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

XPIL (Text-only Patient Information Leaflet)

Source: Humalog_100_Kwikpen_PIL_HLG088_Sep21_NI-IE.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the user

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

insulin lispro

Each KwikPen delivers 1–60 units in steps 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.

What is in this leaflet

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. How to store Humalog KwikPen

6. Contents of the pack and other information

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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 get 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 in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

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 dials 1 unit at a time. The number of units are displayed in the dose window, always check this before your injection. You can give from 1 to 60 units in a single injection. If your dose is more than 60 units, you will need to give yourself more than one injection.

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

Do NOT use Humalog KwikPen

- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see section 3: If you use more Humalog than you should).

- 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 pack and the label of the pre-filled pen for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog KwikPen that your doctor has told you to use.

- If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

- A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

- If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse:

 - Have you recently become ill?

 - Do you have trouble with your kidneys or liver?

 - Are you exercising more than usual?

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

- You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

- Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).

- This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen.

Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area. Contact your doctor if you are currently injecting into a lumpy area before you start injecting a different area. Your doctor may tell you to check your blood sugar more closely and adjust your insulin or other antidiabetic medication dose.

Other medicines and Humalog KwikPen

Your insulin needs may change if you are taking:

- the contraceptive pill

- steroids

- thyroid hormone replacement therapy

- oral hypoglycaemics

- acetylsalicylic acid

- sulpha antibiotics

- octreotide

- “beta2 stimulants” (e.g., ritodrine, salbutamol, terbutaline)

- beta-blockers

- some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)

- danazol

- some angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril)

- angiotensin II receptor blockers

Please tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

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3. How to use Humalog KwikPen

Always use Humalog KwikPen exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Dose

- You should normally inject Humalog within 15 minutes of a meal. If needed, you can inject soon after a meal. Your doctor will have told you exactly how much to use, when to use it, and how often. Follow instructions exactly and visit your diabetes clinic regularly.

- If you change the type of insulin you use (e.g., from human or animal insulin to a Humalog product), you may have to take more or less than before. This may be for the first injection or a gradual change over several weeks or months.

- Humalog KwikPen is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method.

Preparing Humalog KwikPen

- Humalog is already dissolved in water. Use it only if it looks like water: clear, colourless, and free of solid particles. Check each time you inject.

Getting the KwikPen ready to use (see user manual)

- Wash your hands.

- Follow the instructions for using the pre-filled pen carefully.

- Use a clean needle (not included).

- Prime your KwikPen before each use to check insulin flow and clear air bubbles. Small air bubbles are harmless, but large ones may affect your dose.

Injecting Humalog

- Clean your skin as instructed. Inject under the skin, not into a vein. Leave the needle in place for five seconds to ensure the full dose is given. Do not rub the injection site. Rotate injection sites as taught.

After injecting

- Unscrew the needle using the outer needle cap. Replace the pen cap. Do not share needles or pens.

Further injections

- Use a new needle each time. Clear air bubbles before injection. Do not mix with other insulin in the pen. Dispose of empty pens safely.

Using Humalog in an infusion pump

- KwikPen is only for subcutaneous injection. Other Humalog 100 units/ml forms are available for pumps. Speak to your doctor if needed.

If you use more Humalog than you should

- Low blood sugar (hypoglycaemia) may occur. Eat glucose tablets, sugar, or drink a sugary drink, then eat as advised. Severe cases may require glucagon or hospital care.

If you forget to use Humalog

- High blood sugar (hyperglycaemia) may occur. Check your blood sugar.

If you stop using Humalog

- High blood sugar may occur. Do not change your insulin unless advised.

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4. Possible side effects

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

Systemic allergy (rare ≥1/10,000 to <1/1,000):

- rash over the whole body

- difficulty in breathing, wheezing

- sweating, fast heartbeat

- low blood pressure

Local allergy (common ≥1/100 to <1/10):

- redness, swelling or itching at injection site (usually clears in days or weeks)

Lipodystrophy (uncommon ≥1/1,000 to <1/100):

- shrinking or thickening of fat tissue at injection site

- cutaneous amyloidosis (protein build-up causing lumps)

Oedema has been reported, particularly at the start of insulin therapy or during changes.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. Report via:

- Ireland: HPRA Pharmacovigilance (www.hpra.ie)

- UK (Northern Ireland): Yellow Card Scheme (www.mhra.gov.uk/yellowcard)

Common problems of diabetes

A. Hypoglycaemia

- Causes: too much insulin, missed meals, exercise, illness, alcohol, kidney/liver issues

- Symptoms: tiredness, nervousness, shaking, headache, nausea, rapid heartbeat, sweating

- Avoid risky activities (e.g., driving) if not confident recognising symptoms.

B. Hyperglycaemia and diabetic ketoacidosis

- Causes: missed insulin, too little insulin, overeating, stress, illness

- Symptoms: thirst, nausea, vomiting, fruity breath, drowsiness, rapid pulse

- Severe: heavy breathing, rapid pulse – seek immediate medical help.

C. Illness

- Even if not eating, insulin is required. Test urine/blood, follow “sick day rules,” and inform your doctor.

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5. How to store Humalog KwikPen

- Before first use: store in refrigerator (2°C–8°C). Do not freeze.

- In use: store at room temperature (below 30°C). Discard after 28 days.

- Do not expose to heat or sunlight. Do not store with the needle attached.

- Keep out of sight and reach of children.

- Do not use if solution is coloured or contains solid particles (must look like water).

- Do not use after expiry date (last day of month).

- Dispose of pens properly (not via wastewater or household waste).

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6. Contents of the pack and other information

What Humalog 100 units/ml KwikPen contains

- Active substance: insulin lispro (made by recombinant DNA technology).

- Other ingredients: m-cresol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide, water for injection. Acidity adjusted with sodium hydroxide or hydrochloric acid.

What Humalog KwikPen looks like

- Sterile, clear, colourless aqueous solution (100 units/ml).

- Each pen contains 300 units (3 ml).

- Pack sizes: 5 pens or multipacks (2x5 pens). Not all pack sizes marketed.

- Same insulin as Humalog cartridges, but in a built-in cartridge pen.

Marketing Authorisation Holder

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

Manufacturer

Lilly France S.A.S.

Rue du Colonel Lilly, 67640 Fegersheim, France

Local contacts

- Ireland and UK (Northern Ireland): Eli Lilly and Company (Ireland) Limited. Tel: +353 (0)1 661 4377

This leaflet was last revised in September 2021.

Detailed information is available at: www.ema.europa.eu

Code: HLG088