Package leaflet: Information for the user

Actrapid 40 IU/ml (international units/ml) injection solution in vial

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

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

1. What Actrapid is and what it is used for

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

2. What you need to know before using Actrapid

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

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

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

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

Other medicines and Actrapid
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels, meaning your insulin dose may need adjustment. Listed below are the most common medicines that may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) if you take:

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

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

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

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

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

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Actrapid can be used during pregnancy. Your insulin dose may need to be adjusted during pregnancy and after delivery. It is important to control diabetes carefully, especially to prevent episodes of hypoglycaemia, for the health of both mother and baby.
► There are no restrictions on the use of Actrapid during breastfeeding.

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

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

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

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

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

3. How to use Actrapid

Dose and when to administer insulin
Always use insulin exactly as prescribed by your doctor and follow his or her instructions carefully. If you are unsure, consult your doctor, pharmacist, or nurse.
Take a meal or a snack containing carbohydrates within 30 minutes of 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, a dose adjustment may be necessary.
Use in children and adolescents
Actrapid can be used in children and adolescents.
Use in specific patient groups
If you have renal or liver impairment, or if you are over 65 years of age, monitor your blood sugar levels regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
Actrapid is administered by subcutaneous injection (under the skin). Never inject insulin directly into a vein (intravenous route) or into muscle (intramuscular route). If necessary, Actrapid may be administered directly into a vein, but this must be performed exclusively by healthcare professionals.
With each injection, rotate the injection site within the particular area of skin you usually use. This may reduce the risk of developing lumps or skin depressions; see section 4. The best areas for injection are: the abdominal area, the upper arm, or the front of the thigh. Insulin will act more quickly if injected into the abdomen. Always check your blood glucose levels regularly.
How to inject Actrapid
Actrapid in vials is designed to be used with insulin syringes calibrated in units corresponding to
If using only one type of insulin

Draw into the syringe an amount of air equal to the dose of insulin to be injected. Inject this 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 verify that the dose is correct.

If mixing two types of insulin

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

If you inject more insulin than you should
If you inject too much insulin, your blood sugar level will drop too low (hypoglycemia). See Summary of serious and very common adverse effects in section 4.
If you forget to inject your insulin
If you forget to inject your insulin, your blood sugar level will become too high (hyperglycemia). See Effects of diabetes in section 4.
If you stop using your insulin
Do not stop treatment with insulin without first discussing it with your doctor, who will advise you on what to do. Stopping treatment may lead to high blood sugar levels (severe hyperglycemia) and ketoacidosis. See 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 level (hypoglycaemia) is a very common side effect. It may occur in more than 1 in 10 people.
You may experience low blood sugar if:

You inject too much insulin.
You eat too little or skip meals.
You exercise more than usual.
You consume alcohol; see Actrapid with alcohol in section 2.

Warning signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; hunger sensation; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital.
What to do if your blood sugar level is low:
► If your blood sugar is too low, eat sugar lumps or another sugary snack (candies, biscuits, fruit juice). Measure your blood sugar if possible, then rest. Always carry sugar lumps, candies, biscuits or fruit juice with you, to use if needed.
► When symptoms of hypoglycaemia have disappeared or when your blood glucose has stabilized, continue your insulin treatment.
► If you have low blood sugar, you may lose consciousness. If you required a glucagon injection, or if you have frequent episodes of low blood sugar, consult your doctor. A dose adjustment of insulin, as well as timing of insulin, food intake, and physical activity, may be necessary.
Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting (loss of consciousness) due to hypoglycaemia. Explain that, if you faint, they should turn you onto your side and immediately call for medical help. It is important that food or drink not be given, as you could choke.

Severe allergic reaction to Actrapid or to one of its excipients (called systemic allergic reaction) is a rare side effect but can be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

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

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

List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. Also refer to Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but this condition is usually temporary.
Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is a temporary phenomenon that soon disappears. If not, contact your doctor.
Painful neuropathy (pain due to nerve damage): if your blood sugar level improves rapidly, you may experience nerve pain. This is called painful neuropathy and is normally transient.

Very rare side effects
May affect fewer than 1 in 10,000 people
Diabetic retinopathy (a diabetes-related eye disorder that may lead to vision loss). If you have diabetic retinopathy and your blood sugar level improves very rapidly, diabetic retinopathy may worsen. Consult your doctor for further information.

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

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

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

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

5. How to store Actrapid

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the packaging, following "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 may be carried with you and stored at room temperature (below 25°C) for up to 4 weeks.
Always keep the vial in its outer packaging to protect it from light.
Dispose of the needle and syringe after each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Actrapid contains

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

Description of the appearance of Actrapid and contents of the pack
Actrapid is a clear, colourless injectable solution.
Packs of 1 or 5 vials of 10 ml or a multiple pack of 5 packs of 1 x 10 ml vial. Not all pack sizes may be marketed.

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

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

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

Package leaflet: Information for the user

Actrapid 100 IU/ml (international units/ml) solution for injection in vial

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
If you experience any adverse reaction, contact your doctor, pharmacist, or nurse. This includes any adverse reaction not listed in this leaflet. See section 4.

1. What Actrapid is and what it is used for

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

2. What you need to know before using Actrapid

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

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

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

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

Other medicines and Actrapid
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels, meaning your insulin dose may need to be adjusted. Listed below are the most common medicines that may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) if you take:

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

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

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

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

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

Actrapid and alcohol
► If you consume alcohol, your insulin requirement may change, as blood sugar levels may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Actrapid can be used during pregnancy. Dose adjustments may be necessary during pregnancy and after delivery. It is important to carefully control diabetes, particularly to prevent hypoglycaemic episodes, for the health of both mother and baby.
► There are no restrictions on the use of Actrapid during breastfeeding.
Consult your doctor, pharmacist, or nurse before taking any medicine during pregnancy or breastfeeding.

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

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

If your blood sugar is high or low, this may impair your concentration and reaction ability, and consequently your ability to drive or operate machinery. Be aware that you could put yourself and others at risk.

Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose, i.e. Actrapid is essentially "sodium-free".

3. How to use Actrapid

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and follow their advice carefully. If you are
unsure, consult your doctor, pharmacist, or nurse.
Eat a meal or a snack containing carbohydrates within 30 minutes after injection to avoid low blood
sugar.
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be necessary and must be determined by your
doctor.
Use in children and adolescents
Actrapid can be used in children and adolescents.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years old, you should monitor your blood
glucose regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
Actrapid is administered by subcutaneous injection (under the skin). Never inject insulin directly into a
vein (intravenous) or into muscle (intramuscular). If necessary, Actrapid may be administered directly
into a vein, but this must be done exclusively by healthcare professionals.
With each injection, rotate the injection site within the particular area of skin you usually use. This can
help reduce the risk of developing lumps or skin depressions; see section 4. The best areas for
injection are: the abdomen, the upper arm, or the front of the thigh. Insulin will act more quickly if
injected into the abdomen. Always monitor your blood glucose regularly.
How to inject Actrapid
Actrapid in vials is designed to be used with insulin syringes calibrated in units.
If you are using only one type of insulin:

Draw into the syringe an amount of air equal to the dose of insulin you need to inject. Inject this 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 is correct.

If you need to mix two types of insulin:

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

How to inject Actrapid
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or
nurse.
► Keep the needle under the skin for at least 6 seconds to ensure the full dose of insulin has been
injected.
► Dispose of the needle and syringe after each injection.
If you use more insulin than you should
If you use too much insulin, your blood sugar level will drop too low (hypoglycemia). See Summary
of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level may become too high (hyperglycemia). See
Effects of diabetes in section 4.
If you stop using your insulin
Do not stop using insulin without first discussing it with your doctor, who will advise you on what to
do. Stopping treatment could lead to high blood sugar levels (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 affect 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 are more physically active than usual.
You consume alcohol; see Actrapid with alcohol in section 2.

Warning symptoms of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat;
feeling unwell; hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness;
nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to unconsciousness. If prolonged severe hypoglycemia is not treated, it
can cause brain damage (transient or permanent) and may even result in death. Recovery may be
faster with an injection of the hormone glucagon given by someone trained in its use. 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 must 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 snack high in sugar (candy, biscuits, fruit
juice). Check your blood sugar if possible, then rest. Always carry sugar cubes, candy, biscuits, or
fruit juice with you for use in emergencies.
► When symptoms of hypoglycemia have subsided or your blood sugar has stabilized, continue your
insulin treatment.
► If you experience low blood sugar and lose consciousness, require a glucagon injection, or have
frequent episodes of low blood sugar, contact your doctor. A dose adjustment may be needed, as
well as changes to the timing of insulin, food, and physical activity.
Inform people close to you that you have diabetes and explain the possible consequences, including
the risk of fainting (loss of consciousness) due to hypoglycemia. Explain that if you faint, they should
turn you onto your side and seek immediate medical help. It is important that no food or drink is
given, as you could choke.

Severe allergic reaction to Actrapid or one of its excipients (called a systemic allergic reaction) is a
rare side effect but may be life-threatening. It may affect fewer than 1 in 10,000 people.
Contact your doctor immediately:

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

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

List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and
itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If
symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See
also Severe allergic reaction.
Visual disturbances: At the start of insulin treatment, visual disturbances may occur, but this is
usually temporary.
Swollen joints: At the beginning of insulin treatment, fluid retention may cause swelling around the
ankles and other joints. This effect usually resolves quickly. If not, contact your doctor.
Painful neuropathy (pain due to nerve damage): If blood sugar levels improve rapidly, you may
experience nerve pain. This is known as acute painful neuropathy and is usually temporary.

Very rare side effects
May affect fewer than 1 in 10,000 people.
Diabetic retinopathy (a diabetes-related eye disorder that may lead to vision loss). If you have
diabetic retinopathy and your blood sugar improves very rapidly, the retinopathy may worsen. Consult
your doctor for further information.

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

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 required.
You have an infection or fever.
You eat more than usual.
You are less physically active than usual.

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

5. How to store Actrapid

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and packaging, following "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 cooling elements.
Do not freeze.
During use or when carried as a spare supply: do not refrigerate or freeze. It may be carried with you and stored at room temperature (below 25°C) for up to 6 weeks.
Always keep the vial in its outer packaging to protect it from light.
Dispose of the needle and syringe after each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Actrapid contains

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

Description of the appearance of Actrapid and package contents
Actrapid is a clear and colourless injectable solution.
Pack sizes: 1 or 5 vials of 10 ml or a multiple pack of 5 packs of 1 x 10 ml vial.
Not all pack sizes may be marketed.

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

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

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

Package leaflet: Information for the user

Actrapid Penfill 100 UI/ml (international units/ml) injectable solution in cartridge

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Never give it to others. This medicine may be harmful to other people, even if their symptoms are similar to yours.
If you experience any side effect, talk to your doctor, pharmacist, or nurse. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet

What Actrapid is and what it is used for
What you need to know before using Actrapid
How to use Actrapid
Possible side effects
How to store Actrapid
Contents of the pack and other information

1. What Actrapid is and what it is used for

Actrapid is a human insulin with a rapid-acting effect.
Actrapid is used to reduce high blood sugar levels in patients with diabetes mellitus (diabetes).
Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels.
Treatment with Actrapid helps prevent complications of diabetes.
Actrapid begins to lower blood sugar levels within approximately 30 minutes after administration, and its effect lasts for about 8 hours. Actrapid is often administered in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Actrapid

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

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

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

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

Other medicines and Actrapid
Inform your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels, meaning your insulin dose may need to be adjusted. Listed below are the most common medicines that may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) if you take:

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

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

Oral contraceptives (birth control pills)
Thiazides (used to treat high blood pressure or fluid retention)
Glucocorticoids (such as "cortisone" used to treat inflammation)
Thyroid hormones (used to treat thyroid gland disorders)
Sympathomimetics, such as epinephrine (adrenaline), salbutamol 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 usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.

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

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

Pregnancy and breastfeeding
► If you are pregnant or planning to become pregnant, consult your doctor before taking this medicine.
Actrapid can be used during pregnancy. Dose adjustments may be necessary during pregnancy and after delivery. It is important to carefully control diabetes, particularly to prevent hypoglycaemic episodes, for the health of both mother and baby.
► There are no restrictions on the use of Actrapid during breastfeeding.
Consult your doctor, pharmacist or nurse before taking any medicine during pregnancy or breastfeeding.

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

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

If your blood glucose is high or low, this may impair your concentration and reaction ability, and therefore your ability to drive or operate machinery. Bear in mind that you could endanger yourself or others.

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

3. How to use Actrapid

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and follow his or her instructions carefully. If you are
unsure, consult your doctor, pharmacist, or nurse.
Take a meal or a snack containing carbohydrates within 30 minutes of 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, a dose adjustment may be necessary.
Use in children and adolescents
Actrapid can be used in children and adolescents.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years old, you should monitor your blood sugar regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
Actrapid is administered by subcutaneous injection (under the skin). Never inject insulin directly into a vein (intravenous route) or into muscle (intramuscular route). Actrapid Penfill is intended for subcutaneous use only with a reusable insulin pen. Speak with your doctor if you need to administer insulin by another method.
With each injection, rotate the injection site within the particular area of skin you usually use.
This may reduce the risk of developing skin lumps or depressions; see section 4. The best areas for injection are: the abdominal area, the upper arm, or the front of the thigh. Insulin will act more quickly if injected into the abdomen. Always check your blood glucose levels regularly.
► Do not refill the cartridge. Once empty, it must be discarded.
► Actrapid Penfill cartridges are intended for use only with Novo Nordisk insulin delivery systems and with NovoFine or NovoTwist needles.
► If you are treated with Actrapid Penfill and another type of insulin Penfill cartridge, you must use two separate delivery systems, one for each type of insulin.
► Always carry a spare Penfill cartridge with you in case the one in use is lost or damaged.
How to inject Actrapid
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or nurse and as described in the pen’s instruction manual.
► Keep the needle under the skin for at least 6 seconds to ensure the full dose has been delivered. Keep the button fully pressed until you have withdrawn the needle from the skin. This ensures the correct dose has been administered and minimizes the possibility of blood entering the needle or insulin reservoir.
► After each injection, remove and discard the needle and store Actrapid without the needle attached. Otherwise, leakage of liquid may occur, resulting in inaccurate dosing.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia). See Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia).
See Effects of diabetes in section 4.
If you stop treatment with your insulin
Do not stop treatment with insulin without first discussing it with your doctor, who will advise you what to do. Stopping treatment may lead to high blood sugar levels (severe hyperglycaemia) 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 will get them.
Summary of serious and very common side effects.
Low blood sugar level (hypoglycaemia) is a very common side effect. It may occur in more than 1 in 10 people.
You may experience low blood sugar if:

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

Warning signs of low blood sugar: cold sweating; cold and pale skin; headache; rapid heartbeat; feeling unwell; hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent), up to and including death. Recovery of consciousness may be faster with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.
What to do if your blood sugar level is low:
► If your blood sugar is too low, eat sugar lumps or another sugary snack (sweets, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar lumps, sweets, biscuits or fruit juice with you, to use if needed.
► When symptoms of hypoglycaemia have disappeared or your blood glucose has stabilised, continue your insulin treatment.
► If you experience low blood sugar, lose consciousness, have required a glucagon injection, or have frequent episodes of low blood sugar, contact your doctor. A dose adjustment of insulin, as well as of your meal plan and physical activity, may be necessary.
Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting (loss of consciousness) due to hypoglycaemia. Explain that, if you faint, they must turn you onto your side and seek immediate medical help. It is important not to give you food or drink, as you could choke.

Severe allergic reaction to Actrapid or to one of its excipients (called systemic allergic reaction) is a rare side effect but may be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

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

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

List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but this condition is usually temporary.
Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is a temporary phenomenon that soon disappears. If not, contact your doctor.
Painful neuropathy (pain due to nerve damage): rapid improvement in blood sugar levels may cause nerve pain. This is known as acute painful neuropathy and is normally transient.

Very rare side effects
May affect fewer than 1 in 10,000 people.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss). If you have diabetic retinopathy and your blood sugar level improves very rapidly, diabetic retinopathy may worsen. Consult your doctor for further information.

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

Effects of diabetes
High blood sugar level (hyperglycaemia)
You may experience high blood sugar if:

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

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

5. How to store Actrapid

Keep out of the sight and reach of children.
Do not use Actrapid after the expiry date stated on the cartridge label and on the
packaging, following '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 cooling elements.
Do not freeze.
During use or when carried as a spare: do not refrigerate or freeze. It may be carried with you
and stored at room temperature (below 30°C) for up to 6 weeks.
Always keep the cartridge inside its packaging to protect it from light.
Dispose of the needle after each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Actrapid contains

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

Description of the appearance of Actrapid and package contents
Actrapid is a clear, colourless injectable solution.
Pack sizes: 1, 5 or 10 cartridges of 3 ml. Not all pack sizes are marketed.

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

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

This leaflet was last updated on
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Package leaflet: Information for the user
Actrapid InnoLet 100 IU/ml (international units/ml) injectable solution in pre-filled pen
Human insulin
Read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people even if their symptoms are the same as yours.
If you experience 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

What Actrapid is and what it is used for
What you need to know before using Actrapid
How to use Actrapid
Possible side effects
How to store Actrapid
Contents of the pack and other information

1. What Actrapid is and what it is used for

Actrapid is human insulin with a rapid-acting effect.
Actrapid is used to reduce high blood sugar levels in patients with diabetes mellitus (diabetes).
Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels. Treatment with Actrapid helps prevent complications of diabetes.
Actrapid begins to lower blood sugar levels within about half an hour after injection, and its effect lasts for about 8 hours. Actrapid is often administered in combination with intermediate- or long-acting insulin preparations.

2. What you should know before using Actrapid

Do not use Actrapid
► If you are allergic (hypersensitive) to human insulin or to any of the other excipients of
this medicine, see section 6.
► If you experience warning signs of hypoglycemia (low blood sugar levels),
refer to the Summary of serious and very common adverse reactions in section 4.
► In insulin infusion pumps (microinfusers).
► If InnoLet is leaking, damaged, or cracked.
► If it has not been stored correctly or has been frozen, see section 5.
► If the resuspended insulin does not appear as clear, colorless liquid like water.
Do not use Actrapid if any of these situations apply. Speak with your doctor, pharmacist, or nurse for
advice.

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

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney or liver disorders, or abnormalities affecting the adrenal glands, pituitary gland, or
thyroid gland.
► If you have increased physical activity or changes in your usual diet, as these 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 across different time zones may alter your insulin requirements
and timing of doses.

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

Other medicines and Actrapid
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other
medication.
Some medicines affect blood sugar levels, meaning your insulin dose may need to be adjusted. Listed
below are the most important commonly used medicines that may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycemia) if you take:

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

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

Oral contraceptives (birth control pills)
Thiazides (used to treat high blood pressure or fluid retention)
Glucocorticoids (such as "cortisone," used to treat inflammation)
Thyroid hormones (used to treat thyroid gland disorders)
Sympathomimetics (such as epinephrine [adrenaline], salbutamol, or terbutaline, used to treat asthma)
Growth hormone (a medicine used to stimulate skeletal and somatic growth and significantly affecting the body's metabolic processes)
Danazol (a medicine that affects ovulation)

Beta-blockers (tablets used to treat high blood pressure) may weaken or completely suppress the warning
symptoms that help you recognize low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes mellitus)
Some patients with long-standing type 2 diabetes mellitus and with heart disease or a history of stroke
who were treated with pioglitazone and insulin have developed heart failure.
Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of
breath, rapid weight gain, or localized swelling (edema).

If you are taking any of the medicines listed above, inform your doctor, pharmacist, or nurse.

Actrapid with alcohol
► If you consume alcohol, your insulin requirements may change, as blood sugar levels may rise or
fall. Careful monitoring is recommended.

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

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

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

If your blood glucose is too high or too low, your ability to concentrate and react may be impaired,
affecting your ability to drive or operate machinery. Be aware that this could put yourself and others at
risk.

Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose, meaning that Actrapid is essentially
"sodium-free."

3. How to use Actrapid

Dosage and when to take insulin
Always use insulin and adjust the dose exactly as prescribed by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.
Take a meal or a snack containing carbohydrates within 30 minutes after the injection to avoid low blood sugar levels.
Do not change the type of insulin unless your doctor tells you to. If your doctor switches the type or brand of insulin you are using, your dose may need to be adjusted by your doctor.

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

Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years old, your blood sugar levels should be monitored regularly and you should discuss insulin dose adjustments with your doctor.

How and where to inject
Actrapid is administered by subcutaneous injection (under the skin). You must never inject insulin directly into a vein (intravenous route) or into a muscle (intramuscular route). Actrapid InnoLet is intended for subcutaneous use only. Speak with your doctor if another method of insulin administration is required.
Each time you inject, rotate the injection site within the particular area of skin you usually use. This may reduce the risk of developing lumps or skin depressions; see section 4. The best areas for injection are: the abdominal area; the buttocks; the front of the thigh; or the upper arm. Insulin will act more quickly if injected into the abdomen. Always monitor your blood glucose levels regularly.

How to use Actrapid InnoLet
Actrapid InnoLet is a pre-filled pen containing human insulin.
Carefully read the Instructions for Use for Actrapid InnoLet provided in this package leaflet. You must use the pen exactly as described in the Instructions for Use for Actrapid InnoLet.
Always make sure you are using the correct pen before injecting your insulin.

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

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

If you stop using insulin
Do not stop using insulin without first talking to your doctor, who will advise you on what to do. Stopping treatment may lead to high blood sugar levels (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 level (hypoglycaemia) is a very common side effect. It may occur in more than 1 person out of 10.
You may experience low blood sugar if:

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

Warning signs of low blood sugar: cold sweating; cold and pale skin; headache; rapid heartbeat; feeling unwell; hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and may even result in death. You may regain consciousness more quickly with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.
What to do if your blood sugar level is low:
► If your blood sugar is too low, eat sugar cubes or another snack high in sugar (sweets, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar cubes, sweets, biscuits or fruit juice with you to use if needed.
► When symptoms of hypoglycaemia have disappeared or your blood glucose has stabilised, continue your insulin treatment.
► If you have low blood sugar, lose consciousness, have needed a glucagon injection, or have frequent episodes of low blood sugar, contact your doctor. Your insulin dose, meal times and physical activity may need adjustment.
Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Let them know that if you faint, they should turn you onto your side and seek immediate medical help. Do not give food or drink as you could choke.

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

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

List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 patients
Signs of allergy: local allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but this reaction is usually temporary.
Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is normally a temporary condition. If not, contact your doctor.
Painful neuropathy (pain due to nerve damage). If your blood glucose improves very rapidly, it may cause pain originating from nerve fibres. This is known as acute painful neuropathy and is normally transient.

Very rare side effects
May affect fewer than 1 in 10,000 people.
Diabetic retinopathy (a diabetes-related eye disorder that may lead to vision loss). If you have diabetic retinopathy and your blood sugar level improves very rapidly, diabetic retinopathy may worsen. Consult your doctor for further information.

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

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

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

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

5. How to store Actrapid

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the InnoLet label and on the
packaging, following '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 for transport as a spare: do not refrigerate or freeze. It may be carried with you
and kept at room temperature (below 30°C) for up to 6 weeks.
Always keep the pen cap on the InnoLet when not in use to protect it from light.
Dispose of the needle after each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Actrapid contains

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

Description of the appearance of Actrapid and contents of the pack
Actrapid is a clear, colourless injectable solution.
Packs of 1, 5 or 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
This leaflet was last updated on
Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
For instructions on how to use your InnoLet, please turn the page.
Instructions for using Actrapid injectable solution in InnoLet.
Read these instructions carefully before starting to use your InnoLet. If you do not follow these instructions carefully, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
Your InnoLet is a simple, compact pre-filled pen capable of delivering doses from 1 to 50 units in 1-unit increments. InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length. As a precaution, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Blue technical diagram of an InnoLet medical device showing a graduated dial, dose indicator, disassembled components, and directional arrow

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

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

Technical illustration of a medical device with a curved blue arrow indicating counterclockwise rotation of the upper cap

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

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

If no drop of insulin appears after repeating the procedure, the device is faulty and must not be used.

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

Medical illustration of a hand holding a syringe with a graduated scale from 12 to 300 units on a light blue background

Selecting the dose

Always make sure the injection button is fully pressed and the dose selector is set to 0.
Select the number of units to be injected by turning the dose selector clockwise (Figure 2). Do not use the residual insulin scale to measure the insulin dose.
You will hear a click for each single unit selected. The dose can be adjusted by turning the selector in either direction. Always ensure you do not turn the knob or adjust the dose once the needle is inserted into the skin. This could lead to inaccurate dosing, causing blood sugar levels to become too high or too low.

Always use the dose scale and dose selector to check how many units you have selected before injecting insulin. Do not count the clicks of the pen. If you select and inject an incorrect dose, your blood sugar level may become too high or too low. Do not use the residual scale—it only approximately shows how much insulin remains in the pen.
You cannot select a dose greater than the number of units remaining in the cartridge.

Diagram of a timer with numbers from 0 to 50 and two curved blue arrows indicating clockwise rotation between numbers 0 and 30

Injecting insulin

Insert the needle into the skin. Use the injection technique recommended by your doctor.
Deliver the insulin dose by fully pressing the injection button (Figure 3). You will hear clicks as the dose selector returns to 0.
After injection, wait at least 6 seconds before removing the needle to ensure the full dose has been delivered. Make sure not to block the dose selector during injection, as it must be free to return to zero when the injection button is pressed. Always ensure the dose selector returns to zero after injection. If the dose selector stops before reaching zero, the full dose has not been delivered, which may result in high blood sugar levels.
Remove the needle after each injection.

Diagram showing two hands holding a medical device with a numbered dial from 0 to 50 and a blue arrow pointing downward at the upper button

Removing the needle

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

Technical illustration of a medical device with a curved blue arrow indicating clockwise rotation of the upper cap

Always use a new needle for each injection.
Always remove and dispose of the needle after each injection and store your InnoLet without a needle attached. This reduces the risk of contamination, infection, insulin leakage, needle blockage and inaccurate dosing.
Important additional information
Anyone caring for you must take great care when handling used needles to reduce the risk of needlestick injuries and cross-infections.
Dispose of used InnoLet pens carefully, making sure the needle has been removed.
Never share your pen or needles with other people. This could lead to cross-infection.
Never share your pen with other people. The medicine may be harmful to their health.
Always keep InnoLet and needles out of sight and reach of others, especially children.
Pen maintenance
Your InnoLet is designed to function accurately and safely. Handle it with care. If it is dropped, damaged or broken, insulin leakage may occur. This could lead to incorrect dosing, resulting in blood sugar levels that are too high or too low.
You may clean the outside of your InnoLet by wiping it with a disinfectant swab. Do not immerse, wash or lubricate the pen, as this may damage the mechanism and cause incorrect dosing, leading to high or low blood sugar levels.
Do not refill InnoLet. Once empty, it must be discarded.

Package leaflet: Information for the user

Actrapid FlexPen 100 IU/ml (international units/ml) injectable solution in a pre-filled pen
Human insulin
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Never give it to other people. It may be harmful to them even if their symptoms are the same as yours.
If you experience any side effect, talk to your doctor, pharmacist or nurse. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet

What Actrapid is and what it is used for
What you need to know before using Actrapid
How to use Actrapid
Possible side effects
How to store Actrapid
Contents of the pack and other information

1. What Actrapid is and what it is used for

Actrapid is a rapid-acting human insulin.
Actrapid is used to lower 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 Actrapid helps prevent complications of diabetes.
Actrapid begins to reduce blood sugar levels within about half an hour after administration, and its effect lasts for about 8 hours. Actrapid is often administered in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Actrapid

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

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

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

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

Other medicines and Actrapid
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines.
Some medicines affect blood sugar levels, meaning your insulin dose may need to be adjusted. Listed
below are the most common medicines that may affect insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) if you take:

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

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

Oral contraceptives (birth control pills)
Thiazides (used to treat high blood pressure or fluid retention)
Glucocorticoids (such as 'cortisone', used to treat inflammation)
Thyroid hormones (used to treat thyroid gland disorders)
Sympathomimetics such as epinephrine (adrenaline), salbutamol 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)

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

Actrapid and alcohol
► If you consume alcohol, your insulin requirements may change because blood sugar levels may
increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, think you might be pregnant or are planning to become pregnant, consult your
doctor before taking this medicine. Actrapid can be used during pregnancy. Dose adjustments may
be necessary during pregnancy and after delivery. It is important to carefully manage diabetes,
particularly to prevent episodes of hypoglycaemia, for the health of both mother and baby.
► There are no restrictions on the use of Actrapid during breastfeeding.
Consult your doctor, pharmacist or nurse before taking any medicine during pregnancy or
breastfeeding.

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

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

If your blood glucose is high or low, this may impair your ability to concentrate and react, and therefore
your ability to drive or operate machinery. Be aware that you may put yourself and others at risk.

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

3. How to use Actrapid

Dosage and when to take insulin
Always use insulin as prescribed by your doctor and follow his or her advice carefully. If you are
unsure, consult your doctor, pharmacist, or nurse.
Have a meal or snack within 30 minutes after 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, your dose may need to be adjusted by your doctor.
Use in children and adolescents
Actrapid can be used in children and adolescents.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years of age, your blood sugar levels
should be monitored regularly and you should discuss insulin dose adjustments with your doctor.
How and where to inject
Actrapid is administered by subcutaneous injection (under the skin). Never inject insulin directly
into a vein (intravenous route) or into muscle (intramuscular route). Actrapid FlexPen is intended only
for subcutaneous injections. Speak with your doctor if you need to administer insulin by another route.
With each injection, always rotate the injection site within the same general skin area you usually use.
This may reduce the risk of developing lumps or skin depressions; see section 4.
The best areas for injection are: the abdominal area; the buttocks; the front of the thigh; or the upper arm.
Insulin will act more quickly if injected into the abdomen. Always monitor your blood glucose regularly.

How to use Actrapid FlexPen
Actrapid FlexPen is a pre-filled pen containing human insulin.
Read carefully the Instructions for Use for Actrapid FlexPen provided in this package leaflet.
You must use the pen exactly as described in the Instructions for Use for Actrapid FlexPen.
Always make sure you are using the correct pen before injecting insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia). See
Summary of serious and common adverse effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia).
See Effects of diabetes in section 4.
If you stop taking your insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you on what to do.
This could lead to high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See Effects of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

You inject too much insulin.
You eat too little or skip meals.
You exercise more than usual.
You consume alcohol – see Actrapid with alcohol in section 2.

Warning signs of low blood sugar: cold sweating; cold and pale skin; headache; rapid heartbeat; feeling unwell; hunger sensation; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If severe hypoglycaemia is left untreated, it may cause brain damage (transient or permanent) and even death. Recovery of consciousness may be faster with an injection of the hormone glucagon administered by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.
What to do if your blood sugar level is low:
► If your blood sugar is too low, eat sugar cubes or another sugary snack (candies, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar cubes, candies, biscuits or fruit juices with you to use when needed.
► When symptoms of hypoglycaemia have disappeared or when blood glucose has stabilized, continue your insulin treatment.
► If you experience low blood sugar, lose consciousness, require a glucagon injection, or have frequent episodes of low blood sugar, contact your doctor. Your insulin dose, meal schedule, and physical activity may need adjustment.
Inform people close to you that you are diabetic and explain possible consequences, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and immediately call for medical help. It is important not to give you food or drink, as you could choke.

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

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

List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: Visual disturbances may occur at the beginning of insulin treatment, but this reaction is usually temporary.
Swollen joints: At the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This is a temporary phenomenon that usually resolves quickly. If it does not, contact your doctor.
Painful neuropathy (pain due to nerve damage): If blood glucose improves very rapidly, it may cause nerve-related pain. This is known as acute painful neuropathy and is usually temporary.

Very rare side effects
May affect fewer than 1 in 10,000 people.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): If you have diabetic retinopathy and your blood glucose improves very rapidly, the retinopathy may worsen. Consult your doctor for further information.

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

Other effects of diabetes
High blood sugar level (hyperglycaemia)
You may experience high blood sugar if:

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

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

5. How to store Actrapid

Keep out of the sight and reach of children.
Do not use Actrapid after the expiry date stated on the FlexPen label and on the carton,
following 'EXP'. The expiry date refers to the last day of the month.
Before first use: store in a refrigerator at 2°C - 8°C. Keep away from cooling elements.
Do not freeze.
During use or when carried as a spare: do not refrigerate or freeze. It may be carried with you and
stored at room temperature (below 30°C) for up to 6 weeks.
Always keep the pen cap on the FlexPen when not in use, to protect it from light.
Dispose of the needle after each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Actrapid Contains

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

Description of the Appearance of Actrapid and Contents of the Pack
Actrapid is a clear, colourless injectable solution.
Packs of 1, 5, or 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.

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

Manufacturer
The manufacturer can be identified from the batch number printed on the carton flap and on the label:

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

This leaflet was last updated on
Further Information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
For instructions on how to use your FlexPen, please turn the page.
Instructions for using Actrapid injectable solution in FlexPen.
Read carefully the following instructions before using your FlexPen. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could result in blood sugar levels that are too high or too low.
FlexPen is a pre-filled insulin pen for variable dose administration. You can select a dose from 1 to 60 units in 1-unit increments. FlexPen has been designed and tested for use with NovoFine or NovoTwist disposable needles up to 8 mm in length.
As a precaution, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.

Exploded diagram of a blue medical device showing cap, body with transparent container, yellow button, and various replacement components

Pen Maintenance
Handle your FlexPen with care. If it leaks or has been dropped, it may be damaged and insulin may leak out. This could lead to incorrect dosing, resulting in blood sugar levels that are too high or too low.
You may clean the outside of your FlexPen with an alcohol swab. Do not immerse, wash, or lubricate the pen, as this may damage the mechanism.
Do not refill your FlexPen. When empty, it must be discarded.

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

A
Remove the pen cap (see A).

A hand removing a blue protective cap from a cylindrical medical device, indicated by a right-pointing arrow

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

A hand holding a blue injection pen and rotating the end portion toward

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

Technical illustration showing a hand rotating and detaching the upper part of a cylindrical medical device with a directional blue arrow

D
Remove and discard the inner needle cap.
Never try to re-screw the inner needle cap back onto the needle. You may injure yourself with the needle.

Two hands holding an injection pen to prepare the

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

Checking Insulin Flow
E
During normal use, small amounts of air may accumulate in the cartridge before each injection. To avoid injecting air and to ensure correct insulin dosing:
Turn the dose selector to select 2 units.

Two hands holding a blue injection pen with a curved arrow indicating rotation of the dial to adjust the numbered dosage

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

Illustration of a syringe with needle pointing toward the

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

Medical illustration showing a blue injection device with an arrow pointing toward the

Always ensure a drop appears at the needle tip before injecting. This confirms that insulin will be delivered. 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 injecting. If you do not check the flow, you may inject too little insulin or no insulin at all, which could lead to high blood sugar levels.

Selecting the Dose
H
Ensure the dose selector is at 0.
Turn the dose selector to select the number of units to be injected.
You can increase or decrease the dose by turning the selector in either direction until the indicator shows the correct dose. While turning the dose selector, take care not to press the injection button, as this may cause insulin to leak out.
You cannot select a dose greater than the number of units remaining in the cartridge.

Blue illustration showing a hand rotating the dial of an injection pen, with two boxes highlighting dosage ranges 4-6 and 24-26

Before injecting insulin, always use the dose selector and indicator to verify the number of units selected.
Do not count the clicks of the pen. If you select or inject the wrong dose, your blood sugar level may become too high or too low. Do not use the graduated scale, which only approximately indicates how much insulin remains in the pen.

Injection
I
Insert the needle into the skin. Use the injection technique shown by your doctor or nurse.
Administer the insulin dose by pressing the injection button fully until the indicator reaches 0. Be sure to press only the injection button.
Turning the dose selector will not deliver insulin.

A hand pressing down the blue cap of a medical device, with an arrow indicating downward pressure movement

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

Medical illustration of an injection pen positioned vertically above the skin surface for drug administration

K
Place the needle tip into the outer needle cap without touching it. Once covered, carefully press the outer cap fully on and then unscrew the needle.
Dispose of the needle carefully and replace the pen cap.

Two illustrations showing how to attach and rotate a medical device, with a hand holding it and a blue arrow indicating the movement

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

Other Important Information
Anyone handling used needles must take great care to reduce the risk of needle-stick injuries and cross-infections.
Dispose of used FlexPens carefully, ensuring the needle has been removed.
Never share your pen or needles with other people. This could lead to cross-infections.
Never share your pen with other people. The medicine may be harmful to their health.
Always keep the pen and needles out of sight and reach of others, especially children.