Humalog Mix25 100 units/ml Kwikpen suspension for injection

XPIL (Text-only Patient Information Leaflet)

Source: Humalog_Mix25_KwikPen_PIL_HLG092_Sep21_NI-IE.pdf

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

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

Package leaflet: Information for the user

Humalog® Mix25™ 100 units/ml KwikPen® suspension 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.

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

Contents of this leaflet:

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

2. What you need to know before you use 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. 25% of the insulin lispro in Humalog Mix25 KwikPen is dissolved in water and works more quickly than normal human insulin because the insulin molecule has been changed slightly. 75% of the insulin lispro in Humalog Mix25 KwikPen is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should normally use Humalog Mix25 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix25 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.

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 is 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.

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

2. What you need to know before you use Humalog Mix25 KwikPen

Do NOT use Humalog Mix25 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 take more Humalog Mix25 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 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 Mix25 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 (see How to use Humalog Mix25 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 Mix25 KwikPen

Your insulin needs may change if you are taking:

- the contraceptive pill

- steroids

- thyroid hormone replacement therapy

- oral hypoglycaemics

- acetyl salicylic 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

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

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 Mix25 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 Mix25 KwikPen

Always use Humalog Mix25 KwikPen exactly as your doctor has told you. 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 Mix25 within 15 minutes of a meal. If you need to, 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. 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 Mix25 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 Mix25 KwikPen

- Rotate the KwikPen in your hands ten times and invert 180° ten times before use to resuspend insulin until it looks uniformly cloudy or milky. If not, repeat. Cartridges contain a small glass bead to help mixing. Do not shake vigorously (frothing may affect dose measurement).

- Do not use if clumps are present or if solid white particles stick to the bottom or wall of the cartridge (frosted appearance). Check each time you inject.

Getting the KwikPen ready to use

- Wash your hands.

- Read the instructions for your pre-filled insulin pen carefully.

- Use a new sterile needle for each injection (needles not included).

- Prime the pen before each use to clear air and ensure insulin flow. Small air bubbles may remain (harmless), but large bubbles can affect the dose.

Injecting Humalog Mix25

- Clean your skin as instructed. Inject under the skin as taught. Do not inject into a vein. Leave the needle in place for 5 seconds after injection. Do not rub the site. Rotate injection sites, leaving at least 1 cm from the previous site.

After injecting

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

Further injections

- Always use a new needle. Remove air bubbles. Check insulin level using the cartridge scale. Do not reuse empty pens – dispose of them safely.

If you use more Humalog Mix25 than you should

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

If you forget to use Humalog Mix25

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

Three steps to avoid hypo/hyperglycaemia:

- Always keep spare pens/cartridges or syringes and vials.

- Always carry something to show you are diabetic.

- Always carry sugar with you.

If you stop using Humalog Mix25

If you take less than you need, a high blood sugar may occur. Do not change 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.

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

- rash over the whole body

- blood pressure dropping

- difficulty in breathing

- fast heartbeat

- wheezing

- sweating

Tell your doctor immediately if this occurs.

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

- redness, swelling or itching at injection site. Usually clears in a few days to weeks.

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

- 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, 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:

- too much insulin

- missed or delayed meals

- heavy exercise

- illness (esp. diarrhoea or vomiting)

- 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 Mix25 KwikPen

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

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

- Keep out of 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.

- Do not use if clumps are present or solid particles stick to the cartridge (frosted appearance). Check each time.

- Dispose of unused medicine properly.

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

6. Contents of the pack and other information

What Humalog Mix25 contains

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

- Other ingredients: protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide, water for injection. Sodium hydroxide or hydrochloric acid may be used for acidity adjustment.

What it looks like and pack contents

- Sterile, white suspension (100 units/ml).

- 25% dissolved in water, 75% with protamine sulphate.

- Each pen contains 300 units (3 ml).

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

- Same formulation as Humalog Mix25 cartridges; KwikPen has built-in cartridge. Empty pens cannot be reused.

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: HLG092