in your home country.
• Some patients with long-standing type 2 diabetes and a history of heart disease or prior 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 (edema).
• It is not recommended that blind individuals or people with visual impairments use this pen without the assistance of a person trained in the use of the pen.

Other medicines and Humalog Mix25 KwikPen

Your insulin requirements may change if you are using

• contraceptives,
• steroids,
• thyroid hormone replacement therapy,
• oral hypoglycemics,
• 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,
• certain 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 do you intend to become pregnant? Are you breastfeeding? The amount of insulin you need 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 might be pregnant, or plan to become 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 potential problem and consider 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 advisable to drive if you have:

• frequent episodes of hypoglycemia
• difficulty perceiving the symptoms of hypoglycemia or are unable to perceive them

Humalog Mix25 KwikPen contains sodium

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

3. How to use Humalog Mix25 KwikPen

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again. To prevent the possible transmission of disease, each pen must be used only by you, even if the needle is changed.

Dosage

• Humalog Mix25 should normally be injected within 15 minutes before or after a meal. If necessary, it may be administered shortly after a meal. However, your doctor has specifically instructed you on the exact dose you should use, when to take it, and how often. These instructions are individual to you. Follow them exactly and attend your diabetes clinic regularly.
• If you switch the type of insulin you use (for example, from animal or human insulin to a product containing Humalog), you may need to use a different dose—either higher or lower—than before. This may apply only to your first injection or may require a gradual adjustment lasting several weeks or months.
• Humalog Mix25 KwikPen is intended only for subcutaneous injection (just under the skin). Consult your doctor if you need to administer insulin by another method.

How to prepare Humalog Mix25 KwikPen

• Immediately before use, gently roll the KwikPen between the palms of the hands ten times and then invert it 180? ten more times to resuspend the insulin, until the insulin appears uniformly cloudy or milky. If not, repeat the procedure described above until the components are fully mixed. The cartridges contain a small glass bead to aid mixing. Do not shake vigorously, as foam may form and could interfere with accurate dose measurement. Cartridges should be inspected frequently; do not use if clumps or white solid particles adhering to the bottom or walls of the cartridge are visible, giving it a frost-like appearance. Check this each time you inject.

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. Below are some reminders.
• Use a new needle. (Needles are not included).
• Prime your KwikPen before each use. This ensures that insulin comes out and removes air bubbles from your KwikPen. Some 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 Mix25

• Before injecting, clean the skin as you have been instructed. Inject under the skin as you have been shown. Do not inject directly into a vein. After injecting, leave the needle in the skin for five seconds to ensure you have delivered the full dose. Do not rub the area where you have just injected. Make sure to inject at least 1 cm away from your last injection site and rotate your injection sites as you have been instructed.

After the injection

• As soon as you have finished injecting, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and prevent leakage. It will also avoid air entering the pen and needle blockage. Do not share needles. Do not share your pen. Replace the cap on the pen.

Subsequent Injections

• Each time you use a KwikPen, you must 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 left.
• Do not mix any other insulin in the disposable pen. When the KwikPen is empty, it can no longer be used. Dispose of the pen responsibly—your pharmacist or diabetes educator will advise you how to do this.

If you use more Humalog Mix25 than you should

If you use more Humalog Mix25 than you need, or if you are unsure of how much you have injected, your blood sugar may drop. Check your blood sugar level.

If your blood sugar is low (mild hypoglycemia), take glucose tablets, sugar, or a sugary drink. Then eat some fruit, biscuits, or a snack, as your doctor has advised, and rest afterwards. This usually helps overcome mild hypoglycemia or a small insulin overdose. If your condition worsens and your breathing becomes shallow and your skin turns pale, contact your doctor immediately. Severe hypoglycemia can be treated with a glucagon injection. After the glucagon injection, glucose or sugar should be taken. If there is no response to glucagon, you must go to the hospital. Ask your doctor for information about glucagon.

If you forget to use Humalog Mix25

If you use less Humalog Mix25 than you need, or if you are unsure how much you have injected, your blood sugar may rise. Check your blood sugar level.

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

Three simple steps to help prevent hypoglycaemia or hyperglycaemia are:

• Always keep extra syringes and vials of Humalog Mix25, or additional pens and cartridges, in case you lose your KwikPen or it becomes damaged.
• Always wear identification indicating that you are diabetic.
• Always carry a source of sugar with you.

If you interrupt treatment with Humalog Mix25

If you use less Humalog Mix25 than you need, your blood sugar may rise. 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 may cause adverse effects, although not everyone experiences them.

Systemic allergy is rare (≥1/10,000 to <1/1,000). Symptoms include:

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

If you think you are experiencing this type of allergic reaction with Humalog Mix25, contact 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 usually resolves within a few days or weeks. If this occurs, inform your doctor.

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

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

Reporting of adverse reactions

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

Common problems of diabetes

1. Hypoglycemia

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

• having injected too much Humalog Mix25 or any other type of insulin;
• having skipped a meal, delayed a meal, or changed your diet;
• having exerted yourself excessively or done too much physical exercise immediately before or after a meal;
• having an infection or being ill (especially diarrhea or vomiting);
• changes in your insulin requirements; or
• worsening of a kidney or liver condition.

Alcohol and certain medications can affect your blood sugar levels.

The early symptoms of low blood sugar usually appear suddenly and are accompanied by:

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

Until you are certain that you can recognize the warning symptoms, avoid situations (e.g., driving a car) in which you or others could be put at risk if hypoglycemia were to occur.

B. Hyperglycemia and Diabetic Ketoacidosis

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

• not taking Humalog or another insulin;
• taking less insulin than prescribed by your doctor;
• eating much more than your diet allows; or
• having a fever, an 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
• facial flushing – fruity breath odor
• thirst – nausea or vomiting

Severe symptoms include labored breathing and rapid pulse. Seek immediate medical assistance.

C. Illness

If you are ill, 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 take insulin. Test your urine or blood, follow the instructions you have been given for times of illness, and contact your doctor.

5. Storage of Humalog Mix25 KwikPen

• Keep the unopened Humalog Mix25 KwikPen refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Keep in the original carton to protect from light until use.
• Do not use Humalog Mix25 KwikPen after the expiration date stated on the label.
• Once opened (in-use), the Humalog Mix25 KwikPen can be kept either refrigerated or stored at room temperature not exceeding 30°C (86°F) for up to 14 days. Discard the pen after 14 days, even if it still contains insulin.
• Avoid excessive heat and sunlight. Do not store in a car or near a heat source.
• Never store the pen with the needle attached, to prevent contamination, infection, or leakage of insulin.
• Keep out of reach and sight of children.

For additional information on storage, refer to the package insert.

Before first use, store Humalog Mix25 KwikPen in the refrigerator (between 2°C and 8°C). Do not freeze.

Keep your Humalog Mix25 KwikPen in use at room temperature (below 30°C) and discard it after 28 days. Do not place it near heat sources or direct sunlight. Do not store the KwikPen you are currently using in the refrigerator. Do not leave the needle attached to the KwikPen.

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 clumps or solid white particles attached to the bottom or sides of the cartridge, giving it a frost-like appearance. Check this each time before injecting.

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. Contents of the pack and other information

Composition of Humalog Mix25 KwikPen 100 units/ml injectable suspension

• The active substance is insulin lispro. Insulin lispro is produced in the laboratory by a "recombinant DNA technology" process. 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 protamine sulfate, m-cresol, phenol, glycerol, dibasic sodium phosphate·7H2O, zinc oxide, and water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the pH.

Appearance of the product and contents of the pack

Humalog Mix25 KwikPen 100 units/ml injectable suspension is a sterile, white suspension containing 100 units of insulin lispro in each milliliter of injectable suspension (100 units/ml). In Humalog Mix25, 25% of insulin lispro is dissolved in water. A 75% suspension of insulin lispro combined with protamine sulfate has been incorporated into Humalog Mix25. Each Humalog Mix25 KwikPen contains 300 units (3 milliliters). Humalog Mix25 KwikPen is available in a pack of 5 prefilled pens or in a multiple pack consisting of 2 packs of 5 prefilled pens. Not all pack sizes may be marketed. The Humalog Mix25 contained in your KwikPen is identical to that provided in individual Humalog Mix25 cartridges. The KwikPen simply contains a built-in cartridge. When the KwikPen is empty, it cannot be reused.

Marketing Authorisation Holder and Manufacturer Responsible

Humalog Mix25 KwikPen 100 units/ml injectable suspension 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 Authorisation Holder is Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation 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

????????

?? "??? ???? ?????????" ?.?. - ????????

???. + 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 Nederland

170

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Eli Lilly Nederland B.V.

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

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. Pārstāvniecība Latvijā

Tel: +371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

Date of most recent revision of this leaflet:

USER MANUAL

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

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