NOVOMIX 100 U/ML Zawiesina do wstrzykiwań

Treść ulotki

1. NovoMix 30 Penfill 100 units/ml injectable suspension in a cartridge
   1. What is NovoMix 30 and what it is used for
   2. What you need to know before using NovoMix 30
   3. How to use NovoMix 30
   4. Possible side effects
   5. How to store NovoMix 30
   6. Contents of the pack and other information
2. NovoMix 30 FlexPen 100 units/ml injectable suspension in a prefilled pen
   1. What is NovoMix 30 and what it is used for
   2. What you need to know before using NovoMix 30
   3. How to use NovoMix 30
   4. Possible side effects
   5. How to store NovoMix 30
   6. Contents of the pack and other information
3. NovoMix 50 Penfill 100 units/ml injectable suspension in a cartridge
   1. What is NovoMix 50 and what is it used for
   2. What you need to know before using NovoMix 50
   3. How to use NovoMix 50
   4. Possible side effects
   5. How to store NovoMix 50
   6. Contents of the pack and other information
4. NovoMix 50 FlexPen 100 units/ml injectable suspension in a prefilled pen
   1. What is NovoMix 50 and what is it used for
   2. What you need to know before using NovoMix 50
   3. How to use NovoMix 50
   4. Possible side effects
   5. How to store NovoMix 50
   6. Contents of the pack and other information

NovoMix 30 Penfill 100 units/ml injectable suspension in a cartridge

30% soluble insulin aspart and 70% insulin aspart crystallised with protamine

Read this leaflet carefully before you start to use this medicine as it contains
important information for you

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

Contents of this leaflet:

• 1. What NovoMix 30 is and what it is used for
• 2. What you need to know before you use NovoMix 30
• 3. How to use NovoMix 30
• 4. Possible side effects
• 5. How to store NovoMix 30
• 6. Contents of the pack and other information

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

NovoMix 30 is a modern insulin (insulin analogue) with a rapid-acting and intermediate-acting effect, in a 30/70 ratio. Modern insulin medicines are an improved version of human insulin.
NovoMix 30 is used to reduce high blood sugar levels in adults, adolescents and children aged 10 years and over with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels.
NovoMix 30 will start to reduce blood sugar levels 10-20 minutes after its administration, its maximum effect will be between 1 and 4 hours after the injection and will last up to 24 hours.
In the treatment of type 2 diabetes mellitus, NovoMix 30 can be used in combination with diabetes tablets and/or injectable antidiabetic medicines.

2. What you need to know before using NovoMix 30

Do not use NovoMix 30
► If you are allergic to insulin aspart or any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia (low blood sugar)
see a) Summary of serious and very common adverse effects in section 4.
► In microinfusors.
► If the cartridge or the device containing the cartridge is leaking, damaged or has
cracks.
► If it has not been stored correctly or has been frozen, see section 5, How to
store NovoMix 30.
► If the resuspended insulin does not appear uniformly white, milky and watery.
► If after resuspension, there are clumps or white particles attached to the bottom or the
wall of the cartridge giving a frosted appearance.
Do not use NovoMix 30 if any of these occur. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoMix 30
► Check the label to make sure it is the correct type of insulin.
► Always check the cartridge, including the rubber stopper at the bottom of the
cartridge. Do not use it if it appears damaged or if the rubber stopper has been pulled above the
white band at the bottom of the cartridge. This may be the result of insulin leakage. If you suspect the cartridge has been damaged, return it to the
supplier. Consult the pen manual for further information.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoMix 30 Penfill must not be shared with others.
► NovoMix 30 Penfill is only suitable for subcutaneous injections with a reusable pen. Talk
to your doctor if you need to inject the insulin in another way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or problems with the adrenal gland, pituitary gland or thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as
this may vary your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad, travelling to countries with a different time zone may
vary your insulin requirements and timing.
► If you are pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine. There is limited clinical experience with insulin aspart during pregnancy. Your insulin needs may require adjustment during
pregnancy and after delivery. It is important to carefully control your diabetes, especially
preventing episodes of hypoglycaemia, also for the health of your baby.

Changes to the skin at the injection site
The injection site must be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, in a thinned area or in a thickened area (see section 3, How to use NovoMix 30). Tell your doctor if
you notice changes to the skin at the injection site. If you are currently injecting into one of these
affected areas, ask your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes medicines.

Children and adolescents

• NovoMix 30 can be used in adolescents and children from the age of 10 years and older.
• There is limited experience with the use of NovoMix 30 in children between 6-9 years.
• No data are available for NovoMix 30 in children under 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 vary your insulin needs. The most important medicines that can affect your insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• other medicines for the treatment of diabetes
• monoamine oxidase inhibitors (MAOIs) used to treat depression
• beta-blockers used to treat high blood pressure
• angiotensin converting enzyme (ACE) inhibitors used to treat some heart conditions or high blood pressure
• salicylates used to relieve pain and reduce fever
• anabolic steroids such as testosterone
• sulphonamides used to treat infections.

Your blood sugar level may be raised (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 problems)
• sympathomimetics, such as epinephrine (adrenaline), salbutamol or terbutaline used to treat asthma
• growth hormone (a medicine used to stimulate skeletal and body growth and which significantly affects the body's metabolic processes)
• danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used for the treatment of acromegaly, a rare hormonal disorder
usually occurring in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used for the treatment of high blood pressure) can weaken or completely suppress
the warning symptoms that can help you recognise low blood sugar.
Pioglitazone (tablets used for the treatment of type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin, have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoMix 30
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or
decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine. There is limited clinical experience with insulin aspart during
pregnancy. Your insulin needs may require adjustment during
pregnancy and after delivery. It is important to carefully control your diabetes, especially
preventing episodes of hypoglycaemia, also for the health of your baby.
► There are no restrictions on the use of NovoMix 30 during breastfeeding.
Ask your doctor, nurse or pharmacist for advice before taking any medicine during
pregnancy or breastfeeding.

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

• If you have frequent episodes of hypoglycaemia.
• If you have difficulty recognising the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be affected, and
consequently also your ability to drive or use machines. Be aware that you may put yourself or others at risk.
.

Important information about some ingredients of NovoMix 30
NovoMix 30 contains less than 1 mmol of sodium (23 mg) per dose, which means that NovoMix 30 is
essentially “sodium-free”.

3. How to use NovoMix 30

Dosage and when to administer insulin
Always use insulin and adjust the dose as directed by your doctor. If you are unsure, consult your doctor,
nurse or pharmacist.
NovoMix 30 is generally administered immediately before a meal. Take a meal or a
snack within 10 minutes of the injection to avoid a low blood sugar level. When
necessary, NovoMix 30 can be administered immediately after a meal. See below for
information on How and where to inject.
Do not change your insulin unless your doctor tells you to do so. If your doctor has transferred you from one
type or brand of insulin to another, a dose adjustment may be necessary by
the doctor themselves.
When NovoMix 30 is used in combination with tablets for diabetes and/or injectable antidiabetic
medicines, a dose adjustment by your doctor may be required.
.

Use in children and adolescents
NovoMix 30 can be used in adolescents and children from 10 years of age when a premixed
insulin is preferred. Limited clinical data are available for children between 6 and 9 years of age. No data are available
for NovoMix 30 in children under 6 years of age.

Use in special patient groups
If you have kidney or liver failure, or if you are over 65 years of age, blood sugar should be monitored
regularly and discuss dose adjustment of the insulin with your doctor.

How and where to inject
NovoMix 30 is administered under the skin (subcutaneous use). Never inject insulin directly into
a vein (intravenous use) or into a muscle (intramuscular use). NovoMix 30 Penfill is only suitable for
subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject insulin with
another method.
With each injection, always vary the injection site within the particular area of skin you usually use
regularly. This can reduce the risk of developing nodules or skin depressions (see
section 4, Possible side effects). The best sites for injecting are: the abdomen
(stomach), the buttocks, the front of the thigh or the upper arm. Insulin will work more
quickly if injected into the abdomen. It is recommended to check your blood sugar regularly.
► Do not refill the cartridge.
► NovoMix 30 Penfill cartridge is designed to be used with insulin delivery devices from
Novo Nordisk and NovoFine or NovoTwist needles
► If, in addition to NovoMix 30 Penfill, you have been prescribed another insulin in a Penfill cartridge, you must
use two different insulin delivery devices, one for each type of
insulin.
► Always carry a spare Penfill cartridge with you in case the one in use is lost or
damaged.

Resuspension of NovoMix 30
Always check that there is sufficient insulin (at least 12 units) available in the cartridge after
resuspension. If there is not enough residual insulin, use a new one. See the pen manual for further instructions.
► Every time you use a new NovoMix 30 Penfill(before inserting the cartridge into
the delivery device)

• Allow the insulin to reach room temperature before use. This makes it easier to resuspend.
• Rotate the cartridge between the palms of your hands for 10 times - it is important that the cartridge is held horizontally (aligned to the ground) (see figure A).
• Move the cartridge up and down between positions a and b (see figure B) 10 times so that the glass ball can move between the two ends of the cartridge.
• Repeat the procedure (see figures Aand B) until the liquid appears uniformly white, milky and aqueous. Do not use the cartridge if the resuspended insulin does not appear uniformly white, milky and aqueous.
• Quickly perform the next steps for the injection. ► For each subsequent injection
• Move the delivery device with the inserted cartridge up and down between positions a and b (see figure B), at least 10 times until the liquid appears uniformly white, milky and aqueous. Do not use the cartridge if the resuspended insulin does not appear uniformly white, milky and aqueous.
• Quickly complete the other steps necessary for the injection.

How to inject NovoMix 30
► Inject the insulin subcutaneously. Use the technique shown by your doctor or nurse and as
described in the pen manual.
► Keep the needle under the skin for at least 6 seconds. Keep the plunger pressed down fully until the needle
is withdrawn from the skin. This will ensure correct administration and limit possible
blood flow into the needle or insulin deposition.
► After each injection, make sure to remove and dispose of the needle and store NovoMix 30 without
the needle screwed on. Otherwise, the liquid may leak and cause an inaccurate dose.

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

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

If you stop taking insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to very high blood sugar levels (severe hyperglycemia
) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this 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 (hypoglycemia)is a very common side effect. It may affect more than 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoMix 30 in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; excessive hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) and even death. You can regain consciousness more quickly with a glucagon injection given by someone who knows how to use it. If glucagon is administered to you, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you should be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, sweets, biscuits or fruit juice with you, to be used if necessary.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilised, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have frequent episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the dose, timing of your insulin, food and physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that if you should faint, they should turn you onto your side and call for immediate medical assistance. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoMix 30 or any of its ingredients (called a systemic allergic reaction) is a very rare side effect which can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

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

Changes to the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by a build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned, or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: localised allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of starting insulin. If the symptoms do not disappear, see your doctor.
Visual disturbances: visual disturbances may occur when you start insulin treatment, but are usually temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints when you start insulin treatment. This usually goes away quickly. If it does not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar improves very quickly, retinopathy may worsen. Ask 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 improves very quickly, you may have pain originating from the nerve fibres. This is called acute painful neuropathy and is usually transient.

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

c)Effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar:

• If you have not injected enough insulin.
• If you have forgotten to take insulin or have stopped taking it.
• If you repeatedly take less insulin than you need.
• If you have an infection and/or fever.
• If you eat more than usual.
• If you do less physical activity than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, itchy skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be the symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolising fat instead of sugar).
If left untreated, 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 on the
pack after ‘EXP’. The expiry date refers to the last day of the month.
When not in use, always store the cartridge in the outer packaging to protect it from
light. NovoMix 30 must be protected from excessive heat and direct sunlight.

Before opening:NovoMix 30 Penfill not in use must be stored in a refrigerator at 2°C -
8°C, away from refrigerating agents. Do not freeze.
Before using NovoMix 30 Penfill, remove it from the refrigerator. It is recommended to resuspend
the insulin according to the instructions each time you use a new NovoMix 30 Penfill. See
Resuspension of NovoMix 30 in section 3.

During use or when carried with you as a spare:NovoMix 30 Penfill in use or that is being carried
with you as a spare must not be stored in a refrigerator. It can be carried with you at room
temperature (below 30°C) for up to 4 weeks.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NovoMix 30 contains

• The active ingredient 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 of injectable suspension.
• The excipients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.

Description of NovoMix 30 and contents of the pack
NovoMix 30 is presented as an injectable suspension. The cartridge contains a glass ball to
facilitate resuspension. After resuspension the liquid should appear uniformly white,
milky and aqueous. Do not use the insulin if it does not appear uniformly white, milky and aqueous
after resuspension.
Packs of 5 or 10 cartridges of 3 ml. Not all pack sizes may be marketed.
The suspension is milky, white and aqueous.

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

NovoMix 30 FlexPen 100 units/ml injectable suspension in a prefilled pen

30% insulin aspart soluble and 70% insulin aspart crystallised with protamine

Read this leaflet carefully before you start to use this medicine as it contains important information for you

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

Contents of this leaflet:

• 1. What NovoMix 30 is and what it is used for
• 2. What you need to know before you use NovoMix 30
• 3. How to use NovoMix 30
• 4. Possible side effects
• 5. How to store NovoMix 30
• 6. Contents of the pack and other information

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

NovoMix 30 is a modern insulin (insulin analogue) with a rapid-acting and intermediate-acting effect, in a 30/70 ratio. Modern insulin medicines are an improved version of human insulin.
NovoMix 30 is used to reduce high blood sugar levels in adults, adolescents and children from 10 years of age with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels.
NovoMix 30 will begin to reduce blood sugar levels 10-20 minutes after administration, its maximum effect will be between 1 and 4 hours after injection and will last up to 24 hours.
In the treatment of type 2 diabetes mellitus, NovoMix 30 can be used in combination with diabetes tablets and/or injectable antidiabetic medicines.

2. What you need to know before using NovoMix 30

Do not use NovoMix 30
► If you are allergic to insulin aspart or any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia (low blood sugar)
see a) Summary of serious and very common adverse effects in section 4.
► In microinfusors.
► If the FlexPen is leaking, damaged or cracked.
► If it has not been stored correctly or has been frozen, see section 5, How
to store NovoMix 30.
► If the resuspended insulin does not appear uniformly white, milky and watery.
► If after resuspension, there are clumps or white particles stuck to the bottom or on the
wall of the cartridge giving a frosted appearance.
Do not use NovoMix 30, if any of these occur. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoMix 30
► Check the label to make sure it is the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoMix 30 FlexPen must not be shared with others.
► NovoMix 30 FlexPen is only suitable for subcutaneous injections. Talk to your doctor if you need
to inject the insulin in a different way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or problems with the adrenal gland, pituitary gland or thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as
this may vary your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad, travelling to countries with a different time zone may
vary your insulin requirements and timings.

Skin changes at the injection site
The injection site must be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area or into a thickened area (see section 3, How to use NovoMix 30). Tell your doctor if
you notice skin changes at the injection site. If you are currently injecting into one of these
affected areas, ask your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes medicines.

Children and adolescents

• NovoMix 30 can be used in adolescents and children from the age of 10 years and over.
• There is limited experience with the use of NovoMix 30 in children between 6-9 years.
• No data are available for NovoMix 30 in children under 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 blood sugar levels and
this may vary your insulin requirements. The most important medicines that can affect your insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia), if you take:

• other medicines for the treatment of diabetes
• monoamine oxidase inhibitors (MAOIs) used to treat depression
• beta-blockers used to treat high blood pressure
• angiotensin converting enzyme (ACE) inhibitors used to treat some 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 be raised (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 conditions)
• sympathomimetics, such as epinephrine (adrenaline), salbutamol or terbutaline used to treat asthma
• growth hormone (a medicine used to stimulate the growth of the skeleton and body and which significantly affects the body's metabolic processes)
• danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or completely suppress
the warning symptoms that can help you recognise low blood sugar
levels.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin, have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or localised swelling (oedema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoMix 30
► If you drink alcohol, your insulin needs may change as your blood sugar level may
rise or fall. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor for advice before taking this medicine. There is limited clinical experience with insulin
aspart during pregnancy. Your insulin needs may require adjustment during
pregnancy and after delivery. It is important to control your diabetes carefully, especially
preventing episodes of hypoglycaemia, also for the health of your baby.
► There is no restriction on treatment with NovoMix 30 during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

Driving and using machines
► Ask your doctor about whether it is safe to drive or use machines:

• If you have frequent episodes of hypoglycaemia.
• If you have difficulty recognising the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be affected and
consequently also your ability to drive or use machines. Be aware that you could put yourself or others at risk.

Important information about some ingredients of NovoMix 30
NovoMix 30 contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoMix 30 is
essentially “sodium-free”.

3. How to use NovoMix 30

Dose and when to administer insulin
Always use insulin and adjust the dose as directed by your doctor. If you are unsure, consult your doctor,
nurse or pharmacist.
NovoMix 30 is generally administered immediately before a meal. Take a meal or a
snack within 10 minutes of the injection to avoid a low blood sugar level. When
necessary, NovoMix 30 can be administered immediately after a meal. See below for
information on How and where to inject.
Do not change your insulin unless your doctor tells you to do so. If your doctor has transferred you from one
type or brand of insulin to another, a dosage adjustment may be necessary by the doctor himself.
When NovoMix 30 is used in association with tablets for diabetes and/or injectable antidiabetic
medicines, a dose adjustment may be necessary by the doctor himself.

Use in children and adolescents
NovoMix 30 can be used in adolescents and children from 10 years of age when it is preferred to use
a premixed insulin. There are limited clinical data for children between 6 and 9 years of age. No data are available
for NovoMix 30 in children under 6 years of age.

Use in special patient groups
If you have kidney or liver failure, or if you are over 65 years of age, you should monitor your blood sugar
regularly and talk to your doctor about adjusting the insulin dose.

How and where to inject
NovoMix 30 is administered under the skin (subcutaneous use). Never inject insulin directly into
vein (intravenous use) or into the muscle (intramuscular use). NovoMix 30 FlexPen is only suitable for
subcutaneous injections. Talk to your doctor if you need to inject insulin by another method.
With each injection, vary the injection site within the particular area of skin you usually use
regularly. This can reduce the risk of developing nodules or skin indentations (see
paragraph 4 Possible undesirable effects). The best sites for giving yourself an injection are: the abdomen
(stomach), the buttocks, the front of the thigh or the upper arm. Insulin will work more
quickly if injected into the abdomen. It is recommended to check your blood sugar regularly.

How to use NovoMix 30 FlexPen
NovoMix 30 FlexPen is a disposable pre-filled pen, colour-coded, which contains a
mixture of rapid-acting and intermediate-acting insulin aspart in a 30/70 ratio.
as described in the Instructions for Use.
Always make sure you are using the correct pen before injecting your insulin.

If you take more insulin than you should
If you take too much insulin, your blood sugar level will become too low (hypoglycemia). See a)
Summary of serious and very common undesirable effects in paragraph 4.

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

If you stop taking insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a very high blood sugar level (severe hyperglycemia
) and ketoacidosis. See c) Effects of diabetes in paragraph 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 (hypoglycemia)is a very common side effect. It may affect more than 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoMix 30 in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; excessive hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly with a glucagon injection given by someone who knows how to use it. If glucagon is given to you, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you should be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, sweets, biscuits or fruit juice with you, to be used if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilised, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the dose, timing of your insulin, your food or your physical activity.
Tell people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you should faint, they should turn you onto your side and call for immediate medical help. You should not be given food or drink by mouth, as this could cause you to choke.

Serious allergic reactionto NovoMix 30 or any of its ingredients (called a systemic allergic reaction) is a very rare side effect which can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

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

Changes to the skin at the injection site:If you inject insulin into the same place, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin may also be caused by a build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known). Insulin may not work as well as it should if you inject into an area with lumps, an area that has thinned, or an area that has thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: allergic reactions at the injection site (pain, redness, urticaria, inflammation, bruising, swelling and itching). These symptoms usually disappear within a few weeks of starting insulin. If the symptoms do not disappear, see your doctor.
Vision disturbances: vision disturbances may occur when you start insulin treatment, but are usually temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints when you start insulin treatment. This usually disappears quickly. If not, contact your doctor.
Diabetic retinopathy (an eye disease related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar improves very quickly, the retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1,000.
Painful neuropathy (pain due to nerve damage): if your blood sugar improves very quickly, it may cause pain that originates in the nerves. This is called acute painful neuropathy and is usually temporary.

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

c)Effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar:

• If you have not injected enough insulin.
• If you have forgotten to take your insulin or have stopped taking it.
• If you repeatedly take less insulin than you need.
• If you have an infection and/or fever.
• If you eat more than usual.
• If you do less physical activity than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, itchy skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolising fat instead of sugar).
If not treated, this may lead to diabetic coma and eventually to 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 FlexPen label and on the
pack, after ‘EXP’. The expiry date refers to the last day of the month.
When not in use, keep the cap on the FlexPen to protect it from light. NovoMix 30
must be protected from excessive heat and direct sunlight.

Before opening:NovoMix 30 FlexPen not in use must be stored in a refrigerator at 2°C -
8°C, away from freezing agents. Do not freeze.
Before using NovoMix 30 FlexPen, remove it from the refrigerator. It is recommended to resuspend
the insulin according to the instructions each time you use a new pen. See Instructions for Use.

During use or when carried with you as a spare:NovoMix 30 FlexPen in use or that is
carried with you as a spare must not be stored in a refrigerator. It can be carried with you at
room temperature (below 30°C) for up to 4 weeks.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NovoMix 30 contains

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

Description of the appearance of NovoMix 30 and contents of the pack
NovoMix 30 is presented as an injectable suspension in a pre-filled pen. The cartridge
contains a glass ball to facilitate resuspension. After resuspension the liquid must
appear uniformly white, milky and aqueous. Do not use the insulin if it does not appear
uniformly white, milky and aqueous after resuspension.
Packs of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens of 3 ml. Not
all pack sizes may be marketed.
The suspension is milky, white and aqueous.

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

For information on how to use your FlexPen turn the page.
This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the European Medicines
Agency (EMA) website: http://www.ema.europa.eu/.

Instructions on how to useNovoMix 30 injectable suspension in FlexPen.
Read the following instructions carefully before using your FlexPen.If you do not follow
the instructions carefully, you may inject too much or too little insulin which may lead to a level of
blood sugar that is too high or too low.
FlexPen is a pre-filled pen for administering variable-dose insulin.
► You can select a dose between 1 and 60 units in increments of 1 unit.
► FlexPen is designed to be used with NovoFine or NovoTwist single-use needles of
length up to 8 mm.
► Always carry a spare device for administering insulin in case
FlexPen is lost or damaged.

Taking care of the pen
► Your FlexPen must be handled with care. If it leaks or has been knocked there is a risk
that it is damaged and insulin leaks. This can cause incorrect dosages, which can
lead to a blood sugar level that is too high or too low.
► You can clean the outside of your FlexPen with a disinfecting wipe. Do not immerse, wash or
lubricate the pen to avoid damaging the mechanism.

►Do not refill your FlexPen.
Resuspend the insulin
A
Check the name and coloured label of your pento make sure it contains the correct type of
insulin. This is particularly important if you are using more than one type of insulin. If you administer a
wrong type of insulin, the blood sugar level may become too high or too low.

Every time you use a new pen
Allow the insulin to reach room temperature before use. This will make resuspension easier.
Remove the pen cap.

B
Before making the first injection with a new FlexPen, you must resuspend the insulin:
Roll the pen between the palms of your hands 10 times - it is important that the pen is held horizontally
(aligned to the ground).

C
Move the pen up and down 10 times between the two positions as shown, so that the glass ball
moves between the two ends of the cartridge.
Repeat the procedure until the liquid appears uniformly white, milky and aqueous.

For each subsequent injection
Move the pen up and down between the two positions at least 10 times until the liquid appears
uniformly white, milky and aqueous.
► Always make sure you have resuspended the insulin before each injection. This reduces the risk of a
blood sugar level that is too high or too low. After resuspending, quickly perform all subsequent steps.

Always check that there are at least 12 units of insulinavailable in the cartridge to be able to
perform the resuspension. If there are less than 12 units, use a new FlexPen. 12 units
are marked on the scale. See the large figure at the beginning of these instructions.
Do not use the pen if the resuspended insulin does not appear uniformly white, milky and
aqueous.

Attach a needle
D
Take a new needle and remove the protective seal.
Screw the needle onto your FlexPen perpendicularly and firmly.

E
Remove the outer cap of the needle and keep it for later.

F
Remove the inner cap of the needle and discard it.
Never try to put the inner cap of the needle back on the needle itself. You could injure yourself with the needle.

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

Checking the insulin flow
During normal use, small amounts of air can accumulate in the cartridge. Before
each injection, to avoid injecting air and to administer the correct dose of insulin:
G
Rotate the dose selector and select 2 units.

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

I
Holding the needle pointing upwards, press the injection button firmly. The dose selector will
return to 0.
A drop of insulin must come out of the end of the needle. If this does not happen, change the needle and
repeat the procedure no more than 6 times.
If the 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 on the tip of the needle before the injection. This ensures
the flow of insulin. If no drop appears, you will not inject insulin, even if the dose selector moves. This may indicate a blocked or damaged needle.
Always check the flow before the injection. If you do not check the flow, you may inject a
too low amount of insulin or may not inject any at all. This can lead to a
blood sugar level that is too high.

Selecting the dose
Verify that the dose selector is at 0.
J
Rotate the dose selector to select the number of units to be injected.
The dose can be increased or decreasedby rotating the selector in both directions until
the indicator shows the correct dose. When rotating the dose selector, be careful
not to press the injection button to avoid insulin leakage.
You cannot select a dose higher than the number of units remaining in the cartridge.

Before injecting insulin, always use the dose selector and indicator to see how many
units have been selected.
Do not count the pen clicks. If you select and inject the wrong dose, the blood sugar
level may become too high or too low. Do not use the scale, which only
approximately shows how much insulin remains in the pen.

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

K
Administer the dose of insulin by pushing the injection button until the indicator
reaches 0. Be careful to press only the injection button.
Rotating the dose selector will not inject insulin.

L
► Keep the button pressed downand leave the needle under the skin for at least 6 seconds. This
will ensure complete administration of the dose.
► Remove the needle from the skin after releasing the pressure on the injection button.
► Always make sure the dose selector returns to 0 after the injection. If the dose selector
stops before reaching 0, the full dose has not been administered and may
lead to a blood sugar level that is too high.

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

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

Other important information
Anyone caring for you should be very careful when handling used needles to reduce
the risk of needle stick injuries and cross-infections.
Dispose of the used FlexPen with due caution, making sure to remove the needle.
Never share the pen and needles with other people. This can lead to cross-infection.
Never share the pen with other people. The medicine may be dangerous to their
health.
Always keep the pen and needles out of sight and reach of others, especially
children.

NovoMix 50 Penfill 100 units/ml injectable suspension in a cartridge

50% soluble insulin aspart and 50% insulin aspart crystallised with protamine

Read this leaflet carefully before you start to use this medicine as it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What NovoMix 50 is and what it is used for
• 2. What you need to know before you use NovoMix 50
• 3. How to use NovoMix 50
• 4. Possible side effects
• 5. How to store NovoMix 50
• 6. Contents of the pack and other information

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

NovoMix 50 is a modern insulin (insulin analogue) with a rapid-acting and intermediate-acting effect, in a 50/50 ratio. Modern insulin medicines are an improved version of human insulin.
NovoMix 50 is used to reduce high blood sugar levels in patients with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. NovoMix 50 can be used with metformin.
NovoMix 50 will begin to reduce blood sugar levels 10-20 minutes after administration and its maximum effect will be between 1 and 4 hours after injection and will last up to 14-24 hours.

2. What you need to know before using NovoMix 50

Do not use NovoMix 50
► If you are allergic to insulin aspart or any of the other ingredients of this medicine
(see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia (low blood sugar)
see a) Summary of rare and very common adverse effects in section 4.
► In microinfusors.
► If the cartridge or the device containing the cartridge is leaking, damaged or has
cracks.
► If it has not been stored correctly or has been frozen, see section 5, How to
store NovoMix 50.
► If the resuspended insulin does not appear uniformly white, milky and watery.
► If after resuspension, there are clumps or white particles stuck to the bottom or on the
wall of the cartridge giving a frosted appearance.
Do not use NovoMix 50 if any of these occur. Talk to your doctor, nurse or pharmacist
for advice.

Before using NovoMix 50
► Check the label to make sure it is the correct type of insulin
► Always check the cartridge, including the rubber stopper at the bottom of the
cartridge. Do not use it if it appears damaged or if the rubber stopper has been pulled above the
white band at the bottom of the cartridge. This could be the result of an
insulin leakage. If you suspect the cartridge has been damaged, return it to the
supplier. Consult the pen manual for further information.
► Always use a new needle for each injection to prevent contamination
► Needles and NovoMix 50 Penfill must not be shared with others.
► NovoMix 50 Penfill is only suitable for subcutaneous injections with a reusable pen. Talk
to your doctor if you need to inject insulin in another way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Talk to your doctor:
► If you have kidney or liver problems, or problems with the adrenal gland, pituitary gland or thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as
this may change your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you are planning to travel abroad, travelling to countries with a different time zone may
change your insulin requirements and timing.

Skin changes at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area or into a thickened area (see section 3, How to use NovoMix 50). Tell your doctor if
you notice skin changes at the injection site. If you are currently injecting into one of these
affected areas, talk to your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes medicines.

Other medicines and NovoMix 50
Tell your doctor, nurse or pharmacist if you are taking or may take any other
medicines, including those obtained without a prescription. Some medicines affect blood sugar levels and this can change your insulin needs. The most
important medicines that can affect your insulin treatment are listed below.
Your blood sugar may be lowered (hypoglycaemia) if you take:

• other medicines for the treatment of diabetes
• monoamine oxidase inhibitors (MAOIs) used to treat depression
• beta-blockers used to treat high blood pressure
• angiotensin converting enzyme (ACE) inhibitors used to treat some heart conditions or high blood pressure
• salicylates used to relieve pain and reduce fever
• anabolic steroids such as testosterone
• sulphonamides used to treat infections.

Your blood sugar may be raised (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 disorders)
• sympathomimetics, such as epinephrine (adrenaline), salbutamol or terbutaline used to treat asthma
• growth hormone (a medicine used to stimulate skeletal and body growth and that significantly affects the body's metabolic processes)
• danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or completely suppress the warning
symptoms that can help you recognise low blood sugar
levels.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or swelling in the ankles or feet (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoMix 50
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or
decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor for advice before taking this medicine. There is limited clinical experience with insulin
aspart during pregnancy. Your insulin needs may require adjustment during
pregnancy and after delivery. It is important to carefully control your diabetes, especially
preventing episodes of hypoglycaemia, also for the health of your baby.
► There is no restriction on treatment with NovoMix 50 during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during
pregnancy or breastfeeding.

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

• If you have frequent episodes of hypoglycaemia.
• If you have difficulty recognising the warning signs of hypoglycaemia.

If your blood sugar is high or low, your ability to concentrate and react may be affected and
therefore also your ability to drive or use machines. Be aware that you could put yourself or others at risk.

Important information about some ingredients of NovoMix 50
NovoMix 50 contains less than 1 mmol of sodium (23 mg) per dose, which means that NovoMix 50 is
essentially “sodium-free”.

3. How to use NovoMix 50

Dose and when to administer insulin
Always use the insulin and adjust the dose as indicated by your doctor. If you are not sure, consult your doctor,
nurse or pharmacist.
NovoMix 50 is generally administered immediately before a meal. Take a meal or a
snack within 10 minutes of the injection to avoid low blood sugar levels. When
necessary, NovoMix 50 can be administered immediately after a meal. See below for
information on How and where to inject.
When NovoMix 50 is used in association with metformin, the dose must be established based on
individual needs.
Do not change your insulin unless your doctor tells you to. If your doctor has transferred you from one
type or brand of insulin to another, a dosage adjustment by the doctor himself may be necessary.
Use in children and adolescents
There is no clinical experience with NovoMix 50 in children and adolescents under 18 years of age.

Use in particular groups of patients
If you have kidney or liver failure, or if you are over 65 years of age, blood sugar should be monitored
regularly and discuss dose adjustment of the insulin with your doctor.

How and where to inject
NovoMix 50 is administered under the skin (subcutaneous use). Never inject insulin directly into
vein (intravenous use) or into the muscle (intramuscular use). NovoMix 50 Penfill is only suitable for
subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject insulin with
another method.
With each injection, always vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin depressions (see
section 4, Possible undesirable effects). The best sites for self-injection are: the abdomen
(stomach); the buttocks; the front of the thigh or the upper arm. Insulin will work more
quickly if injected into the abdomen. It is recommended to check your blood sugar regularly.
► Do not refill the cartridge.
► NovoMix 50 Penfill cartridge is designed to be used with insulin delivery devices from Novo Nordisk and NovoFine or NovoTwist needles.
► If, in addition to NovoMix 50 Penfill, you have been prescribed another insulin in Penfill cartridge, you must
use two different insulin delivery devices, one for each type of
insulin.
► Always carry a spare Penfill cartridge with you in case the one in use is lost or
damaged.

Resuspension of NovoMix 50
Always check that there is sufficient insulin (at least 12 units) available in the cartridge after
resuspension. If there is not enough residual insulin, use a new one. See the pen manual for further instructions.
► Every time you use a new NovoMix 50 Penfill(before inserting the cartridge into the
delivery device)

• Let the insulin reach room temperature before use. This makes it easier to resuspend.
• Roll the cartridge between the palms of your hands for 10 times - it is important that the cartridge is held horizontally (aligned to the ground) (see figure A).
• Move the cartridge up and down between positions a and b (see figure B) for 10 times so that the glass ball can move between the two ends of the cartridge.
• Repeat the procedure (see figures Aand B) until the liquid appears uniformly white, milky and aqueous. Do not use the cartridge if the resuspended insulin does not appear uniformly white, milky and aqueous.
• Quickly perform the next steps for injection. ►For each subsequent injection
• Move the delivery device up and down between positions a and b with the cartridge inserted (see figure B), at least 10 times until the liquid appears uniformly white, milky and aqueous. Do not use the cartridge if the resuspended insulin does not appear uniformly white, milky and aqueous.
• If the procedure just described is not enough to make the liquid appear uniformly white and milky, repeat the procedure until the liquid appears uniformly white, milky and aqueous.
• Quickly complete the other steps necessary for the injection.

How to inject NovoMix 50
► Inject the insulin subcutaneously. Use the technique shown by your doctor or nurse and as
described in the pen manual.
► Keep the needle under the skin for at least 6 seconds. Keep the plunger pressed down fully until the needle
is withdrawn from the skin. This will ensure correct administration and limit possible
blood backflow into the needle or insulin deposition.
► After each injection, make sure to remove and discard the needle and store NovoMix 50 without
the needle screwed on. Otherwise, the liquid may leak out and cause an inaccurate dose.

If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycemia). See a)
Summary of serious and very common undesirable effects in section 4.

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

If you stop treatment with insulin
Do not stop treatment with insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a very high blood sugar level (severe hyperglycemia
and ketoacidosis). See C) Effects of diabetes in section 4.
If you have any further questions about the use of this medicine, ask your doctor, nurse or
pharmacist.

4. Possible side effects

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

a)Summary of serious and very common side effects
Low blood sugar (hypoglycemia)is a very common side effect. It can occur in more than 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking NovoMix 50 in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; excessive hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe, prolonged hypoglycemia is not treated, it can cause brain damage (temporary or permanent) and even death. You can regain consciousness more quickly with an injection of glucagon hormone by someone who knows how to use it. If glucagon is administered to you, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another high-sugar snack (candies, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, candies, biscuits or fruit juice with you, to be used if necessary.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount, timing of insulin, food and physical activity.
Inform people close to you that you have diabetes and what the consequences may be, including the risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should turn you onto your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoMix 50 or any of its ingredients (called a systemic allergic reaction) is a very rare side effect that can be life-threatening. It can occur in less than 1 in 10,000 people.
Contact your doctor immediately:

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

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, an area that has become thinner, or an area that has become thicker. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: localized allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of starting insulin. If the symptoms do not disappear, see your doctor.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but are usually temporary.
Swollen joints: at the beginning of insulin treatment, fluid retention can cause swelling around the ankles and other joints. This usually resolves quickly. If not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to vision loss): if you have diabetic retinopathy and your blood sugar improves very quickly, diabetic retinopathy may worsen. Ask 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 improves very quickly, you may experience pain originating in the nerve fibers. This is defined as acute painful neuropathy, which is usually transient.

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

c)Effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar:

• If you haven't injected enough insulin.
• If you have forgotten to take insulin or stopped taking it.
• If you repeatedly take less insulin than you need.
• If you have an infection and/or fever.
• If you eat more than usual.
• If you do less physical activity than usual.

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

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 on the
pack, after ‘EXP’. The expiry date refers to the last day of the month.
When not in use, always store the cartridge in the outer packaging to protect it from
light. NovoMix 50 must be protected from excessive heat and direct sunlight.

Before opening:NovoMix 50 Penfill not in use must be stored in a refrigerator at 2°C -
8°C, away from refrigerating elements. Do not freeze.
Before using NovoMix 50 Penfill, remove it from the refrigerator. It is recommended to resuspend
the insulin according to the instructions each time you use a new NovoMix 50 Penfill. See
Resuspension of NovoMix 50 in section 3.

During use or when carried with you as a spare:NovoMix 50 Penfill in use or which is carried
with you as a spare must not be stored in a refrigerator. It can be carried with you at room
temperature (below 30°C) for up to 4 weeks.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This 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% crystalline insulin aspart with protamine. 1 ml contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 ml of injectable suspension.
• The excipients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of NovoMix 50 and contents of the pack
NovoMix 50 is presented as an injectable suspension. The cartridge contains a glass ball to
facilitate resuspension. After resuspension the liquid should appear uniformly white,
milky and aqueous. Do not use the insulin if it does not appear uniformly white, milky and aqueous
after resuspension.
Packs of 1, 5 or 10 cartridges of 3 ml. Not all pack sizes may be
marketed.
The suspension is white, milky and aqueous.

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

NovoMix 50 FlexPen 100 units/ml injectable suspension in a prefilled pen

50% insulin aspart soluble and 50% insulin aspart crystallised with protamine

Read this leaflet carefully before you start to use this medicine as it contains
important information for you

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

In this leaflet:

• 1. What NovoMix 50 is and what it is used for
• 2. What you need to know before you use NovoMix 50
• 3. How to use NovoMix 50
• 4. Possible side effects
• 5. How to store NovoMix 50
• 6. Contents of the pack and other information

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

NovoMix 50 is a modern insulin (insulin analogue) with a rapid and intermediate-acting effect, in a 50/50 ratio. Modern insulin medicines are an improved version of human insulin.
NovoMix 50 is used to reduce high blood sugar levels in patients with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. NovoMix 50 can be used with metformin.
NovoMix 50 will begin to reduce blood sugar levels 10-20 minutes after administration, its maximum effect will be between 1 and 4 hours after the injection and will last up to 14-24 hours.

2. What you need to know before using NovoMix 50

Do not use NovoMix 50
► If you are allergic (hypersensitive) to insulin aspart or any of the other ingredients of this medicine (see section 6, Contents of the pack and other information).
► If you experience the warning signs of hypoglycaemia (low blood sugar), see a) Summary of serious and very common adverse effects in section 4.
► In microinfusion pumps.
► If the FlexPen is leaking, damaged or cracked.
► If it has not been stored correctly or has been frozen, see section 5, How to store NovoMix 50.
► If the resuspended insulin does not appear uniformly white, milky and watery.
► If, after resuspension, there are clumps or white particles attached to the bottom or wall of the cartridge giving a frosted appearance.
Do not use NovoMix 50 if any of these occur. Talk to your doctor, nurse or pharmacist for advice.

Before using NovoMix 50
► Check the label to make sure it is the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoMix 50 FlexPen must not be shared with others.
► NovoMix 50 FlexPen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin in a different way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, or problems with the adrenal gland, pituitary gland or thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as this may change your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.

►If you are planning to travel abroad, travelling to countries with a different time zone may change your insulin requirements and timing.

Changes in the skin at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, an area that is thinned or an area that is thickened (see section 3, How to use NovoMix 50). Tell your doctor if you notice changes in the skin at the injection site. If you are currently injecting into one of these affected areas, consult your doctor before starting to inject into another area. Your doctor may advise you to check your blood sugar more carefully and adjust your insulin or other diabetes medicines.

Other medicines and NovoMix 50
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect blood sugar levels and this may change your insulin requirements. The most important medicines that can affect your insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• other medicines for the treatment of diabetes
• monoamine oxidase inhibitors (MAOIs) used to treat depression
• beta-blockers used to treat high blood pressure
• angiotensin converting enzyme (ACE) inhibitors used to treat some heart conditions or high blood pressure
• salicylates used to relieve pain and reduce fever
• anabolic steroids such as testosterone
• sulphonamides used to treat infections.

Your blood sugar level may be raised (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 conditions)
• sympathomimetics, such as epinephrine (adrenaline), salbutamol or terbutaline used to treat asthma
• growth hormone (a medicine used to stimulate the growth of the skeleton and body and which significantly affects the body's metabolic processes)
• danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or completely suppress the warning symptoms that can help you recognise a hypoglycaemia.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who have been treated with pioglitazone and insulin have developed heart failure. Tell your doctor immediately if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or swelling of the ankles or feet.
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Drinking alcohol and using NovoMix 50
► If you drink alcohol, your insulin needs may change as your blood sugar level may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine. There is limited clinical experience with insulin aspart during pregnancy. Your insulin requirements may need adjustment during pregnancy and after delivery. It is important to control your diabetes carefully, especially to prevent hypoglycaemic episodes, also for the health of your baby.
► There is no restriction on treatment with NovoMix 50 during breastfeeding.
Consult your doctor, nurse or pharmacist before taking any medicine during pregnancy or breastfeeding.

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

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

If your blood sugar is high or low, your ability to concentrate and react may be impaired and consequently also your ability to drive or use machines. Be aware that you may put yourself or others at risk.

Important information about some ingredients of NovoMix 50
NovoMix 50 contains less than 1 mmol of sodium (23 mg) per dose, meaning that NovoMix 50 is essentially “sodium-free”.

3. How to use NovoMix 50

Dosage and when to administer insulin
Always use the insulin and adjust the dose as directed by your doctor. If you are unsure, consult your doctor,
nurse or pharmacist.
NovoMix 50 is generally administered immediately before a meal. Take a meal or a
snack within 10 minutes of the injection to avoid low blood sugar levels. When
necessary, NovoMix 50 can be administered immediately after a meal. See below for
information on How and where to inject.
When NovoMix 50 is used in combination with metformin, the dose must be established based on
individual needs.
Do not change your insulin unless your doctor tells you to do so. If your doctor has switched you from one
type or brand of insulin to another, an adjustment of the
dosage may be necessary by the doctor himself.

Use in children and adolescents
There is no clinical experience with NovoMix 50 in children and adolescents under 18 years of age.

Use in special patient groups
If you have renal or hepatic insufficiency, or if you are over 65 years of age, blood sugar should be monitored
regularly and talk to your doctor about adjusting the insulin dose.

How and where to inject
NovoMix 50 is administered under the skin (subcutaneous use). Never inject insulin directly into
vein (intravenous use) or into the muscle (intramuscular use). NovoMix 50 FlexPen is only suitable for
subcutaneous injections. Talk to your doctor if you need to inject insulin by another method.
With each injection, always vary the injection site within the particular area of skin you usually use
usually. This can reduce the risk of developing nodules or skin depressions (see
paragraph 4 Possible undesirable effects). The best sites for self-injection are: the abdomen
(abdomen), buttocks, the front of the thigh or the upper arm. Insulin will act more
quickly if injected into the abdomen. It is recommended to check your blood sugar regularly.

How to use NovoMix 50 FlexPen
NovoMix 50 FlexPen is a disposable pre-filled pen, color-coded, containing a
mixture of rapid-acting and intermediate-acting insulin aspart in a 50/50 ratio.
as described in the Instructions for Use.
Always make sure to use the correct pen before injecting your insulin.

If you take more insulin than you should
If you take too much insulin, your blood sugar will drop too low (hypoglycemia). See a)
Summary of serious and very common side effects in paragraph 4.

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

If you stop taking insulin
Do not stop treatment with insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a very high blood sugar level (severe hyperglycemia
) and ketoacidosis. See c) Effects of diabetes in paragraph 4.
If you have any further questions about the use of this medicine, ask your doctor, nurse or
pharmacist.

4. Possible side effects

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

a)Summary of serious and very common side effects
Low blood sugar (hypoglycemia)is a very common side effect. It may affect more than 1 in 10 people.
You may have low blood sugar if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and using NovoMix 50 in section 2).

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; excessive hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) leading to death. You can regain consciousness more quickly with an injection of glucagon by someone who knows how to use it. If glucagon is administered to you, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you should be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets, sweets, biscuits or fruit juice with you, for use if necessary.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilised, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have frequent episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the dose, timing of your insulin, food and physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you should faint, they should turn you onto your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto NovoMix 50 or any of its ingredients (called a systemic allergic reaction) is a very rare side effect that can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

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

Changes to the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by a build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: allergic reactions at the injection site (pain, redness, urticaria, inflammation, bruising, swelling and itching). These symptoms usually disappear within a few weeks of starting insulin. If the symptoms do not disappear, see your doctor.
Visual disturbances: visual disturbances may occur at the start of insulin treatment, but are usually temporary.
Swollen joints: fluid retention can cause swelling around the ankles and other joints at the start of insulin treatment. This usually disappears quickly. If not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if your blood sugar improves very quickly, diabetic retinopathy may worsen. Ask 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 improves very quickly, it may cause pain originating from the nerve fibres, this is called acute painful neuropathy which is usually transient.

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

c)Effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar:

• If you have not injected enough insulin.
• If you have forgotten to take insulin or have stopped taking it.
• If you repeatedly take less insulin than you need.
• If you have an infection and/or fever.
• If you eat more than usual.
• If you do less physical activity than usual.

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, itchy skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be the symptoms 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 left untreated, this could lead to diabetic coma and eventually death.

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 on the
pack, after ‘EXP’. The expiry date refers to the last day of the month.
When not in use, keep the cap on the FlexPen to protect it from light. NovoMix 50
must be protected from excessive heat and direct sunlight.

Before opening: NovoMix 50 FlexPen not in use must be stored in a refrigerator at 2°C -
8°C, away from the cooling elements. Do not freeze.
Before using NovoMix 50 FlexPen, remove it from the refrigerator. It is recommended to resuspend
the insulin according to the instructions each time you use a new pen. See Instructions for Use.

During use or when carried with you as a spare:NovoMix 50 FlexPen in use or which is
carried with you as a spare must not be stored in a refrigerator. It can be carried with you at
room temperature (below 30°C) for up to 4 weeks.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NovoMix 50 contains

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

Description of the appearance of NovoMix 50 and contents of the pack
NovoMix 50 is presented as an injectable suspension in a pre-filled pen. The cartridge
contains a glass ball to facilitate resuspension. After resuspension the liquid must
appear uniformly white, milky and watery. Do not use the insulin if it does not appear
uniformly white, milky and watery after resuspension.
Packs of 1, 5 or 10 pre-filled pens of 3 ml. Not all pack sizes may be
marketed.
The suspension is milky, white and watery.

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

For information on how to use your FlexPen turn the page.
This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the European Medicines
Agency (EMA) website: http://www.ema.europa.eu/.

Instructions on how to use NovoMix 50 injectable suspension in FlexPen.
Read the following instructions carefully before using your FlexPen.If you do not follow
the instructions carefully, you may inject too much or too little insulin which may lead to a level of
blood sugar that is too high or too low.
FlexPen is a pre-filled pen for administering variable doses of insulin.
► You can select a dose between 1 and 60 units in increments of 1 unit.
► FlexPen is designed to be used with NovoFine or NovoTwist single-use needles of
length up to 8 mm.
► Always carry a spare device for administering insulin in case
FlexPen is lost or damaged.

Taking care of the pen
► Your FlexPen must be handled with care. If it leaks or has been dropped there is a risk
that it is damaged and insulin leaks. This may cause incorrect dosages, which may
lead to a blood sugar level that is too high or too low.
► You can clean the outside of your FlexPen with a disinfecting wipe. Do not immerse, wash or
lubricate the pen to avoid damaging the mechanism.

►Do not refill your FlexPen.
Resuspend the insulin
A
Check the name and colour label of your pento make sure it contains the correct type of
insulin. This is particularly important if you use more than one type of insulin. If you administer a
wrong type of insulin, the blood sugar level may become too high or too low.

Every time you use a new pen
Allow the insulin to reach room temperature before use. This will make resuspension easier.
Remove the pen cap.

B
Before making the first injection with a new FlexPen you must resuspend the insulin:
Roll the pen between the palms of your hands 10 times - it is important that the pen is held in

horizontal position(aligned with the ground).

C
Move the pen up and down 10 times between the two positions as shown, so that the glass ball
moves between the two ends of the cartridge.
Repeat the procedure until the liquid appears uniformly white, milky and watery.

For each subsequent injection
Move the pen up and down between the two positions at least 10 times until the liquid appears
uniformly white, milky and watery. If the procedure just described is not sufficient to make the liquid
appear uniformly white, milky and watery, repeat the procedure (see B and C) until
the liquid appears uniformly white, milky and watery.
► Always make sure you have resuspended the insulin before each injection. This reduces the risk of a
blood sugar level that is too high or too low. After you have resuspended, quickly perform all subsequent steps.

Always check that there are at least 12 units of insulinavailable in the cartridge to be able to
perform the resuspension. If there are less than 12 units, use a new FlexPen. 12 units
are marked on the scale. See the large figure at the beginning of these instructions.
Do not use the pen if the resuspendedinsulin does not appear uniformly white, milky and
watery.

Attach a needle
D
Take a new needle and remove the protective seal.
Screw the needle firmly and perpendicularly onto your FlexPen.

E
Remove the outer cap of the needle and keep it for later.

F
Remove the inner cap of the needle and discard it.
Never try to put the inner cap of the needle back on the needle itself. You could injure yourself with the needle.

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

Checking the insulin flow
During normal use, small amounts of air can accumulate in the cartridge. Before
each injection, to avoid injecting air and to administer the correct dose of insulin:
G
Rotate the dose selector and select 2 units.

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

I
Holding the needle pointing upwards, press the injection button firmly. The dose selector will
return to 0.
A drop of insulin should come out of the end of the needle. If this does not happen, change the needle and
repeat the procedure no more than 6 times.
If the drop of insulin still does not appear, the pen is defective and you must use a new one.

Always make sure a drop appears at the tip of the needle before the injection. This ensures
insulin flow. If no drop appears, you will not inject insulin, even if the
dose selector moves. This may indicate a blocked or damaged needle.
Always check the flow before the injection. If you do not check the flow, you may inject a
too low amount of insulin or not inject any at all. This can lead to
a blood sugar level that is too high.

Selecting the dose
Verify that the dose selector is at 0.
J
Rotate the dose selector to select the number of units to be injected.
The dose can be increased or decreasedby rotating the selector in both directions until
the indicator shows the correct dose. When rotating the dose selector, be careful
not to press the injection button to avoid insulin leakage.
You cannot select a dose higher than the number of units remaining in the cartridge.

Before injecting the insulin, always use the dose selector and indicator to
see how many units have been selected.
Do not count the pen clicks. If you select and inject the wrong dose, the blood sugar
level may become too high or too low. Do not use the scale, which only
shows approximately how much insulin is left in the pen.

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

K
Administer the dose of insulin by pushing the injection button until the indicator reaches
0. Be careful to press only the injection button.
Rotating the dose selector will not inject insulin.

L
► Keep the button pressed downand leave the needle under the skin for at least 6 seconds. This
will ensure complete administration of the dose.
► Remove the needle from the skin after releasing the pressure on the injection button.
► Always make sure the dose selector returns to 0 after the injection. If the dose selector
stops before reaching 0, the full dose has not been administered and may
cause a blood sugar level that is too high.

M
Insert the needle into the outer cap without touching it. When the needle is covered, press completely
carefully with the outer cap and then unscrew the needle.

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

Other important information
Anyone caring for you must pay close attention to handling the needles to reduce
the risk of needle injuries and cross-infections.
Dispose of the used FlexPen with due caution, making sure you have removed the needle.
Never share the pen and needles with other people. This can lead to cross-infections.
Never share the pen with other people. The medicine may be dangerous to their
health.
Always keep the pen and needles out of sight and reach of others, especially
children.