Product Information for the Patient

Fiasp 100 units/mL injectable solution in vial

Insulin aspart

Read this entire product information carefully before starting to use this medication, 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 medication has been prescribed only for you, and you should not give it to others who 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 are not listed in this product information. See section 4.

1.What is Fiasp and how is it 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 disease in which the body does not produce enough insulin to control blood sugar levels. Treatment with Fiasp helps to prevent diabetes complications.

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

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

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

Additionally, it can be used for continuous infusion in a pump.

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 are listed in section 4 “Possible side effects”. Compared to other insulins taken with meals, 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 are listed in section 4 “Possible side effects”.
• Change from other insulins.You may need your doctor to advise you on your insulin dose.
• If you are combining your insulin treatment with pioglitazone (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 may cause a temporary worsening of visual 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.
• Swelling of the joints: when starting to use the medication, 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, 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 (substance that acts against insulin). However, only in very rare cases, this may require a change in your insulin dose.

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 engage in more physical exercise 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 package to keep a record of the batches used.

Changes in the skin 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 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 antidiabetic medications.

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 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 pectoris).

• 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 (medication 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 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 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 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 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.

When to use Fiasp

Fiasp is an insulin that is administered with meals.

Adults: Fiasp should be injected just before (0 to 2 minutes) of 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) of 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
• cuándo comprobar su nivel de azúcar en sangre y si necesita una dosis más alta o más baja.

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.

Adjustment of dose for type 2 diabetes

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

Use in elderly patients (65 years or more)

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

Where to inject

• The best areas for injection are the front of the abdomen or the upper arm.
• Do not inject it 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 protective cap of the vial is loose or missing. The vial has a plastic protective cap to obtain 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 "Storage of Fiasp").
• if the insulin does not have a transparent (e.g. turbid) and colorless appearance.

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 ensure that 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 identical to the dose of insulin to be injected. Inject the air into the vial.
5. Invert the vial and 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. Dispose of the needle after each injection.

Use in a pump

If you want to use Fiasp through a 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, or pump system failure.You can use Fiasp from a vial in a pump system for a maximum of 6 days.

Pump filling

• 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 prevent 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 pump (catheter and needle) should be changed according to the instructions that appear in the product information that accompany the infusion pump.

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

What to do in case of pump failure

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

Using more Fiasp than you should

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

Forgetting to use Fiasp

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

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

• Always carry spare syringes and a Fiasp vial.
• Always carry something that indicates you are diabetic.

•Always carry something sweet. 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 could 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 level."

Like all medicines, this medicine may 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 recommendations “Low blood sugar” later.

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
• beginning to vomit
• experiencing difficulty breathing
• having palpitations or feeling dizzy.

May produceallergic reactionssuch as generalized skin rash and facial swelling. 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). 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:

Frequent(can affect up to 1 in 10 people)

Reaction at the administration site:May appear localized reactions 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:May appear signs of allergy on the skin such as eczema, rash, itching, hives, and dermatitis.

General effects of insulin treatment including Fiasp

• Low blood sugar (hypoglycemia)(very frequent)

May appear low blood sugar levels if:

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

Warning symptoms of low blood sugar, which may appear suddenly:Headache, difficulty speaking, palpitations, cold sweat, 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).
• 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 drop in blood sugar level may be, including the risk of losing consciousness.

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

• lay you on 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 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 had several recent drops in blood sugar levels.

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

•High blood sugar (hyperglycemia)

May appear high blood sugar levels if:

Eat more or exercise less than usual, drink alcohol, have an infection or fever, not inject enough insulin, repeatedly inject less insulin than needed, 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 drowsy or tired,

dry mouth,

bad breath (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 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 a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. Reporting side effects can help provide more information about 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 freezer. Store the vial in the outer packaging to protect it from light.

Once opened or when carrying as a spare:You may carry the vial and store it at room temperature (not above 30°C) or in the 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 through 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 principle 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 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 injectable preparations.

Appearance of Fiasp and contents of the packaging

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

Each vial contains 10 ml of solution.

Packaging sizes of 1 or 5 vials or a multiple pack of 5 (1 x 10 ml) vials. Some packaging sizes may only be marketed.

Marketing authorization holder and manufacturer responsible

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

Last review date 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