insulin aspart: package leaflet

For patients

Package leaflet, verbatim

Fiasp

Package leaflet: Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen / insulin aspart

1. What Fiasp is and what it is used for

Fiasp is a mealtime insulin with a fast-acting blood sugar lowering effect. Fiasp is a solution for injection containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes is a disease where your body does not produce enough insulin to control the level of blood sugar. Treatment with Fiasp helps to prevent complications from your diabetes.
Fiasp should be injected up to 2 minutes before the start of the meal, with an option to inject up to 20 minutes after starting the meal.
This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.
This medicine should normally be used in combination with intermediate-acting or long-acting insulin preparations.

2. What you need to know before you use Fiasp

Do not use Fiasp
- if you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fiasp. Be especially aware of the following:
- Low blood sugar (hypoglycaemia) - If your blood sugar is too low, follow the guidance for low blood sugar in section 4 ‘Possible side effects’. Fiasp starts to lower blood sugar faster compared to other mealtime insulins. If hypoglycaemia occurs, you may experience it earlier after an injection with Fiasp.
- High blood sugar (hyperglycaemia) - If your blood sugar is too high, follow the guidance for high blood sugar in section 4 ‘Possible side effects’.
- Switching from other insulin medicinal products - Your doctor may need to advise you on your insulin dose.
- If your insulin treatment is being combined with pioglitazone (oral antidiabetic medicine used to treat type 2 diabetes) - Tell your doctor as soon as possible if you get signs of heart failure such

as unusual shortness of breath or rapid increase in weight or localised swelling caused by fluid retention (oedema).
- Eye disorder - Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder such as diabetic retinopathy.
- Pain due to nerve damage - If your blood sugar level improves very fast, you may get nerve related pain, this is usually temporary.
- Swelling around your joints - When you first start using your medicine, your body may keep more water than it should. This causes swelling around your ankles and other joints. This is usually only short-lasting.
- Ensuring you use the right type of insulin – always check the insulin label before each injection to avoid accidental mix-ups between insulin products.
- Insulin treatment can cause the body to produce antibodies to insulin (substance that act against insulin). However, only very rarely, this will require a change to your insulin dose.

If you have poor eyesight, please see section 3 ‘How to use Fiasp’.

Some conditions and activities can affect how much insulin you need. Talk to your doctor:
- if you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
- if you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
- if you are ill, carry on taking your insulin and talk to your doctor.
- If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections.

When using Fiasp it is strongly recommended that the name and batch number of each package is recorded in order to maintain a record of the batches used.

Skin changes at the injection site
The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3 ‘How to use Fiasp’). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents
This medicine is not recommended for use in children below the age of 1 year.

Other medicines and Fiasp
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:
- other medicines for diabetes (oral and injectable)
- sulphonamide antibiotics, (used to treat infections)
- anabolic steroids (such as testosterone)
- beta-blockers (used to treat high blood pressure or angina)
- salicylates (used to relieve pain and lower fever)
- monoamine oxidase inhibitors (MAOI) (used to treat depression)
- angiotensin converting enzyme (ACE) inhibitors (for some heart problems or high blood pressure)

Your blood sugar level may rise (hyperglycaemia) if you take:
- danazol (medicine acting on ovulation)

oral contraceptives (birth control pills)
thyroid hormones (for thyroid problems)
growth hormone (for growth hormone deficiency)
glucocorticoids (such as ‘cortisone’ for inflammation)
sympathomimetics (such as epinephrine (adrenaline), salbutamol or terbutaline for asthma)
thiazides (for high blood pressure or if your body is keeping too much water (water retention))

Octreotide and lanreotide - used to treat a rare condition involving too much growth hormone (acromegaly). They may increase or decrease your blood sugar level.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist.

Fiasp with alcohol
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine can be used during pregnancy; however your insulin dose may need to be changed during pregnancy and after delivery. The amount of insulin you need usually falls during the first 3 months of pregnancy and increases for the remaining 6 months. Careful control of your diabetes is needed in pregnancy. Avoiding low blood sugar (hypoglycaemia) is particularly important for the health of your baby. After you have had your baby your insulin requirements will likely return to how much you needed before your pregnancy.

There are no restrictions on treatment with Fiasp during breast-feeding.

Driving and using machines
Having low blood sugar can affect your ability to drive or use any tools or machines. If your blood sugar is low, your ability to concentrate or react might be affected. This could be dangerous to yourself or others. Ask your doctor whether you can drive if:
- you often get low blood sugar
- you find it hard to recognise low blood sugar.

Important information about some of the ingredients of Fiasp
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3. How to use Fiasp

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.

The pre-filled pen can provide a dose of 1–80 units in one injection in steps of 1 unit.

When to use Fiasp
Fiasp is a mealtime insulin.

Adults: Fiasp should be injected right before (0-2 minutes) the start of the meal, with an option to inject up to 20 minutes after starting the meal.

Children: Fiasp should be injected right before (0-2 minutes) the start of the meal, with the possibility to inject up to 20 minutes after starting the meal in situations, when there is uncertainty about how the child will eat. Ask your doctor for advice on these situations.

This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.

Fiasp dose
Dose for type 1 and type 2 diabetes
Your doctor will decide together with you:
- how much Fiasp you will need at each meal
- when to check your blood sugar level and if you need a higher or lower dose.

If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.

When using other medicines, ask your doctor if your treatment needs to be adjusted.

Dose adjustment for type 2 diabetes
The daily dose should be based on your blood sugar level at mealtimes and bedtime from the previous day.
- Before breakfast - dose should be adjusted according to the blood sugar level before lunch the previous day.
- Before lunch - dose should be adjusted according to the blood sugar level before dinner the previous day.
- Before dinner - dose should be adjusted according to the bedtime blood sugar level the previous day.

Table 1 Dose adjustment
Mealtime or bedtime blood sugar
Dose adjustment

mmol/L mg/dL less than 4 less than 71
Reduce dose by 1 unit
4–6
71–108
No dose adjustment more than 6 more than 108
Increase dose by 1 unit

Use in elderly patients (65 years or older)
This medicine can be used in elderly patients. Talk to your doctor about changes in your dose.

If you have kidney or liver problems
If you have kidney or liver problems you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.

Injecting Fiasp
This medicine is only suitable for injection under the skin (subcutaneous injection).
Before you use Fiasp for the first time, your doctor or nurse will show you how to use the pre-filled pen. Speak to your doctor if you need to inject your insulin by another method.

Where to inject
- The best places to inject are the front of your waist (abdomen) or upper arms.
- Do not inject into a vein or muscle.
- Change the place within the area where you inject each day to reduce the risk of developing changes under the skin (see section 4).

Do not use Fiasp
- if the pen is damaged or if it has not been stored correctly (see section 5 ‘How to store Fiasp’).
- if the insulin does not appear clear (e.g., cloudy) and colourless.

Detailed instructions on how to use your FlexTouch pen are provided on the other side of this leaflet.

If you use more Fiasp than you should
If you use too much insulin your blood sugar may get too low (hypoglycaemia), see advice in section 4 under ‘Low blood sugar’.

If you forget to use Fiasp
If you forget to use your insulin your blood sugar may get too high (hyperglycaemia). See section 4 under ‘High blood sugar’.

Three simple steps that may help to avoid low or high blood sugar are:
- Always keep a spare pen in case you lose your pen or it gets damaged.
- Always carry something to show you have diabetes.
- Always carry products containing sugar with you. See section 4 under ‘What to do if you get low blood sugar’.

If you stop using Fiasp
Do not stop using your insulin without talking to your doctor. If you stop using your insulin this could lead to a very high blood sugar level (severe hyperglycaemia) and ketoacidosis (a condition with too much acid in the blood which is potentially life-threatening). See symptoms and advice in section 4 under ‘High blood sugar’.

4. Possible side effects

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

Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions immediately to increase your blood sugar level. See advice in ‘Low blood sugar’ below.

If you have a serious allergic reaction (including an anaphylactic shock) to insulin or any of the ingredients in Fiasp (how often this occurs is not known), stop using this medicine and contact emergency medical service straight away.

Signs of a serious allergic reaction may include:
- local reactions (e.g., rash, redness and itching) spread to other parts of your body
- you suddenly feel unwell with sweating
- you start being sick (vomiting)
- you experience difficulty in breathing
- you experience rapid heartbeat or feeling dizzy.

Allergic reactions such as generalised skin rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. See a doctor if the symptoms worsen or you see no improvement in a few weeks.

Skin changes at the injection site: If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (these are uncommon and may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.

Other side effects include:

Common (may affect up to 1 in 10 people)
Reaction at administration site: Local reactions at the place you inject yourself may occur. The signs may include: rash, redness, inflammation, bruising, irritation, pain and itching. The reactions usually disappear after a few days.
Skin reactions: Signs of allergy on the skin such as eczema, rash, itching, hives and dermatitis may occur.

General effects from insulin treatment including Fiasp

- Low blood sugar (hypoglycaemia) (very common)
Low blood sugar may happen if you:
Drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.

Warning signs of low blood sugar – these may come on suddenly:
Headache; slurred speech; fast heartbeat; cold sweat; cool pale skin, feeling sick; feeling very hungry;
tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused;
difficulty in concentrating; short-lasting changes in your sight.

What to do if you get low blood sugar
- If you are conscious, treat your low blood sugar immediately with 15–20 g of fast-acting carbohydrate: eat glucose tablets or another high sugar snack, like fruit juice, sweets or biscuits (always carry glucose tablets or a high sugar snack, just in case).
- It is recommended that you retest your blood glucose levels after 15–20 minutes and re-treat if your blood glucose levels are still less than 4 mmol/L.
- Wait until the signs of low blood sugar have gone or when your blood sugar level has settled.
Then carry on with your insulin treatment as usual.

What others need to do if you pass out
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.

Let them know that if you pass out, they must:
- turn you on your side to avoid choking
- get medical help straight away
- not give you any food or drink because you may choke.

You may recover more quickly from passing out with an injection of glucagon. This can only be given by someone who knows how to use it.
- If you are given glucagon you will need sugar or a sugary snack as soon as you come round.
- If you do not respond to a glucagon injection, you will have to be treated in a hospital.

If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long-lasting. It may even cause death.

Talk to your doctor if:
- your blood sugar got so low that you passed out
- you have been given an injection of glucagon
- you have had too low blood sugar a few times recently.
This is because the dosing or timing of your insulin injections, food or exercise may need to be changed.

- High blood sugar (hyperglycaemia)
High blood sugar may happen if you:
Eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin.

Warning signs of high blood sugar – these normally appear gradually:

Flushed skin; dry skin; feeling sleepy or tired; dry mouth; fruity (acetone) breath; urinating more often; feeling thirsty; losing your appetite; feeling or being sick (nausea or vomiting).
These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.

What to do if you get high blood sugar
- Test your blood sugar level.
- Give a correction dose of insulin if you have been taught how to do this.
- Test your urine for ketones.
- If you have ketones, seek medical help straight away.

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

5. How to store Fiasp

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP’. The expiry date refers to the last day of that month.

Before first use
Store in a refrigerator (2°C–8°C). Do not freeze. Keep away from the freezing element. Keep the cap on the pen in order to protect from light.

After first opening or if carried as a spare
You can carry your pre-filled pen (FlexTouch) with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C–8°C) for up to 4 weeks. Always keep the cap on the pen when you are not using it in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fiasp contains
- The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each pre–filled pen contains 300 units of insulin aspart in 3 mL solution.
- The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 under ‘Important information about some of the ingredients of Fiasp’) and water for injections.

What Fiasp looks like and contents of the pack
Fiasp is presented as a clear, colourless and aqueous solution for injection in pre-filled pen.

Pack sizes of 1, 5 or a multipack with 2 x 5 pre-filled pens of 3 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S,
Novo Allé,

DK-2880 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

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

Instructions on how to use Fiasp FlexTouch

Please read these instructions carefully before using your FlexTouch pre-filled pen. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to high or low blood sugar level.

Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Fiasp 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.

Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. You can select a maximum of 80 units per dose, in steps of 1 unit. Your pen is designed to be used with single-use, disposable injection needles of a length between 4 mm and 8 mm and a gauge between 30G and 32G.
Needles are not included in the pack.

Important information
Pay special attention to these notes as they are important for correct use of the pen.

Fiasp pre-filled pen and needle (example)
(FlexTouch)
Outer needle cap
Pen cap
Needle
Paper tab
Insulin scale
Insulin window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
Inner needle cap
FlexTouch
Dose button with two lines

1 Prepare your pen with a new needle

Check the name and strength on the label of your pen, to make sure that it contains Fiasp 100 units/mL. This is especially important if you take more than one type of insulin. If you take a wrong type of insulin, your blood sugar level may get too high or too low.

Pull off the pen cap.

Check that the insulin in your pen is clear and colourless.

Look through the insulin window. If the insulin looks cloudy, do not use the pen.

Take a new needle and tear off the paper tab.

Make sure to attach the needle correctly.

Push the needle straight onto the pen.
Turn until it is on tight.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any insulin.

Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.

Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally prick or injure yourself with the needle.

A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.

Do not attach a new needle to your pen until you are ready for your injection.

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

Never use a bent or damaged needle.

2 Check the insulin flow

Always check the insulin flow before you start.

This helps you to ensure that you get your full insulin dose.

Turn the dose selector to select 2 units. Make sure the dose counter shows 2.

A
2 units selected

Hold the pen with the needle pointing up.

Tap the top of the pen gently a few times to let any air bubbles rise to the top.

Press and hold in the dose button until the dose counter returns to 0.

The 0 must line up with the dose pointer.

A drop of insulin should appear at the needle tip.

A small air bubble may remain at the needle tip, but it will not be injected.

If no drop appears, repeat steps 2A to 2C up to 6 times. If there is still no drop, change the needle and repeat steps 2A to 2C once more.

If a drop of insulin still does not appear, dispose of the pen and use a new one.

Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin is flowing properly.

If no drop appears, no insulin will be injected, even though the dose counter may move. This may indicate a blocked or damaged needle.

Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to high blood sugar level.

3 Select your dose

Make sure the dose counter shows 0 before you start.

The 0 must line up with the dose pointer.

Turn the dose selector to select the dose you need, as directed by your doctor or nurse.

If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose.

The pen can dial up to a maximum of 80 units.

A
Examples
24 units selected
5 units selected

The dose selector changes the number of units. Only the dose counter and dose pointer will show how many units you select per dose.

You can select up to 80 units per dose. When your pen contains less than 80 units, the dose counter stops at the number of units left.

Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.
Do not count the pen clicks to set the dose. If you select and inject the wrong dose, your blood sugar level may get too high or too low.

Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.
The dose selector clicks differently when turned forwards, backwards or past the number of units left.

4 Inject your dose

Insert the needle into your skin as your doctor or nurse has shown you.

Make sure you can see the dose counter.

Do not touch the dose counter with your fingers. This could interrupt the injection.

Press and hold down the dose button. Watch as the dose counter returns to 0. The 0 must line up with the dose pointer. You may then hear or feel a click.

Continue pressing the dose button while keeping the needle in your skin.

Count slowly to 6 while keeping the dose button pressed.

If the needle is removed earlier, you may see a stream of insulin coming from the needle tip. If so, the full dose will not be delivered, and you should increase the frequency of checking your blood sugar level.

C
Count slowly:

Remove the needle from your skin. You can then release the dose button

If blood appears at the injection site, press lightly on the skin for a few minutes to stop the bleeding. Do not rub the area.

You may see a drop of insulin at the needle tip after injecting. This is normal and does not affect your dose.

Always watch the dose counter to know how many units you inject. Hold the dose button down until the dose counter shows 0. If the dose counter does not return to 0, the full dose has not been delivered, which may lead to high blood sugar level.

How to identify a blocked or damaged needle?
- If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case - you have not received any medicine - even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle?
Remove the needle as described in section 5 and repeat all steps starting with section 1: Prepare your pen with a new needle. Make sure you select the full dose you need.

Never touch the dose counter when you inject.
This can interrupt the injection.

5 After your injection

Always dispose of the needle after each injection
This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked, you will not inject any insulin.

Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap.

Once the needle is covered, carefully push the outer needle cap completely on.

Unscrew the needle and dispose of it as instructed by your doctor, nurse, pharmacist or local authorities.

Put the pen cap on your pen after each use to protect the insulin from light.

When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may prick or injure yourself with the needle.

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

6 How much insulin is left?

The insulin scale shows you approximately how much insulin is left in your pen.

A
Approx.
how much insulin is left

To see precisely how much insulin is left, use the dose counter:

Turn the dose selector until the dose counter stops.

If it shows 80, at least 80 units are left in your pen.

If it shows less than 80, the number shown is the number of units left in your pen.

B
Dose counter stopped:
16 units left
Example

Turn the dose selector back until the dose counter shows 0.

If you need more insulin than the units left in your pen, you can split your dose between two pens.

Be very careful to calculate correctly if splitting your dose.
If in doubt, take the full dose with a new pen. If you split the dose wrong, you will inject too little or too much insulin, which can lead to high or low blood sugar levels.

Further important information

Always keep your pen with you.

Always carry an extra pen and new needles with you, in case of loss or damage.

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

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to them.

Caregivers must be very careful when handling used needles – to reduce the risk of needle injury and cross-infection.

Caring for your pen

Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to high or low blood sugar levels.

Do not leave the pen in a car or other place where it can get too hot or too cold.

Do not expose your pen to dust, dirt or liquid.

Do not wash, soak or lubricate your pen. If necessary, clean it with mild detergent on a moistened cloth.

- Do not drop your pen or knock it against hard surfaces.
If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.

Do not try to refill your pen. Once empty, it must be disposed of.

Do not try to repair your pen or pull it apart.

Package leaflet: Fiasp 100 units/mL Penfill solution for injection in cartridge / insulin aspart

1. What Fiasp is and what it is used for

2. What you need to know before you use Fiasp

Do not use Fiasp
- if you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fiasp. Be especially aware of the following:
- Low blood sugar (hypoglycaemia) - If your blood sugar is too low, follow the guidance for low blood sugar in section 4 ‘Possible side effects’. Fiasp starts to lower blood sugar faster compared to other mealtime insulins. If hypoglycaemia occurs, you may experience it earlier after an injection with Fiasp.
- High blood sugar (hyperglycaemia) - If your blood sugar is too high, follow the guidance for high blood sugar in section 4 ‘Possible side effects’.
- Switching from other insulin medicinal products – Your doctor may need to advise you on your insulin dose
- If your insulin treatment is being combined with pioglitazone (oral antidiabetic medicine used to treat type 2 diabetes) - Tell your doctor as soon as possible if you get signs of heart failure such

If you have poor eyesight, please see section 3 ‘How to use Fiasp’.

When using Fiasp it is strongly recommended that the name and batch number of each package is recorded in order to maintain a record of the batches used.

Children and adolescents
This medicine is not recommended for use in children below the age of 1 year.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:
- other medicines for diabetes (oral and injectable)
- sulphonamides antibiotics (used to treat infections)
- anabolic steroids (such as testosterone)
- beta-blockers (used to treat high blood pressure or angina)
- salicylates (used to relieve pain and lower fever)
- monoamine oxidase inhibitors (MAOI) (used to treat depression)
- angiotensin converting enzyme (ACE) inhibitors (for some heart problems or high blood pressure)

Your blood sugar level may rise (hyperglycaemia) if you take:
- danazol (medicine acting on ovulation)

oral contraceptives (birth control pills)
thyroid hormones (for thyroid problems)
growth hormone (for growth hormone deficiency)
glucocorticoids (such as ‘cortisone’ - for inflammation)
sympathomimetics (such as epinephrine (adrenaline), salbutamol or terbutaline - for asthma)
thiazides (for high blood pressure or if your body is keeping too much water (water retention)).

Octreotide and lanreotide - used to treat a rare condition involving too much growth hormone (acromegaly). They may increase or decrease your blood sugar level.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist.

Fiasp with alcohol
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

There are no restrictions on treatment with Fiasp during breast-feeding.

Important information about some of the ingredients of Fiasp
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3. How to use Fiasp

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this insulin medicinal product without any help. Get help from a person with good eyesight who is trained to use the pen.

When to use Fiasp
Fiasp is a mealtime insulin.

Adults: Fiasp should be injected right before (0-2 minutes) the start of the meal, with an option to inject up to 20 minutes after starting the meal.
Children: Fiasp should be injected right before (0-2 minutes) the start of the meal, with the possibility to inject up to 20 minutes after starting the meal in situations, when there is uncertainty about how the child will eat. Ask your doctor for advice on these situations.

This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.

If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.

When using other medicines, ask your doctor if your treatment needs to be adjusted.

Table 1 Dose adjustment
Mealtime or bedtime blood sugar
Dose adjustment

mmol/L mg/dL less than 4 less than 71
Reduce dose by 1 unit
4–6
71–108
No dose adjustment more than 6 more than 108
Increase dose by 1 unit

Use in elderly patients (65 years or older)
This medicine can be used in elderly patients. Talk to your doctor about changes in your dose.

If you have kidney or liver problems
If you have kidney or liver problems you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.

Injecting Fiasp
This medicine is only suitable for injection under the skin (subcutaneous injection) from a Novo Nordisk reusable insulin pen.
Before you use Fiasp for the first time, your doctor or nurse will show you how to use it. Speak to your doctor if you need to inject your insulin by another method.

Do not use Fiasp
- if the cartridge or the reusable pen you are using is damaged. Take it back to your supplier. See your reusable pen manual for further instructions.
- if the cartridge has not been stored correctly (see section 5 ‘How to store Fiasp’).
- if the insulin does not appear clear (e.g., cloudy) and colourless.

How to inject Fiasp

Read the manual that comes with your reusable pen.
Check the name and strength on the label of the cartridge (Penfill) to make sure it is Fiasp.
Always use a new needle for each injection to prevent contamination.
Needles must not be shared.

If you use more Fiasp than you should
If you use too much insulin your blood sugar may get too low (hypoglycaemia), see advice in section 4 under ‘Low blood sugar’.

If you forget to use Fiasp
If you forget to use your insulin your blood sugar may get too high (hyperglycaemia). See section 4 under ‘High blood sugar’.

Three simple steps that may to help avoid low or high blood sugar are:
- Always keep spare cartridges of Fiasp.
- Always carry something to show you have diabetes.
- Always carry products containing sugar with you. See section 4 under ‘What to do if you get low blood sugar’.

4. Possible side effects

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

Other side effects include:

General effects from insulin treatment including Fiasp

- Low blood sugar (hypoglycaemia) (very common)
Low blood sugar may happen if you:
Drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.

Warning signs of low blood sugar – these may come on suddenly:
Headache; slurred speech; fast heartbeat; cold sweat; cool pale skin; feeling sick; feeling very hungry;
tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused;
difficulty in concentrating; short-lasting changes in your sight.

What others need to do if you pass out
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.

Let them know that if you pass out, they must:
- turn you on your side to avoid choking
- get medical help straight away
- not give you any food or drink because you may choke.

If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long-lasting. It may even cause death.

- High blood sugar (hyperglycaemia)
High blood sugar may happen if you:

Eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin.

Warning signs of high blood sugar – these normally appear gradually:
Flushed skin; dry skin; feeling sleepy or tired; dry mouth; fruity (acetone) breath; urinating more often; feeling thirsty; losing your appetite;feeling or being sick (nausea or vomiting).
These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.

5. How to store Fiasp

Before first use
Store in a refrigerator (2°C-8°C). Do not freeze. Keep away from the freezing element. Keep the cartridge in the carton in order to protect from light.

After first opening or if carried as a spare
Do not refrigerate. You can carry your cartridge (Penfill) with you and keep it at room temperature (not above 30°C) for up to 4 weeks. Always keep the cartridge in the carton in order to protect from light.

Throw away the needle after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fiasp contains
- The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 mL solution.
- The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 under ‘Important information about some of the ingredients of Fiasp’) and water for injections.

What Fiasp looks like and contents of the pack
Fiasp is presented as a clear, colourless and aqueous solution for injection in cartridge.

Pack sizes of 5 and 10 cartridges of 3 mL. Not all pack sizes may be marketed.

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

This leaflet was last revised in

Other sources of information

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

Package leaflet: Fiasp 100 units/mL solution for injection in vial / insulin aspart

1. Check the name and strength on the label of the vial to make sure it is Fiasp.

2. Remove the protective cap from the vial.

3. Always use a new needle and syringe for each injection to prevent contamination. Needles and

syringes must not be shared.

4. Draw into the syringe the same amount of air as the dose of insulin you are going to inject.

Inject the air into the vial.

5. Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull

the needle out of the vial. Push the air out of the syringe and check that the dose is correct.

6. Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse.

Throw away the needle after each injection.

For use in an infusion pump system
Follow the instructions and recommendations from your doctor regarding the use of Fiasp in a pump.
Before using Fiasp in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, high or low blood sugar or failure of the pump system. If you use Fiasp from a vial in an infusion pump system it can be used for a maximum of 6 days.

Filling the pump
- Fiasp should never be diluted or mixed with any other insulin.
- Before inserting the needle, use soap and water to clean your hands and the skin where the needle is inserted to avoid any infection at the infusion site.
- When you fill a new reservoir, do not leave large air bubbles in either the syringe or the tubing.
- Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

To get the benefit of insulin infusion and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.

What to do if the pump system fails
You should always have an alternative delivery method for your insulin available for injection under the skin (for example, a pen injector or syringes) in case the pump system fails.

If you use more Fiasp than you should
If you use too much insulin your blood sugar may get too low (hypoglycaemia), see advice in section 4 under ‘Low blood sugar’.

If you forget to use Fiasp
If you forget to use your insulin your blood sugar may get too high (hyperglycaemia). See section 4 under ‘High blood sugar’.

Three simple steps that may help to avoid low or high blood sugar are:
- Always keep spare syringes and a spare vial of Fiasp.
- Always carry something to show you have diabetes.
- Always carry products containing sugar with you. See section 4 under ‘What to do if you get low blood sugar’.

4.
Possible side effects

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

Other side effects include:

General effects from insulin treatment including Fiasp

- Low blood sugar (hypoglycaemia) (very common)
Low blood sugar may happen if you:
Drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.

What to do if you get low blood sugar
- If you are conscious, treat your low blood sugar immediately with 15–20 g of fast-acting carbohydrate: eat glucose tablets or another high sugar snack, like fruit juice, sweets or biscuits (always carry glucose tablets or a high sugar snack, just in case).
- It is recommended that you retest your blood glucose levels after 15–20 minutes and re–treat if your blood glucose levels are still less than 4 mmol/L.
- Wait until the signs of low blood sugar have gone or when your blood sugar level has settled.
Then carry on with your insulin treatment as usual.

What others need to do if you pass out
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.

Let them know that if you pass out, they must:
- turn you on your side to avoid choking
- get medical help straight away
- not give you any food or drink because you may choke.

If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long-lasting. It may even cause death.

- High blood sugar (hyperglycaemia) High blood sugar may happen if you:
Eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin.

Warning signs of high blood sugar – these normally appear gradually:
Flushed skin; dry skin; feeling sleepy or tired; dry mouth; fruity (acetone) breath; urinating more often; feeling thirsty; losing your appetite; feeling or being sick (nausea or vomiting).
These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.

5.
How to store Fiasp

Before first use
Store in a refrigerator (2°C-8°C). Do not freeze. Keep away from the freezing element. Keep the vial in the carton in order to protect from light.

After first opening or if carried as a spare
You can carry your vial with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C-8°C) for up to 4 weeks (including time in a pump reservoir). Always keep the vial in the carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What Fiasp contains
- The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 mL solution.
- The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 under ‘Important information about some of the ingredients of Fiasp’) and water for injections.

What Fiasp looks like and contents of the pack
Fiasp is presented as a clear, colourless and aqueous solution for injection in a vial.
Each vial contains 10 mL solution.

Pack sizes of 1, 5 or a multipack with 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 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

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

Package leaflet: Fiasp 100 units/mL PumpCart solution for injection in cartridge / insulin aspart

1. What Fiasp is and what it is used for

Fiasp is an insulin with a fast-acting blood sugar lowering effect. Fiasp is a solution for injection containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes is a disease where your body does not produce enough insulin to control the level of blood sugar. Treatment with Fiasp helps to prevent complications from your diabetes.

About PumpCart
The PumpCart cartridge is used in an insulin pump designed to be used with this cartridge:
- It covers your total daily insulin needs – both your all-day (basal) and mealtime (bolus) insulin needs.
- Before you use a PumpCart cartridge in the pump, your doctor or nurse must have given you detailed instructions.

All-day (basal) insulin needs:
When you use Fiasp in a pump, your insulin will be constantly delivered into your body.
- This covers your need for insulin throughout the day.
- Before you set or change the all-day (basal) rate, carefully read the pump manual (user guide).
- If you stop the pump, be aware that the insulin effect will gradually decline over 3 to 5 hours

Mealtime (bolus) insulin needs:
- Take your mealtime insulin up to 2 minutes before the start of the meal, with an option to administer up to 20 minutes after starting the meal (see section 3, How to use Fiasp).
- The maximum effect happens between 1 and 3 hours after the mealtime delivery.
- The effect lasts for 3 to 5 hours.

2. What you need to know before you use Fiasp

Do not use Fiasp®
- if you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fiasp. Be especially aware of the following:
- Low blood sugar (hypoglycaemia) – If your blood sugar is too low, follow the guidance for low blood sugar in section 4 ‘Possible side effects’. Fiasp starts to lower blood sugar faster compared to other fast-acting insulins. If hypoglycaemia occurs, you may experience it earlier after an administration with Fiasp.
- High blood sugar (hyperglycaemia) – If your blood sugar is too high, follow the guidance for high blood sugar in section 4 ‘Possible side effects’.
- Switching from other insulin medicinal products – Your doctor may need to advise you on your insulin dose
- If your insulin treatment is being combined with pioglitazone (oral antidiabetic medicine used to treat type 2 diabetes) - Tell your doctor as soon as possible if you get signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling caused by fluid retention (oedema).
- Eye disorder – Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder such as diabetic retinopathy.
- Pain due to nerve damage – If your blood sugar level improves very fast, you may get nerve related pain, this is usually temporary.
- Swelling around your joints – When you first start using your medicine, your body may keep more water than it should. This causes swelling around your ankles and other joints. This is usually only short-lasting.
- Ensuring you use the right type of insulin – always check the insulin label before each injection to avoid accidental mix-ups between insulin products.
- Insulin treatment can cause the body to produce antibodies to insulin (substance that act against insulin). However, only very rarely, this will require a change to your insulin dose.

If you have poor eyesight, please see section 3 ‘How to use Fiasp’.

When using Fiasp it is strongly recommended that the name and batch number of each package is recorded in order to maintain a record of the batches used.

Fiasp PumpCart is only for use with the following insulin infusion pump systems: the Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with other pumps, as this may give you a wrong dose of your insulin and can lead to high or low blood sugar.

Children and adolescents
This medicine is not recommended for use in children below the age of 1 year.

Other medicines and Fiasp

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level – this may mean your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:
- other medicines for diabetes (oral and injectable)
- sulphonamides antibiotics (used to treat infections)
- anabolic steroids (such as testosterone)
- beta-blockers (used to treat high blood pressure or angina)
- salicylates (used to relieve pain and lower fever
- monoamine oxidase inhibitors (MAOI) (used to treat depression)
- angiotensin converting enzyme (ACE) inhibitors (for some heart problems or high blood pressure)

Your blood sugar level may rise (hyperglycaemia) if you take:
- danazol (medicine acting on ovulation)
- oral contraceptives (birth control pills)
- thyroid hormones (for thyroid problems)
- growth hormone (for growth hormone deficiency)
- glucocorticoids (such as ‘cortisone’ – for inflammation)
- sympathomimetics (such as epinephrine (adrenaline), salbutamol or terbutaline – for asthma)
- thiazides (for high blood pressure or if your body is keeping too much water (water retention)).

Octreotide and lanreotide – used to treat a rare condition involving too much growth hormone (acromegaly). They may increase or decrease your blood sugar level.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist.

Fiasp with alcohol
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

There are no restrictions on treatment with Fiasp during breast-feeding.

Important information about some of the ingredients of Fiasp
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3. How to use Fiasp

If you are blind or have poor eyesight and cannot read the screen of the pump, do not use this pump without help. Get help from a person with good eyesight who is trained to use the pump.

Dose and when to use Fiasp
Always use your insulin and adjust your all-day (basal) and mealtime (bolus) doses exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
- Adjust your mealtime (bolus) insulin based on your blood sugar measurement and food intake.

Adults
Fiasp mealtime doses should be taken right before (0-2 minutes) the start of the meal, with an option to take up to 20 minutes after starting the meal.

Children
Fiasp mealtime doses should be taken right before (0-2 minutes) the start of the meal, with the possibility to take up to 20 minutes after starting the meal in situations, when there is uncertainty about how the child will eat. Ask your doctor for advice on these situations.

If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.

When using other medicines, ask your doctor if your treatment needs to be adjusted.

Use in elderly patients (65 years or older)
This medicine can be used in elderly patients. Talk to your doctor about changes in your dose.

If you have kidney or liver problems
If you have kidney or liver problems you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.

Injecting Fiasp
This medicine is only suitable for injection under the skin (subcutaneous). Only use a pump that is designed to be used with this cartridge.
- Before you use the PumpCart cartridge in the pump, your doctor or nurse must have given you detailed instructions.
- Speak to your doctor if you need to inject your insulin by another method.

Where to inject
- Normally you will inject your insulin in the front of your waist (abdomen). However, if your doctor recommends it, you may use your upper arm.
- Do not inject into a vein or muscle.
- When you change the infusion set (tubing and needle), be sure to change where you insert the needle. This may reduce the risk of developing changes under the skin (see section 4 ‘Possible side effects’).

Do not use Fiasp
- if the cartridge or the device containing the cartridge you are using is dropped, damaged or crushed. Take it back to your supplier.
- if the cartridge has not been stored correctly (see section 5 ‘How to store Fiasp’).
- if the insulin does not appear clear (e.g., cloudy) and colourless.

Detailed instructions on how to use your PumpCart are provided on the other side of this leaflet.

How to inject Fiasp
- Read and follow the pump manual (user guide) that comes with your insulin pump.
- Make sure to use an infusion set (tubing and needle) suitable for your insulin pump.

Check the name and strength on the label of the cartridge (PumpCart) to make sure it is Fiasp.
Infusion set (tubing and needle) and the PumpCart cartridge must not be shared.
Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

If you use more Fiasp than you should
If you use too much insulin your blood sugar may get too low (hypoglycaemia), see advice in section 4 under ‘Low blood sugar’.

If you forget to use Fiasp
If you forget to use your insulin your blood sugar may get too high (hyperglycaemia). See section 4 under ‘High blood sugar’.

Three simple steps that may help to avoid low or high blood sugar are:
- Always keep spare cartridges of Fiasp.
- Always carry something to show you have diabetes.
- Always carry products containing sugar with you. See section 4 under ‘What to do if you get low blood sugar’.

4. Possible side effects

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

Signs of a serious allergic reaction may include:
- local reactions (e.g., rash, redness and itching) spread to other parts of your body
- you suddenly feel unwell with sweating
- you start being sick (vomiting)
- you experience difficulty breathing
- you experience rapid heartbeat or feel dizzy.

Skin changes at the injection site: If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (these are uncommon and may affect up to 1 in 100

people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.

Other side effects include:

General effects from insulin treatment including Fiasp

- Low blood sugar (hypoglycaemia) (very common)
Low blood sugar may happen if you:
Drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.

What to do if you get low blood sugar
- If you are conscious, treat your low blood sugar immediately with 15–20 g of fast-acting carbohydrate: eat glucose tablets or another high sugar snack, like fruit juice, sweets or biscuits (always carry glucose tablets or a high sugar snack, just in case) and adjust insulin delivery or stop your pump.
- It is recommended that you retest your blood glucose levels after 15–20 minutes and re-treat if your blood glucose levels are still less than 4 mmol/L.
- Wait until the signs of low blood sugar have gone or when your blood sugar level has settled.
Then carry on with your insulin treatment as usual.

What others need to do if you pass out
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.

Let them know that if you pass out, they must:
- turn you on your side to avoid choking
- get medical help straight away
- not give you any food or drink because you may choke.

If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long-lasting. It may even cause death.

Talk to your doctor if:
- your blood sugar got so low that you passed out
- you have been given an injection of glucagon
- you have had too low blood sugar a few times recently.

This is because the dosing or timing of your insulin injections, food or exercise may need to be changed.

Warning signs of high blood sugar – these normally appear gradually:
Flushed skin; dry skin; feeling sleepy or tired; dry mouth; fruity (acetone) breath; urinating more often; feeling thirsty; losing your appetite; feeling or being sick (nausea or vomiting).
These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.

5. How to store Fiasp

Before first use
Store in a refrigerator (2°C-8°C). Do not freeze. Keep away from the freezing element. Keep the cartridge in the carton in order to protect from light.

After first opening or if carried as a spare
- Do not refrigerate during use.
- You can keep your cartridge (PumpCart) at room temperature (not above 30°C) for up to 2 weeks.
- After that, it can be used for up to 7 days below 37°C in a pump designed to be used with this cartridge.
- Keep the PumpCart cartridge in the outer carton until use to protect it from damage. Always protect the cartridge from light during use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fiasp contains
- The active substance is insulin aspart. 1 mL solution contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 mL solution.

The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 under ‘Important information about some of the ingredients of Fiasp’) and water for injections.

What Fiasp looks like and contents of the pack
Fiasp is presented as a clear, colourless and aqueous solution for injection in cartridge.

Pack sizes of 5 or a multipack with 25 (5 packs of 5) cartridges of 1.6 mL. Not all pack sizes may be marketed.

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

This leaflet was last revised in

Other sources of information

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

Instructions on how to use Fiasp PumpCart pre-filled cartridge.

Only use Fiasp PumpCart with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
- Do not use with other devices not designed for the PumpCart cartridge.
- This is because it may result in incorrect insulin dosing and lead to high blood sugar (hyperglycaemia) or low blood sugar (hypoglycaemia).

Please read these instructions carefully before using your PumpCart cartridge.

Please also read the pump manual (user guide) that comes with your insulin pump.

The PumpCart cartridge is ready for use directly in the pump.

The PumpCart cartridge contains 1.6 mL insulin aspart solution, equivalent to 160 units.

Never mix with any other medicinal products.

Do not refill the PumpCart cartridge. Once empty, it must be disposed.

Always make sure you have a spare PumpCart cartridge available.

Do not use the PumpCart cartridge in an insulin pen, because this may result in incorrect dosing.

Protect the PumpCart cartridge from excessive heat and light during storage and use.

Keep the PumpCart cartridge out of reach of others, especially children.

Plunger
White label band
A

1. Before inserting a PumpCart cartridge into your pump

Bring a PumpCart cartridge to room temperature.

Take the PumpCart cartridge out of its carton and blister package.

Check the label to make sure that it is a Fiasp PumpCart cartridge.

Check the expiry date – which is on the label and the carton.

Always check that the PumpCart cartridge looks the way it should (picture A). Do not use it if any damage or leakage is seen or if the plunger has moved, making the bottom of the plunger visible above the white label band. This could be a result of leakage of insulin. In picture A the bottom of the plunger is hidden behind the white label band as it should be. If you suspect the PumpCart cartridge is damaged, take it back to your supplier.

Check that the insulin in the PumpCart cartridge is clear and colourless. If the insulin looks cloudy, do not use the PumpCart cartridge. The cartridge may contain small bubbles.

2. Inserting a new Fiasp PumpCart cartridge in your pump

Follow the instructions in the pump user manual to insert a new PumpCart cartridge in your pump.

Insert a PumpCart cartridge in the cartridge compartment of the pump. The plunger goes in first.

Connect the infusion set with the PumpCart cartridge by attaching the adapter onto your pump.

Follow the instructions in the pump user manual to continue using your pump.

3. Removing an empty Fiasp PumpCart cartridge from your pump

Follow the instructions in the pump user manual to remove an empty PumpCart cartridge from your pump.

Remove the infusion set adapter from the empty PumpCart cartridge.

Dispose of the empty PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.

Follow the steps described in section 1 and 2 to prepare and insert a new PumpCart cartridge into your pump.

NovoMix

Package leaflet: NovoMix 30 Penfill 100 units/ml suspension for injection in a cartridge

1. What NovoMix 30 is and what it is used for

NovoMix 30 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediate-acting effect, in the ratio 30/70. Modern insulin products are improved versions of human insulin.

NovoMix 30 is used to reduce the high blood sugar level in adults, adolescents and children aged 10 years and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.

NovoMix 30 will start to lower your blood sugar 10–20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 24 hours.

In treatment of type 2 diabetes mellitus, NovoMix 30 may be used in combination with tablets for diabetes and/or with injectable antidiabetic products.

2. What you need to know before you use NovoMix 30

Do not use NovoMix 30

►
If you are allergic to insulin aspart or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
►
In insulin infusion pumps.
►
If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
►
If it has not been stored correctly or if it has been frozen, see section 5, How to store NovoMix 30.
►
If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
►
If after resuspension, clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge.

If any of these apply, do not use NovoMix 30. Talk to your doctor, nurse or pharmacist for advice.
VV-LAB-103275
1.0
.

Before using NovoMix 30

►
Check the label to make sure it is the right type of insulin.
►
Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be the result of an insulin leakage. If you suspect that the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoMix 30 Penfill must not be shared.
►
NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:
►
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
►
If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
►
If you are ill, carry on taking your insulin and consult your doctor.
►
If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoMix 30). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents

NovoMix 30 can be used in adolescents and children aged 10 years and above.
There is limited experience with NovoMix 30 in children aged 6–9 years.
No data are available for NovoMix 30 in children below 6 years of age.

Other medicines and NovoMix 30

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:
- Other medicines for the treatment of diabetes
- Monoamine oxidase inhibitors (MAOI) (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 lower fever)
- Anabolic steroids (such as testosterone)
- Sulfonamides (used to treat infections).

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Your blood sugar level may rise (hyperglycaemia) if you take:
- Oral contraceptives (birth control pills)
- Thiazides (used to treat high blood pressure or excessive fluid retention)
- Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
- Thyroid hormones (used to treat thyroid gland disorders)
- Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)
- Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
- Danazol (medicine acting on ovulation).

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

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoMix 30

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

►
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. There is limited clinical experience with insulin aspart in pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery.
Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
►
There are no restrictions on treatment with NovoMix 30 during breast-feeding.

Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others.

Important information about some of the ingredients in NovoMix 30

NovoMix 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 30 is essentially ‘sodium-free’.
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3. How to use NovoMix 30

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
NovoMix 30 is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, NovoMix 30 can be given soon after a meal.
See How and where to inject, below for information.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

When NovoMix 30 is used in combination with tablets for diabetes and/or with injectable antidiabetic products your dose may have to be adjusted by your doctor.

Use in children and adolescents

NovoMix 30 can be used in adolescents and children aged 10 years and above when premixed insulin is preferred. Limited clinical data exists for children aged 6–9 years. No data are available for NovoMix 30 in children below 6 years of age.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoMix 30 is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly). NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. The insulin will work more quickly if you inject around the waist. You should always measure your blood sugar regularly.

►
Do not refill the cartridge.
►
NovoMix 30 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
►
If you are treated with NovoMix 30 Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
►
Always carry a spare Penfill cartridge in case the one in use is lost or damaged.

Resuspension of NovoMix 30

Always check if there is enough insulin left (at least 12 units) in the cartridge to allow even resuspension. If there is not enough insulin left, use a new one. See your pen manual for further instructions.

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►
Every time you use a new NovoMix 30 Penfill (before you put the cartridge into the insulin delivery system)
- Let the insulin reach room temperature before you use it. This makes it easier to resuspend.
- Roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (level with the ground) (see picture A).
- Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other.
- Repeat the rolling and moving procedures (see pictures A and B) until the liquid does appear uniformly white, cloudy and aqueous. Do not use the cartridge if the resuspended insulin does not look uniformly white, cloudy and aqueous.
- Complete the other stages of injection without delay.
►
For every following injection
- Move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white, cloudy and aqueous. Do not use the cartridge if the resuspended insulin does not look uniformly white, cloudy and aqueous.
- Complete the other stages of injection without delay.

Picture A

How to inject NovoMix 30

►
Inject the insulin under your skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.
►
Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
►
After each injection, be sure to remove and discard the needle and store NovoMix 30 without the needle attached. Otherwise the liquid may leak out, which can cause inaccurate dosing.

If you take more insulin than you should

If you take too much insulin, your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.
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If you stop taking your insulin

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) Effects from diabetes in section 4.

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoMix 30 in section 2).

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness 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 sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:
►
If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
►
When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.
►
If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink because you may choke.

Serious allergic reactions to NovoMix 30 or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life-threatening. It may affect less than 1 in 10,000 people.

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Seek medical advice immediately:
- If signs of allergy spread to other parts of your body.
- If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
►
If you notice any of these signs, seek medical advice immediately.

Skin changes at the injection site: If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally, this soon disappears. If not, contact your doctor.

Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

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

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:
- Have not injected enough insulin.
- Forget to take your insulin or stop taking insulin.
- Repeatedly take less insulin than you need.
- Get an infection and/or a fever.
- Eat more than usual.
- Exercise less than usual.

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Warning signs of high blood sugar:
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.

What to do if you experience high blood sugar:
►
If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
►
These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store NovoMix 30

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the cartridge label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the cartridge in the outer carton when you are not using it, in order to protect it from light. NovoMix 30 must be protected from excessive heat and light.

Before opening: NovoMix 30 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
Before you use NovoMix 30 Penfill, remove it from the refrigerator. It is recommended to resuspend the insulin as instructed every time you use a new NovoMix 30 Penfill. See Resuspension of NovoMix 30 in section 3.

During use or when carried as a spare: NovoMix 30 Penfill that is being used or carried as a spare should not be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What NovoMix 30 contains

The active substance is insulin aspart. NovoMix 30 is a mixture consisting of 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine. 1 ml contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 ml suspension for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.

What NovoMix 30 looks like and contents of the pack

NovoMix 30 is presented as a suspension for injection. The cartridge contains a glass ball to facilitate resuspension. After resuspension, the liquid should appear uniformly white, cloudy and aqueous. Do not use the insulin, if it does not look uniformly white, cloudy and aqueous after resuspension.

Pack sizes of 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

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Marketing Authorisation Holder

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

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

Novo Nordisk Production SAS
45, Avenue d’Orléans
F-28000 Chartres
France

This leaflet was last revised in

Other sources of information

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

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Package leaflet: NovoMix 30 FlexPen 100 units/ml suspension for injection in a pre-filled pen

1. What NovoMix 30 is and what it is used for

NovoMix 30 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediate-acting effect, in the ratio 30/70. Modern insulin products are improved versions of human insulin.

NovoMix 30 will start to lower your blood sugar 10–20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 24 hours.

In treatment of type 2 diabetes mellitus, NovoMix 30 may be used in combination with tablets for diabetes and/or with injectable antidiabetic products.

2. What you need to know before you use NovoMix 30

Do not use NovoMix 30

►
If you are allergic to insulin aspart or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
►
In insulin infusion pumps.
►
If FlexPen is dropped, damaged or crushed.
►
If it has not been stored correctly or if it has been frozen, see section 5, How to store NovoMix 30.
►
If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
►
If after resuspension, clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge.

If any of these apply, do not use NovoMix 30. Talk to your doctor, nurse or pharmacist for advice.

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Before using NovoMix 30

►
Check the label to make sure it is the right type of insulin.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoMix 30 FlexPen must not be shared.
►
NovoMix 30 FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

Children and adolescents

NovoMix 30 can be used in adolescents and children aged 10 years and above.
There is limited experience with NovoMix 30 in children aged 6–9 years.
No data are available for NovoMix 30 in children below 6 years of age.

Other medicines and NovoMix 30

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
Danazol (medicine acting on ovulation).

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoMix 30

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

Important information about some of the ingredients in NovoMix 30

NovoMix 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 30 is essentially ‘sodium-free’.

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3. How to use NovoMix 30

Dose and when to take your insulin

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

When NovoMix 30 is used in combination with tablets for diabetes and/or with injectable antidiabetic products your dose may have to be adjusted by your doctor.

Use in children and adolescents

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoMix 30 is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly). NovoMix 30 FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

How to handle NovoMix 30 FlexPen

NovoMix 30 FlexPen is a pre-filled, colour-coded, disposable pen containing a mixture of rapid-acting and intermediate-acting insulin aspart in the ratio 30/70.

Read carefully the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for use.

Always ensure you use the correct pen before you inject your insulin.

If you take more insulin than you should

If you take too much insulin, your blood sugar gets too low (hypoglycaemia). See a) Summary of serious and very common side effects in section 4.

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If you forget to take your insulin

If you forget to take your insulin, your blood sugar may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoMix 30 in section 2).

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally, this soon disappears. If not, contact your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

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5. How to store NovoMix 30

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the FlexPen label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the pen cap on your FlexPen when you are not using it, in order to protect it from light.
NovoMix 30 must be protected from excessive heat and light.

Before opening: NovoMix 30 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
Before you use NovoMix 30 FlexPen, remove it from the refrigerator. It is recommended to resuspend the insulin as instructed every time you use a new pen. See Instructions for use.

During use or when carried as a spare: NovoMix 30 FlexPen that is being used or carried as a spare should not be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What NovoMix 30 contains

The active substance is insulin aspart. NovoMix 30 is a mixture consisting of 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine. 1 ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml suspension for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.

What NovoMix 30 looks like and contents of the pack

NovoMix 30 is presented as a suspension for injection in a pre-filled pen. The cartridge contains a glass ball to facilitate resuspension. After resuspension, the liquid should appear uniformly white, cloudy and aqueous. Do not use the insulin, if it does not look uniformly white, cloudy and aqueous after resuspension.

Pack sizes 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 suspension is cloudy, white and aqueous.
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Marketing Authorisation Holder

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

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

Novo Nordisk Production SAS
45, Avenue d’Orléans
F-28000 Chartres
France

Now turn over for information on how to use your FlexPen.

This leaflet was last revised in

Other sources of information

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

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Instruction on how to use NovoMix 30 suspension for injection in FlexPen.

Read the following instructions carefully before using your FlexPen. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.

Your FlexPen is a pre-filled dial-a-dose insulin pen.
►
You can select doses from 1 to 60 units in increments of 1 unit.
►
FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm.
►
Always carry a spare insulin delivery device in case your FlexPen is lost or damaged.

Pen cap
NovoMix 30 FlexPen
Glass ball
Cartridge
Pointer
Dose selector
Push- button
Big outer needle cap
Inner needle cap
Needle
Paper tab
12 units
Residual scale
Needle (example)

Caring for your pen

►
Your FlexPen must be handled with care. If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.

►
You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak, wash or lubricate it as it may damage the pen.

►
Do not refill your FlexPen.

Resuspending your insulin

A
Check the name and coloured label of your pen to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you take the wrong type of insulin, your blood sugar level may get too high or too low.

Every time you use a new pen
Let the insulin reach room temperature before you use it. This makes it easier to resuspend.
Pull off the pen cap.

B
Before your first injection with a new FlexPen, you must resuspend the insulin:
Roll the pen between your palms 10 times – it is important that the pen is kept horizontal (level with the ground).

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C
Then move the pen up and down 10 times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.

Repeat rolling and moving the pen until the liquid does appear uniformly white, cloudy and aqueous.

For every following injection
Move the pen up and down between the two positions at least 10 times until the liquid does appear uniformly white, cloudy and aqueous.

►
Always make sure that you have resuspended the insulin prior to each injection. This reduces the risk of too high or too low blood sugar level. After you have resuspended the insulin, complete all the following steps of injection without delay.

Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If there are less than 12 units left, use a new FlexPen. 12 units are marked on the residual scale.
See the big picture on top of this instruction.

Do not use the pen if the resuspended insulin does not look uniformly white, cloudy and aqueous.

Attaching a needle

D
Take a new needle and tear off the paper tab.

Screw the needle straight and tightly onto your FlexPen.

E
Pull off the big outer needle cap and keep it for later.

F
Pull off the inner needle cap and dispose of it.
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Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

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

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

Checking the insulin flow

Prior to each injection, small amounts of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing:

G
Turn the dose selector to select 2 units.

G
2 units selected

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

I
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

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

Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin flows. If no drop appears you will not inject any insulin, even though the dose selector may move. This may indicate a blocked or damaged needle.
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Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.

Selecting your dose

Check that the dose selector is set at 0.

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

The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push- button as insulin will come out.

You cannot select a dose larger than the number of units left in the cartridge.

J
5 units selected
24 units selected

Always use the dose selector and the pointer to see how many units you have selected before injecting the insulin.

Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low. Do not use the residual scale, it only shows approximately how much insulin is left in your pen.

Making the injection

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

K
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting.

Turning the dose selector will not inject insulin.

L
►
Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds. This will make sure you get the full dose.
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►
Withdraw the needle from the skin, then release the pressure on the push-button.

►
Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.

M
Lead the needle into the big outer needle cap without touching it. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.

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

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

Further important information

Caregivers must be very careful when handling used needles to reduce the risk of needle sticks and cross-infection.

Dispose of the used FlexPen carefully without the needle attached.

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

Always keep your pen and needles out of sight and reach of others, especially children.
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Package leaflet: NovoMix 50 Penfill 100 units/ml suspension for injection in a cartridge

1. What NovoMix 50 is and what it is used for

NovoMix 50 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediate-acting effect, in the ratio 50/50. Modern insulin products are improved versions of human insulin.

NovoMix 50 is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).
Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. NovoMix 50 may be used in combination with metformin.

NovoMix 50 will start to lower your blood sugar 10–20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 14–24 hours.

2. What you need to know before you use NovoMix 50

Do not use NovoMix 50

►
If you are allergic to insulin aspart or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
►
In insulin infusion pumps.
►
If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
►
If it has not been stored correctly or if it has been frozen, see section 5, How to store NovoMix 50.
►
If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
►
If after resuspension, clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge.

If any of these apply, do not use NovoMix 50. Talk to your doctor, nurse or pharmacist for advice.

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Before using NovoMix 50

►
Check the label to make sure it is the right type of insulin.
►
Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be the result of an insulin leakage. If you suspect that the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoMix 50 Penfill must not be shared.
►
NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoMix 50). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Other medicines and NovoMix 50

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
Danazol (medicine acting on ovulation).

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoMix 50

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

Important information about some of the ingredients in NovoMix 50

NovoMix 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 50 is essentially ‘sodium-free’.

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3. How to use NovoMix 50

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
NovoMix 50 is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, NovoMix 50 can be given soon after a meal.
See How and where to inject, below for information.

When NovoMix 50 is used in combination with metformin the dose should be adjusted.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

No clinical studies with NovoMix 50 have been carried out in children and adolescents under the age of 18 years.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoMix 50 is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly). NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

►
Do not refill the cartridge.
►
NovoMix 50 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
►
If you are treated with NovoMix 50 Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
►
Always carry a spare Penfill cartridge in case the one in use is lost or damaged.

Resuspension of NovoMix 50

►
Every time you use a new NovoMix 50 Penfill (before you put the cartridge into the insulin delivery system)
- Let the insulin reach room temperature before you use it. This makes it easier to resuspend.
- Roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (level with the ground) (see picture A).
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- Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other.
- Repeat the rolling and moving procedures (see pictures A and B) until the liquid does appear uniformly white, cloudy and aqueous. Do not use the cartridge if the resuspended insulin does not look uniformly white and cloudy.
- Complete the other stages of injection without delay.
►
For every following injection
- Move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white, cloudy and aqueous. Do not use the cartridge if the resuspended insulin does not look uniformly white, cloudy and aqueous.
- If the moving procedure alone is not enough to give a uniformly white, cloudy and aqueous liquid, repeat the rolling and moving procedures described above until the liquid appears uniformly white, cloudy and aqueous.
- Complete the other stages of injection without delay.

Picture A

How to inject NovoMix 50

►
Inject the insulin under your skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.
►
Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
►
After each injection, be sure to remove and discard the needle and store NovoMix 50 without the needle attached. Otherwise the liquid may leak out, which can cause inaccurate dosing.

If you take more insulin than you should

If you take too much insulin, your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

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If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoMix 50 in section 2).

Serious allergic reactions to NovoMix 50 or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life-threatening. It may affect less than 1 in 10,000 people.

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b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally, this soon disappears. If not, contact your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

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5. How to store NovoMix 50

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the cartridge label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the cartridge in the outer carton when you are not using it, in order to protect it from light. NovoMix 50 must be protected from excessive heat and light.

Before opening: NovoMix 50 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
Before you use NovoMix 50 Penfill, remove it from the refrigerator. It is recommended to resuspend the insulin as instructed every time you use a new NovoMix 50 Penfill. See Resuspension of NovoMix 50 in section 3.

During use or when carried as a spare: NovoMix 50 Penfill that is being used or carried as a spare should not be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What NovoMix 50 contains

The active substance is insulin aspart. NovoMix 50 is a mixture consisting of 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine. 1 ml contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 ml suspension for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.

What NovoMix 50 looks like and contents of the pack

NovoMix 50 is presented as a suspension for injection. The cartridge contains a glass ball to facilitate resuspension. After resuspension, the liquid should appear uniformly white, cloudy and aqueous. Do not use the insulin, if it does not look uniformly white, cloudy and aqueous after resuspension.

Pack sizes of 1, 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

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Marketing Authorisation Holder and Manufacturer

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

This leaflet was last revised in

Other sources of information

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

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Package leaflet: NovoMix 50 FlexPen 100 units/ml suspension for injection in a pre-filled pen

1. What NovoMix 50 is and what it is used for

NovoMix 50 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediate-acting effect, in the ratio 50/50. Modern insulin products are improved versions of human insulin.

NovoMix 50 will start to lower your blood sugar 10–20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 14–24 hours.

2. What you need to know before you use NovoMix 50

Do not use NovoMix 50

►
If you are allergic to insulin aspart or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
►
In insulin infusion pumps.
►
If FlexPen is dropped, damaged or crushed.
►
If it has not been stored correctly or if it has been frozen, see section 5, How to store NovoMix 50.
►
If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
►
If after resuspension, clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge.

If any of these apply, do not use NovoMix 50. Talk to your doctor, nurse or pharmacist for advice.

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Before using NovoMix 50

►
Check the label to make sure it is the right type of insulin.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoMix 50 FlexPen must not be shared.
►
NovoMix 50 FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoMix 50). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Other medicines and NovoMix 50

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Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoMix 50

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

Important information about some of the ingredients in NovoMix 50

NovoMix 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 50 is essentially ‘sodium-free’.

3. How to use NovoMix 50

Dose and when to take your insulin

When NovoMix 50 is used in combination with metformin the dose should be adjusted.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

No clinical studies with NovoMix 50 have been carried out in children and adolescents under the age of 18 years.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoMix 50 is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly). NovoMix 50 FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

How to handle NovoMix 50 FlexPen

NovoMix 50 FlexPen is a pre-filled, colour-coded, disposable pen containing a mixture of rapid-acting and intermediate-acting insulin aspart in the ratio 50/50.

Read carefully the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for use.

Always ensure you use the correct pen before you inject your insulin.

If you take more insulin than you should

If you take too much insulin, your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

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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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoMix 50 in section 2).

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b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally, this soon disappears. If not, contact your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

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5. How to store NovoMix 50

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the FlexPen label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the pen cap on your FlexPen when you are not using it, in order to protect it from light.
NovoMix 50 must be protected from excessive heat and light.

Before opening: NovoMix 50 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
Before you use NovoMix 50 FlexPen, remove it from the refrigerator. It is recommended to resuspend the insulin as instructed every time you use a new pen. See Instructions for use.

During use or when carried as a spare: NovoMix 50 FlexPen that is being used or carried as a spare should not be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What NovoMix 50 contains

The active substance is insulin aspart. NovoMix 50 is a mixture consisting of 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine. 1 ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml suspension for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.

What NovoMix 50 looks like and contents of the pack

NovoMix 50 is presented as a suspension for injection in a pre-filled pen. The cartridge contains a glass ball to facilitate resuspension. After resuspension, the liquid should appear uniformly white, cloudy and aqueous. Do not use the insulin, if it does not look uniformly white, cloudy and aqueous after resuspension.

Pack sizes of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

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

Now turn over for information on how to use your FlexPen.

This leaflet was last revised in

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Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
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Instruction on how to use NovoMix 50 suspension for injection in FlexPen.

Pen cap
NovoMix 50 FlexPen
Glass ball
Cartridge
Pointer
Dose selector
Push- button
Big outer needle cap
Inner needle cap
Needle
Paper tab
12 units
Residual scale
Needle (example)

Caring for your pen

►
You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak, wash or lubricate it as it may damage the pen.

►
Do not refill your FlexPen.

Resuspending your insulin

Every time you use a new pen
Let the insulin reach room temperature before you use it. This makes it easier to resuspend.
Pull off the pen cap.

B
Before your first injection with a new FlexPen, you must resuspend the insulin:
Roll the pen between your palms 10 times – it is important that the pen is kept horizontal (level with the ground).

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C
Then move the pen up and down 10 times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.

Repeat rolling and moving the pen until the liquid does appear uniformly white, cloudy and aqueous.

For every following injection
Move the pen up and down between the two positions at least 10 times until the liquid does appear uniformly white, cloudy and aqueous. If the moving procedure alone is not enough to give a uniformly white, cloudy and aqueous liquid, repeat the rolling and moving procedures (see B and C) until the liquid does appear uniformly white, cloudy and aqueous.

Do not use the pen if the resuspended insulin does not look uniformly white, cloudy and aqueous.

Attaching a needle

D
Take a new needle and tear off the paper tab.

Screw the needle straight and tightly onto your FlexPen.

E
Pull off the big outer needle cap and keep it for later.

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F
Pull off the inner needle cap and dispose of it.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

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

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

Checking the insulin flow

Prior to each injection, small amounts of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing:

G
Turn the dose selector to select 2 units.

G
2 units selected

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

I
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

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

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Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.

Selecting your dose

Check that the dose selector is set at 0.

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

You cannot select a dose larger than the number of units left in the cartridge.

J
5 units selected
24 units selected

Always use the dose selector and the pointer to see how many units you have selected before injecting the insulin.

Making the injection

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

K
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting.

Turning the dose selector will not inject insulin.

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L
►
Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds. This will make sure you get the full dose.

►
Withdraw the needle from the skin, then release the pressure on the push-button.

M
Lead the needle into the big outer needle cap without touching it. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.

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

Further important information

Caregivers must be very careful when handling used needles to reduce the risk of needle sticks and cross-infection.

Dispose of the used FlexPen carefully without the needle attached.

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

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

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NovoRapid

Package leaflet: NovoRapid 100 units/ml solution for injection in vial / insulin aspart

1. Just before use, roll the NPH insulin between your hands until the liquid is uniformly white and

cloudy.

2. Draw into the syringe the same amount of air as the dose of the NPH insulin. Inject the air into

the vial containing the NPH insulin and pull out the needle.

3. Draw into the syringe the same amount of air as the dose of NovoRapid. Inject the air into the

vial containing NovoRapid. Turn the vial and syringe upside down and draw up the prescribed dose of NovoRapid. Expel any air from the syringe and check that the dose is correct.

4. Push the needle into the vial of the NPH insulin, turn the vial and syringe upside down and draw

out the dose you have been prescribed. Expel any air from the syringe and check the dose. Inject the mixture immediately.

5. Always mix NovoRapid and the NPH insulin in the same sequence.

How to inject NovoRapid

►
Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse.
►
Keep the needle under your skin for at least 6 seconds to make sure you have injected all the insulin.
►
Discard the needle after each injection.

For use in an infusion pump system

NovoRapid should never be mixed with any other insulin when used in a pump.
Follow the instructions and recommendations from your doctor regarding the use of NovoRapid in a pump. Before use of NovoRapid in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump system.
- Before inserting the needle, use soap and water to clean your hands and the skin where the needle is inserted to avoid any infection at the infusion site.
- When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or the tubing.
- Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.

What to do in case of pump system failure

You should always have an alternative delivery method for your insulin available for injection under the skin in case of pump system failure.

If you take more insulin than you should

If you take too much insulin your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:
►
If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
►
When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
►
If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.

Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 people.

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

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

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:
- Have not injected enough insulin.
- Forget to inject your insulin or stop taking insulin.
- Repeatedly inject less insulin than you need.
- Get an infection and/or a fever.
- Eat more than usual.
- Exercise less than usual.

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 which is stated on the vial label and carton, after ‘EXP’.
The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect it from light.

Before opening: Store in a refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.

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

Discard the needle after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 solution for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What NovoRapid looks like and contents of the pack

NovoRapid is presented as a solution for injection.

Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial. 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 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

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

Package leaflet: NovoRapid Penfill 100 units/ml solution for injection in cartridge / insulin aspart

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent complications from your diabetes.

NovoRapid will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short action NovoRapid should normally be taken in combination with intermediate-acting or long-acting insulin preparations.

2. What you need to know before you use NovoRapid

Do not use NovoRapid

►
If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
►
If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
►
If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid).
►
If the insulin does not appear clear and colourless.

If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice.

Before using NovoRapid

►
Check the label to make sure it is the right type of insulin.
►
Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be a result of leakage of insulin. If you suspect the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoRapid Penfill must not be shared.
►
NovoRapid Penfill is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoRapid). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.

Other medicines and NovoRapid

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may rise (hyperglycaemia) if you take:
- Oral contraceptives (birth control pills)
- Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
Thyroid hormones (used to treat thyroid gland disorders)
Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
Danazol (medicine acting on ovulation).

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoRapid

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

►
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
►
There are no restrictions on treatment with NovoRapid during breast-feeding.

Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others.

NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Important information about some of the ingredients of NovoRapid

NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodium-free’.

3. How to use NovoRapid

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See How and where to inject below for information.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in relation to meals.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject
NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). NovoRapid Penfill is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if injected into the front of your waist. You should always measure your blood sugar regularly.

►
Do not refill the cartridge. Once empty, it must be disposed of.
►
NovoRapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
►
If you are treated with NovoRapid Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
►
Always carry a spare Penfill cartridge in case it is lost or damaged.

How to inject NovoRapid

►
Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.
►
Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
►
Remove and discard the needle after each injection. Always store NovoRapid without the needle attached. Otherwise the liquid may leak out which can cause inaccurate dosing.

If you take more insulin than you should

If you take too much insulin your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:
►
If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
►
When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
►
If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they

must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

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 which is stated on the cartridge label and carton, after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening: NovoRapid Penfill that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.

During use or when carried as a spare: NovoRapid Penfill that is being used or carried as a spare is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 solution for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What NovoRapid looks like and contents of the pack

NovoRapid is presented as a solution for injection.

Pack sizes of 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 Bagsværd, Denmark

Manufacturer

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

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

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

This leaflet was last revised in

Other sources of information

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

Package leaflet: NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen / insulin aspart

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

2. What you need to know before you use NovoRapid

Do not use NovoRapid

►
If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
►
If FlexPen is dropped, damaged or crushed.
►
If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid).
►
If the insulin does not appear clear and colourless.

If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice.

Before using NovoRapid

►
Check the label to make sure it is the right type of insulin.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoRapid FlexPen must not be shared.
►
NovoRapid FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoRapid). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.

Other medicines and NovoRapid

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Listed below are the most common medicines which may affect your insulin treatment.

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
Danazol (medicine acting on ovulation).

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoRapid

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Important information about some of the ingredients of NovoRapid

NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodium-free’.

3. How to use NovoRapid

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See How and where to inject below for information.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). NovoRapid FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if injected into the front of your waist. You should always measure your blood sugar regularly.

How to handle NovoRapid FlexPen

NovoRapid FlexPen is a pre-filled, colour-coded, disposable pen containing insulin aspart.

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

Always ensure you use the correct pen before you inject your insulin.

If you take more insulin than you should

If you take too much insulin your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:
►
If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
►
When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
►
If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
The amount or timing of insulin, food or exercise may need to be adjusted.

►
If you notice any of these signs, seek medical advice immediately.

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

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 which is stated on the FlexPen label and carton, after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening: NovoRapid FlexPen that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.

During use or when carried as a spare: You can carry your NovoRapid FlexPen with you and keep it at a temperature below 30°C or in a refrigerator (2˚C to 8˚C) for up to 4 weeks. If refrigerated, keep away from the cooling element. Do not freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 solution for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What NovoRapid looks like and contents of the pack

NovoRapid is presented as a solution for injection.

Pack sizes 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 Bagsværd, Denmark

Manufacturer

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

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

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

Now turn over for information on how to use your FlexPen.

This leaflet was last revised in

Other sources of information

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

Instructions on how to use NovoRapid solution for injection in FlexPen.

Your FlexPen is a pre-filled dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.

NovoRapid FlexPen
Pen cap
Cartridge
Residual scale
Pointer
Dose selector Push- button
Big outer needle cap
Inner needle cap
Paper tab
Needle
Needle (example)

Caring for your pen
Your FlexPen must be handled with care.
If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.

You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash or lubricate it as it may damage the pen.

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

Preparing your NovoRapid FlexPen

Check the name and coloured label of your pen to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you take the wrong type of insulin, your blood sugar level may get too high or too low.

A
Pull off the pen cap.

B
Remove the paper tab from a new disposable needle.

Screw the needle straight and tightly onto your FlexPen.

C
Pull off the big outer needle cap and keep it for later.

D
Pull off the inner needle cap and dispose of it.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

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

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

Checking the insulin flow

Prior to each injection small amounts of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing:

E
Turn the dose selector to select 2 units.

E
2 units selected

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

G
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

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

Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin flows. If no drop appears, you will not inject any insulin, even though the dose selector may move. This may indicate a blocked or damaged needle.

Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.

Selecting your dose

Check that the dose selector is set at 0.

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

You cannot select a dose larger than the number of units left in the cartridge.

Always use the dose selector and the pointer to see how many units you have selected before injecting the insulin.

Making the injection

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

I
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting.

Turning the dose selector will not inject insulin.

J
Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds.
This will make sure you get the full dose.

Withdraw the needle from the skin, then release the pressure on the push-button.

Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.

K
Lead the needle into the big outer needle cap without touching it. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.

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

Further important information

Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks and cross-infection.

Dispose of your used FlexPen carefully without the needle attached.

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

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

Package leaflet: NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen / insulin aspart

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

2. What you need to know before you use NovoRapid

Do not use NovoRapid

►
If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
►
If InnoLet is dropped, damaged or crushed.
►
If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid).
►
If the insulin does not appear clear and colourless.

If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice.

Before using NovoRapid

►
Check the label to make sure it is the right type of insulin.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoRapid InnoLet must not be shared.
►
NovoRapid InnoLet is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoRapid). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.

Other medicines and NovoRapid

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Listed below are the most common medicines which may affect your insulin treatment.

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
Danazol (medicine acting on ovulation).

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoRapid

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Important information about some of the ingredients of NovoRapid

NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodium- free’.

3. How to use NovoRapid

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). NovoRapid InnoLet is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if injected into the front of your waist. You should always measure your blood sugar regularly.

How to handle NovoRapid InnoLet

NovoRapid InnoLet is a pre-filled disposable pen containing insulin aspart.

Read carefully the instructions on how to use NovoRapid InnoLet included in this package leaflet.
You must use the pen as described in the instructions on how to use NovoRapid Innolet.

Always ensure you use the correct pen before you inject your insulin.

If you take more insulin than you should

If you take too much insulin your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:
►
If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
►
When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
►
If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
The amount or timing of insulin, food or exercise may need to be adjusted.

►
If you notice any of these signs, seek medical advice immediately.

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

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 which is stated on the InnoLet label and carton, after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening: NovoRapid InnoLet that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.

During use or when carried as a spare: NovoRapid InnoLet that is being used or carried as a spare is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 solution for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What NovoRapid looks like and contents of the pack

NovoRapid is presented as a solution for injection.

Pack sizes of 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 Bagsværd, Denmark

Now turn over for information on how to use your InnoLet.

This leaflet was last revised in

Other sources of information

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

Instructions on how to use NovoRapid solution for injection in InnoLet

Read the instructions carefully before using your InnoLet. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.

Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Push-button
Dose selector
Dose scale
Compartment for needles
Residual scale
Insulin cartridge
Disposable needle (example)
Pen cap
Paper tab
Needle
Inner needle cap
Big outer needle cap

Getting started

Check the name and coloured label of your InnoLet to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you take the wrong type of insulin, your blood sugar level may get too high or too low.
Take off the pen cap.

Attaching the needle

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Be careful not to bend or damage the needle before use.
Remove the paper tab from a new disposable needle.
Screw the needle straight and tightly onto your InnoLet (picture 1A).
Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Priming to expel air prior to each injection

Small amounts of air may collect in the needle and cartridge during normal use.

To avoid injection of air and ensure proper dosing:
- Dial 2 units by turning the dose selector clockwise.
- Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture 1B) to make any air bubbles collect at the top of the cartridge.
- Keeping the needle upwards, press the push-button and the dose selector returns to 0.
- Always make sure that a drop appears at the needle tip before injection (picture 1B). This makes sure the insulin flows. If not, change the needle and repeat the procedure no more than 6 times.

If a drop of insulin still does not appear, the device is defective and must not be used.

- If no drop appears, you will not inject any insulin, even though the dose selector may move.
This may indicate a blocked or damaged needle.

Always prime InnoLet before you inject. If you do not prime InnoLet, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.

Setting the dose

Always check that the push-button is fully depressed and the dose selector is set to 0.
Dial the number of units required by turning the dose selector clockwise (picture 2).

You will hear a click for every single unit dialled. The dose can be corrected by turning the dial either way. Make sure not to turn the dial or correct the dose when the needle is inserted in the skin. This may lead to inaccurate dosing that can make your blood sugar level too high or too low.

Always use the dose scale and the dose selector to see how many units you have selected before injecting the insulin. Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low. Do not use the residual scale, it only shows approximately how much insulin is left in your pen.

You cannot set a dose larger than the number of units remaining in the cartridge.

Injecting the insulin

Insert the needle into your skin. Use the injection technique advised by your doctor.
Deliver the dose by pressing the push-button fully down (picture 3). You will hear clicks as the dose selector returns to 0.
After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the full dose has been delivered.
Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to 0 when you press the push-button. Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
Discard the needle after each injection.

Removing the needle

Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully.
Put the pen cap back on your InnoLet to protect the insulin from light.

Always use a new needle for each injection. Always remove and discard the needle after each injection and store your InnoLet without the needle attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.

Further important information

Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks and cross-infection.

Dispose of your used InnoLet carefully without the needle attached.

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

Always keep your InnoLet and needles out of sight and reach of others, especially children.

Caring for your pen

Your InnoLet is designed to work accurately and safely. It must be handled with care. If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
You can clean your InnoLet by wiping it with a medicinal swab. Do not soak, wash or lubricate it.
This may damage the mechanism and may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Do not refill your InnoLet. Once empty, it must be disposed of.

Package leaflet: NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen / insulin aspart

1. What NovoRapid is and what it is used for

NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

2. What you need to know before you use NovoRapid

Do not use NovoRapid

►
If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
►
If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
►
If FlexTouch is dropped, damaged or crushed.
►
If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid).
►
If the insulin does not appear clear and colourless.

If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice.

Before using NovoRapid

►
Check the label to make sure it is the right type of insulin.
►
Always use a new needle for each injection to prevent contamination.
►
Needles and NovoRapid FlexTouch must not be shared.
►
NovoRapid FlexTouch is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoRapid). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.

Other medicines and NovoRapid

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Listed below are the most common medicines which may affect your insulin treatment.

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
Danazol (medicine acting on ovulation).

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoRapid

►
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast- feeding.

Driving and using machines

►
Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Important information about some of the ingredients of NovoRapid

NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodium- free’.

3. How to use NovoRapid

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). NovoRapid FlexTouch is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if injected into the front of your waist. You should always measure your blood sugar regularly.

How to handle NovoRapid FlexTouch

NovoRapid FlexTouch is a pre-filled, colour-coded, disposable pen containing insulin aspart.

Read carefully the instructions on how to use NovoRapid FlexTouch included in this package leaflet.
You must use the pen as described in the instructions on how to use NovoRapid FlexTouch.

Always ensure you use the correct pen before you inject your insulin.

If you take more insulin than you should

If you take too much insulin your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:
►
If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
►
When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
►
If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
The amount or timing of insulin, food or exercise may need to be adjusted.

►
If you notice any of these signs, seek medical advice immediately.

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

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 which is stated on the FlexTouch label and carton, after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light.
NovoRapid must be protected from excessive heat and light.

Before opening: NovoRapid FlexTouch that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.

During use or when carried as a spare: You can carry your NovoRapid FlexTouch with you and keep it at a temperature below 30°C or in a refrigerator (2˚C to 8˚C) for up to 4 weeks. If refrigerated, keep away from the cooling element. Do not freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 solution for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What NovoRapid looks like and contents of the pack

NovoRapid is presented as a solution for injection.

Pack sizes of 1 (with or without needles) or 5 (without needles) or a multipack with 2 x 5 (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

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

Now turn over for information on how to use your FlexTouch.

This leaflet was last revised in

Other sources of information

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

Instructions on how to use NovoRapid 100 units/ml solution for injection in pre-filled pen (FlexTouch)

Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains NovoRapid 100 units/ml, then look at the illustrations to the right to get to know the different parts of your pen and needle.

Your NovoRapid FlexTouch pen is a pre-filled insulin pen. NovoRapid FlexTouch contains 300 units of insulin and delivers doses from 1 to 80 units, in increments of 1 unit.
NovoRapid FlexTouch is designed to be used with NovoFine or NovoTwist single-use disposable needles up to a length of 8 mm.

NovoRapid FlexTouch
Pen cap
Insulin scale
Insulin window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
NovoRapid®
FlexTouch®

Needle (example)
Outer needle cap
Inner needle cap
Needle
Paper tab

Preparing your NovoRapid FlexTouch pen

Check the name and coloured label on your NovoRapid FlexTouch pen to make sure that it contains the type of insulin you need. This is especially important if you take more than one type of

insulin. If you take a wrong type of insulin, your blood sugar level may get too high or too low.

A
Pull off the pen cap.

B
Check that the insulin in your pen is clear and colourless. Look through the insulin window. If the insulin looks cloudy, do not use the pen.

C
Take a new disposable needle, and tear off the paper tab.

D
Screw the needle straight onto the pen. Make sure the needle is on tight.

E
Pull off the outer needle cap and save it. You will need it after the injection to correctly remove the needle from the pen.

Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of insulin may appear at the needle tip. This is normal.

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

Never use a bent or damaged needle.

Checking the insulin flow

Make sure that you receive your full dose by always checking the insulin flow before you select and inject your dose.

F
Turn the dose selector to select 2 units.

F
2 units selected

G
Hold the pen with the needle pointing up.

Tap the top of the pen a few times to let any air bubbles rise to the top.

H
Press the dose button with your thumb until the dose counter returns to 0. The 0 must line up with the dose pointer. A drop of insulin will appear at the needle tip.

If no drop appears, repeat steps F to H up to 6 times. If no drop appears after these new attempts, change the needle and repeat steps F to H once more.

Do not use the pen if a drop of insulin still does not appear.

Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin flows. If no drop appears, you will not inject any insulin, even though the dose counter may move. This may indicate a blocked or damaged needle.

Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.

Selecting your dose

Use the dose selector on your NovoRapid FlexTouch pen to select your dose. You can select up to 80 units per dose.

I
Select the dose you need. You can turn the dose selector forwards or backwards. Stop when the right number of units lines up with the dose pointer.

The dose selector clicks differently when turned forwards, backwards or past the number of units left.

When the pen contains less than 80 units, the dose counter stops at the number of units left.

I
5 units selected
24 units selected

Always use the dose counter and the dose pointer to see how many units you have selected

before injecting the insulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low.

Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.

How much insulin is left?

The insulin scale shows you approximately how much insulin is left in your pen.

Approx.
how much insulin is left

To see precisely how much insulin is left, use the dose counter:
Turn the dose selector until the dose counter stops. If it shows 80, at least 80 units are left in your pen. If it shows less than 80, the number shown is the number of units left in your pen.

Turn the dose selector back until the dose counter shows 0.

If you need more insulin than the units left in your pen, you can split your dose between two pens.

Dose counter stopped:
52 units left
Example

Be very careful to calculate correctly if splitting your dose.

If in doubt, take the full dose with a new pen. If you split the dose wrong, you will inject too little or too much insulin, which can lead to too high or too low blood sugar level.

Injecting your dose

Make sure that you receive your full dose by using the right injection technique.

J
Insert the needle into your skin as your doctor or nurse has shown you. Make sure you can see the dose counter. Do not touch the dose counter with your fingers. This could interrupt the injection.

Press the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer. You may then hear or feel a click.

After the dose counter has returned to 0, leave the needle under the skin for at least 6 seconds to make sure that you get your full dose.

6 seconds
J

K
Remove the needle from the skin.

After that, you may see a drop of insulin at the needle tip. This is normal and has no effect on the dose you just received.

Always dispose of the needle after each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked, you will not inject any insulin.

L
Lead the needle tip into the outer needle cap on a flat surface. Do not touch the needle or the cap.

Once the needle is covered, carefully push the outer needle cap completely on and then unscrew the needle. Dispose of it carefully, and put the pen cap back on after every use.

When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse or local authorities.

Always watch the dose counter to know how many units you inject.
The dose counter will show the exact number of units. Do not count the pen clicks.

Hold the dose button down until the dose counter returns to 0 after the injection. If the dose counter stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

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

Caring for your pen

Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to too high or too low blood sugar level.

Do not leave the pen in a car or other place where it can get too hot or too cold.

Do not expose your pen to dust, dirt or liquid.

Do not wash, soak or lubricate your pen. If necessary, clean it with mild detergent on a moistened cloth.

- Do not drop your pen or knock it against hard surfaces.
If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.

Do not try to refill your pen. Once empty, it must be disposed of.

Do not try to repair your pen or pull it apart.

Important information

Always keep your pen with you.

Always carry an extra pen and new needles with you, in case of loss or damage.

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

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

Caregivers must be very careful when handling used needles – to reduce the risk of needle injury and cross-infection.

Package leaflet: NovoRapid PumpCart 100 units/ml solution for injection in cartridge / insulin aspart

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

NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

NovoRapid PumpCart is for use in a pump and covers your total daily insulin needs: both your all day (basal) and meal-time (bolus) insulin needs. Before you use NovoRapid PumpCart in the pump you must have received a comprehensive instruction by your doctor or nurse.

Basal (all-day) insulin requirements: When you use NovoRapid PumpCart in a pump, your insulin will be constantly delivered to cover your basal need for insulin. If you change the basal insulin setting the change will start to affect you within 10–20 minutes. If you stop the pump, the insulin effect will last for 3 to 5 hours. Before you set or change the basal rate, carefully read the pump manual (user guide).

Bolus (meal-time) insulin requirements: NovoRapid will start to lower your blood sugar within 10– 20 minutes after you start a bolus delivery (see section 3, How to use NovoRapid PumpCart, for more information about how to adjust your bolus dose). The maximum effect occurs between 1 and 3 hours after the bolus delivery and the effect lasts for 3 to 5 hours.

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

Do not use NovoRapid PumpCart

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

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If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
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If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
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If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid PumpCart).
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If the insulin does not appear clear and colourless.

If any of these applies, do not use NovoRapid PumpCart. Talk with your doctor, nurse or pharmacist for advice.

Before using NovoRapid PumpCart

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Check the label to make sure it is the right type of insulin.
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Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage or leakage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be a result of leakage of insulin. If you suspect the cartridge is damaged, take it back to your supplier.
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Infusion sets (tubing and needle) and NovoRapid PumpCart must not be shared.
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NovoRapid PumpCart is only suitable for injecting under the skin (subcutaneously) using a pump. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoRapid). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.

Other medicines and NovoRapid PumpCart

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Listed below are the most common medicines which may affect your insulin treatment.

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
Salicylates (used to relieve pain and lower fever)
Anabolic steroids (such as testosterone)
Sulphonamides (used to treat infections).

Your blood sugar level may rise (hyperglycaemia) if you take:
- Oral contraceptives (birth control pills)
- Thiazides (used to treat high blood pressure or excessive fluid retention)
- Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
- Thyroid hormones (used to treat thyroid gland disorders)
- Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
- Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
- Danazol (medicine acting on ovulation).

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoRapid

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If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast- feeding.

Driving and using machines

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Please ask your doctor whether you can drive a car or operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

Important information about some of the ingredients of NovoRapid

NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodium-free’.

3. How to use NovoRapid PumpCart

Dose and when to take your insulin

Always use your insulin and adjust your basal (all-day) and bolus (meal time) doses exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. Your bolus (meal-time) insulin needs to be adjusted based on your blood sugar measurement and food intake. Eat a meal or snack within 10 minutes of the bolus dose to avoid low blood sugar. When necessary, you can take the bolus dose just after you have finished eating.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

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

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoRapid PumpCart is only suitable for injecting under the skin (subcutaneously) using a pump.
Never inject directly into a vein (intravenously) or muscle (intramuscularly). Speak to your doctor if you need to inject your insulin by another method.

Before using NovoRapid PumpCart in a pump, you must have thorough training in the use of the pump and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump. Follow your doctor’s instructions and advice about the use of NovoRapid PumpCart in the pump.

Normally you will inject your insulin in the front of your waist (abdomen). Alternatively, if your doctor recommends it, you may use your thigh or upper arm. When you change the infusion set (tubing and needle), be sure to change the site for inserting the needle (injection site). This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). Changing the infusion set must be done according to the instructions in the manual supplied with the infusion set.

When you are using an insulin pump

It is best to measure your blood sugar level regularly to get the maximum benefit of insulin delivery, and to make sure the pump is working properly. If you experience any problems contact your doctor.

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NovoRapid PumpCart is only for use with a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
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NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. Follow the pump manual (user guide).
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To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.

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NovoRapid should never be mixed with any other medicinal product including other insulin products when used in a pump.
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Do not refill the cartridge. Once empty, it must be disposed of.
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Always carry a spare NovoRapid PumpCart.

Read carefully the instructions on how to use NovoRapid PumpCart included in this package leaflet.

What to do in case of pump failure

Make sure you have an alternative delivery method for your insulin available for injection under the skin (for example, a pen injector) in case the pump stops working.

If you take more insulin than you should

If you take too much insulin your blood sugar gets 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 may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.

If you stop taking your insulin

If you have any further questions on 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 (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:
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If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice) and adjust insulin delivery or stop your pump. Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
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When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
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If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
The amount or timing of insulin, food or exercise may need to be adjusted.

b)
List of other side effects

Uncommon side effects
May affect less than 1 in 100 people.

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Rare side effects
May affect less than 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

c)
Effects from diabetes

High blood sugar (hyperglycaemia)

5. How to store NovoRapid PumpCart

Before opening: NovoRapid PumpCart that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.

During use or when carried as a spare: NovoRapid PumpCart in use is not to be kept in the refrigerator. NovoRapid PumpCart carried as a spare can be kept for up to 2 weeks below 30°C.
Thereafter it can be used for up to 7 days below 37°C in a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. Keep NovoRapid PumpCart in the blister until use to protect it from damage. Always protect the cartridge from light during use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 solution for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What NovoRapid PumpCart looks like and contents of the pack

NovoRapid PumpCart is presented as a solution for injection.

Pack size of 5 cartridges and a multipack 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 and Manufacturer

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

Please proceed to the information in ‘Instructions on how to use NovoRapid PumpCart pre- filled cartridge’.

This leaflet was last revised in

Other sources of information

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

Instructions on how to use NovoRapid PumpCart pre-filled cartridge.

NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with other devices not designed for NovoRapid PumpCart, as this may result in incorrect insulin dosing and subsequent hyper- or hypoglycaemia.

Please read these instructions carefully before using your NovoRapid PumpCart.

Please also read the pump manual (user guide) that comes with your insulin pump.

Pay special attention to these notes as they are important for safe use of NovoRapid PumpCart.

Treat the pump and cartridge with care and carefully follow the instructions. Rough handling or misuse may cause inaccurate dosing and may lead to too high or too low blood sugar level.

NovoRapid PumpCart is ready for use directly in the pump.

NovoRapid PumpCart contains 1.6 ml insulin aspart solution, equivalent to 160 units.

This medicinal product should never be mixed with any other medicinal products.

Do not refill NovoRapid PumpCart. Once empty, it must be disposed of.

Always make sure you have a spare NovoRapid PumpCart available.

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 should be kept out of reach of others, especially children.

Top of plunger
White label band
A

1.
Before inserting a NovoRapid PumpCart cartridge into your pump

Bring NovoRapid PumpCart to room temperature.

Take NovoRapid PumpCart out of its blister package.

Check the label to make sure that it is NovoRapid PumpCart.

Check the expiry date, which is stated on the label and the carton.

Always check that NovoRapid PumpCart looks the way it should. See picture A.

Only the top of the plunger should be seen above the white label band. If you suspect NovoRapid PumpCart is damaged, take it back to your supplier.

Do not use it if any damage or leakage is seen or if the plunger has moved, making the bottom of the plunger visible above the white label band. This could be a result of leakage of insulin.

Check that the insulin in NovoRapid PumpCart is clear and colourless. If the insulin looks cloudy, do not use NovoRapid PumpCart. The cartridge may contain a minor amount of air in the form of small bubbles.

2.
Inserting a new NovoRapid PumpCart cartridge in your pump

Follow the instructions in the pump manual that comes with your pump to insert a new NovoRapid PumpCart cartridge in your pump.

Insert NovoRapid PumpCart in the cartridge compartment of the pump. The plunger goes in first.

Connect the infusion set with NovoRapid PumpCart by attaching the adapter onto your pump.

Check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin this could also indicate a leakage. Do not use the cartridge if cracks or leakage are seen. Follow the instructions in the pump manual for replacing a cartridge and for cleaning the cartridge compartment in the pump. Insulin leakage can cause inaccurate dosing and may lead to high blood sugar level. See section 4 c) of the package leaflet.

During the day and before going to sleep carefully check that your pump is delivering insulin and there are no leakages. Failure of delivery of your insulin may not result in an alert notification from the pump and you may be unaware that there is a problem. You may need to check your blood sugar levels. Tell your doctor or diabetes care team if you suspect a problem with your insulin delivery.

Always make sure you have an alternative delivery method for your insulin available (for example, a pen injector) in case the pump stops working. Seek medical advice if you think you may have very high blood sugar or diabetic ketoacidosis

3.
Removing an empty NovoRapid PumpCart cartridge from your pump

Follow the instructions in the pump manual to remove an empty NovoRapid PumpCart cartridge from your pump.

Remove the infusion set adapter from the empty NovoRapid PumpCart cartridge.

Dispose of the empty NovoRapid PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.

Follow the steps described in section 1 and 2 to prepare and insert a new NovoRapid PumpCart into your pump.

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.