Product Information for the User

NovoRapid FlexPen 100100 units/mL pre-filled injectable solution

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, nurse or pharmacist.

•This medicine has been prescribed to you alone, 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 adverse effects, consult your doctor, nurse or pharmacist, even if they are not listed in this product information. See section 4.

1.What is NovoRapid and how it is used

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

3.How to use NovoRapid

4.Possible adverse effects

5.Storage of NovoRapid

6.Contents of the package 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 reduce 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 decrease 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.

Do not use NovoRapid

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

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

?If the FlexPen has fallen, been damaged or broken.

?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 colourless 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 that the insulin is the type that you have been prescribed.

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

?Needles and NovoRapid FlexPen must not be shared.

?NovoRapid FlexPen is only indicated for subcutaneous injection. Consult your doctor if you need to inject insulin by another method.

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 exercise than usual or if you want 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 the skin at the injection site

Rotate the injection site to help prevent changes in the adipose 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 thickened, shrunk or lumpy (see section 3, How to use NovoRapid). 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 instruct you to check your blood sugar levels more closely, and adjust your insulin or other diabetes medications.

Children and adolescents

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

Other medicines and NovoRapid

Inform your doctor, nurse 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 medicines for the treatment of diabetes;

•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 diseases 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 excessive fluid retention);

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

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

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

•growth hormone (medicine to stimulate somatic and skeletal growth that has a pronounced effect on metabolic processes);

•danazol (medicine that acts on ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused when the pituitary gland produces an excess of 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 medicines mentioned above, inform your doctor, nurse or pharmacist.

Alcohol and 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 have a careful control.

Pregnancy and breastfeeding

?If you are pregnant,think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine.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 on treatment with NovoRapid during lactation.

Consult your doctor,nurse or pharmacist before using this medicine 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 effect 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, so NovoRapid is 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 avoid 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 in place of human soluble insulin, when a rapid onset of action is preferred. For example, when administration in relation to meals is difficult.

Use in special patient groups

If you have kidney or liver dysfunction, or if you are over 65 years old, you must 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. Never inject it directly into a vein (intravenously) or into a muscle (intramuscularly). NovoRapid FlexPen is only indicated for subcutaneous injection. Consult your doctor if you need to inject insulin by another method.

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 following: 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. You must always regularly measure your blood sugar level.

How to handle NovoRapid FlexPen

NovoRapid FlexPen is a pre-filled, disposable pen with a color code containing insulin aspart.

Read carefully the instructions on how to use NovoRapid FlexPen included in this prospectus. You must use the pen as described in the instructions on how to use NovoRapid FlexPen.

Always make sure you use the correct pen before injecting insulin.

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 treatment with your insulin

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

If you have any other doubts 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 common side effects

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

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:chills, cold and pale 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 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.

What to do if your blood sugar level is low:

?If your blood sugar level is low, take glucose tablets or a sugary product (caramels, cookies, fruit juice). Measure your blood sugar level if possible and then rest. Always carry glucose tablets or sugary 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 give you an injection of glucagon, 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 low blood sugar. Tell 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 10,000people.

Consult your doctor immediately:

•if the 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). Blisters 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

Uncommon side effects

They can affect up to 1 in 100 people.

Allergic reactions: may appearlocal allergic reactionsat the injection site (pain, redness, hives, inflammation, hematomas, swelling, and itching). These reactions usually disappear after a few weeks of treatment. If the 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 not, consult your doctor.

Diabetic retinopathy(a disease of the eyes 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines 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:

symptoms 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 because the body breaks down fat instead of sugar). If not treated, it can cause 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 FlexPen label and on the packaging, after CAD. The expiration date is the last day of the month indicated.

Always keep the pen cap of your FlexPen closed when not in use to protect it from light. NovoRapid must be protected from excessive heat and light.

Before opening:The unused NovoRapid FlexPen must be stored 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:You may carry your NovoRapid FlexPen with you and store it at a temperature below 30°C or in the refrigerator (between 2°C and 8°C) for 4weeks. If stored in the refrigerator, keep it away from the walls or the cooling component of the refrigerator. Do not freeze.

Medications should not be disposed of 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 pre-filled pen contains 300units of insulin aspart in 3ml of injectable solution.

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

Appearance of the product and contents of the pack

NovoRapid is presented as an injectable solution.

Packs containing 1 (with or without needles), 5 (without needles), and 10 (without needles) pre-filled pens of 3ml. Some pack sizes may only be marketed.

The solution is transparent and colourless.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

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

Manufacturer

The manufacturer can be identified by the batch number printed on the carton lid and on the label:

•If the second and third characters are S6, P5, K7, R7, VG, FG, or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

•If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.

Now turn over and read the information on how to use FlexPen.

Last update of the leaflet:03/2023

Other sources of information

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

Instructions for the use of NovoRapid injectable solution in FlexPen.

Read these instructions carefully before using your FlexPen.If you do not follow the instructions carefully, you may administer too little or too much insulin, which could result in a level of blood glucose that is too high or too low.

FlexPen is a pre-filled insulin dosing pen. Doses of 1to 60units can be selected, in increments of 1unit. FlexPen is designed to be used with the disposable needles NovoFine or NovoTwist up to 8mm in length. As a precaution, always carry a spare insulin administration device in case your FlexPen is lost or damaged.

Care of the pen

You must handle your FlexPen with care.

If it falls, is damaged or hit, there is a risk of insulin leakage. This could result in inaccurate dosing, which may cause a level of blood glucose that is too high or too low.

You can clean the outer part of your FlexPen with an alcohol-impregnated cotton swab. Do not submerge it, wash it, or lubricate it, as the pen may be damaged.

Do not refill your FlexPen. Once empty, it must be disposed of.

Preparation of NovoRapid FlexPen

Check the name and labelcolour of your pen to ensure that it contains the correct type of insulin.This is especially important if you use more than one type of insulin. If you use the wrong type of insulin, your level of blood glucose may become too high or too low.

A

Remove the pen cap.

B

Remove the paper clip from a new disposable needle.

Twist the straight needle firmly onto your FlexPen.

C

Remove the large outer needle cap and keep it for later use.

D

Remove the inner needle cap and dispose of it.

Do not attempt to put the inner needle cap back on. You may prick yourself with the needle.

Always use a new needle for each injection. This reduces the risk of contamination, infection, insulin loss, needle blockage, and inaccurate dosing.

Be careful not to bend or damage the needle before use.

Insulin flow check

Before each injection, small amounts of air may be present in the cartridge during normal use. To avoid injecting air and ensure proper dosing:

E

Turn the dose selector until 2units are selected.

F

Hold your FlexPen with the needle pointing upwards and gently tap the cartridge a few times with your finger to deposit the air bubbles at the top of the cartridge.

G

Keeping the needle pointing upwards, press the plunger all the way down. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure up to a maximum of 6times.

If a drop of insulin does not appear yet, the pen is faulty and you must use a new one.

Always ensure a drop appears at the needle tip before injecting. This ensures the insulin flows. If no drop appears, no insulin will be injected, although the dose selector may move. This may indicate the needle is blocked or damaged.

Always check the flow before injecting. If you do not check the flow, you may receive an insufficient or non-existent dose of insulin, which may result in a level of blood glucose that is too high.

Dose selection

Check that the dose selector is set to 0.

H

Turn the dose selector to select the number of units you need to inject.

The dose can be corrected forward and backward by turning the dose selector in either direction until the corrected dose is aligned with the dose marker. When turning the dose selector, be careful not to press the plunger, as insulin may leak out.

You cannot select a dose greater than the number of units remaining in the cartridge.

Before injecting insulin, always use the dose selector and dose marker to see how many units you have selected.

Do not count the clicks of the pen. If you select an incorrect dose and inject it, your level of blood glucose may become too high or too low. Do not use the remaining insulin scale, as it only shows the approximate amount of insulin remaining in the pen.

Injection

Insert the needle under the skin. Use the injection technique recommended by your doctor or nurse.

I

Inject the dose by pressing the plunger all the way down so that the 0aligns with the dose marker. Be careful only to press the plunger when injecting.

Turning the dose selector will not inject insulin.

J

Keep the plunger pressed down and keep the needle under the skin for at least 6seconds. This ensures the full dose is injected.

Remove the needle from the skin and once removed, stop pressing the plunger.

Always ensure the dose selector returns to 0after injection. If the dose selector stops before reaching 0, the full dose has not been administered, which may result in a level of blood glucose that is too high.

K

Put the needle cap back on without touching it. When the needle is covered, press the cap firmly and then twist the needle off.

Dispose of it carefully and put the pen cap back on.

Always remove the needle after each injection and store your FlexPen without the needle attached. This reduces the risk of contamination, infection, insulin loss, needle blockage, and inaccurate dosing.

Other important information

Caregivers must be extremely careful when handling used needles to reduce the risk of accidental needlestick injuries and infections.

Dispose of your used FlexPen carefully without leaving the needle attached.

Never share your pen or needles with others. This may cause infections.

Never share your pen with others. Your medicine may be harmful to their health.

Always keep the pen and needles out of sight and reach of others, especially children.