Package Leaflet: Information for the User

NovoRapid 100units/mL injectable solution in vial

insulin aspart

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

•Keep this leaflet, as you may need to read it again.

•If you have any questions, ask your doctor, nurse or pharmacist.

•This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

•If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1.What NovoRapid is and what it is used for

2.What you need to know before you start using NovoRapid

3.How to use NovoRapid

4.Possible side effects

5.Storage of NovoRapid

6.Contents of the pack and additional information

NovoRapid is a modern insulin (insulin analog) with rapid action. Modern insulins are improved versions of human insulin.

NovoRapid is used to lower high blood sugar levels in adults, adolescents, and children 1 year of age and older with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels. Treatment with NovoRapid helps to prevent diabetes complications.

NovoRapid will start to lower your blood sugar levels 10–20 minutes after administration and reaches its maximum effect between 1 and 3 hours after injection, with a duration of 3–5 hours. Due to this short action, NovoRapid is usually administered in combination with intermediate-acting or long-acting insulin preparations. Additionally, NovoRapid can be used for subcutaneous continuous insulin infusion.

No use NovoRapid

?If you are allergic to insulin aspart or any of the other components of this medication (see section 6, Contents of the pack and additional information).

?If you suspect that you are going to have hypoglycemia (low blood sugar level)(see a) Summary of very common and serious adverse reactions in section 4).

?If you do not have a safety cap or if it is loose. Each vial has a plastic safety cap. If it is not in perfect condition, return the vial to your supplier.r.

?If it has not been stored properly or if it has been frozen (see section 5, Storage of NovoRapid).

?If the insulin does not have a transparent and colorless appearance.

If any of these circumstances affect you, do not use NovoRapid. Consult your doctor, nurse or pharmacist.

Before using NovoRapid

?Check the label and make sure the insulin is the type prescribed to you.

?Remove the safety cap.

?Always use a new needle for each injection to prevent contamination.

?Needles and syringes should not be shared.

Warnings and precautions

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 doing more physical exercise than usual or if you plan to change your diet, as this may affect your blood sugar level.

?If you are ill, continue your insulin treatment and consult your doctor.

?If you plan to travel abroad, time zone differences between countries may affect your insulin requirement and administration schedule.

Changes in skin at the injection site

Rotate the injection site to help prevent 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 an area that is swollen, shrunk or thickened (see section 3, How to use NovoRapid). Inform your doctor if you notice 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 your insulin or other diabetes medications.

Children and adolescents

Do not administer this medication to children under 1 year of age, as no clinical studies have been conducted in children under 1 year.

Other medications and NovoRapid

Inform your doctor, nurse or pharmacist if you are using, have used recently or may need to use any other medication.

Some medications affect your blood sugar level and may require a change in your insulin dose. The following medications may affect your treatment with insulin:

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

•other diabetes medications;

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

•beta-blockers (used to treat high blood pressure);

•angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat certain heart conditions or high blood pressure);

•salicylates (used to relieve pain and reduce fever);

•anabolic steroids (such as testosterone);

•sulfonamides (used to treat infections).

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

•oral contraceptives (birth control pills);

•thiazides (used to treat high blood pressure or fluid retention);

•glucocorticoids (such as "cortisone" used to treat inflammation);

•thyroid hormones (used to treat thyroid gland disorders);

•sympathomimetics (such as epinephrine [adrenaline] or salbutamol or terbutaline used to treat asthma);

•growth hormone (medication to stimulate growth and bone development that has a pronounced effect on metabolic processes);

•danazol (medication that acts on ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may increase or decrease your blood sugar levels.

Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the early warning signs that may help you recognize when you have low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)

Some patients with long-standing type 2 diabetes and pre-existing heart disease or stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as unusual shortness of breath, rapid weight gain or localized inflammation (edema).

If you have taken any of the medications mentioned above, inform your doctor, nurse or pharmacist.

Alcoholic beverages and use of NovoRapid

?If you drink alcohol, it may change your insulin requirement as your blood sugar level may be increased or decreased. It is recommended to monitor your blood sugar levels carefully.

Pregnancy and breastfeeding

?If you arepregnant, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.NovoRapid can be used during pregnancy. You may need to adjust your insulin dose while pregnant and after delivery. It is essential for the health of your baby to have a careful control of your diabetes and especially to prevent hypoglycemia.

• No restrictions apply to the treatment with NovoRapid during lactation.

Consult yourdoctor, nurse or pharmacist before using this medication while pregnant or breastfeeding.

Driving and operating machinery

?Please ask your doctor if you can drive or operate machinery:

•If you have frequent hypoglycemia.

•If you find it difficult to recognize hypoglycemia.

If your blood sugar levels are low or high, your concentration and reaction time may be affected and therefore your ability to drive or operate machinery. Note that you may put your life or the lives of others at risk.

A consequence of the rapid onset of action of NovoRapid is that if hypoglycemia occurs, it may occur more quickly after injection than with human soluble insulin.

Important information about some of the components of NovoRapid

NovoRapid contains less than 23 mg (1 mmol) of sodium per dose, making NovoRapid essentially "sodium-free".

Posology and when to administer insulin

Follow exactly the insulin administration instructions and dosage adjustments indicated by your doctor. In case of doubt, consult your doctor, nurse, or pharmacist.

NovoRapid, in general, should be administered immediately before meals. Take some food within 10 minutes after the injection to prevent hypoglycemia. When necessary, NovoRapid can be administered immediately after a meal. For more information, see below How and where to inject.

Do not change insulin unless your doctor tells you to. If your doctor changes you from one type or brand of insulin to another, you may need to adjust your dosage.

Use in children and adolescents

NovoRapid can be used in adolescents and children aged 1 year and older instead of human soluble insulin, when a rapid onset of action is preferred. For example, when administration is difficult in relation to meals.

Use in special patient groups

If you have kidney or liver dysfunction, or if you are over 65 years old, you should monitor your blood sugar more frequently and consult with your doctor about changes in your insulin dosage.

How and where to inject

NovoRapid should be injected subcutaneously or through continuous infusion in an insulin pump. A healthcare professional should teach you how to administer insulin with a pump. Never inject yourself directly into a vein (intravenously) or into a muscle (intramuscularly). If necessary, NovoRapid can also be administered directly into a vein, but only a doctor or other healthcare professional can do this.

In each injection, change the injection site within the specific area of skin you usually use. This may reduce the risk of developing lumps or depressions in the skin (see section 4, Possible adverse effects). The best areas for injection are the front of your waist (abdomen), the upper arm, or the front of your thighs. Insulin will have a faster effect if injected in the front of your waist. Always measure your blood sugar regularly.

Neutral Protamine Hagedorn (NPH) insulin is the only type of insulin that can be mixed with NovoRapid, and the mixture should be injected immediately subcutaneously. NovoRapid should be introduced into the syringe before extracting the NPH insulin.

How to use NovoRapid

If you use only one type of insulin

1.Load the syringe with an amount of air identical to the insulin dose to be injected. Inject the air into the vial.

2.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.

If you need to mix two types of insulin

1.Just before using it, rotate the NPH insulin between your hands until the liquid is uniformly cloudy.

2.Load the syringe with an amount of air identical to the NPH insulin dose. Inject the air into the vial containing the NPH insulin and remove the needle.

3.Load the syringe with an amount of air identical to the NovoRapid dose. Inject the air into the vial containing NovoRapid. Invert the vial and syringe and extract the prescribed dose of NovoRapid. Remove the air from the syringe and check that the dose is correct.

4.Insert the needle into the NPH insulin vial, invert the vial and syringe, and extract the prescribed dose of insulin. Remove the air from the syringe and check the dose. Inject the mixture immediately.

5.Mix NovoRapid and NPH insulin in the same order.

How to inject NovoRapid

?Inject the insulin subcutaneously.Use the injection technique recommended by your doctor or nurse.

?Keep the needle under the skin for at least 6 seconds to ensure that all the insulin has been injected.

?Dispose of the needle after each injection.

Use in an insulin pump

NovoRapid should not be mixed with other insulins when used in a pump.

Follow the instructions and recommendations of your doctor regarding the use of NovoRapid in a pump. Before using NovoRapid in an insulin pump, you must have been instructed on the use of the pump, as well as have received information on the measures you should take if you suddenly feel unwell, if your blood sugar level is too low or too high, or if the pump fails.

•Before inserting the needle, wash your hands and the area of skin 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 air bubbles in the syringe or in the catheter.

•The infusion equipment (catheter and needle) should be changed according to the instructions provided in the product information that accompany the infusion equipment.

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

What to do in case of pump failure

Always have an alternative insulin administration system available to inject insulin subcutaneously if the pump fails.

If you use more insulin than you should

If you use too much insulin, your blood sugar level may become very low (hypoglycemia). See a) Summary of severe and very frequent adverse effects in section 4.

If you forget to use your insulin

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

If you interrupt your insulin treatment

Do not stop taking your insulin without consulting your doctor, who will tell you what to do. This could cause very high blood sugar levels (severe hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.

If you have any other questions about the use of this medication, ask your doctor, nurse, or pharmacist.

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

a)Summary of serious and very frequent side effects

Low blood sugar (hypoglycemia)is a very frequent side effect.It can affect more than 1 in 10 people.

Symptoms of low blood sugar may appear if:

•too much insulin is injected;

•not enough food is eaten or a meal is skipped;

•more exercise than usual is done;

•alcohol is consumed (see Alcoholic beverages and use of NovoRapid in section 2).

Warning signs of low blood sugar:cold sweat, pale and cold skin, headache, palpitations, nausea, excessive hunger, temporary changes in vision, drowsiness, fatigue and weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

A severe drop in blood sugar can lead to loss of consciousness. If a severe and prolonged drop in blood sugar is not treated, it can cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly if someone who knows how to do it gives you an injection of glucagon. If glucagon is administered, 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.

What to do if your blood sugar level is low:

?If your blood sugar level is low, take glucose tablets or a sweet product (caramels, cookies, fruit juice). Measure your blood sugar level if possible and then rest. Always carry glucose tablets or sweet foods with you in case you need them.

?When the symptoms of hypoglycemia have disappeared or when your blood sugar levels have stabilized, continue treatment with insulin as usual.

?If you have had blood sugar levels so low that you have lost consciousness, if you have needed someone to administer glucagon to you, or if you have had many drops in blood sugar levels, talk to your doctor. You may need to adjust the amount or schedule of insulin, food, or exercise.

Inform others that you have diabetes and what the consequences may be, including the risk of losing consciousness due to a drop in blood sugar levels. Inform them that if you become unconscious, they should lay you on your side and seek medical help immediately. Do not give you anything to eat or drink as you may choke.

Severe allergic reactionsto NovoRapid or any of its components (systemic allergic reaction) is a very rare but potentially fatal side effect. It can affect up to 1 in 10,000 people.

Consult your doctor immediately:

•if signs of allergy spread to other parts of your body.

•if you suddenly feel sick and have sweating, vomiting, difficulty breathing, palpitations, dizziness.

?If you notice any of these symptoms, consult your doctor immediately.

Changes in skin at the injection site: If insulin is injected in the same place, the fatty tissue may shrink (lipatrophy) or become thicker (lipohypertrophy) (it may affect up to 1 in 100 people). Bumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work well if injected in a thickened, shrunk, or swollen area. Change the injection site to help prevent these skin changes.

b)List of other side effects

Frequent side effects

They can affect up to 1 in 100 people.

Allergic reactions: may appearlocal allergic reactionsat the injection site (pain, redness, rashes, inflammation, hematomas, swelling, and itching). These reactions usually disappear after a few weeks of treatment. If symptoms do not disappear or spread to your body, consult your doctor immediately. See also Severe allergic reactions above.

Visual problems:You may have vision problems when starting insulin treatment, but this alteration is usually temporary.

Swollen joints:When starting insulin treatment, fluid accumulation can cause inflammation of the ankles and other joints. This effect usually disappears quickly. If it does not, consult your doctor.

Diabetic retinopathy(a disease related to diabetes that can lead to vision loss):If you have diabetic retinopathy and your blood sugar level improves rapidly, the retinopathy may worsen. Consult your doctor.

Rare side effects

They can affect up to 1 in 1,000 people.

Painful neuropathy(pain due to nerve damage):If your blood sugar level improves rapidly, you may experience nerve-related pain. This is called acute painful neuropathy and is usually temporary.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

c)Diabetes effects

High blood sugar (hyperglycemia)

Symptoms of high blood sugar may appear if:

•not enough insulin is injected;

•if you forget to inject insulin or interrupt insulin treatment;

•if you repeatedly inject less insulin than you need;

•if you have an infection or fever;

•if you eat more than usual;

•if you do less physical exercise than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. These include: increased need to urinate, thirst, loss of appetite, feeling dizzy (nausea or vomiting), drowsiness or fatigue, dry and red skin, feeling of dryness in the mouth, and breath with a fruity odor (acetone).

What to do if your blood sugar level is high:

?If you notice any of the described symptoms: check your blood sugar level, check your urine ketone level if possible, and consult your doctor immediately.

?These may be symptoms of a very serious condition called diabetic ketoacidosis (acid accumulates in the blood due to the body breaking down fat instead of sugar). If not treated, it could produce diabetic coma and death.

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

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

Keep the vial in the outer packaging to protect it from light.

Before opening:store in the refrigerator between 2°C and 8°C away from the walls or the cooling component of the refrigerator. Do not freeze.

During use or when carrying as a spare: the product may be stored for a maximum of 4weeks. Store below 30°C. Do not refrigerate or freeze

Dispose of the needle after each injection.

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

Composition of NovoRapid

•The active ingredient is insulin aspart. Each ml contains 100units of insulin aspart. Each vial contains 1,000units of insulin aspart in 10ml of injectable solution.

•The other components are glycerol, phenol, metacresol, zinc chloride, disodium dihydrogen phosphate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection preparations.

Appearance of the product and contents of the packaging

NovoRapid is presented as an injection solution.

Packaging containing 1 or 5vials of 10ml or in a multiple pack of 5packs of 1vial x 10ml. Some packaging sizes may only be marketed.

The solution is transparent and colorless.

Holder of the marketing authorization and responsible manufacturer

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Last review date of this leaflet:03/2023

Other sources of information

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