Humalog Mix50 100 units/ml suspension for injection in cartridge

XPIL (Text-only Patient Information Leaflet)

Source: Humalog_Mix50_Cartridge_PIL_HLG093_Sep21_NI-IE-MT.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® Mix50™ 100 units/ml suspension for injection in cartridge

insulin lispro

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.

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Contents of this leaflet:

1. What Humalog Mix50 is and what it is used for

2. What you need to know before you use Humalog Mix50

3. How to use Humalog Mix50

4. Possible side effects

5. How to store Humalog Mix50

6. Contents of the pack and other information

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1. What Humalog Mix50 is and what it is used for

Humalog Mix50 is used to treat diabetes. Humalog Mix50 is a premixed suspension. Its active substance is insulin lispro. 50% of the insulin lispro in Humalog Mix50 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 50% of the insulin lispro in Humalog Mix50 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 Mix50 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should normally use Humalog Mix50 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix50 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.

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2. What you need to know before you use Humalog Mix50

Do NOT use Humalog Mix50:

- 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 Mix50 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 cartridge label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog Mix50 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 them, 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).

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 Mix50). 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 Mix50

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 a car 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 Mix50 contains sodium

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

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3. How to use Humalog Mix50

The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens.

Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.

Dose

- You should normally inject Humalog Mix50 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.

- Inject Humalog Mix50 under the skin. You should not administer it using a different route. Under no circumstances should Humalog Mix50 be given intravenously.

Preparing Humalog Mix50

- Cartridges containing Humalog Mix50 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with correct measurement of the dose.

- Do not use if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject.

Getting the pen ready to use

- Wash your hands. Disinfect the rubber membrane of the cartridge.

- Use only Humalog Mix50 cartridges in Lilly insulin pens. Ensure your pen leaflet confirms compatibility. The 3 ml cartridge only fits the 3 ml pen.

- Follow the pen instructions. Put the cartridge into the pen.

- Set the dose to 1 or 2 units. Hold the pen with the needle pointing up and tap the side to move bubbles to the top. Press until a drop of Humalog Mix50 appears. Small bubbles may remain but are harmless unless very large.

Injecting Humalog Mix50

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

After injecting

- Remove the needle with the outer cap. This keeps Humalog Mix50 sterile, prevents leaking, air entry, and needle clogging. Do not share needles or pens. Replace the cap on your pen and leave the cartridge in place.

Further injections

- Before every injection, dial 1 or 2 units and press with the pen pointing up until a drop appears.

- Check how much Humalog Mix50 is left by using the gauge. Each mark represents about 20 units. Replace the cartridge if not enough for your dose.

Do not mix any other insulin in a Humalog Mix50 cartridge. Once the cartridge is empty, do not use it again.

If you use more Humalog Mix50 than you should

A low blood sugar may occur. Check your blood sugar. For mild hypoglycaemia, take glucose tablets, sugar, or a sugary drink. Then eat fruit, biscuits, or a sandwich and rest. Severe symptoms require immediate medical help. A glucagon injection may be needed.

If you forget to use Humalog Mix50

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 Mix50

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

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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

- 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 around the injection site. Usually clears in a few days to weeks.

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

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

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

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

Oedema has been reported, especially at the start of insulin therapy or when changing therapy.

Reporting of side effects

Report to your doctor or pharmacist, or directly via:

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

- Malta: ADR Reporting (www.medicinesauthority.gov.mt/adrportal)

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

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Common problems of diabetes

A. Hypoglycaemia (low blood sugar)

Causes include:

- too much Humalog Mix50 or other insulin

- missed or delayed meals

- heavy exercise before/after meals

- infection or illness (esp. diarrhoea or vomiting)

- changes in insulin need

- worsening kidney or liver problems

First symptoms include:

- tiredness

- rapid heartbeat

- nervousness or shakiness

- nausea

- headache

- cold sweat

Avoid risky situations until you can reliably recognise your symptoms.

B. Hyperglycaemia (high blood sugar) and diabetic ketoacidosis

Causes include:

- not taking enough insulin

- eating too much

- fever, infection, stress

Early symptoms: sleepiness, loss of appetite, flushed face, fruity breath, thirst, nausea. Severe symptoms: heavy breathing, rapid pulse. Get medical help immediately.

C. Illness

When 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.

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5. How to store Humalog Mix50

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

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

- Keep out of sight and reach of children.

- Do not use after expiry date.

- Do not use if clumps are present or white particles stick to bottom or wall (frosted appearance).

- Dispose of unused medicine properly.

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6. Contents of the pack and other information

What Humalog Mix50 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. Acidity adjusted with sodium hydroxide or hydrochloric acid.

What Humalog Mix50 looks like and pack contents

- White, sterile suspension, 100 units/ml.

- 50% dissolved in water, 50% with protamine sulphate.

- Each cartridge: 300 units (3 ml).

- Packs of 5 or 10 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

- Manufacturer: Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.

- Licence holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information, contact local representatives:

Ireland and United Kingdom (Northern Ireland)

Eli Lilly and Company (Ireland) Limited  

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

Malta

Charles de Giorgio Ltd.  

Tel: +356 25600 500

This leaflet was last revised in September 2021.

Detailed information is available on the European Medicines Agency website: www.ema.europa.eu

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Reference code: HLG093