ACTRAPHANE 30 40 IU/ML Zawiesina do wstrzykiwań

Treść ulotki

1. Actraphane 30 40 UI/ml (international units/ml) injectable suspension in a vial
   1. What is Actraphane and what it is used for
   2. What you need to know before using Actraphane
   3. How to use Actraphane
   4. Possible side effects
   5. How to store Actraphane
   6. Contents of the pack and other information
2. Actraphane 30 100 IU/ml (international units/ml) injectable suspension in a vial
   1. What is Actraphane and what is it used for
   2. What you need to know before using Actraphane
   3. How to use Actraphane
   4. Possible side effects
   5. How to store Actraphane
   6. Package Contents and Other Information
   7. What is Actraphane and what is it used for
   8. What you need to know before using Actraphane
   9. How to use Actraphane
   10. Possible side effects
   11. How to store Actraphane
   12. Contents of the pack and other information
3. Actraphane 30 InnoLet 100 IU/ml (international units/ml) injectable suspension in pen
   1. What is Actraphane and what is it used for
   2. What you need to know before using Actraphane
   3. How to use Actraphane
   4. Possible side effects
   5. How to store Actraphane
   6. Contents of the pack and other information
4. Actraphane 30 FlexPen 100 IU/ml (international units/ml) injectable suspension in pen
   1. What is Actraphane and what is it used for
   2. What you need to know before using Actraphane
   3. How to use Actraphane
   4. Possible side effects
   5. How to store Actraphane
   6. Package Contents and Other Information
   7. What is Actraphane and what is it used for
   8. How to use Actraphane
   9. Possible side effects
   10. How to store Actraphane
   11. Contents of the pack and other information

Actraphane 30 40 UI/ml (international units/ml) injectable suspension in a vial

human insulin

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful, even if their symptoms of illness 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 Actraphane and what it is used for

Actraphane is a human insulin with rapid and prolonged action.
Actraphane is used to reduce the high level of sugar in patients with diabetes mellitus (diabetes).
Diabetes is a disease in which the body does not produce enough insulin to control the level
of sugar in the blood. Treatment with Actraphane helps to prevent the complications of diabetes.
Actraphane will begin to reduce the level of sugar in the blood within approximately 30 minutes
of the injection and its effect will last for approximately 24 hours.

2. What you need to know before using Actraphane

Do not use Actraphane
► 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 level),
see the Summary of serious and very common side effects in section 4.
► In infusion pumps.
► If the protective cap is loose or missing. Each vial has a plastic protective cap that is
tamper-evident. If it is not in perfect condition when you take the vial,
return it to the supplier.
► If it has not been stored correctly or has been frozen, see section 5
► If the resuspended insulin does not appear uniformly white and milky.
Do not use Actraphane if any of these apply. Talk to your doctor, pharmacist or nurse
for advice.

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

Warnings and precautions
Some conditions and activities can affect your insulin needs. Ask your doctor:
► If you have kidney or liver problems, abnormalities affecting 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 timing of injections.

Skin changes at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area or into a
thickened area (see section 3). 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 glucose more carefully and adjust your dose of insulin or other antidiabetic medicines.

Other medicines and Actraphane
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 adjusted. 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 reduce fever)
• Anabolic steroids (such as testosterone)
• Sulfonamides (used to treat infections).

Your blood sugar level may increase (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or 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 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 your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low level of
blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or
rapid weight gain or swelling in the ankles (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actraphane 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. Actraphane can be
used during pregnancy. It may be necessary to adjust your dose
during pregnancy and after delivery. It is important to control your diabetes carefully, in
particular to prevent episodes of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with Actraphane 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.

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

3. How to use Actraphane

Dosage and when to administer insulin
Always use insulin and adjust the dose according to your doctor's prescription. 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
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 themselves.

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

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

How and where to inject
Actraphane is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into a muscle (intramuscularly). 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. Your
insulin will work faster if it is injected into the abdomen. Always check your blood glucose regularly.

How to inject Actraphane
Actraphane in vials is designed to be used with insulin syringes with a scale
in units corresponding.

• 1. Rotate the vial between your hands until the liquid appears uniformly white and milky. Resuspension is easier when the insulin has reached room temperature.
• 2. Draw air into the syringe in an amount equal to the dose of insulin to be injected. Inject the air into the vial.
• 3. 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 of insulin is correct

How to inject Actraphane
► 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 ensure you have injected the entire dose.
► 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 will drop too low (hypoglycemia). See
Summary of serious and very common side effects in section 4.

If you forget to take 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 taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high level of sugar in the blood (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 everyone 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 Actraphane 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 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 glucagon hormone performed by someone who knows how to use it. If glucagon is administered, 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 your 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 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 due to hypoglycemia. Explain that, if you were to faint, they should turn you onto your side and seek immediate medical attention. You should not be given food or drink as you could choke.

Serious allergic reactionto Actraphane or any of its ingredients (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 allergy signs 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 into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency with which it occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

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.

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

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

Painful neuropathy(pain related to nerves). If blood sugar improves very quickly, it may cause pain originating in the nerve fibers. This is called acute painful neuropathy and is usually transient.

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

Visual disturbances.Visual disturbances may occur at the beginning of insulin treatment, but this reaction usually disappears.

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 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 Actraphane

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the vial label and on the
pack, after ‘EXP’. The expiry date refers to the last day of the month.
When not in use, always keep the vial in its original packaging to protect it from
light. Actraphane must be protected from excessive exposure to heat and light.

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

During use or when carrying as a supply:do not refrigerate or freeze. It can be carried with you
and kept at room temperature (below 25 ° C) for up to 6 weeks.
Always keep the vial in the packaging when not in use, to protect it from light.
Dispose of the needle and syringe after each injection.
Do not dispose of any medicine in the drain 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 Actraphane 30 contains

• The active ingredient is human insulin. Actraphane is a mixture of 30% soluble insulin and 70% isophane human insulin. Each ml contains 40 IU of human insulin. Each vial contains 400 IU of human insulin in 10 ml of injectable suspension.
• The excipients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

Description of the appearance of Actraphane and contents of the pack
Actraphane is presented as an injectable suspension. After resuspension, the liquid must
appear uniformly white and milky.
Packs of 1 or 5 vials of 10 ml or in a multipack of 5 packs of 1 x 10 ml
vials. Not all pack sizes may be marketed.
The suspension is aqueous, white and milky.

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

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd,
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orléans
F-28000 Chartres,
France

This leaflet was last 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/.

Actraphane 30 100 IU/ml (international units/ml) injectable suspension in a vial

human insulin

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, 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.

1. What is Actraphane and what is it used for

Actraphane is a human insulin with rapid and prolonged action.
Actraphane is used to reduce high blood sugar levels in patients with diabetes mellitus (diabetes).
Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels.
Treatment with Actraphane helps to prevent complications of diabetes.
Actraphane will begin to reduce blood sugar levels approximately 30 minutes after
injection and its effect will last for about 24 hours.

2. What you need to know before using Actraphane

Do not use Actraphane
► 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 level),
see the Summary of serious and very common side effects in section 4.
► In microinfusors.
► If the protective cap is loose or missing. Each vial has a plastic protective cap that is
tamper-evident. If it is not in perfect condition when you take the vial,
return it to the supplier.
► If it has not been stored correctly or has been frozen, see section 5.
► If the resuspended insulin does not appear uniformly white and milky.
Do not use Actraphane if any of these situations occur. Talk to your doctor, pharmacist or nurse
for advice.

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

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► Ifyou have kidney or liver problems, abnormalities of the adrenal gland, pituitary gland or
thyroid.
► If there has been an increase in physical activity or a change in your usual diet as
this may affect your blood sugar level.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you intend 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 should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area or into a
thickened area (see section 3). 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
dose.

Other medicines and Actraphane
Tell your doctor, pharmacist or nurse if you are taking or 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 adjusted. 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 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 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 your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low level of
blood sugar.
.
Pioglitazone (tablets used to treat type 2 diabetes mellitus)
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 a rapid weight gain or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actraphanewith 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. Actraphane can be
used during pregnancy. It may be necessary to adjust your dose
during pregnancy and after delivery. It is important to control diabetes carefully, in
particular to prevent episodes of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with Actraphane 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 or others at risk.

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

3. How to use Actraphane

Dose and when to administer insulin
Always use insulin and adjust the dose according to your doctor's prescription. If you are unsure, consult your
doctor, pharmacist or nurse.
Take a meal or snack containing carbohydrates within 30 minutes of the injection to avoid
low blood sugar levels.
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 to another, a dose adjustment may be necessary
by the doctor himself.

Use in children and adolescents
Actraphane 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, your blood sugar should be monitored
regularly and you should talk to your doctor about adjusting your insulin dose.

How and where to inject
Actraphane is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into a muscle (intramuscularly). 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 administering
the injection are: the abdomen; the buttocks; the front of the thigh or upper arm. Your
insulin will work faster if it is injected into the abdomen. Always check your blood glucose regularly.

How to inject Actraphane
Actraphane in vials is designed to be used with insulin syringes with a scale
in units corresponding to the dosage.

• 1. Rotate the vial between your hands until the liquid appears uniformly white and milky. Resuspension is easier when the insulin has reached room temperature.
• 2. Draw air into the syringe in an amount equal to the dose of insulin to be injected. Inject the air into the vial. 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 of insulin is correct.

How to inject Actraphane
► 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 ensure you have injected the entire dose.
► Dispose of the needle and syringe after each injection.

If you take more Actraphane 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 Actraphane
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 Actraphane
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 sugar in the blood (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 everyone will experience 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 Actraphane 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 prolonged and not
treated, it can cause brain damage (transient or permanent) up to death. You can regain
consciousness more quickly with an injection of glucagon hormone 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 transported 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 your blood sugar has stabilized
continue insulin treatment.
► If you have low blood sugar, you may lose consciousness, if you have needed
the 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 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 Actraphane 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 into the same place, the fatty
tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1
in 100 people). Nodules under the skin may 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 it into an area with nodules, in an area
thinned or in 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, see
your doctor immediately. Also see Serious allergic reaction.

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

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

Painful neuropathy(pain related to nerves). If blood sugar improves very quickly, it may
cause pain originating in the nerve fibers. This is defined as acute painful neuropathy and is
usually transient.

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

Visual disturbances.Visual disturbances may occur at the beginning of insulin treatment, but this
reaction usually disappears.

Reporting side effects
If you experience any side effects, inform 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 haven't 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 a greater amount of urine than
normal; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling
drowsy or tired; dry, red skin; dry mouth and fruity breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for the presence of
ketones in your urine and contact a doctor immediately.
► These may be symptoms of a very serious condition called diabetic ketoacidosis
(build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If left untreated, it can lead to diabetic coma and eventually death.

5. How to store Actraphane

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated 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 freezing agents.
Do not freeze.

During use or when carried as a supply: do not freeze or refrigerate. It is possible to carry it with you
and keep it at room temperature (below 25 ° C) for up to 6 weeks.
When not in use, always keep the vial in its original 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 Actraphane 30 contains

• The active ingredient is human insulin. Actraphane is a mixture of 30% soluble insulin and 70% isophane human insulin. Each ml contains 100 IU of human insulin. Each vial contains 1000 IU of human insulin in 10 ml of injectable suspension.
• The excipients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

Description of Actraphane and package contents
Actraphane is presented as an injectable suspension. After resuspension the liquid should
appear uniformly white and milky.
Packs of 1 or 5 vials of 10 ml or in a multipack of 5 packs of 1 x 10 ml
vials. Not all pack sizes may be marketed.
The suspension is aqueous, white and milky.

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

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd,
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orléans
F-28000 Chartres,
France

This leaflet was last 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

Actraphane 30 Penfill 100 IU/ml (international units/ml) injectable suspension in cartridge
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 Actraphane is and what it is used for
• 2. What you need to know before you use Actraphane
• 3. How to use Actraphane
• 4. Possible side effects
• 5. How to store Actraphane
• 6. Package Contents and Other Information

1. What is Actraphane and what is it used for

Actraphane is a human insulin with rapid and prolonged action.
Actraphane 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 Actraphane helps to prevent complications of diabetes.
Actraphane will begin to reduce blood sugar levels within 30 minutes of injection and its
effect will last for approximately 24 hours.

2. What you need to know before using Actraphane

Do not use Actraphane
► 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 hypoglycemia (low blood sugar level),
see the Summary of serious and very common side effects in section 4..
► In insulin pumps
► If the cartridge or the device containing the cartridge has been dropped, is damaged or cracked
► If it has not been stored correctly or has been frozen, see section 5
► If the resuspended insulin does not appear uniformly white and milky.
Do not use Actraphane if any of these occur. Talk to your doctor, pharmacist or nurse
for advice.

Before using Actraphane
► 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
further information.
► Always use a new needle for each injection to prevent contamination.
► Needles and Actraphane Penfill must not be shared.
► Actraphane Penfill is only suitable for subcutaneous injections with a reusable pen. Talk
to your doctor if you need to inject the insulin in another way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. 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, traveling 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 nodules under the skin.
Insulin may not work as well if you inject into an area with nodules, 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, 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 Actraphane
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 important common ones that can affect insulin treatment are listed below.
Blood sugar levels may be lowered (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 be raised (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 blood
sugar level.
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 localized swelling (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actraphane 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. Actraphane can be
used during pregnancy. It may be necessary to adjust the dose
during pregnancy and after delivery. It is important to carefully control diabetes, in
particular to prevent episodes of hypoglycemia, also for the health of the baby.
► There are no restrictions on treatment with Actraphane 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 have difficulty recognizing the warning signs of hypoglycemia.

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 may
put yourself or others at risk.

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

3. How to use Actraphane

Dose and when to administer insulin
Always use insulin and adjust the dose according to your doctor's prescription. If you are unsure, consult your
doctor, pharmacist, or nurse.
Take a meal or snack containing carbohydrates within 30 minutes of the injection to avoid
low blood sugar levels.
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 to another, a dose adjustment
by the doctor himself may be necessary.

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

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

How and where to inject
Actraphane is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). Actraphane Penfill is suitable
only 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 buttocks; the front of the thigh or
upper arm. Your insulin will work faster if it is injected into the abdomen. Check
your blood glucose regularly.
► Do not refill the cartridge. Once empty, it must be discarded.
► Actraphane Penfill cartridges are designed to be used with insulin delivery devices from Novo Nordisk and NovoFine or NovoTwist needles.
► If, in addition to Actraphane Penfill, you have been prescribed another insulin in a Penfill cartridge, you must
use two different insulin delivery devices, one for each type of insulin.
► Always carry an extra Penfill cartridge with you as a spare in case the one in use is
lost or damaged.

Resuspension of Actraphane
Always check if there is enough residual insulin (at least 12 units) in the cartridge to allow for
resuspension. If there is not enough residual insulin, use a new one. Consult the pen manual for further instructions.
► Every time you use a new Actraphane Penfill(before inserting the cartridge into the insulin delivery device)

• Allow the insulin to reach room temperature before use. This will facilitate resuspension.
• Move the cartridge up and down between positions aand band vice versa (see the figure) so that the glass ball moves from one end to the other of the cartridge at least 20 times.
• Repeat the movement at least 10 times before each injection.
• The movement must always be repeated until the liquid appears uniformly white and milky.
• Complete the other operations illustrated below without delay.

How to inject Actraphane
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or
nurse and as described in the pen manual.
► Keep the needle under the skin for at least 6 seconds. Keep the injection button pressed down
until the needle has been withdrawn from the skin. This will ensure correct
administration and limit possible blood flow into the needle or insulin reservoir.
► After each injection, make sure to remove the needle and discard it and store Actraphane without
the needle attached. Otherwise, liquid may leak out, which could cause an inaccurate dose.

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

If you forget to take 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 taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high level of sugar in the blood (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 everyone will experience 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 Actraphane 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, prolonged hypoglycemia is not treated, it can cause brain damage (transient or permanent) up to and including death. You can regain consciousness more quickly with an injection of glucagon hormone by someone who knows how to use it. If glucagon is administered, you will need glucose or a sugary 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 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 may be, including the risk of fainting due to hypoglycemia. Explain that, if you should 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 Actraphane or any of its ingredients (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 skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned, or an area that is 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, see your doctor immediately. Also see Serious allergic reaction.

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

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

Painful neuropathy(pain related to nerves). If blood sugar improves very quickly, it may cause pain originating in the nerve fibers. This is defined as acute painful neuropathy and is usually transient.

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

Visual disturbances.Visual disturbances may occur at the beginning of insulin treatment, but this reaction usually disappears.

Reporting of side effects
If you experience any side effects, tell 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 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 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 Actraphane

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

Before opening: cstore 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 freeze or refrigerate. It can be carried with you
and kept at room temperature (below 30 ° C) for up to 6 weeks.
When not in use, always store the cartridge in the original pack, to protect it from light.
Dispose of the needle 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 Actraphane 30 contains

• The active substance is human insulin. Actraphane is a mixture of 30% soluble insulin and 70% human isophane insulin. Each ml contains 100 IU of human insulin. Each cartridge contains 300 IU of human insulin in 3 ml of suspension for injection.
• The excipients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

Description of the appearance of Actraphane and contents of the pack
Actraphane is presented as an injectable suspension. After resuspension the liquid must
appear uniformly white and milky.
Packs of 1, 5 and 10 cartridges of 3 ml. Not all pack sizes may be
marketed.
The suspension is aqueous, white and milky.

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

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd,
Denmark
Novo Nordisk Production SAS
45, Avenue d’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/.

Actraphane 30 InnoLet 100 IU/ml (international units/ml) injectable suspension in pen

prefilled
human insulin

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, 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.

Contents of this leaflet:

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

1. What is Actraphane and what is it used for

Actraphane is a human insulin with rapid and prolonged action.
Actraphane is used to reduce the high level of sugar in patients with diabetes mellitus (diabetes).
Diabetes is a condition in which the body does not produce enough insulin to control the level
of sugar in the blood. Treatment with Actraphane helps to prevent the complications of diabetes.
Actraphane will begin to reduce the level of sugar in the blood approximately 30 minutes
after injection and its effect will last for about 24 hours.

2. What you need to know before using Actraphane

Do not use Actraphane
► 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 level),
see the Summary of serious and very common side effects, in section 4.
► In insulin pumps
► If InnoLet has been knocked, is damaged or cracked
► If it has not been stored correctly or has been frozen, see section 5
► If the resuspended insulin does not appear uniformly white and milky.
Do not use Actraphane if any of these apply. Talk to your doctor, pharmacist or nurse
for advice.

Before using Actraphane
► 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 Actraphane InnoLet must not be shared.
► Actraphane 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 affecting 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 could 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.

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

Other medicines and Actraphane
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 adjusted. The most common medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Your blood sugar level may be raised (hyperglycaemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as “cortisone” used to treat inflammation)
• Thyroid hormones (used to treat thyroid 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 your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low blood sugar level.
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 (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actraphane 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. Actraphane can be
used during pregnancy. It may be necessary to adjust your dose during pregnancy and after delivery. It is important to control your diabetes carefully, in
particular to prevent episodes of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with Actraphane 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 high or low, it 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 or others at risk.

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

3. How to use Actraphane

Dosage 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 do so. 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
Actraphane can be used in children and adolescents.

Use in special 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
Actraphane is administered by injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into a muscle (intramuscularly). Actraphane Innolet is suitable
only for subcutaneous injections. Talk to your doctor if you need to inject insulin by another method.
With each injection, vary the injection site within the particular area of skin that 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 buttocks; the front of the thigh or
upper arm. Your insulin will work faster if it is injected into the abdomen. Check
your blood glucose regularly.

How to inject Actraphane 30 InnoLet
Actraphane 30 InnoLet is a prefilled pen containing a mixture of fast-acting insulin and
long-acting human insulin in a 30/70 ratio.
Read carefully the Instructions for use of Actraphane 30 InnoLet included in the leaflet
instructions. You must use the pen as described in the Instructions for use of Actraphane 30 InnoLet.
Always make sure you are using the correct pen before administering 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 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 taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high level of sugar in the blood (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

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 experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You do more physical activity than usual.
• You consume alcohol, see Actraphane with alcohol in paragraph 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 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 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 transported 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, you may lose consciousness, if you have needed
the glucagon injection, or if you have many episodes of low blood sugar, consult
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 due to hypoglycemia. Explain that, if you were to faint, they should
turn you on your side and request immediate medical attention. It is advisable that you are not
given food or drink as you could choke.

Serious allergic reactionto Actraphane 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: 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 into the same place, the fatty
tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1
in 100 people). Lumps under the skin can also be caused by the accumulation of a protein
called amyloid (cutaneous amyloidosis; the frequency with which it 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, 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.

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

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

Painful neuropathy(pain related to nerves). If blood sugar improves very quickly, 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

Visual disturbances.Visual disturbances may occur at the beginning of insulin treatment, but this
reaction usually disappears.

Reporting of side effects
If you experience any side effects, inform your doctor, pharmacist or nurse. This includes
any side effect 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 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 a greater amount of urine than
normal; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling
drowsy or tired; dry, red 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 the presence of
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 Actraphane

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date 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.
When not in use, always keep the pen cap on the InnoLet to protect it from
light.
Dispose of the needle 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. Contents of the pack and other information

What Actraphane 30 contains

• The active ingredient is human insulin. Actraphane is a mixture of 30% soluble human insulin and 70% isophane 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 suspension.
• The excipients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

Description of Actraphane and contents of the pack
Actraphane is presented as an injectable suspension. After resuspension the liquid should
appear uniformly white and milky.
Packs of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be
marketed.
The suspension is aqueous, white and milky.

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 Actraphane 30 injectable suspension in InnoLet.
Read the following instructions carefully before using your InnoLet.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.
InnoLet is a simple and compact pre-filled pen capable of delivering from 1 to 50 units of insulin with
increments of 1 unit. InnoLet is designed to be used with NovoFine or NovoTwist disposable needles
up to 8 mm in length. As a precaution, always carry with you a
insulin delivery device in case the InnoLet in use is lost or damaged.

To get started
Check the name and colored label of yourInnoLet to verify that it contains the correct type
of insulin. This is especially 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. It is easier to resuspend the insulin if it has reached
room temperature.

Resuspending the insulin
Before each injection:

• To allow uniform mixing, make sure there are at least 12 units of insulin in the cartridge. If there are less than 12 units of medicine, use a new InnoLet.
• Move the penbetween positions A and B and vice versa so that the glass ball moves from one end to the other of the insulin cartridge at least 20 times (figure 1A). Repeat the movement 10 times each before subsequent uses. The movement should always be repeated until the liquid appears uniformly white and milky.
• Always make sure to resuspend the insulin before each injection. If you do not resuspend the insulin, this can lead to inaccurate dosages that can make the blood sugar level too high or too low. After resuspending, immediately complete

the other operations illustrated below.

Attaching the needle

• Always use a new needlefor each injection. This reduces the risk of contamination, infection, needle blockage, or incorrect dosage.
• Be careful not to bend or damage the needle before use.
• Remove the protective sealfrom a new disposable needle.
• Screw the needle firmly and perpendicularly onto the InnoLet (figure 1B).
• Remove the large outer needle cap and the inner needle cap.It may be helpful to keep the large outer needle cap in the designated compartment.
• Never try to put the inner needle cap back on the needle itself. You could 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 the InnoLet with the needle pointing upwards and gently tap the insulin cartridge with your fingers several times (figure 1C), allowingair bubbles to collect at the top of the cartridge.
• Still holding the needle pointing upwards, press the injection button all the way down.The dose selector will return to 0.
• Always make sure a drop of insulin comes out of the end of the needle (figure 1C)before the injection. This ensures insulin is flowing. If this does not happen, change the needle and repeat the procedure no more than 6 times.

Further failure to eject a drop of insulin indicates that 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 the injection. If you do not check InnoLet, you may inject too little insulin or may 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 pressed all the way down and that the dose selector is positioned at 0.
• Select the number of units to be injectedby rotating the selector clockwise (figure 2).
• You will feel a click for each single unit selected.The dose can be corrected by rotating the selector in both directions. Make sure not to rotate the knob or correct the dose when the needle is inserted into the skin. This can lead to inaccurate dosages that can make the blood sugar level 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 the wrong dose,
the blood sugar level may be too high or too low. Do not use the residual 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.
• Administer the dose of insulin by pushing the injection button all the way down (figure 3).You will feel clicks as the selector returns to 0.
• After the injection, wait at least 6 seconds before removing the needleto ensure complete delivery of the dose.
• Make sure you do not block the dose selector during injectionas it must be free to return to 0 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 administered and may cause a blood sugar level that is 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 with
  due caution.
• Put the pen cap on your InnoLet to protect the insulin from light.

Always use a new needle for each injection.
Remove and discard the needle after each injection and store 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 pay close attention when handling used needles to reduce
the risk of needle stick injuries and cross-infection.
Dispose of used InnoLet with due caution, making sure to remove the needle.
Never share the pen and needles with other people. This can lead to cross-infection.
Never share the pen with other people. The medicine may be dangerous to their health.
Always keep InnoLet and needles out of 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 has been bumped, is damaged or injured, there is a risk of insulin leakage. 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 the InnoLet by wiping with a disinfecting wipe. Do not immerse, wash or
lubricate it to avoid damaging the mechanism and causing inaccurate dosages, which can lead to
a blood sugar level that is too high or too low.
Do not refill the InnoLet. Once empty, it must be discarded.

Actraphane 30 FlexPen 100 IU/ml (international units/ml) injectable suspension in pen

pre-filled
human insulin

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

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

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

1. What is Actraphane and what is it used for

Actraphane is a human insulin with rapid and prolonged action.
Actraphane is used to reduce the high level of sugar in patients with diabetes mellitus (diabetes).
Diabetes is a disease in which the body does not produce enough insulin to control the level
of sugar in the blood. Treatment with Actraphane helps to prevent the complications of diabetes.
Actraphane will begin to reduce the level of sugar in the blood within 30 minutes
of the injection and its effect will last for approximately 24 hours.

2. What you need to know before using Actraphane

Do not use Actraphane
► 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 microinfusers.
► If FlexPen has been knocked, is damaged or cracked.
► If it has not been stored correctly or has been frozen, see section 5.
► If the resuspended insulin does not appear uniformly white and milky.
Do not use Actraphane if any of these occur. Talk to your doctor, pharmacist or nurse
for advice.

Before using Actraphane
► 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 Actraphane FlexPen should not be shared.
► Actraphane FlexPen is only suitable for subcutaneous injections. Talk to your doctor if you need to
inject the insulin in a different way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver disorders, abnormalities of the adrenal gland, pituitary gland or
thyroid.
► If there has been an increase in physical activity or a change in your usual diet as this may
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.

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, 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, 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 dose of insulin or other antidiabetic medicines.

Other medicines and Actraphane
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 adjusted. 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 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 (oral antidiabetic 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 (edema).
If you have taken any of the medicines listed, tell your doctor, pharmacist or nurse.

Actraphane 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. Actraphane can be
used during pregnancy. It may be necessary to adjust your dose
during pregnancy and after delivery. It is important to carefully control your diabetes, in
particular to prevent episodes of hypoglycaemia, also for the health of the baby.
► There are no restrictions on treatment with Actraphane 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, it 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 or others at risk.

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

3. How to use Actraphane

Dosage and when to take insulin
Always use insulin and adjust the dose according to your doctor's prescription. 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
low blood sugar.
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 to another, a dose adjustment may be necessary
by the doctor himself.

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

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

How and where to inject
Actraphane is administered by injection under the skin (subcutaneous use). Do not inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). Actraphane FlexPen is
suitable only 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 injection are: the abdomen; the buttocks; the front of the thigh or
upper arm. Your insulin will work faster if it is injected into the abdomen. Always check
your blood glucose regularly.

How to inject Actraphane 30 FlexPen
Actraphane 30 FlexPen is a prefilled pen containing a mixture of fast-acting insulin and
long-acting human insulin in a 30/70 ratio.
Read carefully the Instructions on how to use Actraphane 30 FlexPen included in the package leaflet.
You must use the pen as described in the Instructions on how to use Actraphane 30 FlexPen.
Always make sure you are using the correct pen before administration.

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 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 taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a high level of sugar in the blood (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 Actraphane 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 severe hypoglycemia is prolonged and not
treated, it can cause brain damage (transient or permanent) up to death. You can regain
consciousness more quickly with an injection of glucagon hormone 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 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 blood sugar has stabilized
continue insulin treatment.
► If you have low blood sugar, you may lose consciousness, if you have needed
the 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 can be, including the
risk of fainting due to hypoglycemia. Explain that, if you were to faint, they must
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 Actraphane or any of its ingredients (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: start sweating; start feeling sick (vomiting); 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 into the same place, the fatty
tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1
in 100 people). Lumps under the skin can also be caused by the accumulation of a protein
called amyloid (cutaneous amyloidosis; the frequency with which 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, consult your
doctor immediately. Also see Serious allergic reaction.

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

Swollen joints: At the beginning of insulin treatment, fluid retention can cause swelling
around the ankles and other joints. This is usually a temporary phenomenon that goes away soon. If it does not, contact your doctor.

Painful neuropathy(pain related to nerves). If blood sugar improves very quickly, it may
cause pain originating from 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

Visual disturbances.Visual disturbances may occur at the beginning of insulin treatment, but this
reaction normally disappears.

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 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 Actraphane

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

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

During use or when carrying as a spare:do not refrigerate or freeze. It is possible to carry it with you
and keep it at room temperature (below 30 ° C) for up to 6 weeks.
When not in use, always keep the pen cap on the FlexPen to protect it from light.
Dispose of the needle 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 Actraphane 30 contains

• The active substance is human insulin. Actraphane is a mixture of 30% soluble insulin and 70% isophane insulin. Each ml contains 100 IU of human insulin. Each pre-filled pen contains 300 IU of human insulin in 3 ml of injectable suspension.
• The excipients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

Description of Actraphane and package contents
Actraphane is presented as an injectable suspension. After resuspension the liquid should
appear uniformly white and milky.
Packs of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be
marketed.
The suspension is aqueous, white and milky.

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

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd,
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orleans
F-28000 Chartres,
France

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 FlexPen turn the page.
Instructions on how to use Actraphane 30 injectable suspension 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 unique pre-filled pen for delivering 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 to be used with NovoFine or NovoTwist disposable needles up to
8 mm in length. As a precaution, always carry a spare device with you for
insulin delivery in case the FlexPen in use is lost or damaged.

Pen Maintenance
Your FlexPen must be handled with care.
If it leaks or has been knocked, there is a risk that it is damaged and insulin is leaking. 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 Actraphane 30 FlexPen
A
Check the name and coloured label of your pen to verify that 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, the blood sugar level may become too high or too low.

Each time you use a new pen
Allow the insulin to reach room temperature before use.
This will make resuspension easier. Remove the pen cap (see A).

B
Before each injection with a new FlexPen, you must resuspend the insulin:
Move the pen up and down twenty times between the positions as shown, so that the glass ball
moves between the two ends of the cartridge. Repeat the procedure until the liquid appears
uniformly white and milky.

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

Always check that there are at least 12 units of insulin available in the cartridge to be able to
perform the resuspension. If there are less than 12 units, use a new FlexPen. 12 units
are marked on the scale. Observe the large figure at the top of the instructions.

Do not use the pen if the resuspendedinsulin does not appear uniformly white and milky.
Insert the needle
C
Remove the protective seal from a new disposable needle.
Screw the needle onto your FlexPen perpendicularly and firmly.

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

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

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

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

Always make sure a drop appears at the tip of the needle before the injection. This
ensures 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 amount of insulin or may not inject any at all. This can lead to a
blood sugar level that is too high.

Selecting the dose
I
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 the insulin, always use the dose selector and indicator to see how many
units have been selected.

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

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

K
Keep the button pressed down fully and leave the needle in the skin for at least 6 seconds. This will ensure the
complete delivery of the dose.
Withdraw 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 delivered and may
cause a blood sugar level that is too high.

L
Insert the tip of the needle into the outer cap without touching it. When the needle is covered, press
firmly and carefully on the outer cap and then unscrew the needle.

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

Other important information

Anyone caring for you should be very careful when handling used needles to reduce
the risk of needle stick injuries and cross-infection.

Dispose of the used FlexPen with due caution, making sure to remove the needle.

Never share the pen and needles with other people. This can lead to cross-infection.

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

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

Actraphane 5 Penfill 100 IU/ml (international units/ml) suspension 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 only for you. It may be harmful if other people use it, even if their symptoms
  of illness 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 Actraphane and what is it used for
• 2. What you need to know before you use Actraphane
• 3. How to use Actraphane
• 4. Possible side effects
• 5. How to store Actraphane
• 6. Contents of the pack and other information

1. What is Actraphane and what is it used for

Actraphane is a human insulin with rapid and prolonged action.
Actraphane is used to reduce high blood sugar levels in patients with diabetes mellitus (diabetes).
Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels.
Treatment with Actraphane helps to prevent complications of diabetes.
Actraphane will begin to lower blood sugar levels within approximately 30 minutes of injection and its effect will last for approximately 24 hours.

What you need to know before you use Actraphane
Do not use Actraphane
► 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 hypoglycemia (low blood sugar), see the Summary of serious and very common side effects in section 4.
► In microinfusers.
► If the cartridge or the device containing the cartridge has been bumped, is damaged or cracked.
► If it has not been stored correctly or has been frozen, see section 5.
► If the resuspended insulin does not appear uniformly white and milky.
Do not use Actraphane if any of these occur. Talk to your doctor, pharmacist or nurse for advice.

Before using Actraphane
► Check the label to make sure it is the correct type of insulin.
► Always check the cartridge, including the rubber plunger on top of the cartridge. Do not use it if it appears damaged or if the rubber plunger has been pushed beyond the white band on top of the cartridge. This could lead to insulin leakage.
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 Actraphane Penfill should not be shared.
► Actraphane Penfill is only suitable for subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject insulin in another way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, abnormalities of the adrenal gland, pituitary gland or thyroid.
► If you drink alcohol: be careful of any warning signs of hypoglycemia and never drink alcohol on an empty stomach.
► If there has been an increase in physical activity or a change in your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue your insulin therapy and consult your doctor.
► If you plan to travel abroad, traveling to countries with a different time zone may change your insulin needs and schedules.

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 into an area with nodules, an area that is thinned, or an area that is thickened (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 ask you to check your blood sugar more carefully and adjust your dose of insulin or other antidiabetic medications.

Other medicines and Actraphane
Tell your doctor, pharmacist or nurse if you are taking or have recently taken or may take any other medicines.
Some medicines affect blood sugar levels, which means that the dose of insulin may need to be adjusted. The most common medicines that can affect insulin treatment are listed below.
Blood sugar levels may be lowered (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 reduce fever)
• Anabolic steroids (such as testosterone)
• Sulfonamides (used to treat infections).

Blood sugar levels may be increased (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 (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 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 blood sugar level.
Pioglitazone (tablets used to treat type 2 diabetes mellitus)
Some patients with long-lasting 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.

Actraphane with alcohol
► If you drink alcohol, your insulin needs may change as your blood sugar levels 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. Actraphane 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 episodes of hypoglycemia, also for the health of the baby.
► There are no restrictions on the use of Actraphane during breastfeeding.
Consult your doctor, pharmacist or nurse before taking any medicine during pregnancy or breastfeeding.

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

• If you have frequent episodes of hypoglycemia.
• If you find it difficult to recognize the warning signs of hypoglycemia.

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

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

3. How to use Actraphane

Dosage and when to administer insulin
Always use insulin and adjust the dose according to your doctor's prescription. If you are unsure, consult your
doctor, pharmacist or nurse.
Take a meal or snack containing carbohydrates within 30 minutes of the injection to avoid
low blood sugar levels.
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 to another, a dose adjustment may be necessary
by the doctor himself.

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

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

How and where to inject
Actraphane is indicated for injection under the skin (subcutaneous use). Never inject insulin
directly into a vein (intravenously) or into the muscle (intramuscularly). Actraphane Penfill is suitable
only 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 paragraph 4. The
best areas to inject are: the abdomen; the buttocks; the front of the thigh or
upper arm. Your insulin will work faster if it is injected into the abdomen. Always check
your blood sugar levels regularly.
► Do not refill the cartridge. Once empty, it must be discarded.
► Actraphane Penfill cartridges are designed to be used with insulin delivery devices from
Novo Nordisk and NovoFine or NovoTwist needles.
► If, in addition to Actraphane Penfill, you have been prescribed another insulin in a Penfill cartridge, you must
use two different insulin delivery devices, one for each type of insulin.
► Always carry another Penfill cartridge with you as a spare in case the one in use is
lost or damaged.

Resuspension of Actraphane
Always check if there is enough residual insulin (at least 12 units) in the cartridge to allow
resuspension. If there is not enough residual insulin, use a new one. Consult the pen manual for further instructions.
► Every time you use a new Actraphane Penfill(before inserting the cartridge into the insulin device)

• Allow the insulin to reach room temperature before using it. This will facilitate resuspension.
• Move the cartridge up and down between positions aand band vice versa (see the figure) so that the glass ball moves from one end to the other of the cartridge at least 20 times.
• Repeat the movement at least 10 times before each injection.
• The movement must always be repeated until the liquid appears uniformly white and milky.
• Complete the other operations illustrated below without delay.

How to inject Actraphane
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or
nurse and as described in the pen manual.
► Keep the needle under the skin for at least 6 seconds. Keep the injection button pressed down
until the needle has been withdrawn from the skin. This will ensure correct
administration and limit possible blood flow into the needle or insulin reservoir.
► After each injection, make sure to remove the needle and dispose of it and store Actraphane without
the needle attached. Otherwise, liquid may leak out, which could cause an inaccurate dose.

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

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

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

• You inject too much insulin.
• You eat too little or miss meals.
• You do more physical activity than usual.
• You drink alcohol, see Actraphane 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 vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not
treated, it can cause brain damage (transient or permanent) up to 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 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 your blood sugar has stabilized
continue insulin treatment.
► If you have low blood sugar, have needed a 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.
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 must
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 Actraphane 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 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 into the same place, the fatty
tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1
in 100 people). Lumps under the skin can also be caused by the build-up 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, 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, see
your doctor immediately. Also see Serious allergic reaction.

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

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

Painful neuropathy(pain related to nerves). If blood sugar improves very quickly, it may
cause pain originating in nerve fibers. This is defined as acute painful neuropathy which
is normally transient.

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

Visual disturbances.Visual disturbances may occur at the beginning of insulin treatment, but this
reaction usually disappears.

Reporting of side effects
If you get any side effects, tell 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 detailed 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 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 Actraphane

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cartridge label and the
packaging. 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 agents.
Do not freeze.

During use or when carrying as a supply:do not refrigerate or freeze. It is possible to carry it with you
and keep it at room temperature (below 30 ° C) for up to 6 weeks.
When not in use, always store the cartridge in its original 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. Contents of the pack and other information

What Actraphane 50 contains

• The active substance is human insulin. Actraphane is a mixture of 50% soluble insulin and 50% isophane insulin. Each ml contains 100 IU of human insulin. Each cartridge contains 300 IU of human insulin in 3 ml of injectable suspension.
• The excipients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

Description of the appearance of Actraphane and contents of the pack
Actraphane is presented as an injectable suspension. After resuspension, the liquid must
appear uniformly white and milky. Packs of 1, 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.
The suspension is aqueous, white and milky

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

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/.