HUMALOG KWIKPEN 200 Units/mL Injectable Solution in a Pre-filled Pen

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

Do not use Humalog KwikPen

• If you think you are experiencing the start of a hypoglycaemic attack (low blood sugar). Further in this leaflet, it tells you how to deal with a mild hypoglycaemic attack (see Section 3: If you use more Humalog than you need).
• If you are allergic to 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 it is the right one for you.
• If your blood glucose levels are well controlled with your current insulin, you may not feel the warning symptoms of a hypoglycaemic attack as much. You must be careful to check your blood glucose levels regularly.
• Some patients who have had hypoglycaemic attacks after switching from animal insulin to human insulin have reported that the early warning symptoms were less pronounced or different.
• If you answer “yes” to 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, tell your doctor, pharmacist or diabetes educator.
• Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin developed heart failure.
• Do not use this pen without proper instruction from your doctor or diabetes educator.

Other medicines and Humalog KwikPen

Your insulin needs may change if you are taking:

• oral contraceptives,
• corticosteroids,
• thyroid hormone replacement therapy,
• oral hypoglycaemics,
• acetylsalicylic acid,
• 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.

Pregnancy and breast-feeding

Are you pregnant or breast-feeding, thinking of becoming pregnant or planning to breast-feed? Your insulin needs may change during pregnancy or while you are breast-feeding. 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 (low blood sugar). Keep this possible problem in mind in all situations where you might 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
• you 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 as instructed by your doctor.

Dose

• Humalog should be given shortly before meals.

If you need to, you can give yourself a dose shortly after a meal.

Preparing Humalog KwikPen

• Humalog is already dissolved in water, so you do not need to mix it.

Injecting Humalog

• Inject Humalog under your skin as you have been instructed by your doctor or diabetes educator.

After the injection

• After injecting, remove the needle from the pen and put the cap back on the pen.

Further injections

• Always use a new needle for each injection.
• Before each injection, check the pen for any air bubbles and remove them.

Using Humalog in an insulin infusion pump

Humalog KwikPen is only suitable for injection under the skin. If you need to use an insulin infusion pump, you should use a different type of insulin.

If you use more Humalog than you need

If you use more Humalog than you need, you may experience hypoglycaemia (low blood sugar).

If you forget to use Humalog

If you forget to use Humalog, you may experience hyperglycaemia (high blood sugar).

Three simple measuresto prevent hypoglycaemia or hyperglycaemia are:

• Always carry spare insulin and needles with you.
• Always carry something to show you are diabetic.
• Always carry some sugar with you.

4. Possible side effects

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

Systemic allergic reactions are rare (affecting less than 1 in 1,000 people). These symptoms include:

• redness and swelling of the face, lips, tongue or throat
• difficulty breathing
• abnormal heart rhythms
• fall in blood pressure

If you think you are having this type of reaction, contact your doctor immediately.

Local allergic reactions are common (affecting less than 1 in 10 people). Some people get redness, swelling or itching at the injection site. This usually clears up in a few days.

Lipodystrophy (thickening or thinning of the skin) is uncommon (affecting less than 1 in 100 people). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Swelling of the feet, ankles, and hands due to retention of fluid (oedema) has been reported, particularly at the start of treatment or during dose escalation.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Common problems of diabetes

• Hypoglycaemia

Hypoglycaemia means that your blood sugar is too low.

This can be caused by:

• too much Humalog or other insulin
• missing a meal or delaying a meal
• exercising more than usual
• being sick (vomiting) or having a fever

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of a hypoglycaemic attack, which can come on suddenly, are:

• shakiness, sweating, feeling very anxious
• fast heart beat
• palpitations

Until you are confident that you can recognise the warning signs of a hypoglycaemic attack, you should avoid situations (such as driving a car) where you or others would be put at risk if you had a hypoglycaemic attack.

• Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia means that your blood sugar is too high.

This can be caused by:

• not using enough Humalog or other insulin
• using less insulin than your doctor has prescribed
• exercising less than usual
• eating more carbohydrates than usual

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms of diabetic ketoacidosis usually develop gradually, over a few hours or days.

They include:

• feeling sick (nausea), being sick (vomiting)
• dry mouth, thirst, urinating more than usual
• flushed face, feeling very tired

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

5. Storage of Humalog KwikPen

Before 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 pen you are using in the refrigerator. The KwikPen pen should not be stored with the needle attached.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the label and on the

packaging. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice it has color or if it 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 disposed of via wastewater or household waste. 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 KwikPen 100 units/ml solution for injection

• The active substance 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 heptahydrate, zinc oxide, and water for injections. 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 solution for injection is a sterile, transparent, colorless, aqueous solution and contains 100 units of insulin lispro in each milliliter of solution for injection (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 multipack 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 separate 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 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, Netherlands.

You can request more information about this medicine by contacting 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

Ελλ?δα

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

Κ?προς

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly (Suisse) S.A Parstavnieciba Latvija

Tel: +371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

Date of last revision 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 European Medicines Agency website: http://www.ema.europa.eu.