Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1 What Fiasp^® is and what it is used for
2 What you need to know before you use Fiasp^®
3 How to use Fiasp^®
4 Possible side effects
5 How to store Fiasp^®
6 Contents of the pack and other information

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

Talk to your doctor, pharmacist or nurse before using Fiasp^®. Be especially aware of the following:

• Low blood sugar (hypoglycaemia) - If your blood sugar is too low, follow the guidance for low blood sugar in section 4 ‘Possible side effects’. Fiasp^® starts to lower blood sugar faster compared to other mealtime insulins. If hypoglycaemia occurs, you may experience it earlier after an injection with Fiasp^®.
• High blood sugar (hyperglycaemia) - If your blood sugar is too high, follow the guidance for high blood sugar in section 4 ‘Possible side effects’.
• Switching from other insulin medicinal products - Your doctor may need to advise you on your insulin dose.
• If your insulin treatment is being combined with pioglitazone (oral antidiabetic medicine used to treat type 2 diabetes) - Tell your doctor as soon as possible if you get signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling caused by fluid retention (oedema).
• Eye disorder - Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder such as diabetic retinopathy.
• Pain due to nerve damage - If your blood sugar level improves very fast, you may get nerve related pain, this is usually temporary.
• Swelling around your joints - When you first start using your medicine, your body may keep more water than it should. This causes swelling around your ankles and other joints. This is usually only short-lasting.
• Ensuring you use the right type of insulin - always check the insulin label before each injection to avoid accidental mix-ups between insulin products.
• Insulin treatment can cause the body to produce antibodies to insulin (substance that act against insulin). However, only very rarely, this will require a change to your insulin dose.

If you have poor eyesight, please see section 3 ‘How to use Fiasp^®’.

Some conditions and activities can affect how much insulin you need. Talk to your doctor:

• if you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
• if you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
• if you are ill, carry on taking your insulin and talk to your doctor.
• If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections.

When using Fiasp^® it is strongly recommended that the name and batch number of each package is recorded in order to maintain a record of the batches used.

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3 ‘How to use Fiasp^®’). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in 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.

This medicine is not recommended for use in children below the age of 1 year.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

• other medicines for diabetes (oral and injectable)
• sulphonamide antibiotics, (used to treat infections)
• anabolic steroids (such as testosterone)
• beta-blockers (used to treat high blood pressure or angina)
• salicylates (used to relieve pain and lower fever)
• monoamine oxidase inhibitors (MAOI) (used to treat depression)
• angiotensin converting enzyme (ACE) inhibitors (for some heart problems or high blood pressure)

Your blood sugar level may rise (hyperglycaemia) if you take:

• danazol (medicine acting on ovulation)
• oral contraceptives (birth control pills)
• thyroid hormones (for thyroid problems)
• growth hormone (for growth hormone deficiency)
• glucocorticoids (such as ‘cortisone’ for inflammation)
• sympathomimetics (such as epinephrine (adrenaline), salbutamol or terbutaline for asthma)
• thiazides (for high blood pressure or if your body is keeping too much water (water retention))

Octreotide and lanreotide - used to treat a rare condition involving too much growth hormone (acromegaly). They may increase or decrease your blood sugar level.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist.

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine can be used during pregnancy; however your insulin dose may need to be changed during pregnancy and after delivery. The amount of insulin you need usually falls during the first 3 months of pregnancy and increases for the remaining 6 months. Careful control of your diabetes is needed in pregnancy. Avoiding low blood sugar (hypoglycaemia) is particularly important for the health of your baby. After you have had your baby your insulin requirements will likely return to how much you needed before your pregnancy.

There are no restrictions on treatment with Fiasp^® during breast-feeding.

Having low blood sugar can affect your ability to drive or use any tools or machines. If your blood sugar is low, your ability to concentrate or react might be affected. This could be dangerous to yourself or others. Ask your doctor whether you can drive if:

• you often get low blood sugar
• you find it hard to recognise low blood sugar.

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

Fiasp^® is a mealtime insulin.

Adults: Fiasp^® should be injected right before (0-2 minutes) the start of the meal, with an option to inject up to 20 minutes after starting the meal.

Children: Fiasp^® should be injected right before (0-2 minutes) the start of the meal, with the possibility to inject up to 20 minutes after starting the meal in situations, when there is uncertainty about how the child will eat. Ask your doctor for advice on these situations.

This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.

Dose for type 1 and type 2 diabetes

Your doctor will decide together with you:

• how much Fiasp^® you will need at each meal
• when to check your blood sugar level and if you need a higher or lower dose.

If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.

When using other medicines, ask your doctor if your treatment needs to be adjusted.

Dose adjustment for type 2 diabetes

The daily dose should be based on your blood sugar level at mealtimes and bedtime from the previous day.

• Before breakfast - dose should be adjusted according to the blood sugar level before lunch the previous day.
• Before lunch - dose should be adjusted according to the blood sugar level before dinner the previous day.
• Before dinner - dose should be adjusted according to the bedtime blood sugar level the previous day.

Dose adjustment for mealtime or bedtime blood sugar:

Reduce dose by one unit if less than 4mmol/L or less than 71 mg/dL

No dose adjustment for 4-6 mmol/L or 71-108 mg/dL

Increase dose by 1 unit if more than 6mmol/L or more than 108mg/dL

Use in elderly patients (65 years or older)

This medicine can be used in elderly patients. Talk to your doctor about changes in your dose.

If you have kidney or liver problems

If you have kidney or liver problems you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.

This medicine is only suitable for injection under the skin (subcutaneous injection).

Before you use Fiasp^® for the first time, your doctor or nurse will show you how to use the pre-filled pen. Speak to your doctor if you need to inject your insulin by another method.

• The best places to inject are the front of your waist (abdomen) or upper arms.
• Do not inject into a vein or muscle.
• Change the place within the area where you inject each day to reduce the risk of developing changes under the skin (see section 4).

• if the pen is damaged or if it has not been stored correctly (see section 5 ‘How to store Fiasp^®’).
• if the insulin does not appear clear (e.g., cloudy) and colourless.

Detailed instructions on how to use your FlexTouch^® pen are provided on the other side of this leaflet.

If you use too much insulin your blood sugar may get too low (hypoglycaemia), see advice in section 4 under ‘Low blood sugar’.

If you forget to use your insulin your blood sugar may get too high (hyperglycaemia). See section 4 under ‘High blood sugar’.

• Always keep a spare pen in case you lose your pen or it gets damaged.
• Always carry something to show you have diabetes.
• Always carry products containing sugar with you. See section 4 under ‘What to do if you get low blood sugar’.

Do not stop using your insulin without talking to your doctor. If you stop using your insulin this could lead to a very high blood sugar level (severe hyperglycaemia) and ketoacidosis (a condition with too much acid in the blood which is potentially life-threatening). See symptoms and advice in section 4 under ‘High blood sugar’.

Common (may affect up to 1 in 10 people)

Reaction at administration site: Local reactions at the place you inject yourself may occur. The signs may include: rash, redness, inflammation, bruising, irritation, pain and itching. The reactions usually disappear after a few days.

Skin reactions: Signs of allergy on the skin such as eczema, rash, itching, hives and dermatitis may occur.

• Low blood sugar (hypoglycaemia) (very common)

Low blood sugar may happen if you:

Drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.

Headache; slurred speech; fast heartbeat; cold sweat; cool pale skin; feeling sick; feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired; weak and sleepy; feeling confused; difficulty in concentrating; short-lasting changes in your sight.

• If you are conscious, treat your low blood sugar immediately with 15–20 g of fast-acting carbohydrate: eat glucose tablets or another high sugar snack, like fruit juice, sweets or biscuits (always carry glucose tablets or a high sugar snack, just in case).
• It is recommended that you retest your blood glucose levels after 15–20 minutes and re-treat if your blood glucose levels are still less than 4 mmol/L.
• Wait until the signs of low blood sugar have gone or when your blood sugar level has settled. Then carry on with your insulin treatment as usual.

Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.

Let them know that if you pass out, they must:

• turn you on your side to avoid choking
• get medical help straight away
• not give you any food or drink because you may choke.

You may recover more quickly from passing out with an injection of glucagon. This can only be given by someone who knows how to use it.

• If you are given glucagon you will need sugar or a sugary snack as soon as you come round.
• If you do not respond to a glucagon injection, you will have to be treated in a hospital.

If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long-lasting. It may even cause death.

• your blood sugar got so low that you passed out
• you have been given an injection of glucagon
• you have had too low blood sugar a few times recently.

This is because the dosing or timing of your insulin injections, food or exercise may need to be changed.

• High blood sugar (hyperglycaemia

High blood sugar may happen if you:

Eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin.

Flushed skin; dry skin; feeling sleepy or tired; dry mouth; fruity (acetone) breath; urinating more often; feeling thirsty; losing your appetite; feeling or being sick (nausea or vomiting).

These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.

• Test your blood sugar level.
• Give a correction dose of insulin if you have been taught how to do this.
• Test your urine for ketones.
• If you have ketones, seek medical help straight away.

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

Great Britain:

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.

• The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 mL solution.
• The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 under ‘Important information about some of the ingredients of Fiasp^®’) and water for injections.

Fiasp^® is presented as a clear, colourless and aqueous solution for injection in pre-filled pen.

Pack sizes of 1, 5 or a multipack with 2 x 5 pre-filled pens of 3 mL. Not all pack sizes may be marketed.

Pay special attention to these notes as they are important for correct use of the pen.

Fiasp^® pre-filled pen and needle (example) (flextouch®)

Components of pen:

• Pen Cap
• Outer needle cap
• Inner needle cap
• Needle
• Paper tab
• Insulin scale
• Insulin window
• Pen label
• Dose pointer
• Dose selector
• Dose button (dose button with two lines)

• Check the name and strength on the label of your pen, to make sure that it contains Fiasp^® 100 units/mL. This is especially important if you take more than one type of insulin. If you take a wrong type of insulin, your blood sugar level may get too high or too low.
• Pull off the pen cap.

• Check that the insulin in your pen is clear and colourless.
  Look through the insulin window. If the insulin looks cloudy, do not use the pen.

• Take a new needle and tear off the paper tab.

Make sure to attach the needle correctly.

• Push the needle straight onto the pen.
• Turn until it is on tight.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any insulin.

• Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally prick or injure yourself with the needle.

A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.

Do not attach a new needle to your pen until you are ready for your injection.

Always use a new needle for each injection.

This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.

Never use a bent or damaged needle.

• Always check the insulin flow before you start.

This helps you to ensure that you get your full insulin dose.

• Turn the dose selector to select 2 units. Make sure the dose counter shows 2.

• Hold the pen with the needle pointing up.

Tap the top of the pen gently a few times to let any air bubbles rise to the top.

• Press and hold in the dose button until the dose counter returns to 0.

The 0 must line up with the dose pointer.
A drop of insulin should appear at the needle tip.

Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin is flowing properly.

If no drop appears, no insulin will be injected, even though the dose counter may move. This may indicate a blocked or damaged needle.

Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to high blood sugar level.

• Make sure the dose counter shows 0 before you start.
  The 0 must line up with the dose pointer.
• Turn the dose selector to select the dose you need, as directed by your doctor or nurse.
  If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
  The pen can dial up to a maximum of 80 units.

The dose selector changes the number of units. Only the dose counter and dose pointer will show how many units you select per dose.

You can select up to 80 units per dose. When your pen contains less than 80 units, the dose counter stops at the number of units left.

Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.

Do not count the pen clicks to set the dose. If you select and inject the wrong dose, your blood sugar level may get too high or too low.

Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.

The dose selector clicks differently when turned forwards, backwards or past the number of units left.

• Insert the needle into your skin as your doctor or nurse has shown you.
• Make sure you can see the dose counter.

Do not touch the dose counter with your fingers. This could interrupt the injection.

• Press and hold down the dose button. Watch as the dose counter returns to 0.
  The 0 must line up with the dose pointer. You may then hear or feel a click.
• Continue pressing the dose button while keeping the needle in your skin.

• Count slowly to 6 while keeping the dose button pressed.
• If the needle is removed earlier, you may see a stream of insulin coming from the needle tip. If so, the full dose will not be delivered, and you should increase the frequency of checking your blood sugar level.

• Remove the needle from your skin. You can then release the dose button

If blood appears at the injection site, press lightly on the skin for a few minutes to stop the bleeding. Do not rub the area.

You may see a drop of insulin at the needle tip after injecting. This is normal and does not affect your dose.

Always watch the dose counter to know how many units you inject. Hold the dose button down until the dose counter shows 0. If the dose counter does not return to 0, the full dose has not been delivered, which may lead to high blood sugar level.

Always dispose of the needle after each injection

This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked, you will not inject any insulin.

• Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap.

• Once the needle is covered, carefully push the outer needle cap completely on.
• Unscrew the needle and dispose of it as instructed by your doctor, nurse, pharmacist or local authorities.

• Put the pen cap on your pen after each use to protect the insulin from light.

When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may prick or injure yourself with the needle.

Always remove the needle from your pen after each injection and store your pen without the needle attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.

• The insulin scale shows you approximately how much insulin is left in your pen.

• To see precisely how much insulin is left, use the dose counter:
  Turn the dose selector until the dose counter stops.
  If it shows 80, at least 80 units are left in your pen.
  If it shows less than 80, the number shown is the number of units left in your pen.

• Turn the dose selector back until the dose counter shows 0.
• If you need more insulin than the units left in your pen, you can split your dose between two pens.

Be very careful to calculate correctly if splitting your dose.

If in doubt, take the full dose with a new pen. If you split the dose wrong, you will inject too little or too much insulin, which can lead to high or low blood sugar levels.

Further important information

• Always keep your pen with you.
• Always carry an extra pen and new needles with you, in case of loss or damage.
• Always keep your pen and needles out of sight and reach of others, especially children.
• Never share your pen or your needles with other people. It might lead to cross-infection.
• Never share your pen with other people. Your medicine might be harmful to them.
• Caregivers must be very careful when handling used needles - to reduce the risk of needle injury and cross-infection.