Leaflet: information for the user

NovoRapid Penfill 100100 units/mL injectable solution in cartridge

insulin aspart

Read this leaflet carefully before you start using 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, and you must 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, nurse or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is NovoRapid and what it is used for

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

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 the cartridge or the device containing the cartridge 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 check the cartridge, including the rubber stopper at the end of the cartridge. Do not use it if it is damaged or if the rubber stopper has moved above the white band at the end of the cartridge. This could be the result of the insulin having leaked out. If you suspect that the cartridge is damaged, return it to your supplier. For more information, see your pen's manual.

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

?Needles and NovoRapid Penfill must not be shared.

?NovoRapid Penfill is only indicated for injection under the skin with a reusable pen. 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 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 thickened, shrunk or lumpy (see section 3, How to use NovoRapid). Inform your doctor if you detect any change 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 your other diabetes medications.

Children and adolescents

Do not administer this medication to children under 1 year of age, as there have been no clinical studies 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 this may mean that you need to change your insulin dose. The following are the main medications that may affect your insulin treatment:

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 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 (medication to stimulate somatic and skeletal growth, which 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 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 medications 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 lactation

?If you are pregnant, 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 modify your insulin dose while pregnant and after delivery. It is essential for the health of your baby, a careful control of your diabetes and especially the prevention of hypoglycemia.

• No restrictions on treatment with NovoRapid during lactation.

Consult your doctor, 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, also 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 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 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 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 under the skin (subcutaneously). Never inject it directly into a vein (intravenously) or into a muscle (intramuscularly). NovoRapid Penfill is only indicated for injection under the skin with a reusable pen. 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. Always measure your blood sugar regularly.

?Do not fill the cartridge. Once empty, it should be discarded.

?The NovoRapid Penfill cartridges are designed to be used with the Novo Nordisk insulin administration systems and with the NovoFine or NovoTwist needles.

?If you are being treated with NovoRapid Penfill and another insulin in a Penfill cartridge, you must use two separate insulin administration devices, one for each type of insulin.

?Always carry a spare Penfill cartridge in case you lose or break one.

How to inject NovoRapid

?Insulin must be injected under the skin. Use the injection technique advised by your doctor or nurse and described in the instructions for your device.

?Keep the needle under the skin for at least 6 seconds.Keep the plunger fully pressed until the needle is removed from the skin. This will ensure correct administration and limit the possible passage of blood flow to the needle or remaining insulin.

?After each injection, make sure to remove and discard the needle and store NovoRapid without the needle. Otherwise, the liquid may leak out, causing an incorrect dosage.

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 stop 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 may 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: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 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 insulin treatment 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 low blood sugar episodes, 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 may affect up to 1 in 10,000 people.

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). 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)Other side effects list

Uncommon side effects

They may 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 problems with your vision when starting insulin treatment, but this alteration is usually temporary.

Swollen joints:when starting insulin treatment, the accumulation of fluid may 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 very quickly, the retinopathy may worsen. Consult your doctor.

Rare side effects

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

Painful neuropathy(pain due to nerve damage):if your blood sugar level improves very quickly, 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 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:

the warning signs appear gradually. These include: increased need to urinate, thirst, loss of appetite, feeling of dizziness (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 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 cartridge label and on the packaging, after CAD. The expiration date is the last day of the month indicated.

Always keep the cartridge in the outer packaging when not in use, to protect it from light. NovoRapid must be protected from excessive heat and light.

Before opening:The NovoRapid Penfill that is not in use 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 spareTheNovoRapid Penfill that is in useor that is being carried as a spare must not be stored in the refrigerator. It can be carried and stored at room temperature (below 30°C) for 4weeks.

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 cartridge 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 packaging

NovoRapid is presented as an injection solution.

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

The solution is transparent and colorless.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization

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.

Date of the last review of this leaflet:03/2023

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.