Novorapid

Package leaflet: Information for the user

NovoRapid 100 units/ml solution for injection in vial

insulin aspart
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Never give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What NovoRapid is and what it is used for
2. What you need to know before using NovoRapid
3. How to use NovoRapid
4. Possible side effects
5. How to store NovoRapid
6. Contents of the pack and other information

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (insulin analogue) with rapid action. Modern insulins are
an improved version of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents, and children
from the age of 1 year onwards who have diabetes mellitus (diabetes). Diabetes is a condition in which the body
does not produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps prevent complications of diabetes.
NovoRapid begins to reduce blood sugar levels within 10–20 minutes after injection, reaches its maximum effect within 3 hours after injection, and its effect lasts for 3–5 hours. Due to this short duration of action, NovoRapid is usually taken in combination with intermediate- or long-acting insulin preparations. Additionally, NovoRapid can be used for continuous infusion via insulin pumps.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the excipients in this medicine
(see section 6, Contents in the pack and other information).
► If you experience warning signs of hypoglycaemia, i.e. low blood sugar levels
(see section 4, Summary of serious and very common adverse effects).
► If the protective cap is loose or missing. Each vial has a tamper-evident plastic protective cap.
If the cap is not in perfect condition at the time of purchase, return the vial to the supplier.
► If NovoRapid has not been stored correctly or has been frozen (see section 5, How to store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these situations apply. Speak to your doctor, nurse, or pharmacist for advice.

Before using NovoRapid
► Check the label to make sure you are using the correct type of insulin.
► Remove the protective cap.
► Always use a new needle for each injection to prevent contamination.
► Needles and syringes must not be shared with others.

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney, liver, adrenal, pituitary, or thyroid gland disorders.
► If you have increased physical activity or changes in your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad—traveling to countries with different time zones may alter your insulin requirements and injection schedule.

Changes in the skin at the injection site
Injection sites should be rotated to help prevent changes in the fatty tissue under the skin, such as thickening, thinning of the skin, or the appearance of lumps under the skin.
Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening of the skin (see section 3, How to use NovoRapid). Inform your doctor if you notice any skin changes at the injection site. If you currently inject into one of these affected areas, consult your doctor before switching to another site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or that of other antidiabetic medicines.

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 taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that can influence insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) 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 (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 (hyperglycaemia) 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), salbutamol, terbutaline (used to treat asthma)
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and significantly affecting the body's metabolic processes)
• Danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).
If you are taking any of the medicines listed above, inform your doctor, nurse, or pharmacist.

Drinking alcohol and taking NovoRapid
► If you consume alcohol, your insulin requirement may change, as blood sugar levels may rise or fall. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. NovoRapid can be used during pregnancy. Your insulin requirement may need adjustment during pregnancy and after delivery. It is important to carefully control diabetes, particularly to prevent episodes of hypoglycaemia, for the health of both mother and child.
► There are no restrictions on using NovoRapid during breastfeeding.
Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
► Consult your doctor about whether it is safe for you to drive or use machinery:

• if you have frequent episodes of hypoglycaemia
• if you have difficulty recognizing the warning signs of hypoglycaemia

If your blood glucose is high or low, your ability to concentrate and react may be impaired, thereby affecting your ability to drive or use machinery. Bear in mind that you could be putting yourself or others at risk.
NovoRapid acts rapidly; therefore, if hypoglycaemia occurs, it may appear earlier after injection compared to soluble human insulin.

Important information about some excipients in NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoRapid is essentially “sodium-free”.

3. How to use NovoRapid

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and carefully follow their advice. If you are
unsure, consult your doctor, nurse, or pharmacist.
NovoRapid is generally taken just before meals. Eat a meal or snack within 10 minutes after injection
to avoid low blood sugar levels. If necessary, NovoRapid may be administered immediately after a
meal. See How and where to inject for more information.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be required by your doctor.
Use in children and adolescents
NovoRapid can be used in children from the age of 1 year and in adolescents instead of soluble human
insulin when a more rapid onset of action is preferred. For example, when it is difficult to match the
child's insulin dose to meals.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years of age, you should monitor your blood
sugar levels regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
NovoRapid is administered by subcutaneous injection (under the skin) or by continuous infusion using
insulin pumps. Administration via insulin pumps requires detailed instructions from healthcare
professionals. Never inject insulin directly into a vein (intravenous route) or into muscle
(intramuscular route). If necessary, NovoRapid may be given directly into a vein, but this must be done
exclusively by doctors or healthcare professionals.
Each time you inject, rotate the injection site within the particular area of skin you usually use.
This can help reduce the risk of developing lumps or skin depressions (see section 4, Possible side
effects). The best areas for injection are: the abdominal area, the upper arm, or the front of the thigh.
Insulin acts more quickly when injected into the abdomen.
Check your blood glucose levels regularly.
NPH (Neutral Protamine Hagedorn) insulin is the only type of insulin that may be mixed with
NovoRapid, and the mixture must be injected immediately subcutaneously (under the skin).
NovoRapid must be drawn into the syringe before NPH insulin.
How to inject NovoRapid
If you are using only one type of insulin

1. Draw into the syringe an amount of air equal to the dose of insulin you need to inject. Inject this air into the vial.
2. Turn the vial and syringe upside down and draw the correct dose of insulin into the syringe. Remove the needle from the vial. Then expel the air from the syringe and check that the dose is correct.

If it is necessary to mix two types of insulin

1. Immediately before use, roll the vial containing NPH insulin gently between your hands until the liquid appears uniformly white and milky.
2. Draw into the syringe an amount of air equal to the dose of NPH insulin. Inject this air into the vial containing NPH insulin and remove the needle.
3. Draw into the syringe an amount of air equal to the dose of NovoRapid. Inject this air into the vial containing NovoRapid. Turn the vial and syringe upside down and draw the prescribed dose of NovoRapid into the syringe. Then expel the air from the syringe and check that the dose is correct.
4. Insert the needle into the vial containing NPH insulin, turn the vial and syringe upside down, and draw the prescribed dose. Then expel the air from the syringe and check that the dose is correct. Inject the mixed solution immediately.
5. Always mix NovoRapid and NPH insulin in this sequence.

How to inject NovoRapid
► Inject insulin subcutaneously. Use the administration technique provided by your doctor or
nurse.
► Wait at least 6 seconds before removing the needle from under the skin to ensure the full dose of
insulin has been delivered.
► Dispose of the needle after each injection.
Use in insulin pumps
Do not mix NovoRapid with other types of insulin in insulin pumps.
Follow your doctor's instructions regarding the use of NovoRapid in an insulin pump. Before using
NovoRapid in a pump, ensure you fully understand the instructions for use and information on actions to
take in case of illness, hyperglycemia, hypoglycemia, or pump malfunction.

• Before inserting the needle, wash your hands and the skin at the insertion site thoroughly with soap and water to prevent infection at the infusion site.
• When filling a new reservoir, ensure there are no air bubbles in the syringe or tubing.
• The infusion set (tubing and needle) must be changed according to the instructions provided with the infusion set.

To fully benefit from insulin infusion and to detect any insulin pump malfunctions, measure your blood
glucose levels regularly.
What to do in case of insulin pump malfunction
Always keep an alternative method of insulin administration available for subcutaneous injection in
case of insulin pump malfunction.
If you take more insulin than you should
If you take too much insulin, your blood sugar level may drop too low (hypoglycemia). See a) Summary
of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level may become too high (hyperglycemia). See c)
Effects of diabetes in section 4.
If you stop using your insulin
Do not stop using insulin without first discussing it with your doctor, who will advise you on what to
do. Stopping treatment may lead to 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 medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

a) Summary of serious and very common side effects

Low blood sugar level (hypoglycaemia) is a very common side effect. It may occur in more than 1 in 10 people.

You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and using NovoRapid in section 2).

Warning signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.

Severe hypoglycaemia can lead to loss of consciousness. If severe hypoglycaemia is left untreated, it may cause brain damage (temporary or permanent) and even death. You may regain consciousness more quickly with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital.

What to do if your blood sugar level is low:

► If your blood sugar is too low, eat sugar cubes or another sugary snack (candies, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar cubes, candies, or other sugary snacks with you to use if needed.

► When the symptoms of hypoglycaemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.

► If you have low blood sugar, lose consciousness, have required a glucagon injection, or have frequent episodes of low blood sugar, speak to your doctor. You may need an adjustment in your insulin dose, timing of insulin injections, food intake, or physical activity.

Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and seek immediate medical help. It is important not to give you food or drink as these could cause choking.

Severe allergic reaction to NovoRapid or one of its excipients (called systemic allergic reaction) is a very rare side effect that may be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.

Contact your doctor immediately:

• If signs of allergy spread to other parts of the body.
• If you suddenly feel unwell and: start sweating; feel sick (vomiting); have difficulty breathing; your heartbeat is rapid; you feel dizzy.

► If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work as well if you inject into an area with lumps, thinning, or thickening of the skin. Change your injection site with each injection to prevent these skin changes.

b) List of other side effects

Uncommon side effects

May affect fewer than 1 in 100 people.

Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.

Vision disturbances: vision problems may occur at the beginning of insulin treatment, but these are usually temporary.

Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is usually a short-lived phenomenon. If not, contact your doctor.

Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): If you have diabetic retinopathy and your blood sugar improves very rapidly, your retinopathy may worsen. Consult your doctor.

Rare side effects

May affect fewer than 1 in 1,000 people.

Peripheral neuropathy (nerve pain due to nerve damage): a rapid improvement in blood sugar levels may cause nerve pain. This is called peripheral neuropathy and resolves spontaneously.

Reporting of side effects

If you get any side effects, tell your doctor, nurse, or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

c) Other effects of diabetes

High blood sugar level (hyperglycaemia)

You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than needed.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:

Warning signs appear gradually and include: passing more urine than normal; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).

What to do if your blood sugar level is high:

► If you experience any of these symptoms: check your blood sugar, if possible check for ketones in your urine, and contact a doctor immediately.

► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar). If left untreated, it may lead to diabetic coma and possibly death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the packaging, after EXP.
The expiry date refers to the last day of the month indicated.
Keep the vial in its outer packaging to protect it from light.
Before opening: store in a refrigerator at 2°C - 8°C, away from cooling elements. Do not freeze.
During use or when carried as a spare: the product can be stored for a maximum of 4 weeks. Store below 30°C. Do not refrigerate or freeze.
Dispose of the needle after each injection.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NovoRapid contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 ml of injectable solution.
• The excipients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and contents of the pack
NovoRapid is a clear, colourless, injectable solution.
Packs of 1 and 5 vials of 10 ml or in a multiple pack of 5 x (1 x 10 ml) vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer :
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
This leaflet was last revised on
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Package leaflet: Information for the user

NovoRapid Penfill 100 units/ml injection solution in cartridge

insulin aspart
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What NovoRapid is and what it is used for
2. What you need to know before using NovoRapid
3. How to use NovoRapid
4. Possible side effects
5. How to store NovoRapid
6. Contents of the pack and other information

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (an insulin analogue) with a fast-acting profile. Modern insulins are improved versions of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents, and children from the age of 1 year onwards who have diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. Treatment with NovoRapid helps prevent diabetes-related complications.
NovoRapid begins to lower blood sugar levels 10–20 minutes after injection, reaches its maximum effect within 3 hours after injection, and its effect lasts for 3–5 hours. Due to this short duration of action, NovoRapid is usually administered in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the other excipients in this medicine
(see section 6, Contents of the pack and other information).
► If you experience warning signs of hypoglycaemia, i.e. low blood sugar levels
(see a) Summary of serious and very common adverse reactions in section 4).
► If the cartridge or the device containing the cartridge is leaking, damaged, or fractured.
► If NovoRapid has not been stored correctly or has been frozen (see section 5, How to store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these situations apply. Speak with your doctor, nurse, or pharmacist for advice.

Before using NovoRapid
► Check the label to make sure it is the correct type of insulin.
► Always inspect the cartridge, including the rubber plunger at the top of the cartridge. Do not use it if it appears damaged or if the rubber plunger has been pushed beyond the white band at the top of the cartridge. This could result in loss of insulin.
If you suspect the cartridge is damaged, return it to your supplier. Refer to the pen user manual for further information.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoRapid Penfill must not be shared with others.
► NovoRapid Penfill is intended only for subcutaneous injections using a reusable pen. Speak with your doctor if you need to administer insulin by another method.

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney, liver, adrenal, pituitary, or thyroid disorders.
► If you increase your physical activity or change your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad, travelling across different time zones may alter your insulin requirements and injection schedule.

Skin changes at the injection site
Rotate your injection sites to help prevent changes in the fatty tissue under the skin, such as skin thickening, skin thinning, or the appearance of lumps under the skin.
Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening of the skin (see section 3, How to use NovoRapid). Inform your doctor if you notice any skin changes at the injection site. If you currently inject into such an affected area, consult your doctor before switching to another injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or other antidiabetic 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 below this age.

Other medicines and NovoRapid
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that may influence insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) 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 (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)
• Sulphonamides (used to treat infections)

Your blood sugar level may increase (hyperglycaemia) 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), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and that significantly affects the body’s metabolic processes)
• Danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).
If you are taking any of the medicines listed above, inform your doctor, nurse, or pharmacist.

Drinking alcohol and using NovoRapid
► If you consume alcohol, your insulin requirements may change, as blood sugar levels may rise or fall. Careful monitoring is recommended.

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. NovoRapid can be used during pregnancy. Your insulin requirements may need adjustment during pregnancy and after delivery. It is important to carefully control your diabetes, particularly to prevent hypoglycaemic episodes, for the health of both you and your baby.
► There are no restrictions on using NovoRapid during breastfeeding.
Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
► Consult your doctor about whether it is safe for you to drive or use machinery:

• if you have frequent episodes of hypoglycaemia
• if you have difficulty recognizing the warning signs of hypoglycaemia

If your blood glucose is high or low, your ability to concentrate and react may be impaired, thereby affecting your ability to drive or use machinery. Be aware that you could put yourself and others at risk.
NovoRapid acts rapidly; therefore, if hypoglycaemia occurs, it may appear earlier after injection compared to soluble human insulin.

Important information about some of the excipients in NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoRapid is essentially “sodium-free”.

3. How to use NovoRapid

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and follow their instructions carefully. If you are
unsure, consult your doctor, nurse, or pharmacist.
NovoRapid is generally taken immediately before meals. Eat a meal or snack within 10 minutes after
injection to avoid low blood sugar levels. If necessary, NovoRapid may be administered immediately
after a meal. See "How and where to inject" for further information.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be required by your doctor.
Use in children and adolescents
NovoRapid can be used in children aged 1 year and older and in adolescents instead of soluble human
insulin when a more rapid onset of action is preferred. For example, when it is difficult to match insulin
dosing to meals.
Use in specific patient groups
If you have renal or hepatic impairment, or if you are over 65 years of age, you should monitor your
blood sugar levels regularly and discuss dose adjustments with your doctor.
How and where to inject
NovoRapid is administered by subcutaneous injection (under the skin). Never inject insulin directly into
a vein (intravenous) or into muscle (intramuscular). NovoRapid Penfill is intended for subcutaneous
injections only, using a reusable pen device. Talk to your doctor if you need to administer insulin by a
different method.
With each injection, rotate the injection site within the particular area of skin you usually use. This may
reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The best
areas for injection are: the abdominal area, the upper arm, or the front of the thigh. Insulin will act more
rapidly if injected into the abdomen.
Always check your blood glucose levels regularly.
► Do not refill the cartridge. Once empty, it must be discarded.
► NovoRapid Penfill cartridges are designed to be used only with Novo Nordisk insulin delivery
systems and NovoFine or NovoTwist needles.
► If you are treated with NovoRapid Penfill and another type of insulin Penfill cartridge, you must
use two separate delivery systems, one for each type of insulin.
► Always carry a spare Penfill cartridge with you in case you lose or damage your current one.
How to inject NovoRapid
► Inject the insulin under the skin. Use the injection technique recommended by your doctor or
nurse and described in the pen’s instruction manual.
► Keep the needle under the skin for at least 6 seconds. Keep the button fully pressed until you
have withdrawn the needle from the skin. This ensures that you have delivered the correct dose and
minimizes the possibility of blood entering the needle or insulin cartridge.
► After each injection, remove and discard the needle. Store NovoRapid without the needle attached.
Otherwise, liquid may leak out, leading to inaccurate dosing.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia). See a) Summary
of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia). See
c) Effects of diabetes in section 4.
If you stop treatment with your insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you on what to do.
Stopping may lead to high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See c) Effects
of diabetes in section 4.
If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
a) Summary of serious and very common side effects.
Low blood sugar (hypoglycaemia) is a very common side effect. It may occur in more than 1 in 10 people.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You do more physical activity than usual.
• You consume alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it can cause brain damage (transient or permanent) and may even result in death. Recovery of consciousness may be faster with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat sugar lumps or another sugary snack (candies, biscuits, fruit juice). If possible, measure your blood sugar and then rest. Always carry sugar lumps or sugary snacks with you to use in emergencies.
► When symptoms of hypoglycaemia have disappeared or when blood glucose has stabilized, continue your insulin treatment.
► If you experience low blood sugar, lose consciousness, require a glucagon injection, or have frequent episodes of low blood sugar, speak to your doctor. Your insulin dose, timing of insulin injections, food intake, and physical activity may need adjustment.
Inform people close to you that you have diabetes and what the possible consequences are, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and seek immediate medical help. It is important not to give you food or drink, as this could cause choking.
Severe allergic reaction to NovoRapid or one of its excipients (called systemic allergic reaction) is a very rare side effect that may be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

• if signs of allergy spread to other parts of the body
• if you suddenly feel unwell and: start sweating; feel sick (vomiting); have difficulty breathing; your heartbeat becomes rapid; feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening. Rotate your injection site with each injection to prevent these skin changes.
b) List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching) at the insulin injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but this reaction normally resolves.
Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is usually a temporary condition. If it persists, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): if blood glucose improves very rapidly, diabetic retinopathy may worsen. Consult your doctor.
Rare side effects
May affect fewer than 1 in 1,000 people.
Peripheral neuropathy (pain due to nerve damage): If blood glucose improves very rapidly, it may cause pain originating in the nerve fibres. This is known as acute painful neuropathy, which is usually transient.
Reporting of side effects
If you experience any of the side effects, tell your doctor, nurse, or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
c) Other effects of diabetes
High blood sugar (hyperglycaemia)
You may experience high blood sugar if:

• You have not injected enough insulin.
• You forgot to take insulin or stopped taking it.
• You repeatedly take less insulin than needed.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
Warning signs appear gradually. They include: passing more urine than normal; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood glucose; if possible, check for the presence of ketones in your urine; and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, this could lead to diabetic coma and possibly death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cartridge label and packaging, after EXP.
The expiry date refers to the last day of the month.
When not in use, always keep the cartridge in its outer packaging to protect it from light.
NovoRapid must be protected from excessive heat and light.
Before opening: Unused NovoRapid Penfill must be stored in the refrigerator at 2°C–8°C, away from refrigerating elements. Do not freeze.
During use or when carried as a spare: NovoRapid Penfill in use or carried as a spare must not be stored in the refrigerator. It may be carried at room temperature (below 30°C) for up to 4 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NovoRapid contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 ml of injectable solution.
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and package contents
NovoRapid is a solution for injection.
Pack sizes: 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.
The solution is clear and colourless.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the tab of the packaging 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 Bagsvaerd, 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.

This leaflet was last reviewed on
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Package leaflet: Information for the user

NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen

insulin aspart
Please read this leaflet carefully before you start using this medicine because it contains
important information for you.

• Keep this leaflet. 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. Never give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What NovoRapid is and what it is used for
2. What you need to know before using NovoRapid
3. How to use NovoRapid
4. Possible side effects
5. How to store NovoRapid
6. Contents of the pack and other information

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (an insulin analogue) 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 from the age of 1 year onwards who have diabetes mellitus (diabetes). Diabetes is a condition in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent complications of diabetes.
NovoRapid will begin to lower blood sugar levels within 10–20 minutes after injection, reaches its maximum effect between 1 and 3 hours after injection, and its effect lasts for 3–5 hours. Due to this short duration of action, NovoRapid is usually administered in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the other excipients in this medicine
(see section 6 Package contents and other information).
► If you experience warning signs of hypoglycaemia, i.e. low blood sugar levels (see a) Summary of serious and very common adverse reactions in section 4).
► If the FlexPen is leaking, damaged, or cracked.
► If it has not been stored correctly or has been frozen (see section 5 How to store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these situations apply. Speak to your doctor, nurse, or pharmacist for advice.

Before using NovoRapid
► Check the label to make sure you are using the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoRapid FlexPen must not be shared with others.
► NovoRapid FlexPen is intended only for subcutaneous injection. Speak to your doctor if you need to administer insulin by another method.

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney, liver, adrenal, pituitary, or thyroid gland disorders.
► If you have increased physical activity or changes in your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad; travelling across time zones may alter your insulin requirements and injection schedule.

Skin changes at the injection site
Injection sites should be rotated to help prevent changes in the fatty tissue under the skin, such as skin thickening, skin thinning, or the appearance of lumps under the skin.
Insulin may not work as effectively if you inject into an area with lumps, thinning skin, or thickened skin (see section 3, How to use NovoRapid). Inform your doctor if you notice skin changes at the injection site. If you currently inject into such affected areas, consult your doctor before switching to a new injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or other antidiabetic 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 taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that may affect insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) 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 (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 (hyperglycaemia) 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), salbutamol, terbutaline (used to treat asthma)
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and that significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress early warning symptoms that help you recognize low blood sugar levels.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).
If you are taking any of the medicines listed above, inform your doctor, nurse, or pharmacist.

Drinking alcohol and using NovoRapid
► Alcohol may alter your insulin requirements, as blood sugar levels may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. NovoRapid can be used during pregnancy.
Your insulin requirements may need adjustment during pregnancy and after delivery. It is important to control diabetes carefully, particularly to prevent episodes of hypoglycaemia, for the health of both mother and baby.
► There are no restrictions on using NovoRapid during breastfeeding.
Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
► Consult your doctor about whether it is safe for you to drive or operate machinery:

• if you have frequent episodes of hypoglycaemia
• if you have difficulty recognizing the warning signs of hypoglycaemia.
  If your blood glucose is high or low, your ability to concentrate and react may be impaired, thereby affecting your ability to drive or operate machinery. Be aware that you may put yourself and others at risk.
  NovoRapid acts rapidly; therefore, if hypoglycaemia occurs, it may appear earlier after injection compared to soluble human insulin.

Important information about some of the excipients in NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, i.e. NovoRapid is essentially “sodium-free”.

3. How to use NovoRapid

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and follow their instructions carefully. If you
are unsure, consult your doctor, nurse, or pharmacist.
NovoRapid is generally taken immediately before meals. Eat a meal or snack within 10 minutes
after injection to avoid low blood sugar. If necessary, NovoRapid may be administered immediately
after a meal. See "How and where to inject" for further information.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be required by your doctor.
Use in children and adolescents
NovoRapid may be used in adolescents and children from the age of 1 year onwards instead of
soluble human insulin when a rapid onset of action is preferred. For example, when it is difficult to
match insulin dosing to meals.
Use in specific patient groups
If you have renal or hepatic impairment, or if you are over 65 years of age, monitor your blood sugar
regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
NovoRapid is administered by subcutaneous injection (under the skin). Never inject insulin directly
into a vein (intravenous route) or into muscle (intramuscular route). The NovoRapid FlexPen is intended
for subcutaneous injections only. Speak with your doctor if you need to administer insulin by another
method.
Each time you inject, always rotate the injection site within the same general skin area you usually use.
This may reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects).
The best areas for injection are: the abdominal area, the upper arm, or the front of the thigh. Insulin
acts more quickly when injected into the abdomen. Always check your blood glucose levels regularly.
How to use NovoRapid FlexPen
NovoRapid FlexPen is a pre-filled, colour-coded, disposable pen containing insulin aspart.
Carefully read the instructions on how to use the NovoRapid FlexPen provided in this patient information
leaflet. You must use the pen exactly as described in the instructions on how to use NovoRapid
FlexPen.
Always make sure you are using the correct pen before injecting insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia). See a) Summary
of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia). See
c) Effects of diabetes in section 4.
If you stop treatment with your insulin
Do not stop treatment with insulin without first discussing it with your doctor, who will advise you on
what to do. Stopping may lead to high blood sugar levels (severe hyperglycaemia) and ketoacidosis.
See c) Effects of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, nurse, or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
a) Summary of serious and very common adverse effects
Low blood sugar (hypoglycaemia) is a very common adverse effect. It may occur in 1 out of 10 people.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You are more physically active than usual.
• You consume alcohol (see Drinking alcohol and using NovoRapid in section 2).

Warning signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and may even result in death. Recovery of consciousness may occur more rapidly following an injection of the hormone glucagon administered by someone trained in its use. If glucagon is given, you will need glucose or a sweet snack as soon as consciousness is regained. If there is no response to glucagon treatment, you must be taken to hospital immediately.
What to do if blood sugar is low:
► If blood sugar is too low, eat sugar cubes or another high-sugar snack (candy, biscuits, fruit juice). If possible, measure your blood sugar and then rest. Always carry sugar cubes or high-sugar snacks to use in emergencies.
► Once symptoms of hypoglycaemia have subsided or blood sugar has stabilized, continue your insulin treatment.
► If you experience low blood sugar, lose consciousness, require a glucagon injection, or have frequent episodes of low blood sugar, speak with your doctor. A dose adjustment of insulin, timing of insulin administration, food intake, or physical activity may be necessary.
Inform people close to you that you have diabetes and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and immediately call for medical help. It is important that food or drink is not given, as this could cause choking.
Severe allergic reaction to NovoRapid or one of its excipients (called systemic allergic reaction) is a very rare adverse effect that may be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

• if allergy signs spread to other parts of the body
• if you suddenly feel unwell and: begin to sweat; feel sick (vomiting); have difficulty breathing; have a rapid heartbeat; feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening of the skin. Rotate your injection site with each injection to prevent these skin changes.
b) List of other adverse effects
Uncommon adverse effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin therapy, but these are generally temporary.
Swollen joints: at the start of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This condition usually resolves quickly. If not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): if you have diabetic retinopathy and your blood sugar improves very rapidly, the retinopathy may worsen. Consult your doctor.
Rare adverse effects
May affect fewer than 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): if blood sugar improves very rapidly, it may cause pain originating in the nerve fibres. This is known as acute painful neuropathy, which is usually transient.
Reporting of adverse effects
If you experience any of the adverse effects, inform your doctor, nurse, or pharmacist. This includes any adverse effect not listed in this leaflet. You can also report adverse effects directly via the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
c) Other effects of diabetes
High blood sugar (hyperglycaemia)
You may experience high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than required.
• You have an infection or fever.
• You eat more than usual.
• You are less physically active than usual.

Warning signs of high blood sugar:
Warning signs appear gradually. They include: increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).
What to do if blood sugar is high:
► If you experience any of these symptoms: check your blood sugar, and if possible, test your urine for ketones, and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood due to the body metabolizing fat instead of sugar).
If left untreated, it may lead to diabetic coma and possibly death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the FlexPen label and on the
packaging, after EXP. The expiry date refers to the last day of the month.
Always keep the cap on the FlexPen when not in use to protect it from light.
NovoRapid must be protected from excessive heat and light.
Before opening: Unused NovoRapid FlexPen must be stored in a refrigerator at 2°C –
8°C, away from refrigerating elements. Do not freeze.
During use or when carried as a spare: You may carry NovoRapid FlexPen with you and keep it at a
temperature below 30°C or in the refrigerator (2°C – 8°C) for up to 4 weeks. If stored in the refrigerator,
keep it away from refrigerating elements. Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NovoRapid contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution.
• The other ingredients (excipients) are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoRapid and contents of the pack
NovoRapid is a clear, colourless injectable solution.
Packs of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens of 3 ml.
Not all pack sizes may be marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Manufacturer:
The manufacturer can be identified from the batch number printed on the carton flap 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 Bagsvaerd, 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 the leaflet for information on how to use your FlexPen.
This leaflet was last revised on
Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Instructions for using NovoRapid injectable solution in FlexPen.
Read the following instructions carefully before using your FlexPen. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
The FlexPen is a pre-filled insulin delivery pen. You can select a dose between 1 and 60 units in 1-unit increments. The FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.
As a precaution, always keep a spare insulin delivery device available in case your FlexPen is lost or damaged.

Taking care of your pen
Your FlexPen must be handled with care.
If it leaks, has been dropped or damaged, insulin may be lost. This could result in incorrect dosing, which may lead to blood sugar levels that are too high or too low.
You may clean the outside of your FlexPen with an alcohol swab. Do not immerse, wash or lubricate the pen, as this may damage its mechanism.
Do not refill your FlexPen. Once empty, it must be discarded.

Preparing NovoRapid FlexPen
Check the name and the coloured label on your pen to make sure it contains the correct type of insulin. This is especially important if you use more than one type of insulin. If you inject the wrong type of insulin, your blood sugar level may become too high or too low.

A
Remove the pen cap.

B
Remove the protective seal from a new disposable needle.
Screw the needle firmly and perpendicularly onto your FlexPen.

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

D
Remove the inner needle cap and discard it.
Never try to reattach the inner needle cap to the needle. You may injure yourself with the needle.

Always use a new needle for each injection. This reduces the risk of contamination, infection, insulin leakage, blocked needles and incorrect dosing.
Be careful not to bend or damage the needle before use.

Checking insulin flow
During normal use, small amounts of air may accumulate in the cartridge. To avoid injecting air and to ensure the correct insulin dose is delivered:

E
Turn the dose selector to select 2 units.

F
Hold the FlexPen with the needle pointing upwards and tap the cartridge gently several times with your finger so that any air bubbles collect at the top of the cartridge.

G
With the needle pointing upwards, press the injection button fully. The dose selector will return to 0.
A drop of insulin should appear at the tip of the needle. If it does not, change the needle and repeat the procedure no more than 6 times.
If a drop of insulin still does not appear, the pen is faulty and you must use a new one.

Always make sure a drop appears at the needle tip before injecting. This ensures proper insulin flow. If no drop appears, you will not inject insulin, even if the dose selector moves. This may indicate a blocked or damaged needle.
Always check the flow before injecting. If you do not check the flow, you may inject too little insulin or no insulin at all. This could lead to blood sugar levels that are too high.

Selecting the dose
Make sure the dose selector is at 0.

H
Turn the dose selector to select the number of units to be injected.
The dose can be increased or decreased by turning the selector in either direction until the indicator shows the correct dose. When turning the dose selector, be careful not to press the injection button, as this may cause insulin to 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 indicator to confirm how many units have been selected.
Do not count the clicks of the pen. If you select and inject the wrong dose, your blood sugar level may become too high or too low. Do not use the graduated scale, which only approximately indicates how much insulin remains in the pen.

Injection
Insert the needle into the skin. Use the injection technique shown to you by your doctor or nurse.

I
Deliver the insulin dose by pressing the injection button until the indicator reaches 0. Be careful to press only the injection button.
Turning the dose selector will not deliver insulin.

J
Keep the injection button fully pressed and leave the needle in the skin for at least 6 seconds. This ensures complete delivery of the dose.
Remove the needle from the skin and release pressure on the injection button.
Always make sure that the dose selector returns to 0 after injection. If the dose selector stops before reaching 0, the full dose has not been delivered, which may result in blood sugar levels that are too high.

K
Place the needle tip into the outer needle cap without touching the cap itself. Once the needle is covered, press the outer cap down firmly and then unscrew the needle.
Dispose of the needle carefully and replace the pen cap.

Always remove the needle after each injection and store your FlexPen without a needle attached. This reduces the risk of contamination, infection, insulin leakage, blocked needles and incorrect dosing.

Other important information
Anyone caring for you must take great care when handling used needles to reduce the risk of needle-stick injuries and cross-infections.
Dispose of used FlexPens carefully, making sure the needle has been removed.
Never share your pen or needles with other people. This could lead to cross-infection.
Never share your pen with other people. The medicine may be dangerous to their health.
Always keep your pen and needles out of sight and out of reach of others, especially children.

Package leaflet: Information for the user

NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen

insulin aspart
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, nurse or pharmacist
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, because it may be harmful to them
• If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What NovoRapid is and what it is used for
2. What you need to know before you use NovoRapid
3. How to use NovoRapid
4. Possible side effects
5. How to store NovoRapid
6. Contents of the pack and other information

1. What NovoRapid is and what it is used for

NovoRapid is a modern (insulin analogue) rapid-acting insulin. Modern insulins are
an improved version of human insulin.
NovoRapid is used to reduce high blood sugar levels in adults, adolescents, and children
from the age of 1 year onwards with diabetes mellitus (diabetes). Diabetes is a condition in which the
body does not produce enough insulin to control blood sugar levels. Treatment with
NovoRapid helps to prevent diabetes-related complications.
NovoRapid will begin to reduce blood sugar levels 10-20 minutes after injection, reaches its peak effect within 3 hours after injection, and lasts for 3-5 hours. Due to this short duration of action, NovoRapid is usually administered in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart, or to any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience warning signs of hypoglycaemia, i.e. low blood sugar levels (see a) Summary of serious and very common adverse reactions in section 4).
► If InnoLet leaks, is damaged or cracked.
► If it has not been stored correctly or has been frozen (see section 5, How to store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these situations apply. Speak to your doctor, nurse or pharmacist for advice.

Before using NovoRapid
► Check the label to make sure it is the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoRapid InnoLet must not be shared with others.
► NovoRapid InnoLet is intended only for subcutaneous injection. Speak to your doctor if you need to administer insulin by another method.

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney, liver, adrenal, pituitary or thyroid gland disorders.
► If you have increased physical activity or changes in your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad; travelling across time zones may alter your insulin requirements and injection times.

Changes in the skin at the injection site
Rotate your injection sites to help prevent changes in the fatty tissue under the skin, such as thickening, thinning of the skin, or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned or thickened area (see section 3, How to use NovoRapid). Inform your doctor if you notice any skin changes at the injection site. If you currently inject into one of these affected areas, consult your doctor before switching to another area. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or other antidiabetic medicines.

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 taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that may affect insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) 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 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 (hyperglycaemia) 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), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body’s metabolic processes)
• Danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).
If you are taking any of the medicines listed above, inform your doctor, nurse or pharmacist.

Drinking alcohol and using NovoRapid
► If you consume alcohol, your insulin requirement may change because blood sugar levels may rise or fall. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. NovoRapid can be used during pregnancy.
Your insulin requirement may need adjustment during pregnancy and after childbirth. It is important to carefully control diabetes, particularly to prevent episodes of hypoglycaemia, for the health of both mother and baby.
► There are no restrictions on treatment with NovoRapid during breastfeeding.

Consult your doctor, nurse or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
► Consult your doctor about whether it is safe for you to drive or use machinery:

• if you have frequent episodes of hypoglycaemia
• if you have difficulty recognizing the warning signs of hypoglycaemia

If your blood glucose is high or low, your ability to concentrate and react may be impaired, and consequently your ability to drive or operate machinery. Be aware that you could endanger yourself or others.
NovoRapid acts rapidly; therefore, if hypoglycaemia occurs, it may appear earlier after injection compared to soluble human insulin.

Important information about some of the excipients in NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, i.e. NovoRapid is essentially “sodium-free”.

3. How to use NovoRapid

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and carefully follow their advice. If you are
not sure, consult your doctor, nurse, or pharmacist.
NovoRapid is generally taken immediately before meals. Eat a meal or snack within 10 minutes
after injection to avoid low blood sugar levels. If necessary, NovoRapid may be administered
immediately after a meal. See information under How and where to inject.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be required by your doctor.
Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and older instead of soluble human
insulin when a rapid onset of action is preferred. For example, when it is difficult to match the child’s
insulin dose to meals.
No clinical studies with NovoRapid have been conducted in children below 1 year of age. Therefore,
use NovoRapid in children below this age only if your doctor has specifically instructed you to do so.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years old, you should monitor your blood
sugar levels regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
NovoRapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenous route) or into muscle (intramuscular route). NovoRapid InnoLet is
intended only for subcutaneous injections. Speak with your doctor if you need to administer insulin by
another method.
Each time you inject, always rotate the injection site within the particular area of skin you usually use.
This may reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects).
The best areas for self-injection are: the abdominal area, the upper arm, or the front of the thigh.
Insulin will act more quickly if injected into the abdomen. Always monitor your blood glucose levels
regularly.
How to use NovoRapid InnoLet
NovoRapid InnoLet is a disposable pre-filled pen containing insulin aspart.
Read carefully the instructions on how to use NovoRapid InnoLet provided in this package leaflet. You
must use the pen exactly as described in the instructions on how to use NovoRapid InnoLet.
Always make sure you are using the correct pen before injecting insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia). See a)
Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia). See
c) Effects of diabetes in section 4.
If you stop treatment with your insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you on what to
do. Stopping may lead to high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See c)
Effects of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
a) Summary of serious and very common side effects.
Low blood sugar level (hypoglycaemia) is a very common side effect. It may occur in 1 out of 10 people.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it can cause brain damage (transient or permanent) and may even lead to death. Recovery of consciousness may be faster with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital.
What to do if your blood sugar level is low:
► If your blood sugar is too low, eat sugar cubes or another snack high in sugar (candy, biscuits, fruit juice). Measure your blood sugar if possible, then rest. Always carry sugar cubes or sugary snacks with you to use in case of need.
► When symptoms of hypoglycaemia have disappeared or when blood glucose has stabilized, continue your insulin treatment.
► If you experience low blood sugar, you may lose consciousness. If you required a glucagon injection, or if you have frequent episodes of low blood sugar, talk to your doctor. You may need to adjust your insulin dose, insulin administration times, food intake, and physical activity.
Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Explain that, if you faint, they should turn you onto your side and immediately call for medical help. It is important that food or drink should not be given to you, as this could cause choking.
Severe allergic reaction to NovoRapid or one of its excipients (called systemic allergic reaction) is a very rare side effect that may be potentially life-threatening. It may occur in fewer than 1 out of 10,000 people.
Contact your doctor immediately:

• if signs of allergy spread to other parts of the body
• if you suddenly feel unwell and: start sweating; feel sick (vomiting); have difficulty breathing; have a rapid heartbeat; feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work as well as it should if you inject into an area with lumps, thinning, or thickening. Change your injection site with each injection to prevent these skin changes.
b) List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: at the beginning of insulin treatment, visual disturbances may occur, but these are usually temporary.
Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is a temporary condition that soon disappears. If not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): if you have diabetic retinopathy and your blood glucose improves very rapidly, the retinopathy may worsen. Consult your doctor.
Rare side effects
May affect fewer than 1 in 1,000 people.
Peripheral neuropathy (nerve pain due to nerve damage): a rapid improvement in blood sugar levels may cause nerve pain. This is called peripheral neuropathy and resolves spontaneously.
Reporting of side effects
If you experience any of the side effects, inform your doctor, nurse, or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
c) Other effects of diabetes
High blood sugar level (hyperglycaemia)
You may experience high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or stopped taking it.
• You repeatedly take less insulin than needed.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
Warning signs appear gradually. They include: increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).
What to do if your blood sugar level is high:
► If you experience any of these symptoms: check your blood glucose, if possible, check for the presence of ketones in your urine, and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it may lead to diabetic coma and possibly death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the InnoLet label and on the packaging, after EXP. The expiry date refers to the last day of the month.
Always keep the cap on the InnoLet when not in use to protect it from light.
NovoRapid must be protected from excessive heat and light.
Before first use: NovoRapid InnoLet not in use must be stored in a refrigerator at 2°C – 8°C, away from refrigerating elements. Do not freeze.
During use or when carried as a spare: NovoRapid InnoLet in use or carried as a spare must not be stored in the refrigerator. It may be carried at room temperature (below 30°C) for up to 4 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package Contents and Other Information

What NovoRapid Contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution.
• The excipients are: glycerol, phenol, m-cresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections.

Description of the Appearance of NovoRapid and Contents of the Pack
NovoRapid is a solution for injection.
Pack sizes: 1, 5, and 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Now turn the leaflet over for instructions on how to use your InnoLet.

This leaflet was last reviewed on
Other Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Instructions for Using NovoRapid Injectable Solution in InnoLet
Read the following instructions carefully before using your InnoLet. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
InnoLet is a simple, compact pre-filled pen for insulin delivery, delivering doses from 1 to 50 units in 1-unit increments. InnoLet is designed to be used with NovoFine or NovoTwist needles up to 8 mm in length. As a precaution, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Getting Started
Check the name and the coloured label of your InnoLet to make sure it contains the correct type of insulin. This is especially important if you use more than one type of insulin. If you inject the wrong type of insulin, your blood sugar level may become too high or too low.
Remove the pen cap.

Attaching the Needle

• Always use a new needle for each injection. This reduces the risk of contamination, infection, insulin leakage, blocked needles, and incorrect dosing.
• Be careful not to bend or damage the needle before use.
• Remove the protective seal from a new single-use needle.
• Screw the needle firmly and securely onto the InnoLet (Figure 1 A).
• Remove the outer large needle cap and the inner needle cap. It may be helpful to keep the outer large needle cap in its designated compartment.
• Never try to re-screw the inner needle cap back onto the needle. You may injure yourself with the needle.

Preparing to Remove Air Before Each Injection
Small amounts of air may accumulate in the needle and cartridge during use before each injection.
To avoid injecting air and to ensure the correct insulin dose:

• Select 2 units by turning the dose selector clockwise.
• Hold the InnoLet with the needle pointing upwards and gently tap the insulin cartridge several times with your fingers (Figure 1 B). This will cause air bubbles to rise to the top of the cartridge.
• With the needle pointing upwards, press the injection button fully. The dose selector will return to zero.
• Always make sure a drop of insulin appears at the tip of the needle (Figure 1 B) before injecting. This ensures insulin flow. If no drop appears, change the needle and repeat the procedure, no more than 6 times.

If a drop of insulin still fails to appear after repeated attempts, the device is faulty and must not be used.

• If no drop appears, you will not inject insulin, even if the dose selector moves. This may indicate a blocked or damaged needle.
• Always check your InnoLet before injection. If you do not check it, you may inject too little insulin or none at all, which could lead to high blood sugar levels.

Selecting the Dose

• Always make sure the injection button is fully pressed and the dose selector is set to zero.
• Select the number of units to be injected by turning the dose selector clockwise (Figure 2). Do not use the residual insulin scale to measure the insulin dose.
• You will hear a click for each single unit selected. The dose can be adjusted by turning the selector in either direction. Make sure not to rotate the knob or adjust the dose while the needle is inserted into the skin. This could lead to inaccurate dosing, causing blood sugar levels to become too high or too low.
• Always use the dose scale and dose selector to check how many units you have selected before injecting insulin. Do not count the clicks of the pen. If you select and inject the wrong dose, your blood sugar level may become too high or too low. Do not use the residual scale—it only approximately indicates how much insulin remains in the pen.

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

Injection

• Insert the needle into the skin. Use the injection technique recommended by your doctor.
• Deliver the insulin dose by fully pressing the injection button (Figure 3). You will hear clicks as the dose selector returns to zero.
• After injection, wait at least 6 seconds before removing the needle to ensure complete dose delivery.
• Make sure not to block the dose selector during injection, as it must be free to return to zero when the injection button is pressed. Always ensure that the dose selector returns to zero after injection. If the dose selector stops before reaching zero, the full dose has not been delivered, which may result in high blood sugar levels.
• Dispose of the needle after each injection.

Removing the Needle

• Place the outer large protective cap over the needle and unscrew the needle (Figure 4). Remove the needle with care.
• Replace the pen cap on your InnoLet to protect the insulin from light.

Always use a new needle for each injection. Always remove and dispose of the needle after each injection, and store InnoLet without a needle attached. This reduces the risk of contamination, infection, insulin leakage, blocked needles, and inaccurate dosing.
Important Additional Information
Anyone handling used needles must take great care to reduce the risk of needle-stick injuries and cross-infections.
Dispose of the used InnoLet carefully, making sure the needle has been removed.
Never share the pen or needles with other people. This could lead to cross-infections.
Never share the pen with other people. The medicine may be dangerous to their health.
Always keep InnoLet and needles out of sight and reach of others, especially children.

Caring for the Pen
InnoLet is designed to function accurately and safely. It must be handled with care. If it has been dropped, damaged, or impaired, insulin leakage may occur. This could lead to incorrect dosing, resulting in blood sugar levels that are too high or too low.
You may clean the outside of your InnoLet with an alcohol swab. Do not immerse, wash, or lubricate the pen, as this may damage the mechanism and cause incorrect dosing, leading to blood sugar levels that are too high or too low.
Do not refill InnoLet. Once empty, it must be discarded.

Patient Information Leaflet: Information for the User

NovoRapid FlexTouch 100 Units/ml solution for injection in a pre-filled pen

insulin aspart
Please read this leaflet carefully before you start using this medicine because it contains
important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What NovoRapid is and what it is used for
2. What you need to know before using NovoRapid
3. How to use NovoRapid
4. Possible side effects
5. How to store NovoRapid
6. Contents of the pack and other information

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (insulin analogue) with a rapid onset of action. Modern insulins are improved versions of human insulin.
NovoRapid is used to lower high blood sugar levels in adults, adolescents, and children from the age of 1 year onwards who have diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. Treatment with NovoRapid helps prevent complications of diabetes.
NovoRapid begins to lower blood sugar levels 10–20 minutes after injection, reaches its maximum effect within 3 hours after injection, and its effect lasts for 3–5 hours. Because of this short duration of action, NovoRapid is usually taken in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using NovoRapid

Do not use NovoRapid
► If you are allergic to insulin aspart or to any of the other excipients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience warning signs of hypoglycaemia, i.e. low blood sugar levels (see a) Summary of serious and very common adverse reactions in section 4).
► If the FlexTouch pen is leaking, damaged, or cracked.
► If it has not been stored correctly or has been frozen (see section 5, How to store NovoRapid).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid if any of these situations apply. Speak to your doctor, nurse, or pharmacist for advice.

Before using NovoRapid
► Check the label to make sure you are using the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and the FlexTouch pen must not be shared with others.
► The NovoRapid FlexTouch pen is intended only for subcutaneous injections. Speak to your doctor if you need to administer insulin by another method.

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney, liver, adrenal, pituitary, or thyroid gland disorders.
► If you increase your physical activity or change your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad; travelling across different time zones may alter your insulin requirements and injection times.

Skin changes at the injection site
Rotate your injection site to help prevent changes in the fatty tissue under the skin, such as skin thickening, skin thinning, or the appearance of lumps under the skin.
Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening of the skin (see section 3, How to use NovoRapid). Inform your doctor if you notice any skin changes at the injection site. If you currently inject into one of these affected areas, consult your doctor before switching to a different injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or other antidiabetic 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 of age.

Other medicines and NovoRapid
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that may affect insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) 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 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 (hyperglycaemia) 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), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and significantly affecting the body's metabolic processes)
• Danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).
If you are taking any of the medicines listed above, inform your doctor, nurse, or pharmacist.

Drinking alcohol and using NovoRapid
► If you drink alcohol, your insulin requirements may change, as blood sugar levels may rise or fall. Careful monitoring is recommended.

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. NovoRapid may be used during pregnancy.
Your insulin requirements may need adjustment during pregnancy and after delivery. It is important to carefully control diabetes, particularly to prevent episodes of hypoglycaemia, for the health of both mother and baby.
► There are no restrictions on the use of NovoRapid during breastfeeding.
Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
► Consult your doctor about whether it is safe for you to drive or operate machinery:

• if you experience frequent episodes of hypoglycaemia
• if you have difficulty recognizing the warning signs of hypoglycaemia.

If your blood glucose is high or low, your ability to concentrate and react may be impaired, and consequently your ability to drive or operate machinery may also be affected. Be aware that you could be putting yourself or others at risk.
NovoRapid acts rapidly; therefore, if hypoglycaemia occurs, it may appear earlier after injection compared to soluble human insulin.

Important information about some of the excipients in NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, i.e. NovoRapid is essentially “sodium-free”.

3. How to use NovoRapid

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and follow his or her instructions carefully. If you
are not sure, consult your doctor, nurse, or pharmacist.
NovoRapid is generally taken immediately before meals. Eat a meal or snack within 10 minutes of
injection to avoid low blood sugar. If necessary, NovoRapid may be administered immediately after a
meal. See How and where to inject for information.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be required by your doctor.
Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and older instead of soluble human
insulin when a rapid onset of action is preferred. For example, when it is difficult to match insulin dosing
to meals.
No clinical studies with NovoRapid have been conducted in children below 1 year of age. Therefore, use
NovoRapid in children below this age only if your doctor has specifically instructed you to do so.
Use in specific patient groups
If you have renal or hepatic impairment, or if you are over 65 years of age, monitor your blood sugar
regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
NovoRapid is administered by subcutaneous injection (under the skin). Never inject insulin directly into
a vein (intravenous route) or into muscle (intramuscular route). NovoRapid FlexTouch is intended for
subcutaneous use only. Speak with your doctor if you need to administer insulin by another route.
With each injection, rotate the injection site within the particular area of skin you usually use. This may
reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The best
areas for injection are: the abdominal area, the front of the arm, or the front of the thigh. Insulin will act
more rapidly if injected into the abdomen.
Check your blood glucose levels regularly.
How to use NovoRapid FlexTouch
NovoRapid FlexTouch is a pre-filled, disposable pen coded by a colour, containing insulin aspart.
Read carefully the instructions on how to use NovoRapid FlexTouch provided in this package leaflet.
You must use the pen exactly as described in the instructions for use of NovoRapid FlexTouch.
Always make sure you are using the correct pen before injecting insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia).
See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia).
See c) Effects of diabetes in section 4.
If you stop using your insulin
Do not stop using insulin without first discussing it with your doctor, who will advise you on what to do.
Stopping may lead to high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See c) Effects
of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
a) Summary of serious and very common side effects
Low blood sugar level (hypoglycaemia) is a very common side effect. It may occur in 1 out of 10 people.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You are more physically active than usual.
• You drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Warning signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat sugar lumps or another high-sugar snack (sweets, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar lumps or high-sugar snacks with you, to use if needed.
► Once symptoms of hypoglycaemia have disappeared or blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, lose consciousness, require a glucagon injection, or have frequent episodes of low blood sugar, speak with your doctor. You may need an adjustment in your insulin dose, timing of insulin injections, food intake, or physical activity.
Inform people close to you that you have diabetes and what the consequences may be, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and seek immediate medical help. It is important that no food or drink is given, as this could cause choking.
Severe allergic reaction to NovoRapid or one of its excipients (called systemic allergic reaction) is a very rare side effect that may be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

• if signs of allergy spread to other parts of the body
• if you suddenly feel unwell, and: begin to sweat; feel sick (vomiting); have difficulty breathing; have a rapid heartbeat; feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening of the skin. Change your injection site with each injection to prevent these skin changes.
b) List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Vision disturbances: at the beginning of insulin treatment, vision disturbances may occur, but these are generally temporary.
Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is a temporary condition that soon resolves. If not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): if you have diabetic retinopathy and your blood sugar improves very rapidly, the retinopathy may worsen. Consult your doctor.
Rare side effects
May affect fewer than 1 in 1,000 people.
Peripheral neuropathy (nerve pain due to nerve damage): a rapid improvement in blood sugar levels may cause nerve pain. This is called peripheral neuropathy and resolves spontaneously.
Reporting of side effects
If you experience any of the side effects, tell your doctor, nurse, or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
c) Other effects of diabetes
High blood sugar level (hyperglycaemia)
You may experience high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than needed.
• You have an infection or fever.
• You eat more than usual.
• You are less physically active than usual.

Warning signs of high blood sugar:
Warning signs appear gradually. They include: increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar, if possible, check for the presence of ketones in your urine, and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it may lead to diabetic coma and possibly death.

5. How to store NovoRapid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the FlexTouch label and packaging, after EXP. The expiry date refers to the last day of the month.
Always keep the cap on the FlexTouch when not in use to protect it from light.
NovoRapid must be protected from excessive heat and light.
Before opening: Unused NovoRapid FlexTouch must be stored in a refrigerator at 2°C - 8°C, away from refrigerating elements. Do not freeze.
During use or when carried as a spare: You may carry NovoRapid FlexTouch with you and keep it at a temperature below 30°C or in the refrigerator (2°C - 8°C) for up to 4 weeks. If stored in the refrigerator, keep it away from refrigerating elements. Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What NovoRapid Contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution.
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections.

Description of the Appearance of NovoRapid and Contents of the Pack
NovoRapid is a clear, colourless injectable solution.
Pack sizes: 1 (with or without needles), 5 (without needles), or a multipack of 2 x 5 (without needles) 3 ml pre-filled pens. Not all pack sizes may be marketed.
The solution is clear and colourless.
Marketing Authorisation Holder and Manufacturer:
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Now turn the leaflet over for instructions on how to use your FlexTouch.
This leaflet was last approved in
Additional Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Instructions for Using NovoRapid 100 units/ml Solution for Injection in Pre-filled Pen (FlexTouch)
Read the following instructions carefully before using your pre-filled pen. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
Do not use the pen without first receiving adequate training from your doctor or nurse.

Start by checking the pen to make sure it contains NovoRapid 100 units/ml, then refer to the illustrations below to become familiar with the different parts of the pen and the needle.
If you are blind or have severe vision problems and cannot read the dose counter on the pen, do not use this pen without assistance. Ask someone with good eyesight who has been trained to use the FlexTouch pre-filled pen to help you.

NovoRapid FlexTouch is a pre-filled pen containing 300 units of insulin, allowing you to select doses from 1 to 80 units in 1-unit increments. NovoRapid FlexTouch is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.

Preparing the NovoRapid FlexTouch Pen
Check the name and the coloured label to ensure your NovoRapid FlexTouch contains the correct type of insulin. This is especially important if you use more than one type of insulin. Administering the wrong type of insulin may cause your blood sugar level to become too high or too low.

A Remove the pen cap.

B Check that the insulin in the pen is clear and colourless.
Look through the insulin window. Do not use the pen if the insulin appears cloudy.

C Take a new disposable needle and remove the protective seal.

D Screw the needle straight onto the pen. Make sure the needle is firmly attached.

E Remove the outer needle cap and keep it.
You will need it after injection to safely remove the needle from the pen. Remove the inner needle cap and discard it. Do not attempt to reinsert it, as you may accidentally prick yourself with the needle.
A drop of insulin may appear at the tip of the needle. This is normal.

Always use a new needle for each injection. This reduces the risk of contamination, insulin leakage, needle blockage, and incorrect dosing.
Never use a bent or damaged needle.

Checking Insulin Flow
Before each injection, always check the insulin flow to ensure you deliver the correct dose.

Tap the pen gently with your finger several times so that any air bubbles rise to the top.

H Press the injection button with your thumb until the dose counter returns to zero. The "0" must align with the dose indicator. A drop of insulin should appear at the needle tip.
If this does not happen, repeat steps F to H up to six times. If no drop appears after these attempts, replace the needle and repeat steps F to H once more.
Do not use the pen if no drop of insulin appears.

Always ensure a drop appears at the needle tip before injecting. This confirms proper insulin flow. If no drop appears, do not inject insulin, even if the dose counter moves. This may indicate a blocked or damaged needle.

Always check the insulin flow before injection. If you do not check the flow, you may fail to inject any insulin or inject an insufficient amount, which could lead to high blood sugar levels.

Selecting the Dose
Use the dose selector on the NovoRapid FlexTouch pen to select your dose. You can select up to 80 units per injection.
Select the dose you need. You may turn the dose selector forward or backward. Stop when the correct number of units aligns with the dose indicator.
The dose selector makes different clicking sounds when turned forward, backward, or when exceeding the remaining insulin units.
When less than 80 units remain in the pen, the dose counter will display the exact number of units left.

Before injecting insulin, always use the dose counter and dose indicator to verify the selected dose.
Do not count the clicks of the pen to determine your dose. Selecting or injecting the wrong dose may cause your blood sugar level to become too high or too low.
Do not rely on the insulin scale, which only approximately indicates how much insulin remains in the pen.

How much insulin is left?
The insulin scale shows approximately how much insulin remains in the pen.

To see exactly how much insulin remains in the pen, use the dose counter:
Turn the dose selector until the dose counter stops. If it shows 80, there are at least 80 units remaining. If it shows less than 80, the number displayed is the exact number of units left in the pen.
Turn the dose selector back until the dose counter shows 0.
If you need more insulin units than remain in the pen, you may split your dose between two pens.

Be very careful when calculating the correct amount if splitting the dose.
If you are unsure, inject the full dose using a new pen. Incorrectly splitting the dose may result in too low or too high an insulin dose, leading to high or low blood sugar levels.

Injecting the Dose
Use the correct injection technique to ensure you deliver the full dose.
After the dose counter returns to zero, keep the needle under the skin for at least 6 seconds to ensure the complete dose is delivered.

K Remove the needle from the skin.
After this, you may see a drop of insulin at the needle tip. This is normal and does not affect the administered dose.

Always discard the needle after each injection. This reduces the risk of contamination, infection, insulin leakage, needle blockage, and incorrect dosing. If the needle is blocked, you will not be able to inject insulin.

L Place the needle tip into the outer needle cap placed on a flat surface. Do not touch the needle or cap.
Once covered, press the outer cap firmly and then unscrew the needle. Dispose of the needle carefully and replace the cap after each use.
When the pen is empty, discard it without the attached needle, as instructed by your doctor, nurse, or local health authority.

Always check the dose counter to know how many units you are injecting.
The dose counter shows the exact number of units. Do not count the pen clicks. Keep pressing the injection button until the dose counter returns to zero after injection. If the dose counter stops before reaching zero, the full dose has not been delivered, which may result in high blood sugar levels.

Never try to replace the inner needle cap. You may accidentally prick yourself with the needle.

Always remove the needle after each injection and store the pen without a needle attached.
This reduces the risk of contamination, infection, insulin leakage, needle blockage, and incorrect dosing.

Caring for Your Pen
Handle the pen with care. Incorrect or improper use may lead to incorrect dosing, resulting in blood sugar levels that are too high or too low.

• Do not leave the pen in a car or in other places where it could become too hot or too cold.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent on a damp cloth.
• Do not drop the pen or subject it to hard impacts. If the pen is dropped or you suspect damage, always attach a new needle and check the insulin flow before injection.
• Do not attempt to refill the pen. When empty, it must be discarded.
• Do not attempt to repair or disassemble your pen.

Important Information

• Always carry your pen with you.
• Always carry a spare pen and new needles in case your pen or needles are lost or damaged.
• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen and needles with other people. This may lead to cross-infection.
• Never share the pen with other people. The medicine may be harmful to their health.
• Exercise extreme caution when handling used needles to reduce the risk of needlestick injuries and cross-infections.

Package leaflet: Information for the user

NovoRapid PumpCart 100 units/ml solution for injection in cartridge

Insulin aspart
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What NovoRapid PumpCart is and what it is used for
2. What you need to know before using NovoRapid PumpCart
3. How to use NovoRapid PumpCart
4. Possible side effects
5. How to store NovoRapid PumpCart
6. Contents of the pack and other information

1. What NovoRapid PumpCart is and what it is used for

NovoRapid is a modern insulin (an insulin analogue) 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 from the age of 1 year onwards 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 prevent the complications of diabetes.
NovoRapid PumpCart is used with an insulin pump and covers the total daily insulin requirement: both the insulin needed throughout the day (basal) and that needed at mealtimes (bolus).
Before using NovoRapid PumpCart, you must have received proper instructions from your doctor or nurse.
Basal insulin requirement (throughout the day): when using NovoRapid PumpCart with an insulin pump, insulin is continuously delivered to meet basal insulin requirements.
If you change the basal insulin setting, the effects will begin within 10–20 minutes. If you interrupt the insulin pump’s action, the effect of insulin will last for 3 to 5 hours. Before setting or adjusting the basal insulin dose, carefully read the insulin pump instruction manual (user guide).
Bolus insulin requirement (meals): NovoRapid will begin to lower blood sugar levels within 10–20 minutes after starting the bolus administration (see section 3, How to use NovoRapid PumpCart, for further information on how to adjust the bolus insulin dose).
Maximum effect occurs within 3 hours after bolus administration and lasts for 3–5 hours.

2. What you need to know before using NovoRapid PumpCart

Do not use NovoRapid PumpCart
► If you are allergic to insulin aspart or to any of the other excipients in this medicine
(see section 6, Contents of the pack and other information).
► If you experience warning signs of hypoglycaemia, i.e. low blood sugar levels
(see a) Summary of serious and very common adverse effects in section 4).
► If the cartridge or the device containing the cartridge is leaking, damaged or cracked.
► If it has not been stored correctly or has been frozen (see section 5, How to store NovoRapid PumpCart).
► If the insulin does not appear clear and colourless.
Do not use NovoRapid PumpCart if any of these situations apply. Speak with your doctor, nurse or
pharmacist for advice.

Before using NovoRapid PumpCart
► Check the label to make sure it is the correct type of insulin.
► Always inspect the cartridge, including the rubber plunger at the base of the cartridge. Do not use it
if you notice any leakage or damage, or if the plunger is beyond the white band at the base of the cartridge.
This could lead to insulin loss. If you suspect the cartridge is damaged, return it to your supplier.
► The infusion set (tubing and needles) and NovoRapid PumpCart must not be shared with others.
► NovoRapid PumpCart is intended only for subcutaneous injection (under the skin) using a microinfusion pump. Speak with your doctor if you need to administer insulin by another method.

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney, liver or adrenal, pituitary or thyroid gland disorders.
► If you have increased physical activity or changes in your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad; travelling across different time zones may alter your insulin requirements and injection schedule.

Skin changes at the injection site
Rotate the injection site to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as effectively if injected into an area with lumps, thinning or thickening of the skin (see section 3, How to use NovoRapid). Inform your doctor if you notice skin changes at the injection site. If you are currently injecting into one of these affected areas, consult your doctor before starting to inject in another area. Your doctor may advise you to monitor your blood glucose more closely and adjust your insulin dose or other antidiabetic medicines.

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 PumpCart
Inform your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that may affect insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) 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 (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)
• Sulphonamides (used to treat infections)

Your blood sugar level may increase (hyperglycaemia) 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), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and that significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain or localized swelling (oedema).
If you are taking any of the medicines listed above, inform your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoRapid
► If you consume alcohol, your insulin requirements may change, as blood sugar levels may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. NovoRapid may be used during pregnancy. Insulin requirements may need adjustment during pregnancy and after delivery. It is important to carefully control diabetes, especially to prevent episodes of hypoglycaemia, for the health of both mother and baby.
► There are no restrictions on the use of NovoRapid during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
► Consult your doctor about whether it is safe for you to drive or operate machinery:

• if you experience frequent episodes of hypoglycaemia
• if you have difficulty recognizing the warning signs of hypoglycaemia

If your blood glucose is high or low, your ability to concentrate and react may be impaired, which could affect your ability to drive or operate machinery. Be aware that you may be putting yourself or others at risk.

Important information about some of the excipients in NovoRapid
NovoRapid contains less than 1 mmol of sodium (23 mg) per dose, i.e. NovoRapid is essentially “sodium-free”.

3. How to use NovoRapid PumpCart

Dose and when to take insulin
Always use insulin and adjust your basal insulin dose (throughout the day) and bolus dose (for meals) as directed by your doctor. If you are unsure, consult your doctor, nurse, or pharmacist. Your bolus insulin requirement (for meals) should be adjusted based on measured blood glucose levels and the amount of food consumed. Eat or take a snack within 10 minutes after administering a bolus dose to avoid low blood sugar. If necessary, the bolus dose may be given immediately after a meal.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or brand of insulin you are using, a dose adjustment may be required, as determined by your doctor.

Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and older.

Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years of age, monitor your blood sugar regularly and discuss insulin dose adjustments with your doctor.

How and where to inject
NovoRapid PumpCart is intended only for subcutaneous (under the skin) administration using a microinfusion pump. Never inject insulin directly into a vein (intravenous) or into muscle (intramuscular). Speak with your doctor if you are considering alternative methods of insulin administration.
Before using NovoRapid PumpCart with a microinfusion pump, you must have received proper training on pump use and information on actions to take in case of illness, high or low blood sugar levels, or pump malfunction. Always follow your doctor’s instructions and recommendations when using NovoRapid PumpCart with a microinfusion pump.
The usual site for insulin administration is the abdominal area. Alternatively, and if recommended by your doctor, you may use the thigh or upper arm. When changing the infusion set (tubing and needle), always rotate the injection site. This may reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). Change the infusion set according to the instructions provided in the guide included with the infusion set.

When using a microinfusion pump
It is advisable to regularly monitor your blood glucose levels to ensure optimal insulin delivery and to confirm that the microinfusion pump is functioning properly. If you notice any problems, contact your doctor.
► NovoRapid PumpCart must only be used with a microinfusion pump specifically designed for use with this cartridge, such as the Accu-Chek Insight and YpsoPump pumps.
► NovoRapid PumpCart is a pre-filled cartridge ready for direct use in the microinfusion pump. Follow the pump’s user manual (user guide).
► To ensure accurate dosing, NovoRapid PumpCart must never be used in an insulin pen.
► When used in a microinfusion pump, NovoRapid must never be mixed with other medications, including other insulin products.
► Do not refill the cartridge. Once empty, it must be discarded.
► Always carry a spare NovoRapid PumpCart with you.
Read carefully the instructions on how to use NovoRapid PumpCart provided in this package leaflet.

What to do in case of pump malfunction
If the microinfusion pump fails, ensure you have an alternative method available for subcutaneous insulin administration (e.g., an insulin injection pen).

If you take more insulin than you should
Taking too much insulin can cause your blood sugar to drop too low (hypoglycemia). See a) Summary of serious and very common side effects in section 4.

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

If you stop treatment with your insulin
Do not stop insulin treatment without first discussing it with your doctor, who will advise you on what steps to take. Stopping insulin may lead to high blood sugar levels (severe hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
a) Summary of serious and very common side effects
Low blood sugar level (hypoglycaemia) is a very common side effect. It may occur in 1 out of 10 people.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and using NovoRapid in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (temporary or permanent) and even death. You may regain consciousness more quickly with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat sugar cubes or another sugary snack (candy, biscuits, fruit juice) and adjust the amount of insulin injected or stop the insulin pump. Check your blood sugar if possible, then rest. Always carry sugar cubes or sugary snacks with you to use in emergencies.
► When symptoms of hypoglycaemia have disappeared or when blood glucose has stabilized, continue your insulin treatment.
► If you have a low blood sugar level, you may lose consciousness. If you have required a glucagon injection, or if you have frequent episodes of low blood sugar, speak to your doctor. You may need an adjustment in your insulin dose, timing of insulin administration, food intake, or physical activity.
Inform people close to you that you have diabetes and what the consequences may be, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and seek immediate medical help. It is important not to give you food or drink, as this could cause choking.
Severe allergic reaction to NovoRapid or one of its excipients (called systemic allergic reaction) is a very rare side effect that may be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

• if signs of allergy spread to other parts of the body
• if you suddenly feel unwell and: begin to sweat; feel sick (vomiting); have difficulty breathing; have a rapid heartbeat; feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening of the skin. Change your injection site with each injection to prevent these skin changes.
b) List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Vision disturbances: Vision disturbances may occur at the beginning of insulin therapy, but these are usually temporary.
Swollen joints: At the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is a temporary condition that usually resolves quickly. If it does not, contact your doctor.
Diabetic retinopathy (a diabetes-related eye disorder that may lead to vision loss): If you have diabetic retinopathy and your blood glucose improves very rapidly, your retinopathy may worsen. Speak to your doctor.
Rare side effects
May affect fewer than 1 in 1,000 people.
Peripheral neuropathy (nerve pain due to nerve damage): a rapid improvement in blood sugar levels may cause nerve pain. This is called peripheral neuropathy and resolves spontaneously.
Reporting of side effects
If you experience any of the side effects, inform your doctor, nurse, or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
c) Other effects of diabetes
High blood sugar level (hyperglycaemia)
You may experience high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than needed.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
Warning signs appear gradually and include: increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood glucose, and if possible, check for the presence of ketones in your urine, and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, this may lead to diabetic coma and possibly death.

5. How to store NovoRapid PumpCart

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging,
after 'EXP'. The expiry date refers to the last day of the month.
Always keep the cartridge in its packaging when not in use to protect it from light.
NovoRapid PumpCart must be protected from excessive heat and light during storage and use.
Before opening: Unused NovoRapid PumpCart must be stored in the refrigerator at 2°C - 8°C, away from refrigerating elements. Do not freeze.
During use or carried as spare: NovoRapid PumpCart in use must not be stored in the refrigerator. NovoRapid PumpCart carried as a spare may be kept for up to 2 weeks below 30°C. Thereafter, it may be used for 7 days below 37°C with a microinfusion pump designed for use with this cartridge, such as the Accu-Chek Insight and YpsoPump microinfusion pumps. Keep NovoRapid PumpCart in its packaging until use to protect it from damage. During use, always protect the cartridge from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NovoRapid PumpCart contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 ml of injectable solution.
• The excipients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections.

Description of the appearance of NovoRapid PumpCart and contents of the pack
NovoRapid PumpCart is a clear, colourless injectable solution.
Packs of 5 cartridges and multiple packs containing 25 (5 packs of 5) cartridges of 1.6 ml.
Not all pack sizes may be marketed.
The solution is clear and colourless.
Marketing Authorisation Holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Proceed to the information contained in the 'Instructions for use of the NovoRapid PumpCart
pre-filled cartridge'.
This leaflet was last revised on
Further information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Instructions for use of the NovoRapid PumpCart pre-filled cartridge
NovoRapid PumpCart must only be used with an insulin pump designed for use with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with other devices not specifically designed for NovoRapid PumpCart, as this may lead to incorrect insulin dosing and result in hyper- or hypoglycaemia.
Read the following instructions carefully before using NovoRapid PumpCart.
Also read the instruction manual (user guide) provided with the insulin pump.

• NovoRapid PumpCart is ready for direct use with the insulin pump.
• NovoRapid PumpCart contains 1.6 ml of insulin aspart solution, equivalent to 160 units.
• This medicine must never be mixed with other insulin medicines.
• Do not re-fill NovoRapid PumpCart. When empty, it must be discarded.
• Make sure you always have NovoRapid PumpCart available as a spare supply.
• To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.
• NovoRapid PumpCart must be protected from excessive heat and light during storage and use.
• NovoRapid PumpCart must be kept out of sight and reach of others, especially children.

1. Before inserting the NovoRapid PumpCart cartridge into the insulin pump
   • Bring NovoRapid PumpCart to room temperature.
   • Remove NovoRapid PumpCart from its packaging.
   • Check the label to make sure it is NovoRapid PumpCart.
   • Check the expiry date on the label and outer packaging.
   • Always check that NovoRapid PumpCart appears as it should (Figure A). Do not use it if you notice any damage or leakage, or if the plunger has moved, making the lower edge of the plunger visible beyond the white band. This may cause insulin leakage. In Figure A, the lower edge of the plunger is hidden behind the white band, as it should be. If you suspect that NovoRapid PumpCart is damaged, return it to your supplier.

• Check that the insulin in NovoRapid PumpCart is clear and colourless. Do not use NovoRapid PumpCart if the insulin appears cloudy. The cartridge may contain a small amount of air in the form of tiny bubbles.

2. Inserting a new NovoRapid PumpCart cartridge into the infusion pump

• Follow the instructions in the infusion pump user manual provided with the infusion pump to insert a new NovoRapid PumpCart cartridge into the infusion pump.
• Insert a NovoRapid PumpCart into the cartridge holder of the infusion pump. The plunger should be inserted first.
• Connect the infusion set to the NovoRapid PumpCart by reattaching the adapter to the infusion pump.
• Follow the instructions in the infusion pump user manual to continue using the infusion pump.

3. Removing an empty NovoRapid PumpCart cartridge from the infusion pump

• Follow the instructions in the infusion pump’s user manual to remove an empty NovoRapid PumpCart cartridge from the infusion pump.
• Remove the empty NovoRapid PumpCart cartridge from the infusion set adapter.
• Dispose of the empty NovoRapid PumpCart cartridge and the used infusion set according to the instructions provided by your doctor or nurse.
• Follow the steps described in paragraphs 1 and 2 for preparing and inserting a new NovoRapid PumpCart cartridge into the infusion pump.