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Actraphane (insulin human) – Package leaflet - A10AD01

Updated on site: 11-Jul-2017

Package leaflet: Information for the user

Actraphane 30 40 IU/ml (international units/ml) suspension for injection in vial human insulin

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1.What Actraphane is and what it is used for

Actraphane is human insulin with both a fast-acting and a long-acting effect.

Actraphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actraphane helps to prevent complications from your diabetes.

Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.

2. What you need to know before you use Actraphane

Do not use Actraphane

If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6.

If you suspect hypoglycaemia (low blood sugar) is starting, see 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 protective, tamper-proof plastic cap. If it is not in perfect condition when you get the vial, return the vial to your supplier.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

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

Before using Actraphane

Check the label to make sure it is the right 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.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Other medicines and Actraphane

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

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

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)

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

Danazol (medicine acting on ovulation).

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

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

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

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

Actraphane with alcohol

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Actraphane can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

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

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

Driving and using machines

► Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

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

Actraphane contains sodium

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

3. How to use Actraphane

Dose and when to take your insulin

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

Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

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

Use in children and adolescents

Actraphane can be used in children and adolescents.

Use in special patient groups

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

How and where to inject

Actraphane is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).

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

How to take Actraphane

Actraphane vials are for use with insulin syringes with the corresponding unit scale.

1.Roll the vial between your hands until the liquid is uniformly white and cloudy. Resuspension is easier when the insulin has reached room temperature.

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

3.Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.

How to inject Actraphane

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

Keep the needle under your skin for at least 6 seconds to make sure that you have injected all the insulin.

Discard the needle and syringe after each injection.

If you take more insulin than you should

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

If you stop taking your insulin

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

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

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Actraphane with alcohol in section 2.

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

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

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

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

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

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

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

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

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

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

Very rare side effects

May affect less than 1 in 10,000 people.

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

Reporting of side effects

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

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

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

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build–up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5.How to store Actraphane

Keep this medicine out of the sight and reach of children.

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

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

During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you are not using it, in order to protect from light.

Discard the needle and syringe after each injection.

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

6.Contents of the pack and other information

What Actraphane 30 contains

The active substance is human insulin. Actraphane is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin. Each ml contains 40 IU of human insulin. Each vial contains 400 IU of human insulin in 10 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Actraphane looks like and contents of the pack

Actraphane is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.

Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder

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

Manufacturer

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

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

If the second and third characters are A7, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Actraphane 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Actraphane is and what it is used for

Actraphane is human insulin with both a fast-acting and a long-acting effect.

Actraphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actraphane helps to prevent complications from your diabetes.

Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.

2. What you need to know before you use Actraphane

Do not use Actraphane

If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6.

If you suspect hypoglycaemia (low blood sugar) is starting, see 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 protective, tamper-proof plastic cap. If it is not in perfect condition when you get the vial, return the vial to your supplier.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

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

Before using Actraphane

Check the label to make sure it is the right 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.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Other medicines and Actraphane

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

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

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)

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

Danazol (medicine acting on ovulation).

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

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

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

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

Actraphane with alcohol

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Actraphane can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

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

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

Driving and using machines

► Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

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

Actraphane contains sodium

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

3. How to use Actraphane

Dose and when to take your insulin

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

Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

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

Use in children and adolescents

Actraphane can be used in children and adolescents.

Use in special patient groups

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

How and where to inject

Actraphane is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).

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

How to take Actraphane

Actraphane vials are for use with insulin syringes with the corresponding unit scale.

1.Roll the vial between your hands until the liquid is uniformly white and cloudy. Resuspension is easier when the insulin has reached room temperature.

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

3.Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.

How to inject Actraphane

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

Keep the needle under your skin for at least 6 seconds to make sure that you have injected all the insulin.

Discard the needle and syringe after each injection.

If you take more insulin than you should

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

If you stop taking your insulin

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

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

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Actraphane with alcohol in section 2.

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

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

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

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

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

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

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

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

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

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

Very rare side effects

May affect less than 1 in 10,000 people.

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

Reporting of side effects

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

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

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

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build–up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Actraphane

Keep this medicine out of the sight and reach of children.

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

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

During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you are not using it, in order to protect from light.

Discard the needle and syringe after each injection.

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

6. Contents of the pack and other information

What Actraphane 30 contains

The active substance is human insulin. Actraphane is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin. Each ml contains 100 IU of human insulin. Each vial contains 1,000 IU of human insulin in 10 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Actraphane looks like and contents of the pack

Actraphane is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.

Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder

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

Manufacturer

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

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

If the second and third characters are A7, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Actraphane 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Actraphane is and what it is used for

2.What you need to know before you use Actraphane

3.How to use Actraphane

4.Possible side effects

5.How to store Actraphane

6.Contents of the pack and other information

1. What Actraphane is and what it is used for

Actraphane is human insulin with both a fast-acting and a long-acting effect.

Actraphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actraphane helps to prevent complications from your diabetes.

Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.

2. What you need to know before you use Actraphane

Do not use Actraphane

If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6.

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4.

In insulin infusion pumps.

If the cartridge or the device containing the cartridge is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

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

Before using Actraphane

Check the label to make sure it is the right type of insulin.

Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be the result of an insulin leakage. If you suspect that

the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.

Always use a new needle for each injection to prevent contamination.

Needles and Actraphane Penfill must not be shared.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Other medicines and Actraphane

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

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

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)

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

Danazol (medicine acting on ovulation).

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

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

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

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

Actraphane with alcohol

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Actraphane can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

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

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

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

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

Actraphane contains sodium

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

3. How to use Actraphane

Dose and when to take your insulin

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

Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

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

Use in children and adolescents

Actraphane can be used in children and adolescents.

Use in special patient groups

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

How and where to inject

Actraphane is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).

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

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

Actraphane Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.

If you are treated with Actraphane Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.

Always carry a spare Penfill cartridge in case the one in use is lost or damaged.

Resuspension of Actraphane

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

Every time you use a new Actraphane Penfill (before you put the cartridge into the insulin

delivery system).

Let the insulin reach room temperature before you use it. This makes it easier to resuspend.

Move the cartridge up and down between positions a and b and back (see the picture) so that the glass ball moves from one end of the cartridge to the other at least 20 times.

Repeat this movement at least 10 times before each injection.

The movement must always be repeated until the liquid appears uniformly white and cloudy.

Complete the other stages of injection without delay.

How to inject Actraphane

Inject the insulin under your skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.

Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.

After each injection, be sure to remove and discard the needle and store Actraphane without the needle attached. Otherwise the liquid may leak out, which can cause inaccurate dosing.

If you take more insulin than you should

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

If you forget to take your insulin

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

If you stop taking your insulin

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

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

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Actraphane with alcohol in section 2.

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

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

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

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

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

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.

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

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

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

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

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

Very rare side effects

May affect less than 1 in 10,000 people.

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

Reporting of side effects

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

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

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

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build–up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Actraphane

Keep this medicine out of the sight and reach of children.

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

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

During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the cartridge in the outer carton when you are not using it, in order to protect from light.

Discard the needle after each injection.

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

6. Contents of the pack and other information

What Actraphane 30 contains

The active substance is human insulin. Actraphane is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin. Each ml contains 100 IU of human insulin. Each cartridge contains 300 IU of human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Actraphane looks like and contents of the pack

Actraphane is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.

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

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

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

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

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

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Actraphane 30 InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen

human insulin

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Actraphane is and what it is used for

2.What you need to know before you use Actraphane

3.How to use Actraphane

4.Possible side effects

5.How to store Actraphane

6.Contents of the pack and other information

1. What Actraphane is and what it is used for

Actraphane is human insulin with both a fast-acting and a long-acting effect.

Actraphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actraphane helps to prevent complications from your diabetes.

Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.

2. What you need to know before you use Actraphane

Do not use Actraphane

If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6.

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4.

In insulin infusion pumps.

If InnoLet is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

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

Before using Actraphane

Check the label to make sure it is the right type of insulin.

Always use a new needle for each injection to prevent contamination.

Needles and Actraphane InnoLet must not be shared.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Other medicines and Actraphane

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

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

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)

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

Danazol (medicine acting on ovulation).

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

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

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

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

Actraphane with alcohol

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Actraphane can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

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

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

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

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

Actraphane contains sodium

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

3. How to use Actraphane

Dose and when to take your insulin

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

Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

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

Use in children and adolescents

Actraphane can be used in children and adolescents.

Use in special patient groups

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

How and where to inject

Actraphane is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).

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

How to handle Actraphane 30 InnoLet

Actraphane 30 InnoLet is a pre-filled disposable pen containing a mixture of fast-acting and long- acting human insulin in the ratio 30/70.

Read carefully the Instructions on how to use Actraphane 30 InnoLet included in this package leaflet. You must use the pen as described in the Instructions on how to use Actraphane 30 InnoLet.

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

If you take more insulin than you should

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

If you forget to take your insulin

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

If you stop taking your insulin

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

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

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Actraphane with alcohol in section 2.

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

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

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

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

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

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

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

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

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

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

Very rare side effects

May affect less than 1 in 10,000 people.

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

Reporting of side effects

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

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

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

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build–up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Actraphane

Keep this medicine out of the sight and reach of children.

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

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

During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the pen cap on your InnoLet when you are not using it, in order to protect from light.

Discard the needle after each injection.

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

6. Contents of the pack and other information

What Actraphane 30 contains

The active substance is human insulin. Actraphane is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin. Each ml contains 100 IU of human insulin. Each pre-filled pen contains 300 IU of human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Actraphane looks like and contents of the pack

Actraphane is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.

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

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was last revised in

Other sources of information

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

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

Instructions on how to use Actraphane 30 suspension for injection in InnoLet

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

Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of

8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Push-button

 

 

Dose

 

 

selector

 

 

 

 

Residual

 

 

scale

Dose scale

 

 

 

 

Insulin cartridge

Compartment

 

Glass ball

for needles

 

 

 

 

Disposable needle (example)

 

 

Needle

Pen cap

Paper tab

Inner needle

 

cap

Big outer needle cap

Getting started

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

Resuspending the insulin

Before every injection:

Check there are at least 12 units of insulin left in the cartridge to allow even resuspension. If there are less than 12 units left, use a new InnoLet.

Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated until the liquid appears uniformly white and cloudy.

Always make sure that you have resuspended the insulin prior to each injection. If you do not resuspend the insulin, this may cause inaccurate dosing, which can lead to too high or too low blood sugar level. After resuspending, complete all of the following stages of injection without delay.

1A

Attaching the needle

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

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

Remove the paper tab from a new disposable needle.

Screw the needle straight and tightly onto your InnoLet (picture 1B).

Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.

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

1B

Priming to expel air prior to each injection

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

To avoid injection of air and ensure proper dosing:

Dial 2 units by turning the dose selector clockwise.

Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture 1C) to make any air bubbles collect at the top of the cartridge.

Keeping the needle upwards, press the push-button and the dose selector returns to 0.

Always make sure that a drop appears at the needle tip before injection (picture 1C). This makes sure the insulin flows. If not, change the needle and repeat the procedure no more than 6 times.

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

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

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

1C

Setting the dose

Always check that the push-button is fully depressed and the dose selector is set to 0.

Dial the number of units required by turning the dose selector clockwise (picture 2).

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

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

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

Injecting the insulin

Insert the needle into your skin. Use the injection technique advised by your doctor.

Deliver the dose by pressing the push-button fully down (picture 3). You will hear clicks as the dose selector returns to 0.

After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the full dose has been delivered.

Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to 0 when you press the push-button. Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.

Discard the needle after each injection.

Removing the needle

Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully.

Put the pen cap back on your InnoLet to protect the insulin from light.

Always use a new needle for each injection.

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

Further important information

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

Dispose of your used InnoLet carefully without the needle attached.

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

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

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

Caring for your pen

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

You can clean your InnoLet by wiping it with a medicinal swab. Do not soak, wash or lubricate it. This may damage the mechanism and may cause inaccurate dosing, which can lead to too high or too low blood sugar level.

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

Package leaflet: Information for the user

Actraphane 30 FlexPen 100 IU/ml (international units/ml) suspension for injection in pre-filled pen

human insulin

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Actraphane is and what it is used for

2.What you need to know before you use Actraphane

3.How to use Actraphane

4.Possible side effects

5.How to store Actraphane

6.Contents of the pack and other information

1. What Actraphane is and what it is used for

Actraphane is human insulin with both a fast-acting and a long-acting effect.

Actraphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actraphane helps to prevent complications from your diabetes.

Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.

2. What you need to know before you use Actraphane

Do not use Actraphane

If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6.

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4.

In insulin infusion pumps.

If FlexPen is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

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

Before using Actraphane

Check the label to make sure it is the right type of insulin.

Always use a new needle for each injection to prevent contamination.

Needles and Actraphane FlexPen must not be shared.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Other medicines and Actraphane

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

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

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)

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

Danazol (medicine acting on ovulation).

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

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

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

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

Actraphane with alcohol

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Actraphane can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

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

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

Driving and using machines

► Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

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

Actraphane contains sodium

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

3. How to use Actraphane

Dose and when to take your insulin

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

Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

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

Use in children and adolescents

Actraphane can be used in children and adolescents.

Use in special patient groups

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

How and where to inject

Actraphane is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).

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

How to handle Actraphane 30 FlexPen

Actraphane 30 FlexPen is a pre-filled disposable pen containing a mixture of fast-acting and long- acting human insulin in the ratio 30/70.

Read carefully the Instructions on how to use Actraphane 30 FlexPen included in this package leaflet. You must use the pen as described in the Instructions on how to use Actraphane 30 FlexPen.

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

If you take more insulin than you should

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

If you forget to take your insulin

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

If you stop taking your insulin

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

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

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Actraphane with alcohol in section 2.

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

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

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

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

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

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

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

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

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

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

Very rare side effects

May affect less than 1 in 10,000 people.

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

Reporting of side effects

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

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

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

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build–up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Actraphane

Keep this medicine out of the sight and reach of children.

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

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

During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the pen cap on your FlexPen when you are not using it, in order to protect from light.

Discard the needle after each injection.

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

6. Contents of the pack and other information

What Actraphane 30 contains

The active substance is human insulin. Actraphane is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin. Each ml contains 100 IU of human insulin. Each pre-filled pen contains 300 IU of human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Actraphane looks like and contents of the pack

Actraphane is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.

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

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

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

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

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

This leaflet was last revised in

Other sources of information

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

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

Instructions on how to use Actraphane 30 suspension for injection in FlexPen

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

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

Actraphane 30 FlexPen

 

 

Needle (example)

 

 

Glass

Cartridge

Dose

Push-

 

 

 

ball

 

selector

button

 

 

 

Pen cap

 

Pointer

Big outer

Inner

Needle

Paper tab

 

 

 

needle cap

needle cap

 

 

12 units

Residual

 

 

 

 

 

 

scale

 

 

 

 

 

Caring for your pen

Your FlexPen must be handled with care.

If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.

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

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

Preparing your Actraphane 30 FlexPen

A

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

Every time you use a new pen

Let the insulin reach room temperature before you use it.

This makes it easier to resuspend. Pull off the pen cap (see A).

A

B

Before your first injection with a new FlexPen, you must resuspend the insulin:

Move the pen up and down twenty times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other. Repeat until the liquid appears uniformly white and cloudy.

For every following injection, move the pen up and down between the two positions at least 10 times until the liquid appears uniformly white and cloudy.

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

B

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

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

Attaching the needle

C

Remove the paper tab from a new disposable needle.

Screw the needle straight and tightly onto your FlexPen.

C

D

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

D

E

Pull off the inner needle cap and dispose of it.

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

E

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

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

Checking the insulin flow

F

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

Turn the dose selector to select 2 units.

F

2 units selected

G

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

G

H

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

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

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

H

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

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

Selecting your dose

I

Check that the dose selector is set at 0.

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

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

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

I

5 units selected

24 units selected

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

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

Making the injection

J

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

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

Turning the dose selector will not inject insulin.

J

K

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

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

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

K

L

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

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

L

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

Further important information

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

Dispose of your used FlexPen carefully without the needle attached.

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

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

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

Package leaflet: Information for the user

Actraphane 40 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Actraphane is and what it is used for

2.What you need to know before you use Actraphane

3.How to use Actraphane

4.Possible side effects

5.How to store Actraphane

6.Contents of the pack and other information

1. What Actraphane is and what it is used for

Actraphane is human insulin with both a fast-acting and a long-acting effect.

Actraphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actraphane helps to prevent complications from your diabetes.

Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.

2. What you need to know before you use Actraphane

Do not use Actraphane

If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6.

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4.

In insulin infusion pumps.

If the cartridge or the device containing the cartridge is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

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

Before using Actraphane

Check the label to make sure it is the right type of insulin.

Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be the result of an insulin leakage. If you suspect that

the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.

Always use a new needle for each injection to prevent contamination.

Needles and Actraphane Penfill must not be shared.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Other medicines and Actraphane

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

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

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)

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

Danazol (medicine acting on ovulation).

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

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

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

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

Actraphane with alcohol

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Actraphane can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

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

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

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

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

Actraphane contains sodium

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

3. How to use Actraphane

Dose and when to take your insulin

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

Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

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

Use in children and adolescents

Actraphane can be used in children and adolescents.

Use in special patient groups

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

How and where to inject

Actraphane is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).

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

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

Actraphane Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.

If you are treated with Actraphane Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.

Always carry a spare Penfill cartridge in case the one in use is lost or damaged.

Resuspension of Actraphane

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

Every time you use a new Actraphane Penfill (before you put the cartridge into the insulin delivery system).

Let the insulin reach room temperature before you use it. This makes it easier to resuspend.

Move the cartridge up and down between positions a and b and back (see the picture) so that the glass ball moves from one end of the cartridge to the other at least 20 times.

Repeat this movement at least 10 times before each injection.

The movement must always be repeated until the liquid appears uniformly white and cloudy.

Complete the other stages of injection without delay.

How to inject Actraphane

Inject the insulin under your skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.

Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.

After each injection, be sure to remove and discard the needle and store Actraphane without the needle attached. Otherwise the liquid may leak out, which can cause inaccurate dosing.

If you take more insulin than you should

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

If you forget to take your insulin

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

If you stop taking your insulin

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

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

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Actraphane with alcohol in section 2.

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

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

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

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

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

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

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

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

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

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

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

Very rare side effects

May affect less than 1 in 10,000 people.

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

Reporting of side effects

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

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

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

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build–up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Actraphane

Keep this medicine out of the sight and reach of children.

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

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

During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the cartridge in the outer carton when you are not using it, in order to protect from light.

Discard the needle after each injection.

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

6. Contents of the pack and other information

What Actraphane 40 contains

The active substance is human insulin. Actraphane is a mixture consisting of 40% soluble human insulin and 60% isophane human insulin. Each ml contains 100 IU of human insulin. Each cartridge contains 300 IU of human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Actraphane looks like and contents of the pack

Actraphane is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.

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

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Actraphane 50 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Actraphane is and what it is used for

2.What you need to know before you use Actraphane

3.How to use Actraphane

4.Possible side effects

5.How to store Actraphane

6.Contents of the pack and other information

1. What Actraphane is and what it is used for

Actraphane is human insulin with both a fast-acting and a long-acting effect.

Actraphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actraphane helps to prevent complications from your diabetes.

Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.

2. What you need to know before you use Actraphane

Do not use Actraphane

If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6.

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4.

In insulin infusion pumps.

If the cartridge or the device containing the cartridge is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

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

Before using Actraphane

Check the label to make sure it is the right type of insulin.

Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be the result of an insulin leakage. If you suspect that

the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.

Always use a new needle for each injection to prevent contamination.

Needles and Actraphane Penfill must not be shared.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.

Other medicines and Actraphane

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

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

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)

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

Danazol (medicine acting on ovulation).

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

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

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

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

Actraphane with alcohol

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Actraphane can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

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

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

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

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

Actraphane contains sodium

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

3. How to use Actraphane

Dose and when to take your insulin

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

Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar.

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

Use in children and adolescents

Actraphane can be used in children and adolescents.

Use in special patient groups

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

How and where to inject

Actraphane is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).

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

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

Actraphane Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.

If you are treated with Actraphane Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.

Always carry a spare Penfill cartridge in case the one in use is lost or damaged.

Resuspension of Actraphane

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

Every time you use a new Actraphane Penfill (before you put the cartridge into the insulin delivery system).

Let the insulin reach room temperature before you use it. This makes it easier to resuspend.

Move the cartridge up and down between positions a and b and back (see the picture) so that the glass ball moves from one end of the cartridge to the other at least 20 times.

Repeat this movement at least 10 times before each injection.

The movement must always be repeated until the liquid appears uniformly white and cloudy.

Complete the other stages of injection without delay.

How to inject Actraphane

Inject the insulin under your skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.

Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.

After each injection, be sure to remove and discard the needle and store Actraphane without the needle attached. Otherwise the liquid may leak out, which can cause inaccurate dosing.

If you take more insulin than you should

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

If you forget to take your insulin

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

If you stop taking your insulin

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

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

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Actraphane with alcohol in section 2.

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

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

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

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

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

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

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

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

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

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

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

Very rare side effects

May affect less than 1 in 10,000 people.

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

Reporting of side effects

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

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

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

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build–up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Actraphane

Keep this medicine out of the sight and reach of children.

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

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

During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the cartridge in the outer carton when you are not using it, in order to protect from light.

Discard the needle after each injection.

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

6. Contents of the pack and other information

What Actraphane 50 contains

The active substance is human insulin. Actraphane is a mixture consisting of 50% soluble human insulin and 50% isophane human insulin. Each ml contains 100 IU of human insulin. Each cartridge contains 300 IU of human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Actraphane looks like and contents of the pack

Actraphane is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.

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

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was last revised in

Other sources of information

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

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