Prospecto: information for the user

Fiasp 100units/mL PumpCart injectable solution in cartridge

insulin aspart

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

–Keep this prospect, as you may need to read it again.

–If you have any questions, consult your doctor, pharmacist, or nurse.

–This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

–If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1.What is Fiasp and for what it is used

2.What you need to know before starting to use Fiasp

3.How to use Fiasp

4.Possible adverse effects

5.Storage of Fiasp

6.Contents of the package and additional information

Fiasp is an insulin that is administered at mealtime with a rapid effect in reducing blood sugar levels. Fiasp is an injectable solution of insulin aspart and is used to treat type 2 diabetes in adults, adolescents, and children aged 1 year and older. Diabetes is a diseasein which the bodydoes not produce enough insulin to controlthe level of blood sugar. Fiasp treatment helps to prevent diabetes complications.

About PumpCart

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

•Covers your total daily insulin needs: the insulin needed throughout the day (basal) and the insulin needed at mealtime (bolus).

•Before using a PumpCart cartridge in the pump, you must have received detailed instructions from your doctor or nurse.

Daily basal insulin needs:

When using Fiasp in a pump, insulin is released into your body at a constant rate.

• This covers your basal insulin needs throughout the day.

•Before setting or changing the basal dose, read the pump manual (user manual) carefully.

•If you stop the pump, note that the insulin effect will decrease gradually over 3 to 5 hours.

Mealtime bolus insulin needs:

•It must be injected from 2 minutes before starting to eat, with the possibility of administering up to 20 minutes after the start of the meal(see section 3, How to use Fiasp).

• The maximum effect is achieved between 1 and 3 hours after administration at mealtime.
• The effect lasts for 3 to 5 hours.

No use Fiasp

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Fiasp. It is important that you know the following:

• Low blood sugar (hypoglycemia): if your blood sugar level is too low, follow the instructions for low blood sugar that appear in section 4 “Possible side effects”. Compared to other insulins taken at mealtime, Fiasp starts to lower blood sugar faster. If you experience hypoglycemia, you may feel it sooner after an injection of Fiasp.

• High blood sugar (hyperglycemia): if your blood sugar level is too high, follow the instructions for high blood sugar that appear in section 4 “Possible side effects”.

• Switching from other insulins. Your doctor may need to advise you on your insulin dose.

• If you are taking insulin with pioglitazone (oral anti-diabetic medication used to treat type 2 diabetes), talk to your doctor as soon as possible if you experience symptoms of heart failure such as unusual difficulty breathing or rapid weight gain or localized swelling caused by fluid retention (edema).

• Eye disorders: a sudden improvement in blood sugar control may cause a temporary worsening of visual disorders related to diabetes such as diabetic retinopathy.

• Nerve damage: if your blood sugar level improves very quickly, you may experience nerve-related pain that is usually transient.

• Joint swelling: when starting to use the medicine, the body may retain more fluid than it should, causing inflammation of the ankles and other joints. This effect usually disappears quickly.

• Make sure you use the correct type of insulin, always check the insulin label before each injection to avoid accidental mix-ups between insulins.

• Insulin treatment may cause the body to produce antibodies to insulin (substance that acts against insulin). However, this only rarely requires a change in your insulin dose.

In case of reduced vision, see section 3 “How to use Fiasp”.

Some conditions and activities may affect your insulin requirement. Consult your doctor:

• if you have kidney, liver, adrenal gland, pituitary gland or thyroid gland problems.

• if you are exercising more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

• if you are ill, continue your insulin treatment and consult your doctor.

• if you are traveling abroad, traveling to different time zones may affect your insulin needs and injection times.

When using Fiasp, it is strongly recommended that you record the name and batch number of each pack to keep a record of the batches used.

Fiasp PumpCart can only be used with the following insulin pump system: Accu-Chek Insight and insulin pumps YpsoPump. Do not use it with other pumps, as it may deliver an incorrect dose and cause high or low blood sugar.

Changes in the skin at the injection site

Rotate the injection site to help avoid changes in the fatty tissue, such as skin thickening, skin shrinking or lumps under the skin. Insulin may not work well if injected in a thickened, shrunk or lumpy area (see section 3 “How to use Fiasp”). Inform your doctor if you detect any changes in the injection site. Inform your doctor if you are currently injecting in these affected areas, before starting to inject in a different area. Your doctor may advise you to check your blood sugar levels more closely, and adjust the insulin or the dose of your other anti-diabetic medications.

Children and adolescents

This medicine is not recommended for children under 1 year of age.

Other medicines and Fiasp

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. Some medicines affect your blood sugar level and this may mean that you need to change your insulin dose.

The following are the main medicines that may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycemia) if you take:

• other diabetes medicines (orals and injectables)

• sulfonamide 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 reduce fever)

• monoamine oxidase inhibitors (MAOIs) (used to treat depression)

• angiotensin-converting enzyme inhibitors (ACEIs) (to treat certain heart problems or high blood pressure).

Your blood sugar level may increase (hyperglycemia) if you take:

• danazol (medicine that acts on ovulation)

• oral contraceptives (birth control pill)

• thyroid hormones (to treat thyroid gland problems)

• growth hormone (to treat a deficiency of this hormone)

• glucocorticoids (such as “cortisone”, to treat inflammation)

• sympathomimetics (such as adrenaline, salbutamol or terbutaline, to treat asthma)

• thiazides (to treat high blood pressure or if the body retains too much fluid (fluid retention)).

Octreotide and lanreotide, used to treat acromegaly, a rare disorder characterized by excessive growth hormone production. These medicines may increase or decrease your blood sugar level.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist.

Use of Fiasp with alcohol

If you drink alcohol, it may change your insulin needs, as your blood sugar level may be increased or decreased. Therefore, you should monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine. This medicine can be used during pregnancy, however, you may need to modify your insulin dose while pregnant and after delivery. The amount of insulin you normally need decreases during the first 3 months of pregnancy and increases during the remaining 6 months. During pregnancy, careful control of your diabetes is necessary. Avoiding low blood sugar (hypoglycemia) is especially important for your baby's health. After giving birth, your insulin requirements will probably return to what you needed before pregnancy.

There are no restrictions on the use of Fiasp during breastfeeding.

Driving and using machines

Low blood sugar may affect your ability to drive or use tools or machines. If you have low blood sugar, your concentration and reaction times may be impaired. This could put your life or the lives of others at risk. Ask your doctor if you can drive if:

• you experience frequent episodes of hypoglycemia

• you find it difficult to recognize the symptoms of hypoglycemia.

Important information about some of the components of Fiasp

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially “sodium-free”.

If you are blind or have reduced vision and cannot read the pump screen, do not use this pump without assistance. Ask for help from a person with no vision problems and who is trained in the use of the pump.

Dosage and when to use Fiasp

Always use your insulin and adjust your basal (throughout the day) and bolus (with meals) doses as explained by your doctor. If in doubt, consult your doctor, nurse or pharmacist.

•Adjust your prandial (with meals) insulin dose based on your blood sugar measurements and food intake.

Adults

Fiasp doses with meals should be administered just before (0 to 2 minutes) starting to eat, with the possibility of administering up to 20 minutes after the start of the meal.

Children

Fiasp doses with meals should be administered just before (0 to 2 minutes) starting to eat, with the possibility of administering up to 20 minutes after the start of the meal in situations where it is uncertain when the child will eat. Consult your doctor about these situations.

If you want to modify your usual diet, consult your doctor, pharmacist or nurse beforehand, as a change in diet may alter your insulin needs.

When using other medications, ask your doctor if you need to adjust your treatment.

Use in elderly patients (65 years or older)

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

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 possible changes in your dose.

How to inject Fiasp

This medication is only indicated for subcutaneous injection. Only for use with pumps designed for use with this cartridge.

•Before using the PumpCart cartridge in the pump, you must have received detailed instructions from your doctor or nurse.

• Consult your doctor if you need to inject insulin by another method.

Where to inject

•Normally, the insulin injection site is in the front of the abdomen. However, if your doctor recommends it, you can inject it in the upper arm.

•Do not inject it into a vein or muscle.

•When changing the infusion set (catheter and cannula), make sure to change the injection site of the needle. This may reduce the risk of developing skin changes (see section 4 “Possible side effects”).

Do not use Fiasp

•if the cartridge or the device containing the cartridge you are using has fallen, is damaged or crushed. Return it to your supplier.

•if the cartridge has not been stored correctly (see section 5 “Storage of Fiasp”).

•if the insulin does not have a transparent (e.g. turbid) and colorless appearance.

On the other side of this leaflet, detailed instructions are provided on how to use PumpCart.

How to inject Fiasp

•Read and follow the pump manual (user manual) that comes with your insulin pump.

•Make sure to use an infusion set (catheter and needle) suitable for your insulin pump.

•Check the name and concentration on the cartridge label (PumpCart) to ensure it is Fiasp.

•The infusion set (catheter and needle) and the PumpCart cartridge should not be shared.

•The infusion set (catheter and needle) should be changed according to the product information that comes with the infusion set.

What to do in case of pump failure

You must always have an alternative insulin administration system available to inject insulin subcutaneously (e.g. a syringe or insulin pen) in case the pump fails.

Using too much Fiasp

If you use too much insulin, your blood sugar level may become very low (hypoglycemia), see section 4 “Low blood sugar”.

Missing a dose of Fiasp

If you forget to inject insulin, your blood sugar level may become very high (hyperglycemia). See section 4 “High blood sugar”.

Three simple steps to help you avoid low or high blood sugar levels:

•Always carry spare Fiasp cartridges.

•Always carry something that indicates you are diabetic.

•Always carry something sweet with you. See section 4 “What to do if your blood sugar level is low”.

Stopping treatment with Fiasp

Do not stop treatment with your insulin without consulting your doctor. Stopping insulin administration may cause very high blood sugar levels (severe hyperglycemia) and ketoacidosis (a condition that consists of an excessive amount of acid in the blood that is potentially fatal). See symptoms and recommendations in section 4 “High blood sugar”.

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

Low blood sugar (hypoglycemia)is a very common side effect of insulin treatment (it can affect more than 1 in 10 people). It can be very serious. A severe drop in blood sugar can lead to loss of consciousness. A severe hypoglycemia can cause brain damage and put your life at risk. If you have symptoms of low blood sugar, take measures to increase your blood sugar level immediately.right away. See more ahead the recommendations “Low blood sugar”.

If you suffer a severe allergic reaction(including anaphylactic shock) to insulin or to any of the components of Fiasp (the frequency of this is unknown), discontinue treatment with this medicine and contact the emergency medical service immediately.

The symptoms of a severe allergic reaction may include:

•Localized reactions (e.g., rash, redness, and itching) spreading to other parts of the body

•Feeling suddenly unwell with sweating

•Starting to vomit

•Experiencing difficulty breathing

•Having palpitations or feeling dizzy.

Generalized skin rashes and facial swelling may occur as allergic reactions. These are rare and can affect up to 1 in 100 people. Consult a doctor if symptoms worsen or if no improvement is seen in a few weeks.

Changes in skin at the injection site:If insulin is injected in the same place, the fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (these are rare and can affect up to 1 in 100 people). Under-skin lumps may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this is unknown). Insulin may not work well if injected in a swollen, shrunk, or thickened area. Change the injection site to help avoid these skin changes.

Other side effects include:

Common(can affect up to 1 in 10 people)

Reaction at the administration site:Localized reactions may occur at the injection site. Symptoms may include: rash, redness, inflammation, hematomas, irritation, pain, and itching. These reactions usually disappear after a few days.

Reactions on the skin:Generalized skin allergy signs such as eczema, rash, itching, hives, and dermatitis may occur.

General effects of insulin treatment including Fiasp

•Low blood sugar (hypoglycemia)(very common)

Low blood sugar may occur if:

You drink alcohol, inject too much insulin, exercise more than usual, eat very little, or skip a meal.

Warning signs of low blood sugar, which may appear suddenly:Headache, difficulty speaking, palpitations, cold sweats, pale and cold skin, nausea, excessive hunger, tremors, nervousness or concern, unusual fatigue, weakness, and drowsiness, confusion, difficulty concentrating, temporary changes in vision.

What to do if your blood sugar level is low

•If you are conscious, treat your low blood sugar immediately with 15–20 g of rapid-acting carbohydrates: take glucose tablets or a sweet product, such as fruit juice, candies, or cookies (always carry glucose tablets or sweet products with you in case you need them) and adjust the insulin administration or stop the pump.

•It is recommended that you re-examine your blood glucose levels after 15–20 minutes and re-treat if your blood glucose levels are still below 4 mmol/l.

•Wait until the symptoms of hypoglycemia have disappeared or your blood sugar level has stabilized. Continue with insulin treatment as usual.

What to do if you lose consciousness

Inform the people you spend time with that you have diabetes. Tell them what the consequences of a low blood sugar level may be, including the risk of losing consciousness.

Inform them that, if you become unconscious, they should:

•Turn you onto your side to prevent asphyxiation

•Seek immediate medical assistance

•do notgive you anything to eat or drink, as you may asphyxiate.

You may recover consciousness more quickly if someone who knows how to administer it gives you a glucagon injection.

•If you are given glucagon, you should take glucose or a sweet product as soon as you regain consciousness.

•If you do not respond to glucagon treatment, you should be treated in a hospital.

If severe hypoglycemia is not treated, it can cause brain damage over time. This can be temporary or permanent. It may even cause death.

Talk to your doctor if:

•You have had blood sugar levels so low that you lost consciousness

•You have been given a glucagon injection

•You have recently experienced several low blood sugar episodes.

You may need to adjust your insulin dose or frequency, diet, or exercise.

•High blood sugar (hyperglycemia)

High blood sugar may occur if:

You eat more or exercise less than usual, drink alcohol, have an infection or fever, do not inject enough insulin, repeatedly inject less insulin than you need, forget to inject insulin, or interrupt insulin treatment.

Warning signs of high blood sugar, which usually appear gradually:Redness of the skin, dry skin, feeling of drowsiness or fatigue, dry mouth, breath with a fruity odor (acetone), increased need to urinate, thirst, loss of appetite, nausea, or vomiting.

These may be signs of a very serious condition called ketoacidosis. This is a buildup of acid in the blood due to the body metabolizing fat instead of sugar. If not treated, it can cause diabetic coma and even death.

What to do if your blood sugar level is high

•Check your blood sugar level.

•Administer a corrective dose of insulin if you have been taught how to do so.

•Check the level of ketones in your urine.

•If you have ketones, seek immediate medical assistance.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Before first use

Store in refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer. Store the cartridge in the outer packaging to protect it from light.

Once opened or if carried as a spare

•Do not refrigerate during use.

•You can store your cartridge (PumpCart) at room temperature (below 30ºC) for a maximum of 2weeks.

•After that, you can use it for a maximum of 7 days below 37ºC in a pump designed for use with this cartridge.

•Store the cartridge PumpCart in the outer packaging until its use to protect it from any damage. Always protect the cartridge from light during use.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This way, you will help protect the environment.

Composition of Fiasp

•The active ingredient is insulin aspart. 1ml of solution contains 100units of insulin aspart. Each cartridge contains 160units of insulin aspart in 1.6ml of solution.

•The other components are phenol, metacresol, glycerol, zinc acetate, disodium dihydrogen phosphate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 “Important information about some of the components of Fiasp”) and water for injection.

Appearance of Fiasp and contents of the package

Fiasp is presented as a transparent, colourless and aqueous injectable solution in a cartridge.

Pack sizes of 5 or multiple pack with 25 (5packs of 5) cartridges of 1.6ml. Some pack sizes may only be marketed.

Marketing authorisation holder and manufacturer responsible

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

Date of the last review of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for using Fiasp PumpCart pre-filled cartridge.

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

• Do not use it with other devices not designed for the PumpCart cartridge.
• Since this may cause an incorrect dose of insulin to be administered and lead to high blood sugar (hyperglycaemia) or low blood sugar (hypoglycaemia).

Read these instructions carefullybefore using your PumpCart cartridge.

Also read the pump manual (user manual)that comes with the insulin pump.

•The PumpCart cartridge is ready to be used directly in the pump.

•The PumpCart cartridge contains 1.6ml of insulin aspart solution, equivalent to 160units.

•This medicine must never be mixed with any other.

•Do not fill the PumpCart cartridge. Once empty, it must be discarded.

•Always ensure that you have a spare PumpCart cartridge available.

•Do not use the PumpCart cartridge in a syringe, as this may cause 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 reach of other people, especially children.

1. Before inserting a new PumpCart cartridge into your pump

• Bring the PumpCart cartridge to room temperature.

• Remove the PumpCart cartridge from its carton and blister.

• Check the label to ensure that it is a Fiasp PumpCart cartridge.

• Check the expiration date that appears on the label and on the packaging.

•Always check that the PumpCart cartridge has the appearance it should have (Figure A).Do notuse it if it is damaged, if it leaks insulin or if the plunger has moved, making the lower part of the plunger visible above the white band. This may mean that the insulin has leaked out. In Figure A the lower part of the plunger is hidden behind the white band as it should be. If you suspect that the PumpCart cartridge is damaged, return it to your supplier.

•Check that the insulin in the PumpCart cartridge is transparent and colourless. If the insulin appears cloudy, do not use the PumpCart cartridge. The cartridge may contain a small amount of air in the form of small bubbles.

2.Insertion of a new Fiasp PumpCart cartridge into your pump

•Follow the instructions in the user manual that comes with your pump to insert a new PumpCart cartridge into your pump.

•Insert a PumpCart cartridge into the cartridge compartment of the pump. The side of the plunger is the first part to be inserted.

•Connect the infusion set to the PumpCart cartridge by connecting the adapter to your pump.

•Follow the instructions in the pump user manual to continue using your pump.

3.Removal of the empty Fiasp PumpCart cartridge from your pump

•Follow the instructions in the pump user manual to remove the empty PumpCart cartridge from your pump.

•Remove the adapter from the infusion set of the empty PumpCart cartridge.

•Discard the empty PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.

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