Fiasp 100 units/mL solution for injection in vial

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

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

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

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

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

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

Skin changes at the injection site

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Fiasp^® is a mealtime insulin.

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

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

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

Dose for type 1 and type 2 diabetes

Your doctor will decide together with you:

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

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

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

Dose adjustment for type 2 diabetes

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

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

Dose adjustment for mealtime or bedtime blood sugar:

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

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

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

Use in elderly patients (65 years or older)

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

If you have kidney or liver problems

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

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

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

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

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

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

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

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

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

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

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

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

• Always keep spare syringes and a spare vial of Fiasp^®.
• Always carry something to show you have diabetes.
• Always carry products containing sugar with you. See section 4 under ‘What to do if you get low blood sugar’.

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

Common (may affect up to 1 in 10 people)

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

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

General effects from insulin treatment including Fiasp^®

• Low blood sugar (hypoglycaemia) (very common)

Low blood sugar may happen if you:

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

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

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

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

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

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

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

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

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

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

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

• High blood sugar (hyperglycaemia)

High blood sugar may happen if you:

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

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

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

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

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

Great Britain:

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

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

• The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart.
  Each vial contains 1,000 units of insulin aspart in 10 mL solution.
• The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 under ‘Important information about some of the ingredients of Fiasp^®’) and water for injections.

Fiasp^® is presented as a clear, colourless and aqueous solution for injection in a vial. Each vial contains 10 mL solution.

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