ACTRAPID 40 IU/ML Injectable solution

Зміст інструкції

1. Actrapid 40 UI/ml (international units/ml) injectable solution in a vial
   1. What is Actrapid and what is it used for
   2. What you need to know before using Actrapid
   3. How to use Actrapid
   4. Possible side effects
   5. How to store Actrapid
   6. Contents of the pack and other information
2. Actrapid 100 IU/ml (international units/ml) injectable solution in a vial
   1. What is Actrapid and what is it used for
   2. What you need to know before using Actrapid
   3. How to use actrapid
   4. How to store Actrapid
   5. Package Contents and Other Information
   6. What is Actrapid and what is it used for
   7. What you need to know before using Actrapid
   8. How to use Actrapid
   9. Possible side effects
   10. How to store Actrapid
   11. Package Contents and Other Information
   12. What is Actrapid and what is it used for
   13. What you need to know before using Actrapid
   14. How to use Actrapid
   15. Possible side effects
   16. How to store Actrapid
   17. Contents of the pack and other information
   18. What is Actrapid and what is it used for
   19. What you need to know before using Actrapid
   20. How to use Actrapid
   21. Possible side effects
   22. How to store Actrapid
   23. Contents of the pack and other information

Actrapid 40 UI/ml (international units/ml) injectable solution in a vial

human insulin

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What is Actrapid and what is it used for

Actrapid is a human insulin with a rapid-acting effect.
Actrapid 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. Treatment with Actrapid helps to prevent complications of
diabetes.
Actrapid will begin to reduce blood sugar levels approximately half an hour after
administration and its effect will last for about 8 hours. Actrapid is often administered in
combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Actrapid

Do not use Actrapid
► If you are allergic to human insulin, or to any of the other ingredients of this medicine,
see section 6.
► If you experience the warning signs of hypoglycaemia (low blood sugar),
see the section on serious and very common side effects in section 4.
► In insulin infusion pumps.
► If the protective cap is loose or missing. Each vial has a plastic, tamper-evident protective cap.
If the cap is not in perfect condition when you purchase it, return the vial to the supplier.
► If it has not been stored correctly or has been frozen, see section 5.
► If the insulin does not appear as clear, colourless water.
Do not use Actrapid if any of these apply. Talk to your doctor, pharmacist or nurse for
advice.

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

Warnings and precautions
Some conditions and activities can affect your insulin needs. Talk to your doctor:
► If you have kidney or liver problems, abnormalities of the adrenal gland, pituitary gland or
thyroid gland.
► If there is an increase in physical activity or a change in your usual diet, as this
may affect 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 the times you take it.

Changes in 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, an area
thinned skin or an area of thickened skin (see section 3). 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 antidiabetic medicines.
dose.

Other medicines and Actrapid
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels, which means that your insulin
dose may need to be changed. The most common medicines that can affect your
insulin treatment are listed below.
Your blood sugar level may decrease (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat 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 increase (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 somatic growth and that significantly affects the body’s metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder 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.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes mellitus 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 localised swelling (oedema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actrapid with alcohol
► 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 to become pregnant, ask your
doctor for advice before taking this medicine. Actrapid can be used during
pregnancy. You may need an adjustment of your dose during pregnancy and after
delivery. It is important to control your diabetes carefully, especially to prevent episodes
of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with Actrapid during breastfeeding.
Consult your doctor, pharmacist or nurse 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, this can affect your ability to concentrate and react and therefore also your ability to drive or use machines. Be aware that you could put yourself or others at risk.

Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose, which means that Actrapid is
essentially “sodium-free”.

3. How to use Actrapid

Dosage and when to administer insulin
Always use insulin according to your doctor's prescription and carefully follow their advice. If you are not
sure, consult your doctor, pharmacist or nurse.
Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid a
low blood sugar level.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be necessary by the
doctor himself .
Use in children and adolescents
Actrapid can be used in children and adolescents.

Use in particular groups of patients
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 your insulin dose.

How and where to inject
Actrapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). If necessary, Actrapid can
be administered directly into a vein, but this must be done exclusively by healthcare professionals.
With each injection, vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin indentations, see paragraph 4. The
best areas to inject are: the abdomen, the upper arm or the front of the thigh. Insulin will work more quickly if injected into the abdomen. Always check
your blood sugar regularly.

How to inject Actrapid
Actrapid in vials is designed to be used with insulin syringes with a scale in
units corresponding
If you are using only one type of insulin

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

If you need to mix two types of insulin

• 1. Immediately before use, rotate the vial containing the intermediate- or long-acting insulin (milky) between your hands until the liquid appears uniformly white and milky.
• 2. Draw an amount of air into the syringe equal to the dose of intermediate- or long-acting insulin. Inject the air into the vial containing the intermediate- or long-acting insulin and remove the needle.
• 3. Draw an amount of air into the syringe equal to the dose of Actrapid. Inject the air into the vial containing Actrapid. Invert the vial and syringe and draw the prescribed dose of Actrapid. Then expel the air from the syringe and check that the dose is correct.
• 4. Insert the needle into the vial containing the intermediate- or long-acting insulin, invert the vial and syringe and draw the prescribed dose. Then expel the air from the syringe and check that the dose is correct. Inject the mixed solution immediately.
• 5. Always mix Actrapid and the intermediate- or long-acting insulin in the same sequence.

How to inject Actrapid
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or
nurse
► Keep the needle under the skin for at least 6 seconds to make sure you have injected the entire dose of
insulin
► Dispose of the needle and syringe after each injection.
.

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

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

If you stop taking your 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 high blood sugar level (severe
hyperglycemia) and ketoacidosis. See Effects of diabetes in paragraph 4.
If you have any other questions about the use of this medicine, ask your doctor, pharmacist or
nurse

4. Possible side effects

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

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

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol, see Actrapid with alcohol in section 2.

Warning signs of low blood sugar: cold sweat; cold and
pale skin; headache; fast heartbeat; feeling unwell; feeling hungry; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty
concentrating.
Severe hypoglycemia can lead to loss of consciousness. If prolonged severe hypoglycemia is not
treated, it can cause brain damage (transient or permanent) up to and including death. You may 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 must 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 juices with you,
to be used if necessary.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized
continue insulin treatment.
► If you have low blood sugar, or if you have needed
a glucagon injection, or if you have many episodes of low blood sugar, see your
doctor. It may be necessary to adjust the dose and 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 (loss of consciousness) due to hypoglycemia. Explain that, if
you should faint, they should turn you onto your side and seek immediate medical attention. It is
advisable that you are not given food or drink as you could choke.

Serious allergic reactionto Actrapid or one of its excipients (called a systemic allergic
reaction) is a rare side effect but can be life-threatening. It may occur in less than 1 in 10000 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 start to 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 in the skin at the injection site:If you inject insulin too often in 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 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
thinned or an area thickened. Change the injection site with each injection to prevent these
skin changes.

List of other side effects
Uncommon side effects
May affect less than 1 in 100 people

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

Visual disturbances:visual disturbances may occur at the beginning of insulin treatment, but this
disturbance is generally temporary.

Swollen joints: at the beginning of insulin treatment, fluid retention can cause swelling
around the ankles and other joints. This is a phenomenon that soon disappears. If not, contact your doctor.

Painful neuropathy(pain due to nerve damage): if blood sugar levels improve
rapidly, you may experience nerve pain. This is defined as painful neuropathy and is normally
transient.

Very rare side effects
May affect less than 1 in 10000 people

Diabetic retinopathy(an eye condition related to diabetes that can lead to loss of
vision). If you have diabetic retinopathy and your blood sugar levels improve very quickly,
diabetic retinopathy may worsen. Consult your doctor for more information.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes reporting side effects directly through the national reporting system reported
in Appendix V. By reporting side effects you can help provide more information
on the safety of this medicine.

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

• You have not injected enough insulin.
• You have forgotten to take insulin or stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• 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 Actrapid

Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and on the
packaging, after “EXP”. The expiry date refers to the last day of the month.

Before opening:store in a refrigerator at 2°C - 8°C. Keep away from refrigerating elements.
Do not freeze.

During use or when carried as a supply: do not refrigerate or freeze. It is possible to carry it with you
and keep it at room temperature (below 25°C) for up to 4 weeks.
Always keep the vial in the outer packaging to protect it from light.
Dispose of the needle and syringe after each injection.
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 Actrapid contains

• The active ingredient is human insulin. Each ml contains 40 IU of human insulin. Each vial contains 400 IU of human insulin in 10 ml of injectable solution.
• The excipients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Actrapid and contents of the pack
Actrapid is presented as an injectable solution
Packs of 1 or 5 vials of 10 ml or a multipack containing 5 packs of 1 x 10 ml
vial. Not all pack sizes may be marketed.
The solution is clear and colourless.

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

Manufacturer
The manufacturer can be identified by the batch number printed on the package flap and
on the label:

• If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK- 2880 Bagsværd, Denmark.
• If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans F-28000 Chartres, France.

This leaflet was last updated on
Other sources of information
More detailed information on this medicine is available on the European Agency website

Actrapid 100 IU/ml (international units/ml) injectable solution in a vial

Human insulin

Read this leaflet carefully before using 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, pharmacist or nurse.
• This medicine has been prescribed for you personally. Never give it to others. This medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any side effects occur, ask your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

1. What is Actrapid and what is it used for

Actrapid is a human insulin with a rapid-acting effect.
Actrapid is used to reduce high blood sugar levels in patients with diabetes mellitus
(diabetes). It is human insulin used in the treatment of diabetes. Diabetes is a condition in which
the body does not produce enough insulin to control blood sugar levels. Treatment with Actrapid helps to prevent complications of diabetes.
Actrapid will begin to reduce blood sugar levels within approximately half an hour of
administration and its effect will last for about 8 hours. Actrapid is often administered in
combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Actrapid

Do not use Actrapid
► If you are allergic to human insulin, or to any of the other ingredients of this medicine,
see section 6.
► If you experience the warning signs of hypoglycaemia (low blood sugar levels),
see the section on serious and very common side effects in section 4.
► In insulin infusion pumps.
► If the protective cap is loose or missing. Each vial has a plastic, tamper-evident protective cap.
If the cap is not in perfect condition when you purchase it, return the vial to the supplier.
► If it has not been stored correctly or has been frozen, see section 5.
► If the insulin does not appear as clear, colourless water.
Do not use Actrapid if any of these apply. Talk to your doctor, pharmacist or nurse for
advice.

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

Warnings and precautions
Some conditions and activities can affect your insulin needs. Talk to your doctor:
► If you have kidney or liver problems, abnormalities affecting the adrenal gland, pituitary gland or
thyroid gland.
► If there is an increase in physical activity or a change in your usual diet, as this
may affect 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 the times you take it.

Changes in 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 it into an area with lumps, into a thinned area or into a thickened area (see section 3). 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, 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 dose of insulin or other antidiabetic medicines.

Other medicines and Actrapid
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels, which means that your insulin dose
may need to be changed. The most common 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 disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol or terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder 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 mellitus 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 localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actrapid with alcohol
► 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. Actrapid can be used during
pregnancy. You may need an adjustment of your dose during pregnancy and after
delivery. It is important to carefully control your diabetes, in particular to prevent hypoglycaemic episodes, also for the health of the baby.
► There are no restrictions on treatment with Actrapid during breastfeeding.
Consult your doctor, pharmacist or nurse before taking any medicine during
pregnancy or breastfeeding.

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

• if you have frequent episodes of hypoglycaemia
• if you find it difficult to recognise the warning signs of hypoglycaemia.

If your blood sugar is high or low, this can affect your ability to concentrate and react
and therefore also your ability to drive or operate machinery. Be aware that you could
put yourself or others at risk.

Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose, which means that Actrapid is
essentially “sodium-free”.

3. How to use actrapid

Dose and when to administer insulin
Always use insulin according to your doctor's prescription and carefully follow their advice. If you are not
sure, consult your doctor, pharmacist or nurse.
Eat a meal or snack containing carbohydrates within 30 minutes of the injection. To avoid a
low blood sugar level.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or the
brand of insulin you are using, a dose adjustment by the
doctor may be necessary.
Use in children and adolescents
Actrapid can be used in children and adolescents.

Use in particular groups of patients
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 your insulin dose.

How and where to inject
Actrapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into a muscle (intramuscularly). If necessary, Actrapid can
be administered directly into a vein, but this must be done exclusively by healthcare professionals.
With each injection, 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. The
best areas to inject are: the abdomen, the upper arm or the front
of the thigh. Insulin will work more quickly if injected into the abdomen. Always check
your blood sugar levels regularly.

How to inject Actrapid
Actrapid in vials is designed to be used with insulin syringes with a scale in
units.
If you are using only one type of insulin

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

If you need to mix two types of insulin

• 1. Immediately before use, rotate the vial containing the intermediate- or long-acting insulin (milky) between your hands until the liquid appears uniformly white and milky.
• 2. Draw into the syringe an amount of air equal to the dose of intermediate- or long-acting insulin. Inject the air into the vial containing the intermediate- or long-acting insulin and remove the needle.
• 3. Draw into the syringe an amount of air equal to the dose of Actrapid. Inject the air into the vial containing Actrapid. Turn the vial and syringe upside down and draw the prescribed dose of Actrapid. Then expel the air from the syringe and check that the dose is correct.
• 4. Insert the needle into the vial containing the intermediate- or long-acting insulin, turn the vial and syringe upside down and draw the prescribed dose. Then expel the air from the syringe and check that the dose is correct. Inject the mixed solution immediately.
• 5. Always mix Actrapid and the intermediate- or long-acting insulin in the same sequence.

How to inject Actrapid
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or
nurse.
► Keep the needle under the skin for at least 6 seconds to make sure you have injected the entire dose of
insulin.
► Dispose of the needle and syringe after each injection.

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

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

If you stop taking your 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 high blood sugar level (severe
hyperglycemia) and ketoacidosis. See Effects of diabetes in section 4.
If you have any other questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.

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 skip meals.
• You do more physical activity than usual.
• You drink alcohol, see Actrapid with alcohol in section 2.

Warning signs of low blood sugar: cold sweat; cold and
pale skin; headache; rapid heartbeat; feeling unwell; feeling hungry; 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 not treated for a prolonged period, it can cause brain damage (transient or permanent) up to death. You can regain
consciousness more quickly with an injection of the hormone glucagon by someone who knows
how to use it. If you are given glucagon, you will need glucose or a sugary snack
as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to
hospital.
What to do if your blood sugar 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, you have needed a glucagon injection, or you have many episodes of low blood sugar, consult your
doctor. A dose and timing adjustment of insulin, food and physical activity may be necessary.
Inform people close to you that you have diabetes and what the consequences may be, including the
risk of fainting (loss of consciousness) due to hypoglycemia. Explain that, should
you faint, they must turn you onto your side and seek immediate medical attention. It is
advisable that you are not given food or drink as you may choke.

Serious allergic reactionto Actrapid or one of its excipients (called a systemic allergic
reaction) is a rare side effect but 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: start sweating; start feeling sick (vomiting); have difficulty breathing; your heartbeat is racing; you feel dizzy. ► If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site:If you inject insulin too often in the same place,
the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect less
than 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein
called amyloid (cutaneous amyloidosis; the frequency with which it occurs is unknown). Insulin
may not work as well as it should if you inject into an area with nodules, an area
thinned or an area thickened. Change the injection site with each injection to prevent these
skin changes.

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

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

Visual disturbances:visual disturbances may occur at the beginning of insulin treatment, but this
disturbance is usually temporary.

Swollen joints: at the beginning of insulin treatment, fluid retention can cause swelling
around the ankles and other joints. This is a phenomenon that soon disappears. If
otherwise, contact your doctor.

Painful neuropathy(pain due to nerve damage): if your blood sugar level improves
rapidly, you may experience nerve pain. This is defined as acute painful neuropathy and is generally
transient.

Very rare side effects
May affect less than 1 in 10,000 patients.

Diabetic retinopathy(an eye condition related to diabetes that can lead to vision loss). If you have diabetic retinopathy and your blood sugar level improves very rapidly,
diabetic retinopathy may worsen. Consult your doctor for more information.

Reporting of side effects
If you experience any side effects, tell your doctor, pharmacist or nurse. This also applies to reporting side effects directly through the national reporting system
reported in Appendix V. By reporting side effects, you can help provide more
information on the safety of this medicine.

Effects of diabetes
High blood sugar (hyperglycemia)
You may have a high blood sugar level if:

• You have not injected enough insulin.
• You have forgotten to take insulin or stopped taking it.
• You repeatedly take less insulin than necessary.
• You have an infection or fever.
• You eat more than usual.
• 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
drowsy 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 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 Actrapid

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and on the
pack after “EXP”. The expiry date refers to the last day of the month.

Before opening:store in a refrigerator at 2°C - 8°C. Keep away from refrigerating elements.
Do not freeze.

During use or when carried as a spare: do not refrigerate or freeze. It is possible to carry it with you
and keep it at room temperature (below 25°C) for up to 6 weeks.
Always keep the vial in the outer packaging to protect it from light.
Dispose of the needle and syringe after each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Actrapid contains

• The active ingredient is human insulin. Each ml contains 100 IU of human insulin. Each vial contains 1000 IU of human insulin in 10 ml of injectable solution.
• The excipients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Actrapid and contents of the pack
Actrapid is presented as an injectable solution
Packs of 1 or 5 vials of 10 ml or a multipack containing 5 packs of 1 x 10 ml
vial. Not all pack sizes may be marketed.
The solution is clear and colourless.

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

Manufacturer
The manufacturer can be identified by the batch number printed on the package flap and
on the label:

• If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK- 2880 Bagsværd, Denmark.
• If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans F-28000 Chartres, France.

This leaflet was last updated on
Other sources of information
More detailed information on this medicine is available on the website of the European Agency

Actrapid Penfill 100 IU/ml (international units/ml) solution for injection in cartridge
human insulin

Read this leaflet carefully before you start using this medicine because it contains important
information for you.

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

Contents of this leaflet

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

1. What is Actrapid and what is it used for

Actrapid is a human insulin with a rapid-acting effect.
Actrapid 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. Treatment with Actrapid helps to prevent complications of
diabetes.
Actrapid will begin to reduce blood sugar levels within approximately half an hour of
administration and its effect will last for about 8 hours. Actrapid is often administered in
combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Actrapid

Do not use Actrapid
► If you are allergic to human insulin or any of the other ingredients of this medicine,
see section 6.
► If you suspect the onset of hypoglycemia (a set of symptoms indicating a low level of
blood sugar), see the Summary of serious and very common side effects in
section 4.
► In insulin infusion pumps.
► If the cartridge or the device containing the cartridge is leaking, damaged or fractured.
► If it has not been stored correctly or has been frozen, see section 5 .
► If the insulin does not appear as clear, colourless water.
Do not use Actrapid if any of these occur. Talk to your doctor, pharmacist or nurse for
advice.

Before using Actrapid
► Check the label to make sure it is the correct type of insulin.
► Always check the cartridge, including the rubber stopper on top of the
cartridge. Do not use it if it appears damaged or if the rubber stopper has been pushed beyond the
white band on top of the cartridge. This could lead to loss of insulin.
► If you suspect the cartridge is damaged, return it to the supplier. See the pen manual for
more information.
► Always use a new needle for each injection to prevent contamination.
► Needles and Actrapid Penfill must not be shared with others.
► Actrapid Penfill is only suitable for subcutaneous injections with a reusable pen. 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. Talk to your doctor:
► If you have kidney or liver problems, abnormalities affecting the adrenal gland, pituitary gland or
thyroid gland.
► If there is an increase in physical activity or a change in your usual diet, as this
may affect 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 the timing of these.
.

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, in a thinned area or in a thickened area (see section 3). Tell your doctor if you notice skin changes at the
injection site. If you are currently injecting into one of these affected areas, consult
your doctor before starting to inject into another area. Your doctor may advise you to
check your blood sugar more carefully and adjust your insulin or other antidiabetic medicines.

Other medicines and Actrapid
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels, which means that the dose of insulin
may need to be modified. The most common medicines that can affect your
insulin treatment are listed below.
Blood sugar levels may decrease (hypoglycemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (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)
• Sulfonamides (used to treat infections).

Blood sugar levels may increase (hyperglycemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as “cortisone” used to treat inflammation)
• Thyroid hormones (used to treat thyroid disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol or terbutaline, used to treat asthma
• Growth hormone (medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (medicine that acts on ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) may increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognize a low level of
blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes mellitus 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 localized swelling (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actrapid with alcohol
► 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, ask your doctor for advice before taking this medicine.
Actrapid can be used during pregnancy. It may be necessary to adjust
the dose during pregnancy and after delivery. It is important to control diabetes carefully, especially to prevent hypoglycemic episodes, also for the health of the baby.
► There are no restrictions on treatment with Actrapid during breastfeeding.
Consult your doctor, pharmacist or nurse 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 hypoglycemia
• if you find it difficult to recognise the signs of hypoglycemia.

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

Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose, which means that Actrapid is
essentially “sodium-free”.

3. How to use Actrapid

Dosage and when to administer insulin
Always use insulin according to your doctor's prescription and carefully follow their advice. If you are
unsure, consult your doctor, pharmacist or nurse.
Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid a
low blood sugar level.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be necessary by the
doctor himself .
Use in children and adolescents
Actrapid can be used in children and adolescents

Use in particular groups of patients
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 your insulin dose.

How and where to inject
Actrapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). Actrapid Penfill is only suitable
for subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject insulin
using another method.
With each injection, vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin indentations, see section 4. The
best areas to inject are: the abdomen, the upper arm or the front of the thigh. Insulin will act more quickly if injected into the abdomen. Always check
your blood sugar regularly.
► Do not refill the cartridge. Once empty, it must be discarded.
► Actrapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
► If you are treated with Actrapid Penfill and another Penfill insulin cartridge, you must use two different
delivery systems, one for each type of insulin.
► Always carry a Penfill cartridge with you as a spare in case the one in use is lost or
damaged.

How to inject Actrapid
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or
nurse and as described in the pen's instruction manual.
► Keep the needle under the skin for at least 6 seconds to ensure you have injected the entire dose.
Keep the button pressed down fully until you have withdrawn the needle from the skin. This will ensure
you have injected the correct dose and will limit possible blood flow into the needle or insulin reservoir.
► After each injection, remove and discard the needle and store Actrapid without the needle attached. Otherwise, the liquid may leak causing an inaccurate dosage

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

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

If you stop taking your 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 high blood sugar level (severe
hyperglycemia) and ketoacidosis. See Effects of diabetes in section 4.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Summary of serious and very common side effects.
Low blood sugar (hypoglycemia)is a very common side effect. It may 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 Actrapid with alcohol in section 2.

Warning signs of low blood sugar: cold sweat; cold and
pale skin; headache; fast heartbeat; feeling unwell; feeling hungry; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty
concentrating.
Severe hypoglycemia can lead to loss of consciousness. If prolonged severe hypoglycemia is not
treated, it can cause brain damage (transient or permanent) up to and including death. You may regain
consciousness more quickly with an injection of the hormone 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 high-sugar snack
(sweets, biscuits, fruit juice). Measure your blood sugar if
possible and then rest. Always carry glucose tablets, sweets, biscuits or fruit juices
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 glucagon injection, or have many episodes of low blood sugar, see
your doctor. It may be necessary to adjust the dose and timing of
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 (loss of consciousness) due to hypoglycemia. Explain that, if
you should faint, they should turn you onto your side and seek immediate medical attention. It is
advisable that you are not given food or drink as you could choke.

Serious allergic reactionto Actrapid or one of its excipients (called a systemic allergic
reaction) is a rare side effect but can be life-threatening. It may 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 to sweat; you start to 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 in the skin at the injection site:If you inject insulin too often in the same place,
the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect less
than 1 in 100 people). Nodules under the skin can also be caused by the 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 nodules, an area
thinned or an area thickened. Change the injection site with each injection to prevent these
skin changes.

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

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

Visual disturbances:visual disturbances may occur at the start of insulin treatment, but this
disturbance is usually temporary.

Swollen joints: at the start of insulin treatment, fluid retention can cause swelling
around the ankles and other joints. This is a phenomenon that soon disappears. If not, contact your doctor.

Painful neuropathy(pain due to nerve damage): a rapid improvement in blood sugar levels can induce nerve pain. This is defined as acute painful neuropathy and is
normally transient.

Very rare side effects
May affect less than 1 in 10,000 people.

Diabetic retinopathy(an eye disorder related to diabetes that can lead to loss of
vision). If you have diabetic retinopathy and your blood sugar level improves very quickly,
diabetic retinopathy may worsen. Consult your doctor for more information.

Reporting of side effects
If you get any side effects, tell your doctor, pharmacist or nurse. This includes reporting side effects directly through the national reporting system
listed in Appendix V. By reporting side effects you can help provide more
information on the safety of this medicine.

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

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• 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 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 could lead to diabetic coma and eventually death.

5. How to store Actrapid

Keep out of the sight and reach of children.
Do not use Actrapid 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.

Before opening:store in a refrigerator at 2°C - 8°C. Keep away from refrigerating elements
Do not freeze.

During use or when carried as a spare:do not refrigerate or freeze. It can be carried with you
and kept at room temperature (below 30°C) for up to 6 weeks.
Always keep the cartridge inside the pack, to protect it from light.
Dispose of the needle after each injection.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Actrapid contains

• The active ingredient is human insulin. Each ml contains 100 IU of human insulin. Each cartridge contains 300 IU of human insulin in 3 ml of injectable solution.
• The excipients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Actrapid and contents of the pack
Actrapid is presented as an injectable solution.
Packs of 1, 5 or 10 cartridges of 3 ml. Not all pack sizes are marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the package flap and
on the label:

• If the second and third characters are S6, P5, K7, R7, VG, FG or ZF the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
• If the second and third characters are H7 or T6 the manufacturer is Novo Nordisk Production SAS, 45, Avenue d’Orleans, F-28000 Chartres, France.

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

Actrapid InnoLet 100 IU/ml (international units/ml)s prefilled pen solution for injection
Human insulin

Read this leaflet carefully before you start using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this side of the leaflet

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

1. What is Actrapid and what is it used for

Actrapid is a human insulin with a rapid-acting effect.
Actrapid 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. Treatment with Actrapid helps to prevent complications of diabetes.
Actrapid will begin to reduce blood sugar levels within approximately half an hour after injection and its effect will last for about 8 hours. Actrapid is often administered in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Actrapid

Do not use Actrapid
► If you are allergic (hypersensitive) to human insulin or any of the other ingredients of this medicine, see section 6.
► If you experience the warning signs of hypoglycaemia (low blood sugar), see the section on serious and very common adverse effects in section 4.
► In infusion pumps.
► If InnoLet is leaking, damaged or cracked
► If it has not been stored correctly or has been frozen see section 5.
► If the resuspended insulin does not appear as clear, colourless water.
Do not use Actrapid if any of these apply to you. Talk to your doctor, pharmacist or nurse for advice.

Before using Actrapid
► 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 Actrapid InnoLet must not be shared.
► Actrapid InnoLet 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. Talk to your doctor:
► If you have kidney or liver problems, abnormalities of the adrenal gland, pituitary gland or thyroid gland.
► If there has been an increase in physical activity or a change in your usual diet as this may affect 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 the times of these.

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 nodules under the skin.
Insulin may not work as well if you inject it into an area with nodules, into a thinned area or into a thickened area (see section 3). 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, 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 dose of insulin or other antidiabetic medicines.

Other medicines and Actrapid
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Some medicines affect blood sugar levels, which means that the dose of insulin may need to be changed. The most important common ones that can affect your insulin treatment are listed below.
Your blood sugar level may decrease (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat 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 increase (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 somatic growth and which significantly affects the body’s metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder 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 (tablets used to treat high blood pressure) can weaken or completely suppress the warning symptoms that can help you recognise low blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes mellitus)
Some patients with long-standing type 2 diabetes mellitus 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 localised swelling (oedema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actrapid with alcohol
► 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. Actrapid can be
used during pregnancy. A dose adjustment may be necessary during pregnancy and after delivery. It is important to carefully control diabetes, especially to prevent hypoglycaemic episodes, also for the health of the baby.
► There are no restrictions on treatment with Actrapid during breastfeeding.
Consult your doctor, pharmacist or nurse before taking any medicine during
pregnancy or breastfeeding.

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

• If you have frequent episodes of hypoglycaemia.
• If you find it difficult to recognise the warning signs of hypoglycaemia.

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

Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose, which means that Actrapid is
essentially “sodium-free”.

3. How to use Actrapid

Dose and when to take insulin
Always use insulin and adjust the dose according to your doctor's prescription. If you are not sure, consult your
doctor, pharmacist or nurse.
Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid
low blood sugar.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or
brand of insulin you are using to another, a dose adjustment may be necessary
by the doctor himself.

Use in children and adolescents
Actrapid can be used in children and adolescents.

Use in particular groups of patients
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 your insulin dose.

How and where to inject
Actrapid is administered by injection under the skin (subcutaneous use). You should never inject
insulin directly into the vein (intravenous route) or into the muscle (intramuscular). Actrapid InnoLet
is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin using another
method.
With each injection, vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin indentations, see section 4. The
best areas for self-injection are: the abdomen; the buttocks; the front of the thigh or
upper arm. Insulin will work faster if injected into the abdomen. Always check
your blood sugar regularly.

How to use Actrapid InnoLet
Actrapid InnoLet is a prefilled pen containing human insulin.
Read carefully the Instructions on how to use Actrapid InnoLet contained in this leaflet.
You must use the pen as described in the Instructions on how to use Actrapid InnoLet.
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 will drop too low (hypoglycemia). See
Summary of serious and very common side effects, in section 4.

If you forget to take your insulin
If you forget to take insulin, your blood sugar will become too high (hyperglycemia).
See Effects of diabetes in section 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 high level of blood sugar (severe
hyperglycemia) and ketoacidosis. See Effects of diabetes in section 4.
If you have any other questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

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.
It can occur if:

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol, see Actrapid with alcohol in section 2.

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; feeling hungry; 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 prolonged severe hypoglycemia is not treated, it can cause brain damage (transient or permanent) and even 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, 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 frequent episodes of low blood sugar, see your doctor. It may be necessary to adjust the dose and timing of your insulin, food and 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 seek immediate medical attention. You should not be given food or drink as you could choke.

Serious allergic reactionto Actrapid or any of its ingredients (called a systemic allergic reaction) is a rare side effect but 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 your 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 in the skin at the injection site:If you inject insulin too often in the same place, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the 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 has thinned, or an area that has thickened. Change the injection site with each injection to prevent these skin changes.

List of other side effects
Uncommon side effects
May affect less than 1 in 100 patients

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

Visual disturbances:visual disturbances may occur at the start of insulin treatment, but this reaction is usually temporary.

Swollen joints: at the start of insulin treatment, fluid retention can cause swelling around the ankles and other joints. This is usually a temporary phenomenon. If it does not disappear, contact your doctor.

Painful neuropathy(pain due to nerve damage). If your blood sugar improves very quickly, it may cause pain originating in the nerve fibres. This is called acute painful neuropathy and is normally transient.

Very rare side effects
May affect less than 1 in 10,000 people.

Diabetic retinopathy(an eye disorder related to diabetes that can lead to blindness). If you have diabetic retinopathy and your blood sugar improves very quickly, diabetic retinopathy may worsen. Consult your doctor for more information.

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

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

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or a fever.
• You eat more than usual.
• 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 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 could lead to diabetic coma and eventually death.

5. How to store Actrapid

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

Before opening:store in a refrigerator at 2°C - 8°C. Keep away from refrigerating elements.
Do not freeze.

During use or when carried as a spare:do not refrigerate or freeze. It can be carried with you
and kept at room temperature (below 30°C) for up to 6 weeks.
Always keep the pen cap on the InnoLet when not in use, to protect it from light.
Dispose of the needle after each injection
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Actrapid contains

• The active ingredient is human insulin. Each ml contains 100 IU of human insulin. Each pre-filled pen contains 300 IU of human insulin equivalent to 3 ml of injectable solution.
• The other excipients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.

Description of Actrapid and contents of the pack
Actrapid is presented as an injectable solution.
Packs of 1, 5 or 10 pre-filled 3 ml pens. Not all pack sizes are marketed.
The solution is clear and colourless.

Marketing authorisation holder and manufacturer
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

This leaflet was last updated on
Further information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

For information on how to use your InnoLet, turn the page.
Instructions on how to use Actrapid injectable solution in InnoLet.
Read the following instructions carefully before starting to use your InnoLet.If you do not
follow the instructions carefully, you may inject too much or too little insulin which can lead to a
blood sugar level that is too high or too low.
Your InnoLet is a simple and compact pre-filled pen capable of delivering from 1 to 50 units
in 1-unit increments. InnoLet is designed to be used with NovoFine or NovoTwist single-use needles
up to 8 mm in length. As a precaution, always carry an
insulin delivery device with you in case the InnoLet in use is lost or damaged.

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

Attaching the needle

• Always use a new needlefor each injection. This reduces the risk of contamination, infection, needle blockage, inaccurate dosing or insulin leakage.
• Be careful not to bend or damage the needle before use.
• Remove the protective sealfrom a new single-use needle.
• Screw the needle on firmly and perpendicularly to the InnoLet(figure 1A)
• Remove the large outer cap and the inner needle cap. You can keep the large outer needle cap in the designated compartment.
• Never try to put the inner needle cap back on the needle itself. You may injure yourself with the needle.

Preparing to remove air before each injection
Small amounts of air may accumulate in the needle and insulin cartridge during normal use.
To avoid injecting air and to ensure you deliver the correct dose of insulin:

• Select 2 unitsby turning the dose selector clockwise.
• Hold your InnoLet with the needle pointing upwards and gently tap the insulin cartridge with your fingersseveral times.This will cause air bubbles to collect at the top of the cartridge (figure 1B).
• Still holding the needle pointing upwards, push the injection button all the way down.The dose selector will return to zero.
• Always make sure a drop of insulin comes out of the needle tip(figure 1B) before injecting. This ensures that insulin is flowing. If this does not happen, change the needle and repeat the procedure no more than 6 times.

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

• If no drop appears, the insulin will not be injected, even if the dose selector moves. This may indicate that the needle is blocked or damaged.
• Always check your InnoLet before injecting. If you do not check InnoLet, you may inject too little insulin or not inject any at all. This can lead to a blood sugar level that is too high.

Selecting the dose

• Always make sure the injection button is fully depressed and the dose selector is at 0.
• Select the number of units to be injectedby turning the selector clockwise (figure 2). Do not use the insulin residue scale to measure the insulin dose
• You will feel a click for each single unit selected.The dose can be corrected by turning the selector in both directions. Make sure not to turn the knob or correct the dose when the needle is inserted into the skin. This can lead to inaccurate dosages that can cause your blood sugar level to become too high or too low.

Always use the dose scale and dose selector to see how many units you have selected
before injecting the insulin. Do not count the pen clicks. If you select and inject a wrong dose,
your blood sugar level may be too high or too low. Do not use the
residue scale, it only shows approximately how much insulin is left in the pen.
It is not possible to select a dose higher than the number of units remaining in the cartridge .

Injecting the insulin

• Insert the needle into the skin.Use the injection technique recommended by your doctor.
• Deliver the dose of insulin by pushing the injection button all the way down(figure 3). You will feel clicks as the dose selector returns to 0.
• After the injection, wait at least 6 seconds before removing the needleto ensure complete delivery of the dose. Make sure not to block the dose selector during injectionas it must be free to return to zero when the injection button is pressed. 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 delivered and may cause your blood sugar level to be too high.
• Remove the needle after each injection.

Removing the needle

• Put the large outer protective cap on and unscrew the needle (figure 4). Dispose of the needle withdue care.
• Put the pen cap on your InnoLet to protect the insulin from light.

Always use a new needle for each injection.
Always remove and dispose of the needle after each injection and store your InnoLet without the needle attached. This
reduces the risk of contamination, infection, needle blockage and inaccurate dose.

Further important information
Anyone caring for you should be very careful when handling used needles to reduce the
risk of needle-stick injuries and cross-infection.
Dispose of the used InnoLet with due care, 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 InnoLet and needles out of the sight and reach of others, especially children.

Pen maintenance
Your InnoLet is designed to work accurately and safely. It should be handled with
care. If it is dropped, damaged or broken, there is a risk of insulin leakage. This can cause inaccurate dosages, which can lead to a blood sugar level that is too high or too low.
You can clean the outside of your InnoLet by wiping with a disinfecting wipe. Do not immerse, wash or
lubricate
the pen to avoid damaging the mechanism and causing inaccurate dosages, which can lead to a
blood sugar level that is too high or too low.

Actrapid FlexPen 100 IU/ml (International Units/ml) injectable solution in pre-filled pen
Human insulin

Read this leaflet carefully before you start using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is Actrapid and what is it used for

Actrapid is a fast-acting human insulin.
Actrapid 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. Treatment with Actrapid helps to prevent the
complications of diabetes.
Actrapid will begin to reduce blood sugar levels approximately half an hour after
administration and its effect will last for about 8 hours. Actrapid is often administered in
combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Actrapid

Do not use Actrapid
► If you are allergic to human insulin or any of the other ingredients of this medicine,
see section 6.
► If you experience the warning signs of hypoglycaemia (low blood sugar levels),
see the Summary of serious and very common side effects in section 4.
► In insulin infusion pumps.
► If the FlexPen is leaking, damaged or cracked.
► If it has not been stored correctly or has been frozen see section 5.
► If the insulin does not appear as clear, colourless water.
Do not use Actrapid if any of these apply to you. Talk to your doctor, pharmacist or nurse for
advice.

Before using Actrapid
► 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 Actrapid FlexPen must not be shared with others.
► Actrapid 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. Talk to your doctor:
► If you have kidney or liver problems, abnormalities of the adrenal gland, pituitary gland or
thyroid gland.
► If there is an increase in physical activity or a change in your usual diet, as this
may affect your blood sugar levels.
► If you become ill: you need to 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 the times of these.

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 it into an area with lumps, into a thinned area or into a
thickened area (see section 3). 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
ask you to check your blood sugar more carefully and adjust your dose of insulin or other antidiabetic medicines.

Other medicines and Actrapid
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels, which means that your insulin dose
may need to be changed. The most common medicines that can affect insulin treatment are listed
below.
Your blood sugar level may decrease (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat 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 increase (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 somatic growth and which significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder 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 mellitus 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 localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse

Actrapid with alcohol
► 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 or suspect you may be pregnant, ask your doctor for advice before taking this medicine. Actrapid can be used during
pregnancy. You may need an adjustment of your dose during pregnancy and after
delivery. It is important to control diabetes carefully, especially to prevent episodes of
hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with Actrapid during breastfeeding.
Consult your doctor, pharmacist or nurse 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 find it difficult to recognise the warning signs of hypoglycaemia.

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

Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose, which means that Actrapid is
essentially “sodium-free”.

3. How to use Actrapid

Dose and when to take insulin
Always use insulin according to your doctor's prescription and follow their advice carefully. If you are not
sure, consult your doctor, pharmacist or nurse.
Eat a meal or snack within 30 minutes of the injection to avoid low blood sugar.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type
or brand of insulin you are using, a dose adjustment by your doctor may be necessary.

Use in children and adolescents
Actrapid can be used in children and adolescents.

Use in specific 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 your insulin dose.

How and where to inject
Actrapid is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into a muscle (intramuscularly). Actrapid FlexPen is only suitable
for subcutaneous injections. Talk to your doctor if you need to inject insulin using another method.
With each injection, always vary the injection site within the same area of skin that you usually use.
This can reduce the risk of developing nodules or skin indentations, see paragraph

• 4. The best areas to inject are: the abdomen; the buttocks; the front of the thigh or the upper arm. Your insulin will work more quickly if it is injected into the abdomen. Always check your blood sugar regularly.

How to use Actrapid FlexPen
Actrapid FlexPen is a prefilled pen containing human insulin.
You must use the pen as described in the Instructions for use of Actrapid FlexPen.
Always make sure you are using the correct pen before injecting insulin.

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

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

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

4. Possible side effects

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

Summary of serious and very common side effects.
Low blood sugar (hypoglycemia)is a very common side effect. It may affect 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 Actrapid with alcohol in section 2.

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; feeling hungry; 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 prolonged severe hypoglycemia is not treated, it can cause brain damage (transient or permanent) up to death. You can regain consciousness more quickly with an injection of the hormone glucagon performed 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 sugar cubes or another high-sugar snack (candies, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry sugar cubes, candies, biscuits or fruit juices with you, to be used if necessary.
► When the symptoms of hypoglycemia have disappeared or when blood sugar has stabilized, continue insulin treatment.
► If you have low blood sugar, you may lose consciousness, if you have needed a glucagon injection, or if you have many episodes of low blood sugar, see a doctor. It may be necessary to adjust the dose and 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 on your side and seek immediate medical attention. You should not be given food or drink as you could choke.

Serious allergic reactionto Actrapid or any of its ingredients (called a systemic allergic reaction) is a rare side effect but 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 start to 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 in the skin at the injection site:If you inject insulin too often in 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 it occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, in a thinned area or in a thickened area. Change the injection site with each injection to prevent these skin changes.

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

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

Visual disturbances:visual disturbances may occur at the beginning of insulin treatment, but this reaction is generally temporary.

Swollen joints: at the beginning of insulin treatment, fluid retention can cause swelling around the ankles and other joints. This is a phenomenon that soon disappears. If not, contact your doctor.

Painful neuropathy(pain due to nerve damage): if blood sugar improves very rapidly, it may cause pain originating in the nerve fibers. This is defined as acute painful neuropathy and is normally transient.

Very rare side effects
May affect less than 1 in 10,000 people.

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

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

Other effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or stopped taking it.
• You repeatedly take less insulin than necessary.
• You have an infection or fever.
• You eat more than usual.
• 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 could lead to diabetic coma and eventually death.

5. How to store Actrapid

Keep out of sight and reach of children.
Do not use Actrapid after the expiry date stated on the FlexPen label and the packaging, after ‘EXP’. The expiry date refers to the last day of the month.

Before opening:store in a refrigerator at 2°C - 8°C. Keep away from refrigerating elements.
Do not freeze.

During use or when carried as a spare: do not refrigerate or freeze. It can be carried with you and
kept at room temperature (below 30°C) for up to 6 weeks.
Always keep the pen cap on the FlexPen when not in use, to protect it from light.
Discard the needle after each administration.
Do not dispose of any medicine in wastewater 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 Actrapid contains

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

Description of the appearance of Actrapid and contents of the pack
Actrapid is presented as an injectable solution
Packs of 1, 5 or 10 pre-filled pens of 3 ml. Not all pack sizes are marketed.
The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the package tab and
on the label:

• If the second and third characters are S6, P5, K7, R7, VG, FG, or ZF the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
• If the second and third characters are H7 or T6 the manufacturer is Novo Nordisk Production SAS, 45, Avenue d’Orleans, F-28000 Chartres, France.

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

For information on how to use your FlexPen turn the page.
Instructions on how to use Actrapid injectable solution in FlexPen.
Read the following instructions carefully before using the FlexPen.If you do not follow
the instructions carefully, you may inject too much or too little insulin which can lead to a level of
blood sugar that is too high or too low .
FlexPen is a pre-filled pen for the administration of variable-dose insulin. It is possible to
select a dose between 1 and 60 units in increments of 1 unit. FlexPen has been designed and
tested for use with NovoFine or NovoTwist single-use needles up to 8 mm in length.
As a precaution, always carry an insulin delivery device with you in
case the FlexPen is lost or damaged.

Pen maintenance
FlexPen must be handled with care. If it leaks or has been dropped, there is a risk that it may
be damaged and insulin may leak. 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. Once empty, it must be discarded.

Preparing Actrapid FlexPen
Check the name and coloured label of your pen to ensure it contains the correct
type of insulin.This is very important if you use more than one type of insulin. If you administer a
wrong type of insulin, your blood sugar level may become too high or too low.

A
Remove the pen cap (see A)

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

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

D
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 to prevent contamination. 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
E
During normal use, small amounts of air may accumulate
in the cartridge before each injection. To avoid injecting air and to administer the correct dose of insulin:
Rotate the dose selector and select 2 units.

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

G
Holding the needle pointing upwards, press the injection button down fully. The dose selector will
return to 0.
A drop of insulin should appear at 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 should use a new one.

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

Selecting the dose
H
Verify that the dose selector is at 0.
Rotate the dose selector to select the number of units to be injected.
The dose can be increased or decreased by 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 clicks of the pen. If you select and inject the wrong dose, your blood sugar
level may become too high or too low. Do not use the scale, which only shows
approximately how much insulin is left in the pen.

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

J
Keep the button pressed down and leave the needle in the skin for at least 6 seconds. This will ensure the
complete administration of the dose.
Remove the needle from the skin and release the pressure on the injection button.
Always make sure that 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.

K
Insert the tip of the needle into the outer cap without touching it. When the needle is covered, press
the outer cap down completely and then unscrew the needle.
Dispose of the needle carefully and replace the pen cap.

Always remove the needle after each injection and store your FlexPen without 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-infection.

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-infection.

Never share the pen with other people. The medicine may be dangerous to their
health.

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