FIASP

Package leaflet: Information for the patient

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

insulin aspart
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Fiasp is and what it is used for
2. What you need to know before using 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 rapid blood glucose-lowering effect. Fiasp is an injectable solution containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children aged 1 year and older. Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels. Treatment with Fiasp helps prevent complications of diabetes.
Fiasp should be injected up to 2 minutes before starting a meal, with the possibility of injecting it up to 20 minutes after starting the meal.
The maximum effect of the medicine occurs between 1 and 3 hours after injection, and the effect lasts for 3–5 hours.
This medicine should normally be used in combination with intermediate- or long-acting insulin preparations.

2. What you should know before using Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or to 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. Pay particular attention to:

• Low blood sugar (hypoglycaemia) – if your blood sugar level is too low, follow the instructions for low blood sugar in section 4 ‘Possible side effects’. Fiasp begins to lower blood sugar more quickly than other prandial insulins. Hypoglycaemia may therefore occur earlier after a Fiasp injection.
• High blood sugar (hyperglycaemia) – if your blood sugar level is too high, follow the instructions for high blood sugar in section 4 ‘Possible side effects’.
• Switching from other insulin medicines – your doctor may need to advise you on your insulin dose.
• If your insulin treatment is combined with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes) – inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling due to fluid retention (oedema).
• Eye problems – rapid improvement in blood glucose control may lead to a temporary worsening of eye disorders such as diabetic retinopathy.
• Pain due to nerve damage – if your blood sugar level improves very rapidly, you may experience nerve-related pain, which is usually temporary.
• Swelling around joints – at the beginning of treatment, your body may retain more fluid than normal. This effect causes swelling around the ankles and other joints. It usually lasts only a short time.
• Make sure you are using the correct type of insulin: always check the insulin label before each injection to avoid accidental mix-ups between insulin products.
• Insulin treatment may cause your body to produce antibodies against insulin (substances that act against insulin). However, only very rarely does this require a change in insulin dose.

If you have vision problems, see section 3 ‘How to use Fiasp’.
Certain conditions and activities may affect your insulin requirements. Talk to your doctor:

• if you have kidney, liver, or adrenal gland problems, or problems with your pituitary or thyroid gland
• if you are doing more physical activity than usual or wish to change your usual diet, as this may affect your blood sugar level
• if you become ill, continue using insulin and consult your doctor.
• If you are travelling abroad, crossing different time zones may affect your insulin requirements and the timing of injections.

When using Fiasp, it is strongly recommended to record the name and batch number of each package to keep a record of the batches used.
Skin changes at the injection site
Injection sites should be rotated to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin, or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area, or into a thickened area (see section 3 ‘How to use Fiasp’). Inform your doctor if you notice skin changes at the injection site. If you are currently injecting into one of these affected areas, consult your doctor before starting to inject in another area. Your doctor may ask you to monitor your blood glucose more closely and adjust your insulin dose or that of your other antidiabetic medicines.

Children and adolescents
This medicine is not recommended for use in children under 1 year of age.

Other medicines and Fiasp
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines affect blood sugar levels, which may mean that your insulin dose needs to be changed.
Below is a list of the most common medicines that can affect insulin treatment.
Your blood sugar level may decrease (hypoglycaemia) if you use:

• other antidiabetic medicines (oral and injectable)
• sulphonamide antibiotics (used to treat infections)
• anabolic steroids (e.g. testosterone)
• beta-blockers (used to treat high blood pressure or angina)
• salicylates (used to relieve pain and reduce fever)
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• angiotensin-converting enzyme (ACE) inhibitors (for certain heart conditions or high blood pressure)

Your blood sugar level may increase (hyperglycaemia) if you use:

• danazol (a medicine that affects 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, terbutaline – for asthma)
• thiazides (for high blood pressure or excessive fluid retention)

Octreotide and lanreotide – used to treat a rare disease characterised by excessive production of growth hormone (acromegaly). These may increase or decrease your blood sugar level.
If any of these situations apply to you (or if you are unsure), consult your doctor or pharmacist.

Fiasp with alcohol
If you consume alcohol, your insulin requirement may change because blood sugar levels may increase or decrease. You should therefore monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine. This medicine may be used during pregnancy, although your insulin dose may need to be adjusted during pregnancy and after delivery. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months.
Careful diabetes control is essential during pregnancy, and it is particularly important for the baby’s health to prevent low blood sugar (hypoglycaemia). After delivery, your insulin requirement will likely return to what it was before pregnancy.
There are no restrictions on using Fiasp during breastfeeding.

Driving and using machines
Low blood sugar levels can affect your ability to drive or operate tools or machinery. If your blood sugar level is too low, your concentration or reaction ability may be impaired. This could endanger yourself or others. Ask your doctor whether you may drive if:

• your blood sugar level often becomes too low
• you have difficulty recognizing the signs of low blood sugar.

Important information about some ingredients of Fiasp
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Fiasp

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
If you are blind or have serious vision problems and cannot read the dose counter, do not use
this pen without assistance. Let a person with good eyesight, trained in using the pre-filled pen FlexTouch,
help you.
The pre-filled pen can deliver a dose from 1 to 80 units in one injection, in increments of 1 unit.
When to use Fiasp
Fiasp is a mealtime insulin.
Adults: Fiasp should be injected immediately before (0–2 minutes) starting a meal, with the possibility of
injection up to 20 minutes after starting the meal.
Children: Fiasp should be injected immediately before (0–2 minutes) starting a meal, with the possibility of
injection up to 20 minutes after starting the meal, when there is uncertainty that the child will eat.
Ask your doctor for advice in these situations.
The maximum effect of the medicine will occur between 1 and 3 hours after injection, and the effect will last for 3–5 hours.
Dose of Fiasp
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 monitor your blood sugar levels and whether a higher or lower dose is needed.

If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as a change in diet may alter your insulin requirements.
When using Fiasp with other medicines, ask your doctor whether your treatment needs to be adjusted.
Dose adjustment for type 2 diabetes
The daily dose should be based on blood sugar levels at mealtimes and at bedtime the previous day.

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

Use in elderly patients (65 years of age or older)
This medicine can be used in elderly patients. Talk to your doctor about dose adjustments.

If you have kidney or liver problems
If you have kidney or liver problems, you may need to monitor your blood sugar levels more frequently. Talk to your doctor about dose adjustments.

Fiasp injection
This medicine is intended only for subcutaneous injection (injection under the skin).
Before using Fiasp for the first time, your doctor or nurse must show you how to use the pre-filled pen. Talk to your doctor if you need to inject insulin in another way.

Where to inject

• The best areas for injection are the front of the waist (abdomen) or the upper parts of the arms.
• Do not inject the medicine into a vein or into a muscle.
• Rotate the injection site daily within the chosen area to reduce the risk of developing skin changes (see section 4).

Do not use Fiasp

• if the pen is damaged or has not been stored correctly (see section 5, 'How to store Fiasp').
• if the insulin does not appear clear (for example, if it is cloudy) and colourless.

Detailed instructions on how to use the FlexTouch pen are provided on the reverse of this leaflet.

If you use more Fiasp than you should
If you use too much insulin, your blood sugar level may become too low (hypoglycaemia); see advice in section 4 under 'Blood sugar level too low'.

If you forget to use Fiasp
If you forget to use your insulin, your blood sugar level may become too high (hyperglycaemia). See section 4 under 'Blood sugar level too high'.

Three simple measures that can help prevent your blood sugar level from becoming too low or too high are:

• Always carry a spare pen in case your pen is lost or damaged.
• Always carry something that shows you have diabetes.
• Always carry sugary products. See section 4 under 'What to do if blood sugar is too low'.

If you stop using Fiasp
Do not stop using insulin without first talking to your doctor. If you stop using insulin, you may develop very high blood sugar (severe hyperglycaemia) and ketoacidosis (a condition characterised by excessive acid in the blood, which can be life-threatening). See symptoms and advice in section 4 under 'Blood sugar level too high'.

4. Possible side effects

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

Very low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can become very serious. If your blood sugar drops very low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, act immediately to raise it. See advice in the section 'Low blood sugar' below.

If you experience a severe allergic reaction (including anaphylactic shock) to insulin or to any of the ingredients of Fiasp (the frequency of which is unknown), stop using this medicine and seek immediate medical help at an emergency department.

Signs of a severe allergic reaction may include:

• localized reactions (rash, redness and itching) spreading to other parts of the body
• suddenly feeling unwell and starting to sweat
• feeling sick (nausea or vomiting)
• difficulty breathing
• rapid heartbeat or dizziness.

Allergic reactions such as widespread rash and swelling of the face may occur. These are uncommon and may affect up to 1 in 100 people. Contact a doctor if symptoms worsen or do not improve within a few weeks.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (these are uncommon effects and may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work as effectively if injected into an area with lumps, thinning or thickening of the skin. Change your injection site with each injection to prevent these skin changes.

Other side effects include:

Common (may affect up to 1 in 10 people)

Reaction at the injection site: Local reactions may occur at the site of injection. Signs may include rash, redness, inflammation, bruising, irritation, pain and itching. These reactions usually disappear within a few days.

Skin reactions: Skin allergy signs such as eczema, rash, itching, hives and dermatitis may occur.

General effects of insulin treatment including Fiasp

• Low blood sugar (hypoglycaemia) (very common)

Your blood sugar may become too low if you:
Drink alcohol; use too much insulin; exercise more than usual; eat too little or skip a meal.

Warning signs of low blood sugar, which may occur suddenly:
Headache; slurred speech; rapid heartbeat; cold sweat; cold and pale skin; feeling unwell; extreme hunger; trembling or feeling anxious or nervous; unusual tiredness, weakness or drowsiness; confusion; difficulty concentrating; vision problems.

What to do if your blood sugar is too low

• If you are conscious, treat low blood sugar immediately with 15–20 g of fast-acting carbohydrates: eat sugar cubes or a sugary snack such as fruit juice, sweets or biscuits (always carry sugar cubes or a sugary snack with you).
• It is recommended to measure your blood sugar 15–20 minutes later and repeat treatment if blood sugar levels are still below 4 mmol/L.
• Wait until symptoms of low blood sugar have disappeared or until your blood sugar has stabilized, then continue your insulin treatment as usual.

What others should do if you faint

Tell everyone you spend time with that you have diabetes and what the possible consequences are, including the risk of fainting due to low blood sugar.

Explain to them that if you faint, they should:

• turn you onto your side to prevent choking
• seek immediate medical help
• not give you food or drink, as this could cause choking.

You may regain consciousness more quickly with a glucagon injection, which must only be administered by someone trained in its use.

• If you are given glucagon, you will need sugar or a sweet snack as soon as you regain consciousness.
• If you do not respond to glucagon injection, you must be taken to hospital.

If severe hypoglycaemia is not treated promptly, it may cause temporary or permanent brain damage and may even lead to death.

Contact your doctor if:

• your blood sugar has become so low that you fainted

• you were given a glucagon injection

• you have recently had repeated episodes of low blood sugar. Your insulin dose, timing of injections, diet or physical activity may need to be adjusted.

• High blood sugar (hyperglycaemia)

Your blood sugar may become too high if you:
Eat more than usual or exercise less than usual; drink alcohol; have an infection or fever; do not use enough insulin; continue to use less insulin than you need; forget to use insulin or stop using insulin.

Warning signs of high blood sugar, which usually develop gradually:
Flushed skin; dry skin; drowsiness or tiredness; dry mouth; fruity breath (acetone); more frequent urination; thirst; loss of appetite; feeling unwell (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 metabolizing fat instead of sugar. If untreated, it may lead to diabetic coma and possibly death.

What to do if your blood sugar is too high

• Measure your blood sugar.
• Use a corrective dose of insulin, if you have been taught how to do so.
• Check for the presence of ketones in your urine.
• If ketones are present, contact a doctor immediately.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By 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 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 refrigerating elements.
Keep the cap on the pen to protect the medicine from light.

After first opening or carried as a spare
You may carry the pre-filled pen (FlexTouch) as a spare and store it at room temperature (below 30°C) or in the refrigerator (2°C–8°C) for up to 4 weeks. When not in use, keep the cap on the pen to protect the medicine from light.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Fiasp Contains

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

Description of the Appearance of Fiasp and Contents of the Pack
Fiasp is a clear, colourless, aqueous injectable solution contained in a pre-filled pen.
Pack size: 1, 5, or a multiple pack containing 2 x 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

Other Sources of Information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions on How to Use Fiasp FlexTouch
Read these instructions carefully before using the FlexTouch pre-filled pen. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
Do not use the pen without first receiving adequate training from your doctor or nurse.

Start by checking the pen to ensure it contains Fiasp 100 units/mL, then review the illustrations below to become familiar with the different parts of the pen and the needle.

If you are blind or have severe visual problems and cannot read the dose counter, do not use
this pen without assistance. Have a person with good eyesight who has been trained to use the FlexTouch pre-filled pen assist you.

The pen is a pre-filled, insulin pen with adjustable dosing, containing 300 units of insulin.
You can select a maximum dose of 80 units per injection, in 1-unit increments. The pen is designed to be used with disposable injection needles 4 mm to 8 mm in length and with 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 the correct use of the pen.

1 Preparing the Pen with a New Needle

• Check the name and strength on the pen label to ensure the pen contains Fiasp 100 units/mL. This is especially important if you use more than one type of insulin. Administering the wrong type of insulin may cause your blood sugar level to become too high or too low.
• Remove the pen cap.

• Check that the insulin in the pen is clear and colourless. Look through the insulin window. Do not use the pen if the insulin appears cloudy.

• Take a new needle and remove the protective seal.

Make sure you attach the needle correctly.

• Push the needle onto the pen.
• Rotate it until it is secure.

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.

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

• Remove the inner needle cap and discard it. If you try to replace it, you may accidentally prick or injure yourself with the needle.

A drop of insulin may appear at the tip of the needle. This is normal, but you must still check the insulin flow.
Do not attach a new needle to the pen until you are ready to administer the injection.

Always use a new needle for each injection

This reduces the risk of contamination, infection, insulin leakage, needle blockage, and incorrect dosing.
Never use a bent or damaged needle.

2 Checking the Insulin Flow

• Always check the insulin flow before starting. This helps ensure the full dose of insulin is delivered.
• Turn the dose selector and set 2 units. Make sure the dose counter shows 2.

• Hold the pen with the needle pointing upwards. Gently tap the top of the pen several times with your finger so that air bubbles rise to the top.

• Press and hold the injection button until the dose counter returns to zero. The 0 must align with the dose indicator. 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 2 A to 2 C up to six times. If still no drop appears, change the needle and repeat steps 2 A to 2 C once more.
If no insulin drop appears even after changing the needle, discard the pen and use a new one.
Always ensure a drop appears at the needle tip before injection. This

ensures proper insulin flow.
If this does not happen, no insulin will be injected, even if the dose counter moves.
This situation may indicate a blocked or damaged needle.
Always check the flow before injecting. If you do not check the flow, you may fail to inject

any insulin or inject an insufficient amount, which could cause high blood sugar levels.

3 Selecting the Dose

• Before starting, ensure the dose counter is at 0. The 0 must align with the dose indicator.
• Turn the dose selector to set the required dose, as instructed by your doctor or nurse. If you set the wrong dose, you can correct it by turning the dose selector forward or backward.

You can select up to a maximum of 80 units on the pen.

The dose selector changes the number of units. Only the dose counter and the dose indicator show how many units have been selected for each injection.
You can select up to 80 units per dose. When less than 80 units remain in the pen, the dose counter will display the number of units left.
Before injecting insulin, always use the dose counter and dose indicator to

check how many units have been selected.
Do not count the clicks of the pen to set the dose. If you select and inject an incorrect dose, your blood sugar level may become too high or too low.
Do not use the insulin scale, which only approximately indicates how much insulin remains in the pen.
The dose selector makes a different click sound when turned forward, backward, or when exceeding the number of units remaining.

4 Injecting the Dose

• Insert the needle into the skin as shown by your doctor or nurse.
• Ensure you can see the dose counter. Do not touch the dose counter with your fingers, as this may interrupt the injection.

• Press and hold the injection button. Watch the dose counter return to 0. The 0 must align with the dose indicator. You may hear or feel a click.
• Continue holding the injection button while keeping the needle in the skin.

• Count slowly to 6 while holding the injection button down.
• If the needle is withdrawn before this, insulin may leak from the needle tip. In this case, the full dose will not have been delivered, and you should increase the frequency of your blood sugar monitoring.

• Remove the needle from the skin. You can now release the injection button.

If bleeding occurs at the injection site, apply light pressure to the area for a few minutes to stop the bleeding, without rubbing.

After injection, you may see a drop of insulin at the needle tip. This is normal and does not affect the dose administered.
Always watch the dose counter to know how many units you are injecting. Keep

the injection button pressed until the dose counter shows 0. If the dose counter does not return to 0, the full dose has not been delivered, which may cause high blood sugar levels.

How to Identify a Blocked or Damaged Needle

• If the dose counter does not show 0 after continuously pressing the injection button, you may have used a blocked or damaged needle.
• In this case, no medication will have been administered, even if the dose counter has moved from the originally set dose.

How to Handle a Blocked Needle
Remove the needle as described in section 5 and repeat all steps starting from step 1: Preparing the Pen with a New Needle. Make sure to select the full required dose.
Never touch the dose counter during injection.
This may interrupt the injection.

5 After Injection
Always dispose of the needle after each injection.
This reduces the risk of contamination, infection, insulin leakage, needle blockage, and incorrect dosing. If the needle is blocked, you will not be able to inject insulin.

• Place the needle tip into the outer cap placed on a flat surface, without touching the needle or the outer needle cap.

• Once the needle is covered, press the outer cap fully and carefully.
• Unscrew the needle and dispose of it carefully according to instructions from your doctor, nurse, pharmacist, or local authorities.

• Replace the pen cap after each use to protect the insulin from light.

When the pen is empty, discard it without the needle attached, as per instructions from your doctor, nurse, pharmacist, or local authorities.
Never attempt to replace the inner needle cap. You may prick or injure yourself with the needle.

Always remove the needle from the pen after each injection and store the pen without the needle

attached. This reduces the risk of contamination, infection, insulin leakage, needle blockage, and incorrect dosing.

6 How Much Insulin is Left?

• The insulin scale shows approximately how much insulin remains in the pen.

• To see exactly 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 remain in the pen. If it shows less than 80, the number displayed is the exact number of units remaining.

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

If you split the dose, be very careful to calculate the correct amount.

If you are unsure, inject the full dose using a new pen. If you split the dose incorrectly, you may inject too little or too much insulin, which could lead to blood sugar levels that are too high or too low.

Other Important Information

• Always carry the pen with you.
• Always carry a spare pen and new needles, in case you lose or damage your pen or needles.
• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen or needles with other people. This may lead to cross-infection.
• Never share the pen with other people. The medicine may be dangerous to their health.
• Exercise extreme caution when handling used needles to reduce the risk of needle-stick injuries and cross-infection.

Pen Maintenance

• Handle the pen with care. Incorrect or improper use may result in incorrect dosing, which could lead to blood sugar levels that are too high or too low.
• Do not leave the pen in a car or in other places where it could become too hot or too cold.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent on a damp cloth.
• Do not drop the pen or allow it to hit hard surfaces. If the pen is dropped or you suspect damage, attach a new needle and check the insulin flow before injection.
• Do not attempt to refill the pen. When empty, it must be discarded.
• Do not attempt to repair or disassemble the pen.

Patient information leaflet

Fiasp 100 units/mL Penfill solution for injection in cartridge

insulin aspart
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Fiasp is and what it is used for
2. What you need to know before using 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 rapid blood glucose-lowering effect. Fiasp is an injectable solution containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children aged 1 year and older. Diabetes is a disease in which the body does not produce enough insulin to control blood glucose levels. Treatment with Fiasp helps prevent diabetes complications.
Fiasp should be injected up to 2 minutes before starting a meal, with the possibility of administering it up to 20 minutes after starting the meal.
The maximum effect of the medicine occurs between 1 and 3 hours after injection, and the effect lasts for 3–5 hours.
This medicine is normally to be used in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or to 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. Pay particular attention to:

• Low blood sugar level (hypoglycaemia) – if your blood sugar level is too low, follow the instructions for low blood sugar in section 4 ‘Possible side effects’. Fiasp begins to lower blood sugar more quickly than other prandial insulins. Hypoglycaemia may therefore occur earlier after an injection of Fiasp.
• High blood sugar level (hyperglycaemia) – if your blood sugar level is too high, follow the instructions for high blood sugar in section 4 ‘Possible side effects’.
• Switching from other insulin medicines – your doctor may need to advise you on your insulin dose.
• If your insulin treatment is combined with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes) – inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling due to fluid retention (oedema).
• Eye problems – rapid improvement in blood glucose control may lead to a temporary worsening of eye disorders such as diabetic retinopathy.
• Pain due to nerve damage – if your blood sugar level improves very rapidly, you may experience nerve-related pain, which is usually temporary.
• Swelling around joints – at the beginning of treatment, your body may retain more fluid than normal. This effect causes swelling around the ankles and other joints. It usually lasts only a short time.
• Make sure you are using the correct type of insulin: always check the label on the insulin before each injection to avoid accidental mix-ups between insulin products.
• Insulin treatment may cause your body to produce antibodies against insulin (substances that act against insulin). However, very rarely, this may require a change in insulin dose.

If you have vision problems, see section 3 ‘How to use Fiasp’.
Certain conditions and activities may affect your insulin requirements. Talk to your doctor:

• if you have kidney, liver, or adrenal gland problems, or disorders of the pituitary or thyroid gland
• if you are doing more physical activity than usual or if you wish to change your usual diet, as this may affect your blood sugar level
• if you become ill, continue using insulin and contact your doctor.
• if you are travelling abroad, travelling across different time zones may affect your insulin requirements and the timing of injections.

When using Fiasp, it is strongly recommended to record the name and batch number of each pack to maintain a record of the batches used.
Skin changes at the injection site
Injection sites should be rotated to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin, or the appearance of lumps under the skin.
Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening of the skin (see section 3 ‘How to use Fiasp’). Inform your doctor if you notice skin changes at the injection site. If you are currently injecting into one of these affected areas, consult your doctor before starting to inject in another area. Your doctor may advise you to monitor your blood glucose more closely and adjust your insulin dose or that of other antidiabetic medicines.

Children and adolescents
This medicine is not recommended for use in children under 1 year of age.

Other medicines and Fiasp
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Some medicines affect your blood sugar level, which may require a change in insulin dose.
Below are listed the most common medicines that can affect insulin treatment.
Your blood sugar level may decrease (hypoglycaemia) if you use:

• other diabetes medicines (oral and injectable)
• sulphonamide antibiotics (used to treat infections)
• anabolic steroids (e.g. testosterone)
• beta-blockers (used to treat high blood pressure or angina)
• salicylates (used to relieve pain and reduce fever)
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• angiotensin-converting enzyme (ACE) inhibitors (for certain heart conditions or high blood pressure)

Your blood sugar level may increase (hyperglycaemia) if you use:

• danazol (a medicine affecting 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, terbutaline – for asthma)
• thiazides (for high blood pressure or excessive fluid retention)

Octreotide and lanreotide – used to treat a rare disease characterised by excessive production of growth hormone (acromegaly). These may increase or decrease your blood sugar level.
If any of these situations apply to you (or if you are unsure), talk to your doctor or pharmacist.

Fiasp and alcohol
If you consume alcohol, your insulin requirement may change because your blood sugar level may increase or decrease. Therefore, you should monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine. This medicine may be used during pregnancy, although your insulin dose may need to be adjusted during pregnancy and after delivery. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months.
Careful diabetes control is essential during pregnancy, and it is particularly important for your baby’s health to prevent low blood sugar (hypoglycaemia). After delivery, your insulin requirement will likely return to what it was before pregnancy.
There are no restrictions on the use of Fiasp during breastfeeding.

Driving and using machines
Low blood sugar levels can affect your ability to drive or operate tools or machinery. If your blood sugar level is too low, your concentration or reaction ability may be impaired. This could endanger yourself or others. Ask your doctor whether you may drive if:

• your blood sugar level often becomes too low
• you have difficulty recognizing the signs of low blood sugar.

Important information about some ingredients of Fiasp
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Fiasp

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you are blind or have severe vision problems and cannot read the dose counter, do not use this insulin medicine without assistance. Have someone with good eyesight who has been trained to use the pen help you.

When to use Fiasp
Fiasp is a mealtime insulin.
Adults: Fiasp should be injected immediately before (0–2 minutes before) the start of a meal, with the possibility of injecting up to 20 minutes after starting the meal.
Children: Fiasp should be injected immediately before (0–2 minutes before) the start of a meal, with the possibility of injecting up to 20 minutes after the start of the meal, when there is uncertainty whether the child will eat.
Ask your doctor for advice in these situations.
The maximum effect of the medicine will occur between 1 and 3 hours after injection, and the effect will last for 3–5 hours.

Dose of Fiasp
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 monitor your blood sugar levels and whether a higher or lower dose is needed

If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as a change in diet may alter your insulin requirements.
When using Fiasp together with other medicines, ask your doctor whether your treatment needs to be adjusted.

Dose adjustment for type 2 diabetes
The daily dose should be based on blood sugar levels at mealtimes and at bedtime the previous day.

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

Use in elderly patients (65 years of age or older)
This medicine can be used in elderly patients. Talk to your doctor about dose adjustments.

If you have kidney or liver problems
If you have kidney or liver problems, you may need to monitor your blood sugar levels more frequently. Talk to your doctor about dose adjustments.

Fiasp Injection
This medicine is intended only for subcutaneous injection (injection under the skin) using a Novo Nordisk reusable pen.
Before using Fiasp for the first time, your doctor or nurse must show you how to use it. Talk to your doctor if you need to inject insulin by another method.

Where to inject

• The best areas for injection are the front of the waist (abdomen) or the upper arms.
• Do not inject the medicine into a vein or into a muscle.
• Rotate the injection site daily within the chosen area to reduce the risk of developing skin changes (see section 4).

Do not use Fiasp

• if the cartridge or reusable pen you are using is damaged. Return it to your supplier. For further instructions, see the reusable pen user manual.
• if the cartridge has not been stored properly (see section 5 ‘How to store Fiasp’).
• if the insulin does not appear clear (for example, if it is cloudy) and colourless.

How to inject Fiasp

• Read the instructions provided with the reusable pen.
• Check the name and dosage on the cartridge (Penfill) label 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 level may become too low (hypoglycaemia); see advice in section 4 under ‘Blood sugar level too low’.

If you forget to use Fiasp
If you forget to take your insulin, your blood sugar level may become too high (hyperglycaemia). See section 4 under ‘Blood sugar level too high’.

Three simple precautions that may help prevent blood sugar levels from becoming too low or too high are:

• Always carry spare Fiasp cartridges with you.
• Always carry something that shows you have diabetes.
• Always carry sugar-containing products. See section 4 under ‘What to do if blood sugar is too low’.

If you stop using Fiasp
Do not stop using insulin without talking to your doctor. If you stop using insulin, you may develop very high blood sugar (severe hyperglycaemia) and ketoacidosis (a condition characterised by excess acid in the blood, which can be life-threatening). See symptoms and advice in section 4 under ‘Blood sugar level too high’.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Very low blood sugar level (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can become very serious. If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, act immediately to raise it. See the advice in the section 'Low blood sugar level' below.

If you experience a severe allergic reaction (including anaphylactic shock) to insulin or to any of the ingredients of Fiasp (frequency of occurrence is unknown), stop using this medicine and seek immediate medical help at an emergency department.

Signs of a severe allergic reaction may include:

• localized skin reactions (rash, redness, itching) spreading to other parts of the body
• suddenly feeling unwell and starting to sweat
• feeling sick (nausea or vomiting)
• difficulty breathing
• rapid heartbeat or dizziness.

Allergic reactions such as generalized rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. Contact a doctor if symptoms worsen or do not improve within a few weeks.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (these are uncommon effects and may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is unknown). Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening. Rotate your injection site with each injection to prevent these skin changes.

Other side effects include:

Common (may affect up to 1 in 10 people)
Reaction at the injection site: Local reactions may occur at the site of injection. Signs may include: rash, redness, inflammation, bruising, irritation, pain, and itching. Reactions usually disappear within a few days.

Skin reactions: Skin allergy signs such as eczema, rash, itching, hives, and dermatitis may appear.

General effects of insulin treatment including Fiasp

• Low blood sugar level (hypoglycaemia) (very common)
  Your blood sugar level may become too low if you:
  Drink alcohol; use too much insulin; do more physical activity than usual; eat too little or skip a meal.

Warning signs of low blood sugar level, which may occur suddenly:
headache; confused speech; rapid heartbeat; cold sweating; cold and pale skin; feeling unwell; extreme hunger; trembling or feeling nervous or anxious; unusual tiredness, weakness, or drowsiness; confusion; difficulty concentrating; temporary vision disturbances.

What to do if your blood sugar level is too low

• If you are conscious, treat low blood sugar immediately with 15–20 g of fast-acting carbohydrates: eat sugar cubes or a sugary snack such as fruit juice, sweets, or biscuits (always carry sugar cubes or a sugary snack with you).
• It is recommended to measure your blood sugar level after 15–20 minutes and repeat treatment if blood sugar levels are still below 4 mmol/L.
• Wait until symptoms of low blood sugar have disappeared or your blood sugar level has stabilized, then continue insulin treatment as usual.

What others should do if you faint
Inform everyone you spend time with that you have diabetes and explain the possible consequences, including the risk of fainting due to low blood sugar.

Explain to them that if you faint, they should:

• turn you onto your side to prevent choking
• call for immediate medical help
• not give you food or drink, as this could cause choking.

You may regain consciousness more quickly with a glucagon injection, which should only be administered by someone trained in its use.

• If glucagon is given, you will need sugar or a sweet snack as soon as you regain consciousness.
• If you do not respond to the glucagon injection, you must be taken to hospital.

If severe hypoglycaemia is not treated promptly, it can cause temporary or permanent brain damage and may even result in death.

Contact your doctor if:

• your blood sugar level became so low that you fainted

• you were given a glucagon injection

• you have recently had several episodes of low blood sugar. Your insulin dose, timing of injections, diet, or physical activity may need adjustment.

• High blood sugar level (hyperglycaemia)
  Your blood sugar level may become too high if you:
  Eat more than usual or exercise less than usual; drink alcohol; have an infection or fever; have not used enough insulin; continue to use less insulin than you need; forget to use insulin or stop using insulin.

Warning signs of high blood sugar level, which usually develop gradually:
flushed skin; dry skin; feeling drowsy or tired; dry mouth; fruity breath (acetone); more frequent urination; thirst; loss of appetite; feeling unwell (nausea or vomiting).

These may be signs of a very serious condition called ketoacidosis. This is a buildup of acid in the blood because the body is metabolizing fat instead of sugar. If untreated, it can lead to diabetic coma and possibly death.

What to do if your blood sugar level is too high

• Measure your blood sugar level.
• Use a corrective dose of insulin, if you have been taught how to do so.
• Check for the presence of ketones in your urine.
• If ketones are present, contact a doctor immediately.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By 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 the carton after
'Exp.'. The expiry date refers to the last day of that month.
Before first use:
Store in the refrigerator (2°C – 8°C). Do not freeze. Keep away from cooling elements.
Keep the cartridge in its packaging to protect the medicine from light.
After first opening or carried as a spare
Do not refrigerate. You may carry the cartridge (Penfill) as a spare and keep it at room temperature
(below 30°C) for up to 4 weeks. Always keep the cartridge in its packaging to
protect the medicine from light.
Dispose of the needle after each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Fiasp contains

• The active substance is insulin aspart. 1 mL of solution contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 mL of solution.
• The other ingredients are phenol, metacresol, glycerol, zinc acetate, dibasic sodium phosphate dihydrate, hydrochloride arginine, nicotinamide (vitamin B), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2, 'Important information on some ingredients of Fiasp') and water for injections.

Description of the appearance of Fiasp and pack contents
Fiasp is a clear, colourless, aqueous injectable solution contained in a cartridge.
Packs 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient information leaflet: information for the patient

Fiasp 100 units/mL solution for injection in vial

insulin aspart
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Fiasp is and what it is used for
2. What you need to know before using 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 prandial insulin with a rapid blood glucose-lowering effect. Fiasp is an injectable solution containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children aged 1 year and older. Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels. Treatment with Fiasp helps prevent diabetes-related complications.
Fiasp should be injected up to 2 minutes before starting a meal, with the possibility of injecting it up to 20 minutes after starting the meal.
The maximum effect of the medicine occurs between 1 and 3 hours after injection, and the effect lasts for 3–5 hours.
This medicine should normally be used in combination with intermediate- or long-acting insulin preparations.
Additionally, this medicine can be used for continuous infusion via insulin pumps.

2. What you need to know before using Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or to 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. Pay particular attention to:

• Low blood sugar (hypoglycaemia) – if your blood sugar level is too low, follow the instructions for low blood sugar in section 4 ‘Possible side effects’. Fiasp begins lowering blood sugar more quickly than other prandial insulins. Any hypoglycaemia may therefore occur earlier after a Fiasp injection.
• High blood sugar (hyperglycaemia) – if your blood sugar level is too high, follow the instructions for high blood sugar in section 4 ‘Possible side effects’.
• Switching from other insulin medicines – your doctor may need to advise you on your insulin dose.
• If your insulin treatment is combined with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes) – inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling caused by fluid retention (oedema).
• Eye problems – rapid improvement in blood glucose control may lead to a temporary worsening of eye disorders such as diabetic retinopathy.
• Pain due to nerve damage – if your blood sugar level improves very rapidly, you may experience nerve-related pain, which is usually temporary.
• Swelling around joints – when starting this medicine, your body may retain more water than it should. This effect causes swelling around the ankles and other joints. It usually lasts only a short time.
• Make sure you are using the correct type of insulin: always check the insulin label before each injection to avoid accidental mix-ups between insulin products.
• Insulin treatment may cause your body to produce antibodies against insulin (substances that act against insulin). However, very rarely, this may require a change in insulin dose.

Certain conditions and activities may affect your insulin requirement. Talk to your doctor:

• if you have kidney, liver, or adrenal gland problems, or disorders of the pituitary or thyroid gland
• if you are doing more physical activity than usual or if you wish to change your usual diet, as this may affect your blood sugar level
• if you become ill, continue using insulin and consult your doctor.
• If you are travelling abroad, crossing different time zones may affect your insulin requirement and the timing of injections.

When using Fiasp, it is strongly recommended to record the name and batch number of each pack to maintain a record of the batches used.
Skin changes at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin, or the appearance of lumps under the skin. Insulin may not work as well if you inject into an area with lumps, into a thinned area, or into a thickened area (see section 3 ‘How to use Fiasp’). Inform your doctor if you notice skin changes at the injection site. If you currently inject into one of these affected areas, consult your doctor before starting to inject into another area. Your doctor may ask you to monitor your blood glucose more closely and may adjust your insulin dose or the dose of your other antidiabetic medicines.
Children and adolescents
This medicine is not recommended for use in children under 1 year of age.
Other medicines and Fiasp
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Some medicines affect blood sugar levels, which may mean that your insulin dose needs to be changed.
Below are listed the most common medicines that can affect insulin treatment.
Your blood sugar level may decrease (hypoglycaemia) if you use:

• other antidiabetic medicines (oral and injectable)
• sulphonamide antibiotics (used to treat infections)
• anabolic steroids (e.g. testosterone)
• beta-blockers (used to treat high blood pressure or angina)
• salicylates (used to relieve pain and reduce fever)
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• angiotensin-converting enzyme (ACE) inhibitors (for certain heart conditions or high blood pressure).

Your blood sugar level may increase (hyperglycaemia) if you use:

• danazol (a medicine that affects 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, terbutaline – for asthma)
• thiazides (for high blood pressure or excessive fluid retention).

Octreotide and lanreotide – used to treat a rare disease characterised by excessive production of growth hormone (acromegaly). These may increase or decrease your blood sugar level.
If any of these situations apply to you (or if you are unsure), talk to your doctor or pharmacist.
Fiasp and alcohol
If you consume alcohol, your insulin requirement may change because your blood sugar level may increase or decrease. You should therefore monitor your blood sugar level more frequently than usual.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine. This medicine may be used during pregnancy, although your insulin dose may need to be adjusted during pregnancy and after delivery. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months. Careful diabetes control is essential during pregnancy, and it is particularly important for your baby’s health to prevent low blood sugar (hypoglycaemia). After delivery, your insulin requirement will likely return to what it was before pregnancy.
There are no restrictions on the use of Fiasp during breastfeeding.
Driving and using machines
Low blood sugar can affect your ability to drive or operate tools or machinery. If your blood sugar level is too low, your concentration or reaction time may be impaired. This could endanger yourself or others. Ask your doctor whether you may drive if:

• your blood sugar level often becomes too low
• you have difficulty recognising the signs of low blood sugar.

Important information on some ingredients of Fiasp
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.

3. How to use Fiasp

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

When to use Fiasp
Fiasp is a mealtime insulin.
Adults: Fiasp should be injected immediately before (0–2 minutes before) starting a meal, with the possibility of injecting up to 20 minutes after the start of the meal.
Children: Fiasp should be injected immediately before (0–2 minutes before) starting a meal, with the possibility of injecting up to 20 minutes after the start of the meal when there is uncertainty that the child will eat.
Ask your doctor for advice in these situations.
The maximum effect of this medicine will occur between 1 and 3 hours after injection, and the effect will last for 3–5 hours.

Dose of Fiasp
Dose for type 1 and type 2 diabetes
Your doctor will decide together with you:

• how much Fiasp you need at each meal
• when to check your blood sugar levels and whether a higher or lower dose is needed

If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as a change in diet may alter your insulin requirements.
When using Fiasp with other medicines, ask your doctor whether your treatment needs to be adjusted.

Dose adjustment for type 2 diabetes
The daily dose should be based on blood sugar levels at mealtimes and at bedtime the previous day.

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

Use in elderly patients (65 years of age and older)
This medicine can be used in elderly patients. Talk to your doctor about any dose adjustments.

If you have kidney or liver problems
If you have kidney or liver problems, you may need to monitor your blood sugar levels more frequently. Talk to your doctor about any dose adjustments.

Fiasp Injection
This medicine is administered by subcutaneous injection (injection under the skin) or by continuous infusion using insulin pumps. Administration via insulin pump requires detailed instructions from healthcare professionals.

Where to inject

• The best areas for injection are the front of the waist (abdomen) or the upper arms.
• Do not inject the medicine into a vein or into a muscle.
• Rotate the injection site daily within the chosen area to reduce the risk of developing skin changes (see section 4).

Do not use Fiasp

• if the protective cap of the vial is loose or missing. The vial has a plastic protective cap to provide tamper-evidence. If the vial is not in perfect condition when purchased, return it to the supplier.
• if the vial has not been stored correctly (see section 5, ‘How to store Fiasp’).
• if the insulin does not appear clear (for example, if it is cloudy) and colourless.

How to inject Fiasp
Before using Fiasp for the first time, your doctor or nurse must show you how to use it.
1 Check the name and strength on the vial label to make sure it is Fiasp.
2 Remove the protective cap from the vial.
3 Always use a new needle and a new syringe for each injection to prevent contamination. Needles and syringes must not be shared.
4 Draw into the syringe an amount of air equal to the dose of insulin you are going to inject. Inject this air into the vial.
5 Turn the vial and syringe upside down and draw the correct dose of insulin into the syringe. Remove the needle from the vial. Then expel the air from the syringe and check that the dose is correct.
6 Inject the insulin under the skin. Use the administration technique provided by your doctor or nurse.
7 Dispose of the needle after each injection.

For use in insulin pumps
Follow your doctor’s instructions and recommendations regarding the use of Fiasp in an insulin pump. Before using Fiasp in an insulin pump, make sure you fully understand the instructions for use and information on any actions to take in case of illness, hyperglycaemia or hypoglycaemia, or insulin pump malfunction. If Fiasp is used from a vial in an insulin pump, it may be used for up to 6 days.

Filling the insulin pump

• Fiasp must never be diluted or mixed with other insulins.
• Before inserting the needle, wash your hands and the skin at the infusion site thoroughly with soap and water to prevent infections at the infusion site.
• When filling a new reservoir, ensure there are no air bubbles in either the syringe or the tubing.
• The infusion set (tubing and needle) must be changed according to the instructions provided with the infusion set.

To fully benefit from insulin infusion and to detect any insulin pump malfunction early, measure your blood glucose regularly.

What to do if the insulin pump malfunctions
Always keep an alternative method of insulin administration available (e.g. insulin pen or syringes) for subcutaneous injection in case the insulin pump malfunctions.

If you use more Fiasp than you should
If you use too much insulin, your blood sugar level may become too low (hypoglycaemia); see advice in section 4 under ‘Blood sugar level too low’.

If you forget to use Fiasp
If you forget to use your insulin, your blood sugar level may become too high (hyperglycaemia). See section 4 under ‘Blood sugar level too high’.

Three simple precautions that may help prevent blood sugar levels from becoming too low or too high are:

• Always carry a spare syringe and a spare vial of Fiasp.
• Always carry something that shows you have diabetes.
• Always carry sugar-containing products. See section 4 under ‘What to do if blood sugar is too low’.

If you stop using Fiasp
Do not stop using insulin without first talking to your doctor. If you stop using insulin, you may develop very high blood sugar (severe hyperglycaemia) and ketoacidosis (a condition characterised by high levels of acid in the blood, which can be life-threatening). See symptoms and advice in section 4 under ‘Blood sugar level too high’.

4. Possible side effects

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

Low blood sugar level (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can become very serious. If your blood sugar level drops very low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, act immediately to raise it. See the advice in the section 'Low blood sugar level' below.

If you experience a severe allergic reaction (including anaphylactic shock) to insulin or to any of the ingredients of Fiasp (frequency unknown), stop using this medicine and seek immediate medical help.

Signs of a severe allergic reaction may include:

• localized skin reactions (rash, redness, itching) spreading to other parts of the body
• suddenly feeling unwell and starting to sweat
• feeling sick (vomiting)
• difficulty breathing
• rapid heartbeat or dizziness.

Allergic reactions such as widespread rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. Contact a doctor if symptoms worsen or do not improve within a few weeks.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (these are uncommon effects and may affect less than 1 in 100 people). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening. Rotate your injection site with each injection to prevent these skin changes.

Other side effects include:

Common (may affect up to 1 in 10 people)

Reaction at the injection site: Local reactions may occur at the injection site. Signs may include: rash, redness, inflammation, bruising, irritation, pain, and itching. Reactions usually disappear within a few days.

Skin reactions: Skin allergy signs such as eczema, rash, itching, hives, and dermatitis may appear.

General effects of insulin treatment including Fiasp

• Low blood sugar level (hypoglycaemia) (very common) Your blood sugar level may become too low if: You drink alcohol; use too much insulin; exercise more than usual; eat too little or skip a meal.

Warning signs of low blood sugar level, which may occur suddenly:

headache; confused speech; rapid heartbeat; cold sweating; cold and pale skin; feeling unwell; intense hunger; trembling or feeling nervous or anxious; unusual tiredness, weakness, or drowsiness; confusion; difficulty concentrating; temporary vision disturbances.

What to do if your blood sugar level is too low

• If you are conscious, treat low blood sugar immediately with 15–20 g of fast-acting carbohydrates: eat sugar cubes or a sugary snack such as fruit juice, sweets, or biscuits (always carry sugar cubes or a sugary snack with you).
• It is recommended to measure your blood sugar level after 15–20 minutes and repeat treatment if blood sugar is still below 4 mmol/L.
• Wait until symptoms of low blood sugar have disappeared or blood sugar has stabilized, then continue your insulin treatment as usual.

What others should do if you lose consciousness

Tell everyone you spend time with that you have diabetes and what the consequences may be, including the risk of fainting due to low blood sugar.

Explain to them that, if you lose consciousness, they should:

• turn you onto your side to prevent choking
• seek immediate medical help
• not give you food or drink as this could cause choking.

You may regain consciousness more quickly with a glucagon injection, which should only be administered by someone who knows how to use it.

• If glucagon is administered, you will need sugar or a sweet snack as soon as you regain consciousness.
• If you do not respond to glucagon injection, you must be taken to hospital.

If severe hypoglycaemia is not treated promptly, it can cause temporary or permanent brain damage and may even result in death.

Contact your doctor if:

• your blood sugar level became so low that you lost consciousness

• you received a glucagon injection

• you have recently had several episodes of low blood sugar. Your insulin dose, timing of injections, diet, or physical activity may need to be adjusted.

• High blood sugar level (hyperglycaemia) Your blood sugar level may become too high if: You eat more or exercise less than usual; drink alcohol; have an infection or fever; have not used enough insulin; continue to use less insulin than you need; forget to use insulin or stop using insulin.

Warning signs of high blood sugar level, which usually develop gradually:

flushed skin; dry skin; feeling drowsy or tired; dry mouth; fruity breath (acetone); more frequent urination; thirst; loss of appetite; feeling unwell (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 metabolising fat instead of sugar. If untreated, it can lead to diabetic coma and possibly death.

What to do if your blood sugar level is too high

• Measure your blood sugar level.
• Use a corrective dose of insulin, if you have been taught how to do so.
• Check for the presence of ketones in your urine.
• If ketones are present, contact a doctor immediately.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By 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 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 refrigerating elements.
Keep the vial in its packaging to protect the medicine from light.
After first opening or when carried as a spare
You may carry the vial with you and store it at room temperature (below 30°C) or in the refrigerator (2°C – 8°C) for up to 4 weeks (including the time inside the pump reservoir). Always keep the vial in its packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fiasp contains

• The active substance is insulin aspart. 1 mL of solution contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 mL of solution.
• The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2, 'Important information on some of the ingredients of Fiasp'), and water for injections.

Description of the appearance of Fiasp and contents of the pack
Fiasp is a clear, colourless, aqueous injectable solution contained in a vial.
Pack sizes: 1, 5 or a multiple pack of 5 x (1 x 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient Information Leaflet

Fiasp 100 units/mL PumpCart injectable solution in cartridge

insulin aspart
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Fiasp is and what it is used for
2. What you need to know before using 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 rapid blood glucose-lowering effect. Fiasp is an injectable solution containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children aged 1 year and older. Diabetes is a condition in which the body does not produce enough insulin to control blood glucose levels. Treatment with Fiasp helps prevent complications of diabetes.

Information about PumpCart
The PumpCart cartridge must be used with an insulin pump designed to be compatible with this cartridge:

• it covers the total daily insulin requirement – both the insulin needed throughout the day (basal) and that needed during meals (bolus).

• Before using a PumpCart cartridge in an insulin pump, your doctor or nurse must have provided you with detailed instructions.

Insulin requirement throughout the day (basal):
When you use Fiasp in an insulin pump, insulin is continuously delivered into your body.

• This covers your insulin needs during the day.
• Before setting or adjusting the basal rate, carefully read the insulin pump user manual (user guide).
• If you interrupt the action of the insulin pump, keep in mind that the insulin effect will gradually decrease over 3 to 5 hours.

Insulin requirement during meals (bolus):

• Take insulin at mealtimes up to 2 minutes before starting the meal, with the possibility of administering it up to 20 minutes after starting the meal (see section 3, How to use Fiasp).
• The maximum effect of the medicine occurs between 1 and 3 hours after administration at mealtimes.
• The effect lasts for 3–5 hours.

2. What you need to know before using Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or to 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. Pay particular attention to:

• Low blood sugar level (hypoglycaemia) – if your blood sugar level is too low, follow the instructions for low blood sugar in section 4 ‘Possible side effects’. Fiasp starts lowering blood sugar more quickly than other rapid-acting insulins. Hypoglycaemia may therefore occur earlier after an injection of Fiasp.
• High blood sugar level (hyperglycaemia) – if your blood sugar level is too high, follow the instructions for high blood sugar in section 4 ‘Possible side effects’.
• Switching from other insulin medicines – your doctor may need to advise you on your insulin dose.
• If your insulin treatment is combined with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes) – Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling due to fluid retention (oedema).
• Eye disorders – rapid improvement in blood glucose control may lead to a temporary worsening of eye disorders such as diabetic retinopathy.
• Pain due to nerve damage – if your blood sugar level improves very rapidly, you may experience nerve-related pain, which is usually temporary.
• Swelling around joints – at the beginning of treatment, your body may retain more water than usual. This effect causes swelling around the ankles and other joints. It usually lasts only a short time.
• Make sure you are using the correct type of insulin: always check the insulin label before each injection to avoid accidental mix-ups between insulin products.
• Insulin treatment may cause your body to produce antibodies against insulin (substances that act against insulin). However, very rarely, this may require a change in insulin dose.

If you have vision problems, see section 3 ‘How to use Fiasp’.
Certain conditions and activities can affect your insulin requirement. Talk to your doctor:

• if you have kidney, liver, or adrenal gland problems, or disorders of the pituitary or thyroid gland
• if you are doing more physical activity than usual or if you wish to change your usual diet, as this may affect your blood sugar level
• if you become ill, continue using insulin and consult your doctor.
• If you are travelling abroad, crossing different time zones may affect your insulin requirement and the timing of injections.

When using Fiasp, it is strongly recommended to record the name and batch number of each pack to maintain a record of the batches used.
Fiasp PumpCart must only be used with the following insulin microinfusion devices: the Accu-Chek Insight and YpsoPump insulin microinfusion devices. It must not be used with other microinfusion devices, as this could result in you receiving an incorrect dose of insulin and may lead to blood sugar levels that are too high or too low.
Skin changes at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin, or the appearance of lumps under the skin. Insulin may not work as well if you inject into an area with lumps, an area that is thinned, or an area that is thickened (see section 3 ‘How to use Fiasp’). Inform your doctor if you notice skin changes at the injection site. If you are currently injecting into one of these affected areas, consult your doctor before starting to inject in another area. Your doctor may advise you to monitor your blood glucose more closely and adjust your insulin dose or other antidiabetic medicines.
Children and adolescents
This medicine is not recommended for use in children under 1 year of age.
Other medicines and Fiasp
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Some medicines affect blood sugar levels; this may mean that a change in insulin dose is needed.
Below are listed the most common medicines that can affect insulin treatment.
Your blood sugar level may decrease (hypoglycaemia) if you use:

• other antidiabetic medicines (oral and injectable)
• sulphonamide antibiotics (used to treat infections)
• anabolic steroids (e.g. testosterone)
• beta-blockers (used to treat high blood pressure or angina)
• salicylates (used to relieve pain and reduce fever)
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• angiotensin-converting enzyme (ACE) inhibitors (for certain heart conditions or high blood pressure).

Your blood sugar level may increase (hyperglycaemia) if you use:

• danazol (a medicine that affects 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, terbutaline for asthma)
• thiazides (for high blood pressure or excessive fluid retention).

Octreotide and lanreotide – used to treat a rare disease characterized by excessive production of growth hormone (acromegaly). These may increase or decrease your blood sugar level.
If any of these situations apply to you (or if you are unsure), consult your doctor or pharmacist.
Fiasp with alcohol
If you consume alcohol, your insulin requirement may change because your blood sugar level may increase or decrease. You should therefore check your blood sugar level more frequently than usual.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine. This medicine can be used during pregnancy, although your insulin dose may need to be adjusted during pregnancy and after delivery. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months.
Careful diabetes control is necessary during pregnancy, and it is particularly important for your baby’s health to prevent low blood sugar (hypoglycaemia). After giving birth, your insulin requirement will likely return to what it was before pregnancy.
There are no restrictions on treatment with Fiasp during breastfeeding.
Driving and using machines
Low blood sugar can affect your ability to drive or use tools or machinery. If your blood sugar level is too low, your concentration or reaction ability may be impaired. This could endanger yourself or others. Ask your doctor whether you can drive if:

• your blood sugar level often becomes too low
• you have difficulty recognizing the signs of low blood sugar.

Important information about some ingredients of Fiasp
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Fiasp

If you are blind or have severe vision problems and cannot read the screen of your insulin pump, do not use the insulin pump without assistance. Ask someone with good eyesight, who has been trained to use the insulin pump, to help you.

Dose and when to use Fiasp
Always use insulin and adjust your doses throughout the day (basal) and at mealtimes (bolus) exactly as instructed by your doctor. If you have any doubts, consult your doctor, nurse, or pharmacist.

• Adjust your mealtime insulin (bolus) according to blood glucose measurements and food intake.

Adults:
Fiasp mealtime doses should be injected immediately before (0–2 minutes before) starting a meal, with the possibility of injecting up to 20 minutes after the start of the meal.

Children:
Fiasp mealtime doses should be injected immediately before (0–2 minutes before) starting a meal, with the possibility of injecting up to 20 minutes after the start of the meal, when there is uncertainty whether the child will eat. Ask your doctor for advice in these situations.

If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as changes in diet may alter your insulin requirements.

When using other medicines, consult your doctor whether 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 any necessary dose adjustments.

If you have kidney or liver problems
If you have kidney or liver problems, you may need to monitor your blood sugar levels more frequently. Talk to your doctor about any necessary dose adjustments.

Injection of Fiasp
This medicine is intended only for subcutaneous injection (injection under the skin). Only use an insulin pump specifically designed for use with this cartridge.

• Before using PumpCart cartridges in the insulin pump, your doctor or nurse must provide you with detailed instructions.
• Talk to your doctor if you need to inject insulin by another method.

Where to inject

• You will generally inject insulin into the front of your waist (abdomen). However, if advised by your doctor, you may also inject insulin into the upper arms.
• Do not inject this medicine into a vein or into a muscle.
• When changing the infusion set (tubing and needle), make sure to change the site where the needle is inserted. This may reduce the risk of developing skin changes (see section 4 "Possible side effects").

Do not use Fiasp

• if the cartridge or the cartridge-containing device has been dropped, damaged, or crushed. Return it 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., if it is cloudy) and colourless.

Detailed instructions on how to use PumpCart are provided on the reverse side of this patient information leaflet.

How to inject Fiasp

• Read and follow the instructions in the user manual of the insulin pump provided with the device.
• Make sure you use an infusion set (tubing and needle) compatible with your insulin pump.
• Check the name and strength on the cartridge (PumpCart) label to ensure it is Fiasp.
• The infusion set (tubing and needle) and the PumpCart cartridge must not be shared.
• Replacement of the infusion set (tubing and needle) must be performed according to the instructions provided in the product information for the infusion set.

What to do if the insulin pump fails
You must always have an alternative method of insulin administration available for subcutaneous injection (e.g., an insulin injection pen or syringes) in case the insulin pump stops working.

If you use more Fiasp than you should
If you use too much insulin, your blood sugar level may become too low (hypoglycaemia). See advice in section 4 under ‘Blood sugar level too low’.

If you forget to use Fiasp
If you forget to use your insulin, your blood sugar level may become too high (hyperglycaemia). See section 4 under ‘Blood sugar level too high’.

Three simple measures that may help prevent blood sugar levels from becoming too low or too high are:

• Always carry spare Fiasp cartridges with you.
• Always carry something that shows you have diabetes.
• Always carry sugar-containing products. See section 4 under ‘What to do if blood sugar is too low’.

If you stop using Fiasp
Do not stop using insulin without first talking to your doctor. If you stop using insulin, you may develop very high blood sugar (severe hyperglycaemia) and ketoacidosis (a condition characterised by excess acid in the blood, which can be life-threatening). See symptoms and advice in section 4 under ‘Blood sugar level too high’.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Very low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can become very serious. If your blood sugar drops too low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, act immediately to raise it. See advice in the section 'Low blood sugar' below.
If you experience a severe allergic reaction (including anaphylactic shock) to insulin or any of the ingredients of Fiasp (the frequency of which is unknown), stop using this medicine and seek immediate medical attention at an emergency department.
Signs of a severe allergic reaction may include:

• localized reactions (rashes, redness, itching) spreading to other parts of the body
• sudden feeling unwell and starting to sweat
• feeling sick (nausea or vomiting)
• difficulty breathing
• rapid heartbeat or dizziness.

Allergic reactions such as generalized rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. Contact a doctor if symptoms worsen or do not improve within a few weeks.
Changes in the skin at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (these are uncommon effects and may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening of the skin. Rotate your 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 the injection site: Local reactions may occur at the site of injection. Signs may include: rash, redness, inflammation, bruising, irritation, pain, and itching. These reactions usually disappear within a few days.
Skin reactions: Signs of allergy on the skin such as eczema, rash, itching, hives, and dermatitis may occur.
General effects of insulin treatment including Fiasp

• Low blood sugar (hypoglycaemia) (very common) Your blood sugar may become too low if: You drink alcohol; use too much insulin; are more physically active than usual; eat too little or skip a meal.

Warning signs of low blood sugar, which may occur suddenly:
headache; confusion; rapid heartbeat; cold sweating; cold and pale skin; feeling unwell; extreme hunger; trembling or feeling nervous or anxious; unusual tiredness, weakness, or drowsiness; confusion; difficulty concentrating; temporary vision disturbances.
What to do if your blood sugar is too low

• If you are conscious, treat low blood sugar immediately with 15–20 g of fast-acting carbohydrates: eat sugar lumps or a sugary snack such as fruit juice, sweets, or biscuits (always carry sugar lumps or a sugary snack with you, if needed), and adjust your insulin dose or stop your insulin pump.
• It is recommended to check your blood sugar levels after 15–20 minutes and repeat treatment if blood sugar levels are still below 4 mmol/L.
• Wait until symptoms of low blood sugar have disappeared or blood sugar has stabilized, then continue insulin treatment as usual.

What others should do if you faint
Inform everyone you spend time with that you have diabetes and what the possible consequences are, including the risk of fainting due to low blood sugar.
Explain to them that if you faint, they should:

• turn you onto your side to prevent choking
• call for immediate medical help
• not give you food or drink, as this could cause choking.

You may regain consciousness more quickly with a glucagon injection, which should only be administered by someone trained in its use.

• If you are given glucagon, you will need sugar or a sweet snack as soon as you regain consciousness.
• If you do not respond to glucagon injection, you must be taken to hospital.

If severe hypoglycaemia is not treated promptly, it can cause temporary or permanent brain damage and may even lead to death.
Contact your doctor if:

• your blood sugar has become so low that you fainted
• you have received a glucagon injection
• you have recently had several episodes of low blood sugar. Your insulin dose, timing of injections, diet, or exercise may need to be adjusted.
• High blood sugar (hyperglycaemia) Your blood sugar may become too high if: You eat more or exercise less than usual; drink alcohol; have an infection or fever; have not used enough insulin; continue to use less insulin than you need; forget to use insulin or stop using insulin.

Warning signs of high blood sugar, which usually develop gradually:
flushed skin; dry skin; drowsiness or tiredness; dry mouth; fruity breath (acetone); increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting).
These may be signs of a very serious condition called ketoacidosis. This is a buildup of acid in the blood because the body is metabolizing fat instead of sugar. If left untreated, it can lead to diabetic coma and possibly death.
What to do if your blood sugar is too high

• Check your blood sugar level.
• Use a corrective dose of insulin, if you have been instructed how to do so.
• Check for the presence of ketones in your urine.
• If ketones are present, contact a doctor immediately.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By 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 stated on the label and the 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 cooling elements.
Keep the cartridge in its packaging to protect the medicine from light.

After first opening or carried as a spare:

• Do not refrigerate during use.
• The cartridge (PumpCart) may be stored at room temperature (not above 30°C) for up to 2 weeks.
• Thereafter, it may be used for up to 7 days at a temperature below 37°C in a microinfusion pump designed for use with this cartridge.
• Keep the PumpCart cartridge in its packaging until the time of use to protect it from damage. Always protect the cartridge from light during use.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fiasp contains

• The active substance is insulin aspart. 1 mL of solution contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 mL of solution.
• The other ingredients are phenol, m-cresol, glycerol, zinc acetate, disodium phosphate dihydrate, hydrochloride arginine, nicotinamide (vitamin B_), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2, ‘Important information on some ingredients of Fiasp’) and water for injections.

Description of the appearance of Fiasp and contents of the pack
Fiasp is a clear, colourless, aqueous injectable solution contained in a cartridge.
Pack of 5 or a multiple pack of 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
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .
Instructions on how to use the Fiasp PumpCart pre-filled cartridge
Fiasp PumpCart must only be used with an insulin pump designed for use with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.

• It must not be used with other devices not designed for the PumpCart cartridge.
• This is because it may cause incorrect insulin dosing and lead to high blood sugar levels (hyperglycaemia) or low blood sugar levels (hypoglycaemia).

Read carefully the following instructions before using the PumpCart cartridge.
Also read the instruction manual (user guide) provided with the insulin pump.

• The PumpCart cartridge is ready for direct use with the insulin pump.
• The PumpCart cartridge contains 1.6 mL of insulin aspart solution, equivalent to 160 units.
• This medicinal product must never be mixed with other medicinal products.
• Do not refill the PumpCart cartridge. When empty, it must be discarded.
• Make sure you always have a spare PumpCart cartridge available.
• The PumpCart cartridge must not be used in an insulin pen, as this may result in incorrect dosing.
• The PumpCart cartridge must be protected from excessive heat and light during storage and use.
• The PumpCart cartridge must be kept out of the reach of others, especially children.

1. Before inserting the PumpCart cartridge into the insulin pump
   • Bring the PumpCart cartridge to room temperature.
   • Remove the PumpCart cartridge from its packaging.
   • Check the label to ensure it is a Fiasp PumpCart cartridge.
   • Check the expiry date on the label and outer packaging.
   • Always check that the PumpCart cartridge appears as it should (Figure A). Do not use it if you notice any damage or leakage, or if the plunger has moved, making the lower part of the plunger visible beyond the white band. This may cause insulin leakage. In Figure A, the lower part of the plunger is hidden behind the white band as it should be. If you suspect the PumpCart cartridge is damaged, return it to your supplier.

• Check that the insulin in the PumpCart cartridge is clear and colourless. Do not use the PumpCart cartridge if the insulin appears cloudy. The cartridge may contain a small amount of air in the form of tiny bubbles.

2. Inserting a new Fiasp PumpCart cartridge into the infusion pump

• Follow the instructions in the infusion pump user manual provided with the pump to insert a new PumpCart cartridge into the infusion pump.
• Insert a PumpCart cartridge into the cartridge compartment of the infusion pump. The plunger should be inserted first.
• Connect the infusion set to the PumpCart cartridge by reattaching the adapter to the infusion pump.
• Follow the instructions in the infusion pump user manual to continue using the infusion pump.

3. Removing an empty Fiasp PumpCart cartridge from the infusion pump

• Follow the instructions in the infusion pump user manual to remove an empty PumpCart cartridge from the infusion pump.
• Remove the empty PumpCart cartridge from the infusion set adapter.
• Dispose of the empty PumpCart cartridge and the used infusion set according to the instructions provided by your doctor or nurse.
• Follow the steps described in paragraphs 1 and 2 for preparing and inserting a new PumpCart cartridge into the infusion pump.