Product Information for the Patient

Fiasp 100100 units/mL Penfill injectable solution in cartridge

insulin aspart

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

–Keep this product information, 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 for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

–If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. 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 side 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 controlblood sugar levels. Fiasp treatment helps to prevent diabetes complications.

Fiasp should be injected 2minutes before starting to eat, with the possibility of administration up to 20minutes after the start of the meal.

This medication reaches its maximum effect between 1 and 3hours after injection and its effect lasts between 3 and 5hours.

This medication should be used normally in combination with intermediate- or long-acting insulins.

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 more quickly. 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 (an 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.

• Swelling of the joints: 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.

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

• The treatment with insulins may cause the body to produce antibodies to insulin (a substance that acts against insulin). However, only in very rare cases, this will require 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 recommended to record the name and batch number of each pack to keep a record of the batches used.

Changes in the skin at the injection site

Rotate the injection site to help avoid changes in the fatty tissue, such as thickening of the skin, shrinking of the skin or lumps under the skin. Insulin may not work well if injected in a swollen, shrunk or thickened 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 using, have used recently or may need to use 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 (a 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 production of growth hormone. 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 are planning 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 the health of your baby. 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 operating machinery

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 affected. 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”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this medication without help. Ask for help from a person with normal vision who is trained in the use of the pen.

When to use Fiasp

Fiasp is an insulin that is administered with meals.

Adults: Fiasp should be injected 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 should be injected 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.

This medication reaches its maximum effect between 1 and 3 hours after injection and the effect lasts between 3 and 5 hours.

Fiasp Dose

Dose for type 1 and type 2 diabetes

Your doctor will decide with you:

• What amount of Fiasp you need for each meal

• When to check your blood sugar level and if you need a higher or lower dose.

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

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

Adjusting the dose for type 2 diabetes

The daily dose depends on your blood sugar level at mealtime the day before and at night before.

• Before breakfast: the dose should be adjusted according to the blood sugar level before lunch the day before.

• Before lunch: the dose should be adjusted according to the blood sugar level before dinner the day before.

• Before dinner: the dose should be adjusted according to the blood sugar level at night the day before.

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 level more frequently. Talk to your doctor about possible changes in your dose.

Injecting Fiasp

This medication is only indicated for subcutaneous injection with a reusable insulin pen from Novo Nordisk.

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

Where to inject

• The best areas for injection are the front of the abdomen or the upper arm.

• Do not inject into a vein or muscle.

• Change the injection site every day within the area where you inject 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 them to your supplier. See the pen manual for more information.

• If the cartridge has not been stored correctly (see section 5 "Storing Fiasp").

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

How to inject Fiasp

• Read the manual that comes with the reusable pen.

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

• Always use a new needle for each injection to avoid contamination.

• Needles should not be shared.

If you use more Fiasp than you should

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

If you forget to use Fiasp

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

Three simple steps that may 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".

If you interrupt treatment with Fiasp

Do not interrupt your insulin treatment without consulting your doctor. Stopping insulin administration could produce 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 level".

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.immediately. See more ahead “Low blood sugar” recommendations.

If you suffer a severe allergic reaction(including anaphylactic shock) to insulin or 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:

•local 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.

Reactions such as generalized skin rash and facial swelling may occur. 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 the skin at the injection siteIf 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). Blisters under the skin 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 thickened, shrunk, or swollen area. Change the injection site to help prevent these skin changes.

Other side effects include:

Common(can affect up to 1 in 10 people)

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

Reactions on the skin:Signs of skin allergy such as eczema, rash, itching, hives, and dermatitis may appear.

General effects of insulin treatment including Fiasp

•Low blood sugar (hypoglycemia)(very common)

Low blood sugar may occur if:

Drinking alcohol, injecting too much insulin, exercising more than usual, eating very little, or skipping a meal.

Warning signs of low blood sugar, which may appear suddenly:

Headache,

difficulty speaking,

palpitations,

chills,

cool and pale skin,

nausea,

excessive hunger,

shaking, 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).

•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 low blood sugar may be, including the risk of losing consciousness.

Tell 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 choke.

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 can even lead to death.

Talk to your doctor if:

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

•You have been given a glucagon injection

•You have recently had 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:

Eating more or exercising less than usual, drinking alcohol, suffering from an infection or fever, not injecting enough insulin, repeatedly injecting less insulin than needed, forgetting to inject insulin, or interrupting insulin treatment.

Warning signs of high blood sugar, which usually appear gradually:

Redness of the skin,

dry skin,

feeling offatigue or drowsiness,

dry mouth,

breath with a fruity odor (acetone),

increased need to urinate,

thirst,

loss of appetite,

nausea or vomiting.

These may be symptoms of a very serious condition called ketoacidosis. This is an accumulation 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 the Vigilance 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 when carrying as a spare

Do not refrigerate. You may carry the cartridge (Penfill) with you and store it at room temperature (not above 30°C) for 4 weeks. Store the cartridge always in the outer packaging to protect it from light.

Discard the needle after each injection.

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

Composition of Fiasp

•The active principle is insulin aspart. 1ml of solution contains 100units of insulin aspart. Each cartridge contains 300units of insulin aspart in 3ml 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 preparations.

Appearance of Fiasp and contents of the packaging

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

Packaging sizes of 5 and 10cartridges of 3ml. Some packaging sizes may only be marketed.

Marketing authorization 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.