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

XPIL (Text-only Patient Information Leaflet)

Source: Humalog_100_Junior_KwikPen_PIL_HLG087_Sep21_NI-IE.pdf

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

---------------------------------------------------------------

Package leaflet: Information for the user

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

insulin lispro

Each Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units.

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 this leaflet:

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

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

3. How to use Humalog Junior KwikPen

4. Possible side effects

5. How to store Humalog Junior KwikPen

6. Contents of the pack and other information

---------------------------------------------------------------

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

Humalog Junior KwikPen is used to treat diabetes. Humalog works more quickly than normal human insulin because insulin lispro has been changed slightly in comparison to human insulin. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

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 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.

Humalog is suitable for use in adults and children.

Humalog 100 units/ml Junior 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 half unit (0.5 unit) at a time. The number of units is displayed in the dose window – always check this before your injection. You can give from 0.5 unit to 30 units in a single injection. If your dose is more than 30 units, you will need to give yourself more than one injection.

---------------------------------------------------------------

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

Do NOT use Humalog Junior KwikPen:

- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

- 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).

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 100 units/ml Junior KwikPen that your doctor has told you to use.

- Do NOT mix the Humalog 100 units/ml solution for injection in your pre-filled pen (the Junior KwikPen) with any other insulins or any other medicine.

- 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 in section 4. 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?

- 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 (see How to use Humalog Junior KwikPen). 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 to adjust your insulin or your other antidiabetic medication dose.

Other medicines and Humalog Junior KwikPen

Your insulin needs may change if you are taking:

- the contraceptive pill

- steroids

- thyroid hormone replacement therapy

- oral hypoglycaemics (e.g. metformin, acarbose, sulphonylurea agents, pioglitazone, empagliflozin, DPP-4 inhibitors like sitagliptin or saxagliptin)

- acetyl salicylic acid

- sulpha antibiotics

- somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone)

- beta2 stimulants such as salbutamol or terbutaline to treat asthma, or ritodrine used to stop premature labour

- beta-blockers (to treat high blood pressure)

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

- danazol (medicine acting on ovulation)

- some angiotensin converting enzyme (ACE) inhibitors used to treat certain heart conditions or high blood pressure (e.g. captopril, enalapril)

- specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart problems (angiotensin II receptor blockers)

Tell your doctor if you are taking, have recently taken, or might take any other medicines (see also section “Warnings and precautions”).

Humalog with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin needed may change.

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving or operating machinery). You should contact your doctor about the advisability of driving if you have:

- frequent episodes of hypoglycaemia

- reduced or absent warning signs of hypoglycaemia

Humalog Junior KwikPen contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

---------------------------------------------------------------

3. How to use Humalog Junior KwikPen

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

Dose

- The number of half units (0.5 units) is shown in the dose window of your pen. The half units are shown as lines between the numbers.

- Always check the number in the dose window to make sure you have dialled the correct dose.

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

- If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be 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 Junior KwikPen

- Humalog is already dissolved in water, so you do not need to mix it. Use it only if it looks like water: clear, colourless, and without solid pieces. Check each time you inject.

Getting the Junior KwikPen ready to use (see user manual)

- Wash your hands.

- Read and follow the instructions for your pre-filled insulin pen.

- Use a clean needle (needles not included).

- Prime your Junior KwikPen before each use. This checks that insulin comes out and clears air bubbles. Small bubbles may remain but are harmless. Very large bubbles may affect the dose.

Injecting Humalog

- Clean your skin as instructed. Inject under the skin as taught. Do not inject directly into a vein. After injecting, leave the needle in the skin for 5 seconds. Do not rub the injection area. Rotate injection sites, leaving at least 1 cm from the last site. Humalog works faster than soluble human insulin regardless of site (arm, thigh, buttock, or abdomen).

- Do not administer Humalog intravenously unless under medical supervision in special circumstances (e.g. surgery or severe illness with high glucose levels).

After injecting

- Unscrew the needle with the outer cap. This keeps insulin sterile, prevents leaks and clogging, and avoids air entry. Do not share needles or pens. Replace the pen cap.

Further injections

- Use a new needle for every injection. Clear air bubbles before each injection. Check how much insulin remains using the cartridge scale. Do not reuse empty pens – dispose of them safely.

Using Humalog in an infusion pump

- Junior KwikPen is only suitable for injections under the skin. Do not use this pen for infusion pumps. Other forms of Humalog 100 units/ml are available for that use.

If you use more Humalog than you should

A low blood sugar may occur. Check your blood sugar. For mild hypoglycaemia, eat glucose or sugar, then fruit, biscuits, or a sandwich and rest. Severe symptoms may require glucagon injection or hospital care.

If you forget to use Humalog

A high blood sugar may occur. Check your blood sugar. Untreated low or high blood sugar can be very serious (see section 4).

If you stop using Humalog

If you take less than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

---------------------------------------------------------------

4. Possible side effects

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

Severe allergy (rare, may affect up to 1 in 1,000 people):

- rash over the whole body

- blood pressure dropping

- difficulty in breathing

- fast heartbeat

- wheezing

- sweating

Contact a doctor immediately if this occurs.

Local allergy (common, may affect up to 1 in 10 people):

- redness, swelling or itching at injection site. Usually clears within days or weeks.

Lipodystrophy (uncommon, may affect up to 1 in 100 people):

- shrinkage (lipoatrophy) or thickening (lipohypertrophy) of fatty tissue

- cutaneous amyloidosis (protein build-up lumps under the skin)

Insulin may not work well if injected into lumpy areas. Rotate injection sites.

Oedema (swelling in arms, ankles; fluid retention) has been reported, especially when starting or changing insulin therapy.

Reporting of side effects

Report to your doctor or pharmacist, or directly via:

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

- United Kingdom (Northern Ireland): Yellow Card Scheme (www.mhra.gov.uk/yellowcard or via MHRA app)

---------------------------------------------------------------

Common problems of diabetes

Hypoglycaemia (low blood sugar)

Causes include:

- too much Humalog or other insulin

- missed or delayed meals

- heavy exercise

- infection or illness

- changes in insulin need

- worsening kidney or liver problems

First symptoms:

- tiredness

- rapid heartbeat

- nervousness or shakiness

- nausea

- headache

- cold sweat

Avoid risky situations until you can reliably recognise your symptoms.

Hyperglycaemia (high blood sugar) and diabetic ketoacidosis

Causes:

- not taking enough insulin

- eating too much

- stress, fever, or infection

Early symptoms: sleepiness, loss of appetite, flushed face, fruity breath, thirst, nausea.  

Severe symptoms: heavy breathing, rapid pulse. Get medical help immediately.

Illness

If you are ill, insulin needs may change. Even if not eating normally, you still need insulin. Test urine or blood, follow ‘sick rules’, and inform your doctor.

---------------------------------------------------------------

5. How to store Humalog Junior KwikPen

- Keep out of the sight and reach of children.

- Do not use after the expiry date on the label/carton. The expiry date refers to the last day of that month.

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

- In use: keep at room temperature (below 30°C) and discard after 28 days. Do not expose to heat or sun. Do not refrigerate pens in use. Do not store with needle attached.

- Use only if clear, colourless, and without solid particles. Check each time.

- Dispose of unused pens properly.

---------------------------------------------------------------

6. Contents of the pack and other information

What Humalog 100 units/ml Junior KwikPen contains

- Active substance: insulin lispro. Each ml contains 100 units (U). Each pre-filled pen (3 ml) contains 300 units (U).

- Other ingredients: metacresol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide, water for injections. Sodium hydroxide or hydrochloric acid may be used for acidity adjustment.

What it looks like and pack contents

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

- Each pen contains 300 units (3 ml).

- Packs: 1 or 5 pens, or multipacks of 2x5 pens. Not all pack sizes marketed.

- Pen is blue with ridged blue dose knob. White label with orange colour bar and orange-yellow/burgundy band.

- Each Junior KwikPen delivers 0.5 – 30 units in 0.5 unit steps.

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.

For information, contact:

Ireland and United Kingdom (Northern Ireland)

Eli Lilly and Company (Ireland) Limited

Tel: +353-(0)1-661-4377

This leaflet was last revised in September 2021.

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

---------------------------------------------------------------

Reference code: HLG087