Fiasp - patient leaflet, side effects, dosage

Patient leaflet - Fiasp

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

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

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, 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.

What is in this leaflet

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

1. What Fiasp is and what it is used for

Fiasp is a mealtime insulin with a fast-acting blood sugar lowering effect. Fiasp is a solution for injection containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes is a disease where your body does not produce enough insulin to control the level of blood sugar. Treatment with Fiasp helps to prevent complications from your diabetes.

Fiasp should be injected up to 2 minutes before the start of the meal, with an option to inject up to 20 minutes after starting the meal.

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

This medicine should normally be used in combination with intermediate-acting or long-acting insulin preparations.

2. What you need to know before you use Fiasp

Do not use Fiasp

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

Warnings and precautions

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.

Children and adolescents

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

Other medicines and Fiasp

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.

Fiasp with alcohol

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

Important information about some of the ingredients of Fiasp

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

3. How to use Fiasp

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.

The pre-filled pen can provide a dose of 1–80 units in one injection in steps of 1 unit.

When to use Fiasp

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.

Fiasp dose

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.

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.

Injecting Fiasp

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.

Where to inject

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).

Do not use Fiasp

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 more Fiasp than you should

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 Fiasp

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

Three simple steps that may help to avoid low or high blood sugar are:

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’.

If you stop using Fiasp

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’.

4. Possible side effects

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

Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions immediately to increase your blood sugar level. See advice in ‘Low blood sugar’ below.

If you have a serious allergic reaction (including an anaphylactic shock) to insulin or any of the ingredients in Fiasp (how often this occurs is not known), stop using this medicine and contact emergency medical service straight away.

Signs of a serious allergic reaction may include:

local reactions (e.g., rash, redness and itching) spread to other parts of your body
you suddenly feel unwell with sweating
you start being sick (vomiting)
you experience difficulty in breathing
you experience rapid heartbeat or feeling dizzy.

Allergic reactions such as generalised skin rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. See a doctor if the symptoms worsen or you see no improvement in a few weeks.

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

Other side effects include:

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.

General effects from insulin treatment including Fiasp

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.

Warning signs of low blood sugar – these may come on suddenly:

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.

What to do if you get low blood sugar

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.

What others need to do if you pass out

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.

Talk to your doctor if:

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.

Warning signs of high blood sugar – these normally appear gradually:

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.

What to do if you get high blood sugar

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.

Reporting of side effects

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 the national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fiasp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP’. 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. Keep away from the freezing element. Keep the cap on the pen in order to protect from light.

After first opening or if carried as a spare

You can carry your pre-filled pen (FlexTouch) with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C-8°C) for up to 4 weeks. Always keep the cap on the pen when you are not using it in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fiasp contains

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.

What Fiasp looks like and contents of the pack

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 × 5 pre-filled pens of 3 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Instructions on how to use Fiasp FlexTouch

Please read these instructions carefully before using your FlexTouch pre-filled pen. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to high or low blood sugar level.

Do not use the pen without proper training from your doctor or nurse.

Start by checking your pen to make sure that it contains Fiasp 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.

Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. You can select a maximum of 80 units per dose, in steps of 1 unit. Your pen is designed to be used with single-use, disposable injection needles of a length between 4 mm and 8 mm and a gauge between 30G and 32G. Needles are not included in the pack.

△ Important information

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

Fiasp pre-filled pen and needle (example) (FlexTouch)

Pen cap

Insulin scale

Insulin window

Pen label

Dose counter

Dose pointer

Dose selector

Needle

Paper tab

Outer needle cap

Inner needle cap

Dose button

Dose button with two lines

1 Prepare your pen with a new needle

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.

2 Check the insulin flow

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.

A small air bubble may remain at the needle tip, but it will not be injected.

If no drop appears, repeat steps 2A to 2C up to 6 times. If there is still no drop, change the needle and repeat steps 2A to 2C once more.

If a drop of insulin still does not appear, dispose of the pen and use a new one.

△ 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.

3 Select your dose

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.

4 Inject your dose

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.

C Count slowly:

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.

A 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.

How to identify a blocked or damaged needle?

If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
In this case – you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle?

Remove the needle as described in section 5 and repeat all steps starting with section 1: Prepare your pen with a new needle. Make sure you select the full dose you need.

Never touch the dose counter when you inject.

This can interrupt the injection.

5 After your injection

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.

6 How much insulin is left?

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.

Caring for your pen

Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to high or low blood sugar levels.
Do not leave the pen in a car or other place where it can get too hot or too cold.
Do not expose your pen to dust, dirt or liquid.
Do not wash, soak or lubricate your pen. If necessary, clean it with mild detergent on a

moistened cloth.

Do not drop your pen or knock it against hard surfaces.

If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.

Do not try to refill your pen. Once empty, it must be disposed of.

Do not try to repair your pen or pull it apart.

Package leaflet: Information for the patient

Fiasp 100 units/mL Penfill solution for injection in cartridge insulin aspart

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, 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.

What is in this leaflet

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

1. What Fiasp is and what it is used for

Fiasp should be injected up to 2 minutes before the start of the meal, with an option to inject up to 20 minutes after starting the meal.

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

This medicine should normally be used in combination with intermediate-acting or long-acting insulin preparations.

2. What you need to know before you use Fiasp

Do not use Fiasp

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

Warnings and precautions

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

Children and adolescents

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

Other medicines and Fiasp

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)
sulphonamides 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.

Fiasp with alcohol

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.

Pregnancy and breast-feeding

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

Driving and using machines

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

Important information about some of the ingredients of Fiasp

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

3. How to use Fiasp

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this insulin medicinal product without any help. Get help from a person with good eyesight who is trained to use the pen.

When to use Fiasp

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.

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

Fiasp dose

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.

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.

Injecting Fiasp

This medicine is only suitable for injection under the skin (subcutaneous injection) from a Novo Nordisk reusable insulin pen.

Before you use Fiasp for the first time, your doctor or nurse will show you how to use it. Speak to your doctor if you need to inject your insulin by another method.

Where to inject

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).

Do not use Fiasp

if the cartridge or the reusable pen you are using is damaged. Take it back to your supplier. See

your reusable pen manual for further instructions.

if the cartridge has not been stored correctly (see section 5 ‘How to store Fiasp’).
if the insulin does not appear clear (e.g., cloudy) and colourless.

How to inject Fiasp

Read the manual that comes with your reusable pen.
Check the name and strength on the label of the cartridge (Penfill) to make sure it is Fiasp.
Always use a new needle for each injection to prevent contamination.
Needles must not be shared.

If you use more Fiasp than you should

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 Fiasp

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

Three simple steps that may to help avoid low or high blood sugar are:

Always keep spare cartridges of Fiasp.
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’.

If you stop using Fiasp

4. Possible side effects

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

Signs of a serious allergic reaction may include:

local reactions (e.g., rash, redness and itching) spread to other parts of your body
you suddenly feel unwell with sweating
you start being sick (vomiting)
you experience difficulty in breathing
you experience rapid heartbeat or feeling dizzy.

Other side effects include:

Common (may affect up to 1 in 10 people)

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

General effects from insulin treatment including Fiasp

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.

Warning signs of low blood sugar – these may come on suddenly:

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.

What to do if you get low blood sugar

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.

What others need to do if you pass out

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.

Talk to your doctor if:

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:

Warning signs of high blood sugar – these normally appear gradually:

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).

What to do if you get high blood sugar

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.

Reporting of side effects

5. How to store Fiasp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP’. 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. Keep away from the freezing element. Keep the cartridge in the carton in order to protect from light.

After first opening or if carried as a spare

Do not refrigerate. You can carry your cartridge (Penfill) with you and keep it at room temperature (not above 30°C) for up to 4 weeks. Always keep the cartridge in the carton in order to protect from light.

Throw away the needle after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fiasp contains

The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each cartridge 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.

What Fiasp looks like and contents of the pack

Fiasp is presented as a clear, colourless and aqueous solution for injection in cartridge.

Pack sizes of 5 and 10 cartridges of 3 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

Fiasp 100 units/mL solution for injection in vial insulin aspart

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, 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.

What is in this leaflet

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

1. What Fiasp is and what it is used for

Fiasp should be injected up to 2 minutes before the start of the meal, with an option to inject up to 20 minutes after starting the meal.

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

This medicine should normally be used in combination with intermediate-acting or long-acting insulin preparations.

This medicine can also be used for continuous infusion in a pump system.

2. What you need to know before you use Fiasp

Do not use Fiasp

if you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

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.

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

Children and adolescents

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

Other medicines and Fiasp

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)
sulphonamides 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.

Fiasp with alcohol

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.

Pregnancy and breast-feeding

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

Driving and using machines

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

Important information about some of the ingredients of Fiasp

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

3. How to use Fiasp

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

When to use Fiasp

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.

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

Fiasp dose

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.

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.

Injecting Fiasp

This medicine is for injection under the skin (subcutaneous injection) or for continuous infusion in pumps. Administration in a pump will require a comprehensive instruction by your healthcare professional.

Where to inject

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).

Do not use Fiasp

if the protective cap on the vial is loose or missing. The vial contains a protective plastic cap in order to obtain a tamper-proof container. If the vial is not in perfect condition when you get it, return the vial to your supplier.
if the vial has not been stored correctly (see section 5 ‘How to store Fiasp’).
if the insulin does not appear clear (e.g., cloudy) and colourless.

How to inject Fiasp

Before you use Fiasp for the first time, your doctor or nurse will show you how to use it.

1 Check the name and strength on the label of the vial to make sure it is Fiasp.
2 Remove the protective cap from the vial.
3 Always use a new needle and syringe for each injection to prevent contamination. Needles and syringes must not be shared.
4 Draw into the syringe the same amount of air as the dose of insulin you are going to inject. Inject the air into the vial.
5 Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull the needle out of the vial. Push the air out of the syringe and check that the dose is correct.
6 Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse.
7 Throw away the needle after each injection.

For use in an infusion pump system

Follow the instructions and recommendations from your doctor regarding the use of Fiasp in a pump. Before using Fiasp in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, high or low blood sugar or failure of the pump system. If you use Fiasp from a vial in an infusion pump system it can be used for a maximum of 6 days.

Filling the pump

Fiasp should never be diluted or mixed with any other insulin.
Before inserting the needle, use soap and water to clean your hands and the skin where the needle is inserted to avoid any infection at the infusion site.
When you fill a new reservoir, do not leave large air bubbles in either the syringe or the tubing.
Changing of the infusion set (tubing and needle) must be done according to the instructions in

the product information supplied with the infusion set.

To get the benefit of insulin infusion and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.

What to do if the pump system fails

You should always have an alternative delivery method for your insulin available for injection under the skin (for example, a pen injector or syringes) in case the pump system fails.

If you use more Fiasp than you should

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 Fiasp

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

Three simple steps that may help to avoid low or high blood sugar are:

Always keep spare syringes and a spare vial of Fiasp.
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’.

If you stop using Fiasp

4. Possible side effects

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

Signs of a serious allergic reaction may include:

local reactions (e.g., rash, redness and itching) spread to other parts of your body
you suddenly feel unwell with sweating
you start being sick (vomiting)
you experience difficulty in breathing
you experience rapid heartbeat or feeling dizzy.

Other side effects include:

Common (may affect up to 1 in 10 people)

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

General effects from insulin treatment including Fiasp

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.

Warning signs of low blood sugar – these may come on suddenly:

What to do if you get low blood sugar

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.

What others need to do if you pass out

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.

Talk to your doctor if:

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:

Warning signs of high blood sugar – these normally appear gradually:

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).

What to do if you get high blood sugar

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.

Reporting of side effects

5. How to store Fiasp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP’. 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. Keep away from the freezing element. Keep the vial in the carton in order to protect from light.

After first opening or if carried as a spare

You can carry your vial with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C-8°C) for up to 4 weeks (including time in a pump reservoir). Always keep the vial in the carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fiasp contains

The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 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.

What Fiasp looks like and contents of the pack

Fiasp is presented as a clear, colourless and aqueous solution for injection in a vial.

Each vial contains 10 mL solution.

Pack sizes of 1, 5 or a multipack with 5 x (1 × 10 mL) vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

Fiasp 100 units/mL PumpCart solution for injection in cartridge insulin aspart

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, 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.

What is in this leaflet

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

1. What Fiasp is and what it is used for

Fiasp is an insulin with a fast-acting blood sugar lowering effect. Fiasp is a solution for injection containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes is a disease where your body does not produce enough insulin to control the level of blood sugar. Treatment with Fiasp helps to prevent complications from your diabetes.

About PumpCart

The PumpCart cartridge is used in an insulin pump designed to be used with this cartridge:

It covers your total daily insulin needs – both your all-day (basal) and mealtime (bolus) insulin needs.
Before you use a PumpCart cartridge in the pump, your doctor or nurse must have given you detailed instructions.

All-day (basal) insulin needs:

When you use Fiasp in a pump, your insulin will be constantly delivered into your body.

This covers your need for insulin throughout the day.
Before you set or change the all-day (basal) rate, carefully read the pump manual (user guide).
If you stop the pump, be aware that the insulin effect will gradually decline over 3 to 5 hours

Mealtime (bolus) insulin needs:

Take your mealtime insulin up to 2 minutes before the start of the meal, with an option to administer up to 20 minutes after starting the meal (see section 3, How to use Fiasp).
The maximum effect happens between 1 and 3 hours after the mealtime delivery.
The effect lasts for 3 to 5 hours.

2. What you need to know before you use Fiasp

Do not use Fiasp®

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

Warnings and precautions

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 fast-acting insulins. If hypoglycaemia occurs, you may experience it earlier after an administration 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.

Fiasp PumpCart is only for use with the following insulin infusion pump systems: the Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with other pumps, as this may give you a wrong dose of your insulin and can lead to high or low blood sugar.

Skin changes at the injection site

Children and adolescents

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

Other medicines and Fiasp

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)
sulphonamides 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.

Fiasp with alcohol

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.

Pregnancy and breast-feeding

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

Driving and using machines

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

Important information about some of the ingredients of Fiasp

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

3. How to use Fiasp

If you are blind or have poor eyesight and cannot read the screen of the pump, do not use this pump without help. Get help from a person with good eyesight who is trained to use the pump.

Dose and when to use Fiasp

Always use your insulin and adjust your all-day (basal) and mealtime (bolus) doses exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Adjust your mealtime (bolus) insulin based on your blood sugar measurement and food intake.

Adults

Fiasp mealtime doses should be taken right before (0–2 minutes) the start of the meal, with an option to take up to 20 minutes after starting the meal.

Children

Fiasp mealtime doses should be taken right before (0–2 minutes) the start of the meal, with the possibility to take 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.

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.

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.

Injecting Fiasp

This medicine is only suitable for injection under the skin (subcutaneous). Only use a pump that is designed to be used with this cartridge.

Before you use the PumpCart cartridge in the pump, your doctor or nurse must have given you detailed instructions.
Speak to your doctor if you need to inject your insulin by another method.

Where to inject

Normally you will inject your insulin in the front of your waist (abdomen). However, if your doctor recommends it, you may use your upper arm.
Do not inject into a vein or muscle.
When you change the infusion set (tubing and needle), be sure to change where you insert the needle. This may reduce the risk of developing changes under the skin (see section 4 ‘Possible side effects’).

Do not use Fiasp

if the cartridge or the device containing the cartridge you are using is dropped, damaged or

crushed. Take it back to your supplier.

if the cartridge 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 PumpCart are provided on the other side of this leaflet.

How to inject Fiasp

Read and follow the pump manual (user guide) that comes with your insulin pump.
Make sure to use an infusion set (tubing and needle) suitable for your insulin pump.
Check the name and strength on the label of the cartridge (PumpCart) to make sure it is Fiasp.
Infusion set (tubing and needle) and the PumpCart cartridge must not be shared.
Changing of the infusion set (tubing and needle) must be done according to the instructions in

the product information supplied with the infusion set.

What to do if the pump system fails

You should always have an alternative delivery method for your insulin available for injection under the skin (for example, a pen injector or syringes) in case the pump system fails.

If you use more Fiasp than you should

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 Fiasp

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

Three simple steps that may help to avoid low or high blood sugar are:

Always keep spare cartridges of Fiasp.
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’.

If you stop using Fiasp

4. Possible side effects

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

Signs of a serious allergic reaction may include:

local reactions (e.g., rash, redness and itching) spread to other parts of your body
you suddenly feel unwell with sweating
you start being sick (vomiting)
you experience difficulty breathing
you experience rapid heartbeat or feel dizzy.

Other side effects include:

Common (may affect up to 1 in 10 people)

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

General effects from insulin treatment including Fiasp

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.

Warning signs of low blood sugar – these may come on suddenly:

What to do if you get low blood sugar

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) and adjust insulin delivery or stop your pump.
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.

What others need to do if you pass out

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.

Talk to your doctor if:

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:

Warning signs of high blood sugar – these normally appear gradually:

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).

What to do if you get high blood sugar

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.

Reporting of side effects

5. How to store Fiasp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP’. 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. Keep away from the freezing element. Keep the cartridge in the carton in order to protect from light.

After first opening or if carried as a spare

Do not refrigerate during use.
You can keep your cartridge (PumpCart) at room temperature (not above 30°C) for up to
2 weeks.

After that, it can be used for up to 7 days below 37°C in a pump designed to be used with this cartridge.
Keep the PumpCart cartridge in the outer carton until use to protect it from damage. Always protect the cartridge from light during use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fiasp contains

The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 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.

What Fiasp looks like and contents of the pack

Fiasp is presented as a clear, colourless and aqueous solution for injection in cartridge.

Pack sizes of 5 or a multipack with 25 (5 packs of 5) cartridges of 1.6 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Instructions on how to use Fiasp PumpCart pre-filled cartridge.

Only use Fiasp PumpCart with an insulin infusion pump system designed to be used with this cartridge , such as the Accu-Chek Insight and YpsoPump insulin pumps.

Do not use with other devices not designed for the PumpCart cartridge.
This is because it may result in incorrect insulin dosing and lead to high blood sugar

(hyperglycaemia) or low blood sugar (hypoglycaemia).

Please read these instructions carefully before using your PumpCart cartridge.

Please also read the pump manual (user guide) that comes with your insulin pump.

The PumpCart cartridge is ready for use directly in the pump.
The PumpCart cartridge contains 1.6 mL insulin aspart solution, equivalent to 160 units.
Never mix with any other medicinal products.
Do not refill the PumpCart cartridge. Once empty, it must be disposed.
Always make sure you have a spare PumpCart cartridge available.
Do not use the PumpCart cartridge in an insulin pen, because this may result in incorrect dosing.
Protect the PumpCart cartridge from excessive heat and light during storage and use.
Keep the PumpCart cartridge out of reach of others, especially children.

1. Before inserting a PumpCart cartridge into your pump

Bring a PumpCart cartridge to room temperature.
Take the PumpCart cartridge out of its carton and blister package.
Check the label to make sure that it is a Fiasp PumpCart cartridge.
Check the expiry date – which is on the label and the carton.
Always check that the PumpCart cartridge looks the way it should (picture A). Do not use it if

any damage or leakage is seen or if the plunger has moved, making the bottom of the plunger visible above the white label band. This could be a result of leakage of insulin. In picture A the bottom of the plunger is hidden behind the white label band as it should be. If you suspect the PumpCart cartridge is damaged, take it back to your supplier.

Check that the insulin in the PumpCart cartridge is clear and colourless. If the insulin looks cloudy, do not use the PumpCart cartridge. The cartridge may contain small bubbles.
2. Inserting a new Fiasp PumpCart cartridge in your pump

Follow the instructions in the pump user manual to insert a new PumpCart cartridge in your pump.
Insert a PumpCart cartridge in the cartridge compartment of the pump. The plunger goes in first.
Connect the infusion set with the PumpCart cartridge by attaching the adapter onto your pump.
Follow the instructions in the pump user manual to continue using your pump.
3. Removing an empty Fiasp PumpCart cartridge from your pump

Follow the instructions in the pump user manual to remove an empty PumpCart cartridge from

your pump.

Remove the infusion set adapter from the empty PumpCart cartridge.
Dispose of the empty PumpCart cartridge and the used infusion set as instructed by your doctor

or nurse.

Follow the steps described in section 1 and 2 to prepare and insert a new PumpCart cartridge into your pump.

Fiasp - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Fiasp

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

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

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

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