HUMALOG 200 UNITS/ML KWIKPEN SOLUTION FOR INJECTION IN A PRE-FILLED PEN - patient leaflet, side effects, dosage

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 200 units/ml KwikPen is and what it is used for

• 2. What you need to know before you use Humalog 200 units/ml KwikPen

• 3. How to use Humalog 200 units/ml KwikPen

• 4. Possible side effects

• 5. How to store Humalog 200 units/ml KwikPen

• 6. Contents of the pack and other information

1. what humalog 200 units/ml kwikpen is and what it is used for

Humalog 200 units/ml 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 200 units/ml 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.

Humalog 200 units/ml KwikPen should be reserved for the treatment of adults with diabetes requiring daily doses of more than 20 units of rapid-acting insulin.

Humalog 200 units/ml KwikPen is a disposable pre-filled pen containing 3 ml (600 units, 200 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.

2. what you need to know before you use humalog 200 units/ml kwikpen

Do NOT use Humalog 200 units/ml 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 200 units/ml KwikPen that your doctor has told you to use.
• The Humalog 200 units/ml solution for injection in your pre-filled pen (the KwikPen) should ONLY be injected with this pre-filled pen. Do not transfer the insulin lispro from your Humalog 200 units/ml KwikPen to a syringe. The markings on the insulin syringe will not measure your dose correctly. A severe overdose can result, causing low blood sugar which may put your life in danger. Do not transfer insulin from your Humalog 200 units/ml KwikPen to any other insulin delivery devices like insulin infusion pumps.
• Do NOT mix the Humalog 200 units/ml solution for injection in your pre-filled pen (the KwikPen) with any other insulin or any other medicine. The Humalog 200 units/ml solution for injection should not be diluted.
• 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 of 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?

• 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 or 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 200 units/ml 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 medications dose.

Other medicines and Humalog 200 units/ml 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 saxagliptine),
• 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., or
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
• (medicine acting on ovulation),
• some angiotensin converting (ACE) inhibitors, used to treat certain heart conditions or high blood pressure (for example captopril, enalapril), and
• specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart problems (angiotensin II receptor blockers).

Please 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. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines). 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 200 units/ml 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 200 units/ml kwikpen

Always use this medicine 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 pen must be used by you only, even if the needle is changed.

Humalog 200 units/ml KwikPen is for patients taking more than 20 units of rapid-acting insulin a day.

Do not transfer insulin from your Humalog 200 units/ml KwikPen to a syringe. The markings on the insulin syringe will not measure your dose correctly. A severe overdose can result, causing low blood sugar which may put your life in danger.

Do not use Humalog 200 units/ml KwikPen solution for injection in an insulin infusion pump.

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.
• Inject Humalog under the skin (subcutaneously).

Preparing Humalog 200 units/ml KwikPen

• Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time you inject yourself.

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

• First wash your hands.
• Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions carefully. Here are some reminders.
• Use a clean needle. (Needles are not included).
• Prime your KwikPen before each use. This checks that insulin comes out and clears the air bubbles from your KwikPen. There may still be some small air bubbles left in the pen – these are harmless. But if the air bubbles are too large it may affect the insulin dose.
• Do not inject Humalog 200 units/ml KwikPen solution for injection directly into a vein (intravenously).

Injecting Humalog

• Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human insulin.

After injecting

• As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap on your pen.

Further injections

• Every time you use a KwikPen you must use a new needle. Before every injection, clear any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing up.
• Once the KwikPen is empty, do not use it again. Please get rid of it carefully – your pharmacist or diabetes nurse will tell you how to do this.

If you use more Humalog than you should

If you use more Humalog than you need or are unsure how much you have injected, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia) , eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need or are unsure how much you have injected, a high blood sugar may occur. Check your blood sugar.

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids (dehydration), unconsciousness, coma or even death (see section 4 “Possible side effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

• Always carry a spare pen in case you lose your KwikPen or it gets damaged.
• Always carry something to show you are diabetic.
• Always carry sugar with you.

If you stop using Humalog.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows:

• rash over the whole body
• difficulty in breathing
• wheezing

If you think you are having this sort contact a doctor at once.

Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Lipodystrophy is uncommon (may affect up to 1 in 100 people). If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

Common problems of diabetes

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

• you take too much Humalog or other insulin;
• you miss or delay meals or change your diet;
• you exercise or work too hard just before or after a meal;
• you have an infection or illness (especially diarrhoea or vomiting);
• there is a change in your need for insulin; or
• you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels (see section 2).

5. how to store humalog 200 units/ml kwikpen

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Before the first use store your Humalog 200 units/ml KwikPen in a refrigerator (2°C – 8°C). Do not freeze.

Keep your Humalog 200 units/ml KwikPen in use at room temperature (below 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The KwikPen should not be stored with the needle attached.

Do not use this medicine if you notice the solution is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

If your medicine shows any signs of deterioration or discolouration, seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information- the active substance is insulin lispro. each ml of solution contains 200 units (u) of insulin lispro. each pre-filled pen (3 ml) contains 600 units (u) of insulin lispro.

• – The other ingredients are metacresol, glycerol, trometamol, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog 200 units/ml KwikPen looks like and contents of the pack

Humalog 200 units/ml KwikPen solution for injection is a sterile, clear, colourless, aqueous solution and contains 200 units of insulin lispro in each millilitre (200 units/ml) solution for injection. Each Humalog 200 units/ml KwikPen contains 600 units (3 millilitres).

The Humalog 200 units/ml KwikPen comes in a pack of 5 pre-filled pens.

The KwikPen simply has a built in cartridge. When the pre-filled pen is empty you cannot use it again.

Manufacturer

Manufactured by Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.

Or

Eli Lilly Italia S.p.A., Via Gramsci 731–733, 50019 Sesto Florentine, (FI) Italy. Procured from within the EU and repackaged by the Product Licence holder: G Pharma Ltd, Dakota Avenue, Salford M50 2PU.

POM PLGB 16369/1952                                     -------

USER MANUAL- Please read the User Manual enclosed

Humalog is a registered trademark belonging to Eli Lilly and Company.

Blind or partially sighted?

Is this leaflet hard to see or read? Call 0161 877 8999 to obtain the leaflet in a format suitable for you.

The first symptoms of low blood sugar usually come on quickly and include the following:

While you are not confident about recognising your warning symptoms, avoid situations such as driving a car, in which you or others would be put at risk by hypoglycaemia.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

• not taking your Humalog or other insulin;
• taking less insulin than your doctor tells you to;
• eating a lot more than your diet allows; or
• fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

• no appetite
• fruity smell on the breath
• feeling or being sick

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

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

Step 4:

Pull off the Outer Needle Shield.

Do not throw it away.

Pull off the Inner Needle Shield and throw it away.

Priming your Pen

Prime before each injection.

Step 9:

Choose your injection site.

Humalog 200 units/ml solution for injection is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.

Wipe your skin with a swab, and let your skin dry before you inject your dose.

Step 10:

Insert the Needle into your skin.

Push the Dose Knob all the way in.

Do not try to inject your insulin by turning the Dose Knob. You will NOT receive your insulin by turning the Dose Knob.

Step 11:

Pull the Needle out of your skin.

• A drop of insulin at the Needle tip is normal. It will not affect your dose.
• Check the number in the Dose Window. If you see “0” in the Dose

Window, you have received the full amount you dialled.

• If you do not see “0” in the Dose Window, do not redial. Insert the needle into your skin and finish your injection.
• If you still do not think you received the full amount you dialled for your injection, do not start over or repeat that injection. Monitor your blood glucose as instructed by your healthcare professional.

The plunger only moves a little with each injection and you may not notice that it moves. If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or a swab. Do not rub the area.

After your injection

Step 12:

Carefully replace the Outer Needle Shield.

Step 13:

Unscrew the capped Needle and dispose of it as described below (see Disposing of Pens and Needles section).

Do not store the Pen with the Needle attached to prevent leaking, blocking the Needle, and air from entering the Pen.

Step 14:

Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

Disposing of Pens and Needles

• Put used Needles in a sharps container or hard plastic container with a secure lid. Do not throw needles directly into your household waste.
• Do not recycle the filled sharps container.
• Ask your healthcare professional about options to dispose of the Pen and the sharps container properly.
• The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

Storing your Pen

Unused Pens

• Store unused Pens in the refrigerator at 2°C to 8°C.
• Do not freeze Humalog 200 units/ml solution for injection. Do not use if it has been frozen.
• Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept

in the refrigerator.

In-use Pen

• Store the Pen you are currently using at room temperature (below 30°C) and away from dust, food and liquids, heat and light.
• Throw away the Pen you are using after 28 days, even if it still has insulin left in it.

General information about the safe and effective use of your Pen

• Keep your Pen and Needles out of the sight and reach of children.
• Do not use your Pen if any part looks broken or damaged.
• Always carry an extra Pen in case yours is lost or damaged.

Troubleshooting

• If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap

straight off.

• If the Dose Knob is hard to push;

• – Pushing the Dose Knob more slowly will make it easier to inject.

• – Your Needle may be blocked. Put on a new Needle and prime the Pen.

• – You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen. You may need to get a prescription from your healthcare professional.

• Do not transfer insulin from the Pen to a syringe or an insulin pump. Severe overdose can result.

If you have any questions or problems with your Humalog 200 units/ml KwikPen, call your healthcare professional for help or contact your local Lilly affiliate.

Procured from within the EU and repackaged by the Product Licence holder: G Pharma Ltd, Dakota

Avenue, Salford M50 2PU.

PLGB 16369/1952

Leaflet revision date: 22/10/2021