FIASP 100 units/mL injectable solution in vial

2. What you need to know before you use Fiasp

Do not use Fiasp

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

Warnings and precautions

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

• Low blood sugar level (hypoglycemia): if your blood sugar level is too low, follow the instructions for low blood sugar level that appear in section 4 "Possible side effects". Compared to other insulins that are administered at mealtimes, Fiasp starts to lower blood sugar faster. If you suffer from hypoglycemia, you may feel it sooner after a Fiasp injection.
• High blood sugar level (hyperglycemia): if your blood sugar level is too high, follow the instructions for high blood sugar level that appear in section 4 "Possible side effects".
• Change from other insulins. Your doctor may need to advise you on your insulin dose.
• If you are combining your insulin treatment with pioglitazone (an oral antidiabetic 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 can cause a temporary worsening of vision disorders related to diabetes, such as diabetic retinopathy.
• Nerve damage pain: 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 label of the insulin before each injection to avoid accidental mixing of insulins.
• Insulin treatment can cause the body to produce antibodies to insulin (a substance that acts against insulin). However, only in very rare cases will this require a change in your insulin dose.

Some conditions and activities can affect your insulin requirements. Talk to your doctor:

• if you have kidney, liver, adrenal, pituitary, or thyroid problems.
• if you do more physical exercise than usual or if you want to change your usual diet, as this can affect your blood sugar level.
• if you are sick, continue your insulin treatment and talk to your doctor.
• if you are going to travel abroad, traveling to different time zones can 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.

Skin changes at the injection site

The injection site should be rotated 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 into a swollen, shrunk, or thickened area (see section 3 "How to use Fiasp"). Tell your doctor if you notice any changes in the injection site. Tell your doctor if you are currently injecting into these affected areas, before starting to inject into a different area. Your doctor may indicate that you should check your blood sugar levels more closely and adjust the insulin or the dose of your other antidiabetic medications.

Children and adolescents

It is not recommended to use this medicine in children under 1 year of age.

Other medicines and Fiasp

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. 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 can affect your treatment with insulin.

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

• other medicines for diabetes (oral and injectable)
• antibiotics of the sulfonamide type (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 (MAOIs) (used to treat depression)

• angiotensin-converting enzyme inhibitors (ACE inhibitors) (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 problems)
• growth hormone (to treat a deficiency of this hormone)
• glucocorticoids (such as "cortisone", to treat inflammation)

• sympathomimetics (such as epinephrine (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 can increase or decrease your blood sugar level.

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

Using Fiasp with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine. This medicine can be used during pregnancy, however, it may be necessary to change the insulin dose while you are pregnant and after giving birth. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months. During pregnancy, it is necessary to carefully control your diabetes. Avoiding a low blood sugar level (hypoglycemia) is especially important for the health of your baby. After having your baby, your insulin requirements will probably return to what they were before pregnancy.

There are no restrictions on treatment with Fiasp during the breastfeeding period.

Driving and using machines

A low blood sugar level can affect your ability to drive or use tools or machines. If you have a low blood sugar level, your ability to concentrate and react may be affected. This could put your life or the lives of others at risk. Ask your doctor if you can drive if:

• you have frequent episodes of hypoglycemia
• you have difficulty recognizing the symptoms of hypoglycemia.

Important information about some of the 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

Follow the instructions for administration of this medicine exactly as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

When to use Fiasp

Fiasp is an insulin that is administered at mealtimes.

Adults: Fiasp should be injected just before (0 to 2 minutes) starting to eat, with the possibility of administration 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 administration up to 20 minutes after the start of the meal in situations where it is uncertain when the child will eat. Talk to your doctor about these situations.

This medicine 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 together with you:

• how much Fiasp you 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, talk to your doctor, pharmacist, or nurse before, as a change in diet can alter your need for insulin.

When using other medicines, ask your doctor if it is necessary to adjust your treatment.

Dose adjustment for type 2 diabetes

The daily dose depends on your blood sugar level at mealtimes the previous day and the previous night.

• 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 the previous night.

Use in elderly patients (65 years or older)

This medicine 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 check your blood sugar level more frequently. Talk to your doctor about possible changes in your dose.

Injecting Fiasp

This medicine is injected under the skin (subcutaneous injection) or through continuous infusion pumps. It is necessary that a healthcare professional explains everything related to administration through a pump.

Where to inject

• The best areas for injection are the front of the waist (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 changes under the skin (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 ensure a safe container. If the vial is not in perfect condition at the time of use, return it to the supplier.
  • if the vial has not been stored correctly (see section 5 "Storing Fiasp").
  • if the insulin does not have a transparent and colorless appearance (e.g., cloudy).

How to inject Fiasp

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

1. Check the name and concentration 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 should not be shared.
4. Load the syringe with an amount of air equal to the dose of insulin to be injected. Inject the air into the vial.
5. Invert the vial and the syringe and load the syringe with the correct dose of insulin. Remove the needle from the vial. Remove the air from the syringe and check that the dose is correct.
6. Inject the insulin under the skin. Use the injection technique recommended by your doctor or nurse.
7. Discard the needle after each injection.

Using Fiasp in an infusion pump

If you want to use Fiasp through an infusion pump, follow the instructions and recommendations of your doctor. Before using Fiasp in the pump, you must receive detailed instructions and information on what to do in case of illness, high or low blood sugar level, or pump system failure. You can use Fiasp from a vial in an infusion pump system for a maximum of 6 days.

Filling the pump

• Fiasp should never be diluted or mixed with another insulin.

• Before inserting the needle, wash your hands and the skin area where you will insert the needle with water and soap to avoid any infection at the infusion site.
• When filling a new reservoir, make sure there are no large bubbles in the syringe or catheter.
  • The infusion equipment (catheter and needle) should be changed according to the instructions that appear in the product information that accompanies the infusion equipment.

To get the most out of insulin infusion and detect possible pump failure, it is recommended to regularly measure your blood sugar level.

What to do in case of pump failure

You should always have an alternative insulin administration system on hand (for example, an injection pen or syringes) in case the pump fails.

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 the insulin, your blood sugar level may become very high (hyperglycemia). See section 4 "High blood sugar level".

Three simple stepsthat can help youavoid low or high blood sugar levels:

• Always carry spare syringes and a vial of Fiasp.

• Always carry something that indicates you are diabetic.

• Always carry sugary products with you. See section 4 "What to do if your blood sugar level is low".

If you stop using Fiasp

Do not stop your insulin treatment without consulting your doctor. Stopping insulin administration could cause a very high blood sugar level (severe hyperglycemia) and ketoacidosis (a problem 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".

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Low blood sugar level (hypoglycemia)is a very frequent adverse 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. 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. See the recommendations "Low blood sugar level" below.

If you suffer a severe allergic reaction(including anaphylactic shock) to insulin or any of the components of Fiasp (the frequency at which this occurs 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 (such as 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

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

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

Other adverse effects include:

Frequent(may affect up to 1 in 10 people)

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

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

General effects of insulin treatment, including Fiasp

• Low blood sugar level (hypoglycemia)(very frequent)

Low blood sugar levels may occur if:

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

Warning symptoms of low blood sugar, which can appear suddenly:Headache, difficulty speaking, palpitations, cold sweat, cold and pale skin, nausea, excessive hunger, tremor, nervousness or anxiety, unusual fatigue, weakness, and somnolence, 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 grams of fast-acting carbohydrates: take glucose tablets or a sugary product, such as fruit juice, candies, or cookies (always carry glucose tablets or sugary products with you in case you need them).
• It is recommended that you recheck your blood glucose levels after 15-20 minutes and retreat 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 your insulin treatment as usual.

What people close to you should 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 do the following:

• lay you on your side to prevent choking
• seek immediate medical attention

• do not give you anything to eat or drink, as you may choke.

You may regain consciousness more quickly if someone who knows how to do so administers a glucagon injection to you.

• If you are given glucagon, you should take glucose or a sugary 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, which can be temporary or permanent. It can even lead to death.

Talk to your doctor if:

• you have had low blood sugar levels that have caused you to lose consciousness
• you have been given a glucagon injection
• you have had several episodes of low blood sugar recently.

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

• High blood sugar level (hyperglycemia)

High blood sugar levels 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 symptoms of high blood sugar, which usually appear gradually:

Redness of the skin,

dry skin,

feeling of drowsiness or fatigue,

dry mouth,

fruity breath odor (acetone),

increased need to urinate,

thirst,

loss of appetite,

nausea or vomiting.

These can be symptoms of a very serious condition called ketoacidosis. It is an accumulation of acid in the blood because the body is metabolizing fat instead of sugar. If left untreated, it can lead to diabetic coma and even death.

What to do if your blood sugar level is high

• Check your blood sugar level.
• Administer a correction dose of insulin if you have been taught how to do so.
• Check the ketone level in your urine.
• If you have ketones, seek immediate medical attention.

Reporting adverse effects

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

5. Storage of Fiasp

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

Do not use this medicine after the expiration date stated on the label and carton after EXP. The expiration date is the last day of the month indicated.

Before first use:

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

Once opened or when carried as a spare:You can carry the vial with you and store it at room temperature (not above 30°C) or in a refrigerator (between 2°C and 8°C) for 4 weeks (including the time in the pump reservoir). Always store the vial in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Fiasp

• 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, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see the end of section 2 "Important information about some of the ingredients of Fiasp") and water for injections.

Appearance of Fiasp and package contents

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

Each vial contains 10 ml of solution.

Package sizes of 1 or 5 vials or a multipack of 5 (1 x 10 ml) vials. Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

Date of the last revision of this leaflet:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.