Levemir

Patient Information Leaflet: Information for the User

Levemir 100 units/ml solution for injection in cartridge

insulin detemir
Please 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 questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any of the side effects, including those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levemir is and what it is used for

Levemir is a modern long-acting insulin (insulin analogue).
Modern insulin medicines are improved versions of human insulin.
Levemir is used to lower high blood sugar levels in adults, adolescents, and children from 1 year of age with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels.
Levemir may be used together with fast-acting prandial insulin medicines.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with oral diabetes tablets and/or injectable antidiabetic medicines other than insulin.
Levemir has a prolonged and consistent blood sugar-lowering effect starting within 3–4 hours after injection. Levemir provides basal insulin coverage for up to 24 hours.

2. What you need to know before using Levemir

Do not use Levemir
► If you are allergic to insulin detemir or to any of the other excipients of this medicine,
see section 6, Contents of the pack and other information.
► If you are experiencing warning signs of hypoglycaemia (low blood sugar),
see a) Summary of serious and very common adverse effects in section 4.
► In insulin infusion pumps.
► If the cartridge or the device containing the cartridge is leaking, damaged, or cracked.
► If it has not been stored correctly or has been frozen, see section 5, How to store Levemir.
► If the insulin does not appear as clear, colourless, aqueous solution.
Do not use Levemir if any of these situations apply. Speak to your doctor, nurse, or pharmacist for advice.

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

Warnings and precautions
Certain conditions and activities may affect your insulin requirement. Consult your doctor:
► If you have kidney or liver problems, or abnormalities affecting the adrenal glands, pituitary gland, or thyroid gland.
► If you have increased your physical activity or changed your usual diet, as this may alter your blood sugar levels.
► If you become ill, continue taking your insulin and consult your doctor.
► If you plan to travel abroad; travelling across different time zones may affect your insulin requirements and injection schedule.
► If you have very low albumin levels, you should monitor your blood sugar levels carefully. Discuss this with your doctor.

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

Children and adolescents
Levemir can be used in adolescents and children from 1 year of age.
The safety and efficacy of Levemir in children below 1 year of age have not been established.
Data not available.

Other medicines and Levemir
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirement. Listed below are the most important medicines that may affect insulin treatment.

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

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

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

• oral contraceptives (birth control pills)
• thiazides (used to treat high blood pressure or fluid retention)
• glucocorticoids (such as "cortisone", used to treat inflammation)
• thyroid hormones (used to treat thyroid disorders)
• sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• growth hormone (a medicine used to stimulate skeletal and somatic growth, significantly affecting the body's metabolic processes)
• danazol (a medicine that affects ovulation)

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

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

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

Pregnancy and breastfeeding
► If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. Your insulin dose may need adjustment during pregnancy and after delivery. It is important to carefully control diabetes, especially to prevent episodes of hypoglycaemia, for the health of your baby.
► If you are breastfeeding, consult your doctor, as you may need adjustments to your insulin dose.
Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

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

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

If your blood sugar is too high or too low, this may affect your concentration and reaction ability, and consequently your ability to drive a vehicle or operate machinery. Be aware that you could endanger yourself or others.

Important information about some ingredients of Levemir
Levemir contains less than 1 mmol of sodium (23 mg) per dose, i.e., Levemir is essentially “sodium-free”.

3. How to use Levemir

Dose and when to take insulin
Always use insulin and adjust the dose exactly as directed by your doctor. If you are unsure,
consult your doctor, nurse, or pharmacist.
Levemir can be used in combination with rapid-acting prandial insulin products.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with
oral diabetes medications and/or injectable antidiabetic medicines other than insulin.
Do not change your insulin unless your doctor tells you to do so.
Your doctor may need to adjust your dose if:

• your doctor has changed the type or brand of insulin you are using, or
• your doctor has added another medicine for the treatment of diabetes to your treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children from the age of 1 year.
No clinical studies with Levemir have been conducted in children under 1 year of age.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years old, you should monitor your blood sugar regularly and discuss insulin dose adjustments with your doctor.
How often to inject
Levemir should be administered once daily when used in combination with oral diabetes medications and/or in combination with injectable antidiabetic medicines other than insulin. When Levemir is used as part of a basal-bolus insulin regimen, it should be administered once or twice daily according to individual need. The dose of Levemir must be individually adjusted. The injection can be given at any time of day, but should be given at the same time each day. In cases where two daily doses are required to optimize blood glucose control, the evening dose may be administered in the evening or before bedtime.
How and where to inject
Levemir is administered by subcutaneous injection (under the skin). Never inject Levemir directly into a vein (intravenous route) or into a muscle (intramuscular route). Levemir Penfill is intended only for subcutaneous injections using a reusable insulin pen. Talk to your doctor if you need to administer insulin by another method.
With each injection, rotate the injection site within the particular area of skin you usually use.
This may reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The best areas for self-injection are: the front of the thigh, the abdomen, or the upper arm. You are advised to check your blood sugar regularly.
► Do not refill the cartridge.
► Levemir Penfill cartridges are designed to be used with Novo Nordisk insulin delivery devices and NovoFine or NovoTwist needles.
► If you are treated with Levemir Penfill and other Penfill products, you must use two separate insulin delivery devices, one for each type of insulin.
► Always carry a spare Penfill cartridge with you in case the one in use is lost or damaged.
How to inject Levemir
► Inject the insulin under your skin. Use the injection technique recommended by your doctor or nurse and described in the pen’s instruction manual.
► Keep the needle under the skin for at least 6 seconds to ensure the full dose has been delivered. Keep the injection button fully pressed until the needle is withdrawn from the skin. This ensures proper delivery and minimizes backflow of blood into the needle or residual insulin.
► After each injection, make sure to remove and dispose of the needle, and store Levemir without the needle attached. Otherwise, liquid may leak out, resulting in an inaccurate dose.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycemia). See a) Summary of serious and very common side effects in section 4.
If you forget to take insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycemia).
See c) Effects of diabetes in section 4.
If you stop using insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you on what to do. This could lead to very high blood sugar (severe hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

a) Summary of serious and very common side effects

Low blood sugar (hypoglycaemia) is a very common side effect. It may occur in more than 1 in 10 people.

You may experience low blood sugar if:

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

Warning signs of low blood sugar: cold sweat; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.

Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and may even result in death. Recovery of consciousness may be faster with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.

What to do if your blood sugar is low:

► If your blood sugar is too low, eat sugar cubes or another snack high in sugar (candies, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar cubes or a sugary snack with you, to be used if needed.

► When symptoms of hypoglycaemia have disappeared or when your blood glucose has stabilised, continue your insulin treatment.

► If you have experienced low blood sugar, lost consciousness, needed a glucagon injection, or had frequent episodes of low blood sugar, speak to your doctor. You may need adjustments to your insulin dose, timing of administration, food intake, or physical activity.

Inform people close to you that you have diabetes and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and seek immediate medical help. It is important that no food or drink is given, as this could cause choking.

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

Contact your doctor immediately:

• If signs of allergy spread to other parts of the body.
• If you suddenly feel unwell and: start sweating; feel sick (vomiting); have difficulty breathing; have a rapid heartbeat; feel dizzy.

► If you notice any of these signs, contact your doctor immediately.

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

b) List of other side effects

Uncommon side effects
May affect fewer than 1 in 100 people.

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

Vision disturbances: Vision problems may occur at the beginning of insulin treatment, but these are usually temporary.

Swollen joints: At the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This usually resolves quickly. If not, contact your doctor.

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

Rare side effects
May affect fewer than 1 in 1,000 people.

Peripheral neuropathy (nerve pain due to nerve damage): a rapid improvement in blood sugar levels may cause nerve pain, known as peripheral neuropathy, which resolves spontaneously.

Reporting of side effects

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

c) Effects of diabetes

► High blood sugar (hyperglycaemia)

You may have high blood sugar if:

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

Warning signs of high blood sugar:
Symptoms develop gradually and include: increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or fatigue; dry, flushed skin; dry mouth and fruity breath (acetone).

What to do if your blood sugar is high:

► If you experience any of these symptoms: check your blood glucose, and if possible, test for the presence of ketones in your urine, and contact a doctor immediately.

► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolising fat instead of sugar). If left untreated, this may lead to diabetic coma and possibly death.

5. How to store Levemir

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cartridge label and
packaging after ‘EXP’. The expiry date refers to the last day of the month indicated.
When not in use, always keep the cartridge in its outer packaging to protect it from
light.
Levemir must be protected from excessive heat and light.
Before opening: Levemir Penfill not in use should be stored in a refrigerator at 2°C - 8°C,
away from refrigerating elements. Do not freeze.
During use or when carried as a spare: Levemir Penfill in use or being carried
as a spare must not be stored in the refrigerator. It may be kept at room temperature
(below 30°C) for up to 6 weeks.
When not in use, always keep the cartridge in its outer packaging to protect it from
light.
Levemir must be protected from excessive heat and from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levemir contains

• The active substance is insulin detemir. Each ml contains 100 units of insulin detemir. Each cartridge contains 300 units of insulin detemir in 3 ml of injectable solution. 1 unit of insulin detemir corresponds to 1 International Unit of human insulin.
• The other ingredients are: glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of Levemir and contents of the pack
Levemir is a solution for injection.
Packs of 1, 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the carton flap and on the label:

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

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

Package leaflet: Information for the user

Levemir 100 units/ml injection solution in pre-filled pen

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

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

Contents of this leaflet:

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

1. What Levemir is and what it is used for

Levemir is a modern, long-acting insulin (insulin analogue). Modern insulin medicines are improved versions of human insulin.
Levemir is used to lower high blood sugar levels in adults, adolescents, and children from the age of 1 year with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels.
Levemir may be used in combination with fast-acting prandial insulin medicines.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with oral diabetes tablets and/or injectable antidiabetic medicines other than insulin.
Levemir has a prolonged and steady blood sugar-lowering effect that begins within 3–4 hours after injection. Levemir provides basal insulin coverage for up to 24 hours.

2. What you need to know before using Levemir

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

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

Warnings and precautions
Certain conditions and activities may affect your insulin requirement. Consult your doctor:
► If you have kidney or liver problems, or disorders of the adrenal glands, pituitary, or thyroid.
► If you have increased physical activity or changes in your usual diet, as this may alter your blood sugar levels.
► If you become ill, continue taking your insulin and consult your doctor.
► If you plan to travel abroad; travelling across different time zones may affect your insulin requirements and injection schedule.
► If you have very low albumin levels, you should closely monitor your blood sugar levels. Discuss this with your doctor.

Skin changes at the injection site
You should rotate injection sites to help prevent changes in the fatty tissue under the skin, such as thickening of the skin, thinning of the skin, or lumps under the skin (lipohypertrophy or lipoatrophy).
Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening of the skin (see section 3, How to use Levemir). Inform your doctor if you notice skin changes at the injection site. If you currently inject into such an affected area, speak with your doctor before switching to another injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin or other antidiabetic medication dosage.

Children and adolescents
Levemir can be used in adolescents and children from 1 year of age.
The safety and efficacy of Levemir in children below 1 year of age has not been established.
Data not available.

Other medicines and Levemir
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirement. Listed below are the most important medicines that may affect insulin treatment.

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

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

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

• oral contraceptives (birth control pills)
• thiazides (used to treat high blood pressure or fluid retention)
• glucocorticoids (such as "cortisone", used to treat inflammation)
• thyroid hormones (used to treat thyroid disorders)
• sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline (used to treat asthma)
• growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease your blood sugar levels.

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

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

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

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

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. Your insulin dose may need to be adjusted during pregnancy and after delivery. It is important to manage diabetes carefully, especially to prevent episodes of hypoglycaemia, for the health of your baby.
► If you are breastfeeding, consult your doctor as you may need adjustments to your insulin dose.
Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

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

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

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

Important information about some ingredients of Levemir
Levemir contains less than 1 mmol of sodium (23 mg) per dose, i.e., Levemir is essentially “sodium-free”.

3. How to use Levemir

Dose and when to take insulin
Always use insulin and adjust the dose exactly as your doctor has instructed. If you are unsure,
consult your doctor, nurse, or pharmacist.
Levemir may be used in combination with rapid-acting prandial insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with
oral diabetes tablets and/or injectable antidiabetic medicines other than insulin.
Do not change your insulin unless your doctor tells you to do so.
Your doctor may need to adjust your dose if:

• your doctor has changed the type or brand of insulin you are using, or
• your doctor has added another medicine for treating diabetes to your treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children from the age of 1 year.
No clinical studies with Levemir have been conducted in children under 1 year of age.
Use in specific patient groups
If you have renal or hepatic impairment, or if you are over 65 years old, you should monitor your blood sugar regularly and discuss insulin dose adjustments with your doctor.
How often to inject
Levemir should be administered once daily when used in combination with oral diabetes tablets and/or injectable antidiabetic medicines other than insulin. When Levemir is used as part of a basal-bolus insulin regimen, it should be administered once or twice daily according to individual need. The dose of Levemir must be individually adjusted. The injection can be given at any time of day, but should be given at the same time each day. In cases where two daily doses are required to optimize blood sugar control, the evening dose may be administered in the evening or before bedtime.
How and where to inject
Levemir is administered by subcutaneous injection (under the skin). Never inject Levemir directly into a vein (intravenous route) or into muscle (intramuscular route). Levemir FlexPen is intended for subcutaneous use only. Speak with your doctor if you need to administer insulin by another method.
With each injection, rotate the injection site within the particular area of skin you usually use.
This may reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The best areas for self-injection are: the front of the thigh, the abdomen, or the upper arm. It is recommended to check your blood sugar regularly.
How to use Levemir FlexPen
Levemir FlexPen is a disposable, pre-filled pen, colour-coded, containing insulin detemir.
Read carefully the instructions for use provided in this package leaflet. You must use the pen as described in the Instructions for Use.
Always make sure you are using the correct pen before injecting your insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia). See a)
Summary of serious and very common side effects in section 4.
If you forget to take insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia).
See c) Effects of diabetes in section 4.
If you stop treatment with insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you on what to do. Stopping treatment may lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• You inject too much insulin.
• You eat too little or miss meals.
• You are more physically active than usual.
• You consume alcohol (see Drinking alcohol and taking Levemir in section 2).

Warning signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If severe hypoglycaemia is left untreated, it may cause brain damage (transient or permanent) and may even result in death. Recovery from unconsciousness may be faster with an injection of the hormone glucagon given by someone trained in its use. If glucagon is administered, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.
What to do if your blood sugar level is low:
► If your blood sugar is too low, eat sugar lumps or another sugary snack (candies, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar lumps or a sugary snack with you to use if needed.
► Once the symptoms of hypoglycaemia have disappeared or your blood glucose has stabilised, continue your insulin treatment.
► If you have had low blood sugar, lost consciousness, required a glucagon injection, or experienced frequent episodes of low blood sugar, speak to your doctor. You may need adjustments to your insulin dose, timing of administration, food intake, or physical activity.
Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and seek immediate medical help. Do not give you food or drink, as this could cause choking.
Severe allergic reaction to Levemir or one of its excipients (called systemic allergic reaction) is a very rare side effect but may be potentially life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

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

Skin changes at the injection site: If you inject insulin repeatedly into the same spot, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening. Rotate your injection site with each injection to prevent these skin changes.
b) List of other side effects
Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but these are usually temporary.
Swollen joints: at the start of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This usually resolves quickly. If not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): if you have diabetic retinopathy and your blood sugar improves very rapidly, the retinopathy may worsen. Consult your doctor.
Rare side effects
May affect fewer than 1 in 1000 people.
Peripheral neuropathy (nerve pain due to nerve damage): a rapid improvement in blood sugar levels may cause nerve pain, known as peripheral neuropathy, which resolves spontaneously.
Reporting of side effects
If you experience any of the side effects, tell your doctor, nurse, or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
c) Effects of diabetes
► High blood sugar level (hyperglycaemia)
You may experience high blood sugar if:

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

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

5. How to store Levemir

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the FlexPen label and on the
packaging after ‘EXP’. The expiry date refers to the last day of the month indicated.
When not in use, always keep the cap on the FlexPen to protect it from light.
Levemir must be protected from excessive heat and light.
Before opening: Unused Levemir FlexPen must be stored in a refrigerator at 2°C - 8°C,
away from refrigerating elements. Do not freeze.
During use or when carried as a spare: Levemir FlexPen may be carried with you and
stored at a temperature below 30°C or in the refrigerator (2°C - 8°C) for up to 6 weeks. If
stored in the refrigerator, keep it away from refrigerating elements. Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levemir contains

• The active substance is insulin detemir. Each ml contains 100 units of insulin detemir. Each pre-filled pen contains 300 units of insulin detemir in 3 ml of injectable solution. 1 unit of insulin detemir corresponds to 1 International Unit (IU) of human insulin.
• The other excipients are: glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections.

Description of the appearance of Levemir and contents of the pack
Levemir is a clear injectable solution.
Packs of 1 (with or without needles), 5 (without needles), and 10 (without needles) 3 ml pre-filled pens.
Not all pack sizes may be marketed.

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

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

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

Now turn the leaflet over for instructions on how to use your FlexPen.
This leaflet was last reviewed on
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu/.

Instructions for using LEVEMIR injectable solution in FlexPen.
Read the following instructions carefully before using your FlexPen. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
FlexPen is a pre-filled pen for variable-dose insulin administration.
You can select a dose between 1 and 60 units in 1-unit increments.
FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.
As a precaution, always keep a spare insulin delivery device available in case your FlexPen is lost or damaged.

Caring for your pen
Your FlexPen must be handled with care. If it leaks, has been dropped, or is damaged, insulin may be lost. This could result in incorrect dosing, leading to blood sugar levels that are too high or too low.
You may clean the outside of your FlexPen with a disinfectant wipe. Do not immerse, wash, or lubricate the pen, as this may damage its mechanism.
Do not refill your FlexPen.

Preparing Levemir FlexPen
Check the name and the colored label on your pen to make sure it contains the correct type of insulin. This is especially important if you use more than one type of insulin. If you inject the wrong type of insulin, your blood sugar level may become too high or too low.

A
Remove the pen cap.

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

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

D
Remove and discard the inner needle cap.
Never try to reinsert the inner needle cap onto the needle. You could injure yourself.

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

Checking insulin flow
During normal use, small amounts of air may accumulate in the cartridge. Before each injection, to avoid injecting air and to ensure correct insulin dosing:

E
Turn the dose selector to select 2 units.

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

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

Always make sure a drop appears at the needle tip before injecting. This ensures proper insulin flow. If no drop appears, you will not inject insulin, even if the dose selector moves. This may indicate a blocked or damaged needle.
Always check the flow before each injection. If you do not check the flow, you may inject too little insulin or no insulin at all, which could lead to high blood sugar levels.

Selecting the dose
Make sure the dose selector is at 0.

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

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

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

I
Administer the insulin dose by pressing the injection button fully until the indicator reaches 0. Be careful to press only the injection button.
Turning the dose selector will not deliver insulin.

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

K
Place the needle tip into the outer cap without touching the cap itself. Once the needle is covered, press the outer cap firmly into place and then unscrew the needle.
Dispose of the needle carefully and replace the pen cap on the FlexPen.

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

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

Package leaflet: Information for the user

Levemir 100 units/ml injection solution in pre-filled pen

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

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

Contents of this leaflet:

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

1. What Levemir is and what it is used for

Levemir is a modern, long-acting insulin (an insulin analogue).
Modern insulin medicines are improved versions of human insulin.
Levemir is used to reduce high blood sugar levels in adults, adolescents, and children from 1 year of age with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels.
Levemir may be used together with rapid-acting prandial insulin medicines.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with oral diabetes tablets and/or injectable antidiabetic medicines other than insulin.
Levemir has a prolonged and consistent blood sugar-lowering effect, starting within 3–4 hours after injection. Levemir provides basal insulin coverage for up to 24 hours.

2. What you need to know before using Levemir

Do not use Levemir
► If you are allergic to insulin detemir or to any of the other excipients of this medicine,
see section 6, Contents of the pack and other information.
► If you experience warning signs of hypoglycaemia (low blood sugar levels),
see a) Summary of serious and very common adverse effects in section 4.
► In insulin pumps.
► If InnoLet leaks, is damaged or cracked.
► If it has not been stored correctly or has been frozen, see section 5, How to
store Levemir.
► If the insulin does not appear as clear, colourless, watery liquid.
Do not use Levemir if any of these situations apply. Speak to your doctor, nurse or pharmacist for
advice.

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

Warnings and precautions
Certain conditions and activities may affect your insulin requirements. Consult your doctor:
► If you have kidney or liver problems, or disorders of the adrenal glands, pituitary or thyroid gland.
► If you increase your physical activity or change your usual diet, as this may alter your blood sugar levels.
► If you become ill, continue taking your insulin and consult your doctor.
► If you plan to travel abroad, travelling across different time zones may affect your insulin requirements and your injection schedule.
► If you have very low albumin levels, you should monitor your blood sugar levels carefully. Discuss this with your doctor.

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

Children and adolescents
Levemir can be used in adolescents and children from 1 year of age.
The safety and efficacy of Levemir in children below 1 year of age has not been established.
Data not available.

Other medicines and Levemir
Inform your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that may affect insulin treatment.

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

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

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

• oral contraceptives (birth control pills)
• thiazides (used to treat high blood pressure or fluid retention)
• glucocorticoids (such as "cortisone", used to treat inflammation)
• thyroid hormones (used to treat thyroid disorders)
• sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• growth hormone (a medicine used to stimulate skeletal and somatic growth and significantly affecting the body's metabolic processes)
• danazol (a medicine affecting ovulation).

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

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

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

Drinking alcohol and using Levemir
► If you drink alcohol, your insulin requirements may change, as blood sugar levels may rise or fall. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your insulin dose may need adjustment during pregnancy and particularly after delivery. It is important to control diabetes carefully, especially to prevent episodes of hypoglycaemia for the health of your baby.
► If you are breastfeeding, consult your doctor as you may need adjustments to your insulin dose.
Consult your doctor, nurse or pharmacist before taking any medicine during pregnancy or breastfeeding.

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

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

If your blood sugar is too high or too low, this may impair your concentration and reaction ability, and consequently your ability to drive a vehicle or operate machinery. Be aware that this could endanger yourself or others.

Important information about some ingredients of Levemir
Levemir contains less than 1 mmol of sodium (23 mg) per dose, i.e. Levemir is essentially “sodium-free”.

3. How to use Levemir

Dose and when to take insulin
Always use insulin and adjust the dose exactly as directed by your doctor. If you are unsure, consult your doctor, nurse, or pharmacist.
Levemir may be used in combination with rapid-acting prandial insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with oral diabetes tablets and/or injectable antidiabetic medicines other than insulin.
Do not change your insulin unless your doctor tells you to do so.
Your doctor may need to adjust your dose if:

• your doctor has changed the type or brand of insulin you are using, or
• your doctor has added another medicine for the treatment of diabetes to your treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children aged 1 year and older.
No clinical studies with Levemir have been conducted in children under 1 year of age.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years old, you should monitor your blood sugar regularly and discuss insulin dose adjustments with your doctor.
How often to inject
Levemir should be administered once daily when used in combination with oral diabetes tablets and/or injectable antidiabetic medicines other than insulin. When Levemir is used as part of a basal-bolus insulin regimen, it should be administered once or twice daily according to individual need. The dose of Levemir must be individually adjusted. The injection can be given at any time of day, but should be given at the same time each day. In cases where two daily doses are required to optimize blood sugar control, the evening dose may be administered in the evening or before bedtime.
How and where to inject
Levemir is administered by subcutaneous injection (under the skin). Never inject Levemir directly into a vein (intravenous route) or into muscle (intramuscular route). Levemir InnoLet is intended for subcutaneous injections only. Speak with your doctor if you need to administer insulin by another method.
With each injection, rotate the injection site within the particular area of skin you usually use. This may reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The best areas for injection are: the front of the thigh, the abdomen, or the upper arm. You are advised to check your blood sugar regularly.
How to use Levemir InnoLet
Levemir InnoLet is a disposable pre-filled pen containing insulin detemir.
Read carefully the instructions for use provided in this package leaflet. You must use the pen exactly as described in the Instructions for Use.
Always make sure you are using the correct pen before injecting your insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level may become too low (hypoglycaemia). See a) Summary of serious and very common side effects in section 4.
If you forget to take insulin
If you forget to take your insulin, your blood sugar level may become too high (hyperglycaemia). See c) Effects of diabetes in section 4.
If you stop treatment with insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you on what to do. Stopping insulin treatment may lead to very high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Warning signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital.
What to do if your blood sugar level is low:
► If your blood sugar is too low, eat sugar cubes or another high-sugar snack (candy, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar cubes or a high-sugar snack with you, to use if needed.
► When the symptoms of hypoglycaemia have disappeared or when your blood sugar has stabilised, continue your insulin treatment.
► If you have low blood sugar, lose consciousness, have required a glucagon injection, or have frequent episodes of low blood sugar, talk to your doctor. Your doctor may need to adjust your insulin dose, timing of insulin injections, food intake, and physical activity.
Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they must turn you onto your side and immediately call for medical help. It is important that no food or drink is given, as this could cause choking.
Severe allergic reaction to Levemir or one of its excipients (called systemic allergic reaction) is a very rare side effect but may potentially be life-threatening. It may occur in fewer than 1 person out of 10,000.
Contact your doctor immediately:

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

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (affecting fewer than 1 person in 100). Lumps under the skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work as well as expected if you inject into an area with lumps, thinning, or thickening of the skin. Change your injection site with each injection to prevent these skin changes.
b) List of other side effects
Uncommon side effects
May affect fewer than 1 person in 100.
Signs of allergy: local allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but these are usually temporary.
Swollen joints: at the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This usually resolves quickly. If not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): if you have diabetic retinopathy and your blood sugar level improves very rapidly, the retinopathy may worsen. Consult your doctor.
Rare side effects
May affect fewer than 1 person in 1000.
Peripheral neuropathy (nerve pain due to nerve damage): a rapid improvement in blood sugar control may cause nerve pain, known as peripheral neuropathy, which resolves spontaneously.
Reporting of side effects
If you experience any of the side effects, inform your doctor, nurse, or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
c) Effects of diabetes
► High blood sugar level (hyperglycaemia)
You may have a high blood sugar level if:

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

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

5. How to store Levemir

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the InnoLet label and the carton after 'EXP'. The expiry date refers to the last day of the month indicated.
When not in use, always keep the cap on the FlexPen to protect it from light.
Levemir must be protected from excessive heat and light.
Before opening: Unused Levemir InnoLet should be stored in a refrigerator at 2°C - 8°C, away from refrigerating elements. Do not freeze.
During use or when carried as a spare: Levemir InnoLet in use or being carried as a spare must not be stored in the refrigerator. It may be carried at room temperature (below 30°C) for up to 6 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Levemir Contains

• The active substance is insulin detemir. Each ml contains 100 units of insulin detemir. Each pre-filled pen contains 300 units of insulin detemir in 3 ml of injectable solution. 1 unit of insulin detemir corresponds to 1 International Unit (IU) of human insulin.
• The other excipients are glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections.

Description of the Appearance of Levemir and Contents of the Package
Levemir is a clear, colourless, aqueous solution for injection.
Pack sizes: 1, 5, and 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.

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

Now turn over the leaflet for instructions on how to use your InnoLet.
This leaflet was last reviewed on
Other Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/.

Instructions for Using LEVEMIR Injectable Solution in InnoLet
Read the following instructions carefully before using your InnoLet. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.

The InnoLet is a simple, compact pre-filled pen capable of delivering 1 to 50 units of insulin in 1-unit increments. The InnoLet has been specifically designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length. As a precaution, always keep a spare insulin delivery device available in case your current InnoLet is lost or damaged.

Getting Started
Check the name and the coloured label on your InnoLet to make sure it contains the correct type of insulin. This is especially important if you use more than one type of insulin. Administering the wrong type of insulin may cause your blood sugar level to become too high or too low.
Remove the cap.

Attaching the Needle

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

Preparing the Pen to Remove Air Before Each Injection
During normal use, small amounts of air may accumulate in the needle and insulin cartridge.
To avoid injecting air and to ensure the correct dose of insulin is delivered:

• Select 2 units by turning the dose selector clockwise.
• Hold the InnoLet with the needle pointing upwards and gently tap the insulin cartridge several times with your finger (Figure B). This will cause air bubbles to rise to the top of the cartridge.
• While keeping the needle pointing upwards, press the injection button fully. The dose selector will return to 0.
• Always make sure a drop of insulin appears at the tip of the needle before injecting (Figure B). This ensures insulin flow. If no drop appears, replace the needle and repeat this procedure no more than 6 times.

If insulin still fails to appear after repeated attempts, the device may be defective and should not be used.

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

Selecting the Dose

• Always ensure that the injection button is fully pressed and that the dose selector is set to 0.
• Select the number of units to be injected by rotating the dose selector clockwise (Figure C).
• You will hear a click for each single unit selected. The dose can be adjusted by rotating the selector in either direction. Make sure not to rotate the knob or adjust the dose while the needle is inserted into the skin, as this may lead to inaccurate dosing, causing blood sugar levels to become too high or too low.

Always use the dose scale and dose selector to verify how many units you have selected before injecting insulin. Do not count the clicks of the pen. If you select and inject the wrong dose, your blood sugar level may become too high or too low. Do not use the remaining scale, as it only approximately indicates how much insulin is left in the pen.
A dose greater than the number of units remaining in the cartridge cannot be selected.

Injecting the Insulin

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

Removing the Needle

• Replace the large outer protective cap and unscrew the needle (Figure E). Dispose of the needle with appropriate caution.

• Replace the pen cap on your InnoLet to protect the insulin from light.

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

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

Caring for Your Pen
The InnoLet has been designed to function accurately and safely. It must be handled with care. If it is dropped, damaged, or broken, insulin leakage may occur. This could lead to incorrect dosing, resulting in blood sugar levels that are too high or too low.
You may clean the outside of your InnoLet with an alcohol swab. Do not immerse, wash, or lubricate the pen, as this may damage the mechanism and cause incorrect dosing, leading to high or low blood sugar levels.
Do not refill the InnoLet.

Package leaflet: Information for the user

Levemir 100 units/ml injectable solution in pre-filled pen

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

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

Contents of this leaflet:

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

1. What Levemir is and what it is used for

Levemir is a modern, long-acting insulin (an insulin analogue). Modern insulin medicines are improved versions of human insulin.
Levemir is used to reduce high blood sugar levels in adults, adolescents, and children from 1 year of age with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels.
Levemir may be used in combination with fast-acting prandial insulin medicines.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with oral antidiabetic tablets and/or injectable antidiabetic medicines other than insulin.
Levemir has a prolonged and consistent blood sugar-lowering effect, starting within 3–4 hours after injection. Levemir provides basal insulin coverage for up to 24 hours.

2. What you need to know before using Levemir

Do not use Levemir
► If you are allergic to insulin detemir or to any of the other excipients of this medicine,
see section 6, Contents of the pack and other information.
► If you experience warning signs of hypoglycaemia (low blood sugar levels),
see a) Summary of serious and very common adverse effects in section 4.
► In insulin pumps.
► If FlexTouch is leaking, damaged or cracked.
► If it has not been stored correctly or has been frozen, see section 5, How to store Levemir.
► If the insulin does not appear as clear, colourless, watery liquid.
Do not use Levemir if any of these situations apply. Speak to your doctor, nurse or pharmacist for advice.

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

Warnings and precautions
Certain conditions and activities may affect your insulin requirement. Consult your doctor:
► If you have kidney or liver problems, or disorders of the adrenal glands, pituitary gland or thyroid gland.
► If you have increased physical activity or changes in your usual diet, as this may affect your blood sugar levels.
► If you become ill, continue taking your insulin and consult your doctor.
► If you plan to travel abroad, travelling across different time zones may affect your insulin requirements and injection schedule. Consult your doctor if you are planning such travel.
► If you have very low levels of albumin, you should monitor your blood sugar levels carefully. Discuss this with your doctor.

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

Children and adolescents
Levemir can be used in adolescents and children from 1 year of age.
The safety and efficacy of Levemir in children below 1 year of age has not been established.
Data not available.

Other medicines and Levemir
Inform your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Some medicines affect blood sugar levels and may alter your insulin requirement. Listed below are the most important medicines that may affect insulin treatment.
Your blood sugar level may decrease (hypoglycaemia) if you take:

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

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

• oral contraceptives (birth control pills)
• thiazides (used to treat high blood pressure or fluid retention)
• glucocorticoids (such as "cortisone" used to treat inflammation)
• thyroid hormones (used to treat thyroid disorders)
• sympathomimetics such as epinephrine (adrenaline), salbutamol, terbutaline (used to treat asthma)
• growth hormone (a medicine used to stimulate skeletal and somatic growth and that significantly affects the body's metabolic processes)
• danazol (a medicine that affects ovulation).

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

Drinking alcohol and using Levemir
► If you drink alcohol, your insulin requirement may change, as blood sugar levels may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
► If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your insulin dose may need adjustment during pregnancy and after delivery. It is important to control diabetes carefully, especially to prevent episodes of hypoglycaemia, for the health of your baby.
► If you are breastfeeding, consult your doctor as you may need adjustments to your insulin dose.
Consult your doctor, nurse or pharmacist before taking any medicine during pregnancy or breastfeeding.

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

• If you experience frequent episodes of hypoglycaemia.
• If you have difficulty recognizing the warning signs of hypoglycaemia.
  High or low blood sugar levels may impair your concentration and reaction ability, and thus affect your ability to drive a vehicle or operate machinery. Be aware that you could put yourself and others at risk.

Important information about some ingredients of Levemir
Levemir contains less than 1 mmol of sodium (23 mg) per dose, i.e. Levemir is essentially "sodium-free".

3. How to use Levemir

Dose and when to take insulin
Always use insulin and adjust the dose exactly as directed by your doctor. If you are unsure, consult
your doctor, nurse, or pharmacist.
Levemir may be used in combination with rapid-acting mealtime insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir may also be used in combination with oral diabetes
tablets and/or injectable antidiabetic medicines other than insulin.
Do not change your insulin unless your doctor tells you to do so.
Your doctor may need to adjust your dose if:

• your doctor has changed the type or brand of insulin you are using, or
• your doctor has added another medicine for the treatment of diabetes to your treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children from 1 year of age.
No clinical studies with Levemir have been conducted in children below 1 year of age.
Use in specific patient groups
If you have kidney or liver impairment, or if you are over 65 years old, you should monitor your blood
sugar regularly and discuss insulin dose adjustments with your doctor.
How often to inject
Levemir should be administered once daily when used in combination with oral diabetes tablets and/or
injectable antidiabetic medicines other than insulin. When Levemir is used as part of a basal-bolus
insulin regimen, it should be administered once or twice daily according to individual need. The dose of
Levemir must be individually adjusted. The injection can be given at any time of day, but should be given
at the same time each day. In cases where two daily doses are required to optimise blood sugar control,
the evening dose may be administered in the evening or before bedtime.
How and where to inject
Levemir is administered by subcutaneous injection (injected under the skin). Never inject insulin
directly into a vein (intravenous route) or into muscle (intramuscular route). Levemir FlexTouch is
intended for subcutaneous injection only. Speak with your doctor if you need to administer insulin by
another method.
With each injection, rotate the injection site within the particular area of skin you usually use. This can
help reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The
best areas for injection are: the front of the thigh, the abdomen, or the upper arm. It is recommended to
monitor your blood sugar regularly.
How to use Levemir FlexTouch
Levemir FlexTouch is a disposable, pre-filled pen coded by colour, containing insulin detemir.
Read carefully the instructions for use provided in this package leaflet. You must use the pen as
described in the Instructions for Use.
Always make sure you are using the correct pen before injecting your insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level may drop too low (hypoglycaemia). See a) Summary
of serious and very common side effects in section 4.
If you forget to take insulin
If you forget to take your insulin, your blood sugar level may become too high (hyperglycaemia). See c)
Effects of diabetes in section 4.
If you stop using insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you on what to
do. Stopping insulin treatment may lead to very high blood sugar levels (severe hyperglycaemia) and
ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

a) Summary of serious and very common side effects

Low blood sugar level (hypoglycaemia) is a very common side effect. It may occur in more than 1 in 10 people.

You may experience low blood sugar if:

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

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.

Severe hypoglycaemia can lead to loss of consciousness. If prolonged severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and may even lead to death. Recovery of consciousness may be faster with an injection of the hormone glucagon given by someone trained in its use. If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.

What to do if your blood sugar is low:

► If your blood sugar is too low, eat sugar lumps or another snack high in sugar (sweets, biscuits, fruit juice). If possible, check your blood sugar and then rest. Always carry sugar lumps or a sugary snack with you to use if needed.

► When symptoms of hypoglycaemia have gone or your blood glucose has stabilised, continue your insulin treatment.

► If you have low blood sugar, lose consciousness, require a glucagon injection, or have frequent episodes of low blood sugar, speak to your doctor. Your doctor may need to adjust your insulin dose, timing of administration, food intake, or physical activity.

Inform people close to you that you are diabetic and explain the possible consequences, including the risk of fainting due to hypoglycaemia. Explain that if you faint, they should turn you onto your side and seek immediate medical help. Do not give you food or drink as these could cause choking.

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

Contact your doctor immediately:

• If signs of allergy spread to other parts of the body
• If you suddenly feel unwell and: start sweating; feel sick (vomiting); have difficulty breathing; your heartbeat is rapid; or feel dizzy.

► If you notice any of these signs, contact your doctor immediately.

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

b) List of other side effects

Uncommon side effects
May affect fewer than 1 in 100 people.

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

Vision disturbances: Vision disturbances may occur at the beginning of insulin treatment, but these are usually temporary.

Swollen joints: At the beginning of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This usually resolves quickly. If not, contact your doctor.

Diabetic retinopathy (a diabetes-related eye disorder that may lead to vision loss): If you have diabetic retinopathy and your blood sugar level improves very rapidly, the retinopathy may worsen. Consult your doctor.

Rare side effects
May affect fewer than 1 in 1,000 people.

Peripheral neuropathy (nerve pain due to nerve damage): Rapid improvement in blood sugar levels may cause nerve pain, known as peripheral neuropathy, which resolves spontaneously.

Reporting of side effects

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

c) Effects of diabetes

► High blood sugar level (hyperglycaemia)

You may have high blood sugar if:

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

Warning signs of high blood sugar:
Symptoms develop gradually and include: increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).

What to do if your blood sugar is high:

► If you experience any of these symptoms: check your blood glucose, and if possible, test for ketones in your urine, and contact a doctor immediately.

► These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolising fat instead of sugar). If left untreated, this may lead to diabetic coma and possibly death.

5. How to store Levemir

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the FlexTouch label and on the carton after 'EXP'. The expiry date refers to the last day of the month indicated.
When not in use, always keep the cap on the FlexPen to protect it from light.
Levemir must be protected from excessive heat and light.
Before opening: Unused Levemir FlexTouch must be stored in the refrigerator at 2°C - 8°C, away from refrigerating elements. Do not freeze.
During use or when carried as a spare: Levemir FlexTouch may be carried with you and stored either at a temperature below 30°C or in the refrigerator (2°C - 8°C) for up to 6 weeks. If stored in the refrigerator, keep it away from refrigerating elements. Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Levemir Contains

• The active substance is insulin detemir. Each ml contains 100 units of insulin detemir. Each pre-filled pen contains 300 units of insulin detemir in 3 ml of injectable solution. 1 unit of insulin detemir corresponds to 1 International Unit (IU) of human insulin.
• The other excipients are: glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the Appearance of Levemir and Contents of the Pack
Levemir is an injectable solution.
Pack sizes: 1 (with or without needles), 5 (without needles), or a multipack containing 2 x 5 pre-filled pens of 3 ml (without needles). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Now turn over the leaflet for information on how to use your FlexTouch.
This leaflet was last revised in
Other Sources of Information
More detailed information about this medicine is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/.
Instructions for Using Levemir 100 units/ml Injectable Solution in Pre-filled Pen (FlexTouch)
Read the following instructions carefully before using your pre-filled pen FlexTouch. If you do not follow these instructions carefully, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
Do not use the pen without having received adequate training from your doctor or nurse.
Start by checking the pen to make sure it contains Levemir 100 units/ml, then look at the illustrations below to learn about the different parts of the pen and the needle.
If you are blind or have severe visual problems and cannot read the dose counter on the pen, do not use this pen without help. Ask someone with good eyesight who has been trained in the use of the pre-filled FlexTouch pen to assist you.
Levemir FlexTouch is a pre-filled insulin pen. Levemir FlexTouch contains 300 units of insulin, and doses from 1 to 80 units can be selected in increments of 1 unit.
Levemir FlexTouch is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.

Preparing the Levemir FlexTouch Pen
Check the name and the coloured label to make sure your Levemir FlexTouch contains the correct type of insulin. This is especially important if you use more than one type of insulin. If you inject the wrong type of insulin, your blood sugar level may become too high or too low.
A. Remove the pen cap.

B. Check that the insulin in the pen is clear and colourless.
Look through the insulin window. If the insulin appears cloudy, do not use the pen.

C. Take a new single-use needle and remove the protective seal.

D. Screw the needle straight onto the pen. Make sure the needle is firmly attached.

E. Remove the outer needle cap and keep it.
You will need it after the injection to properly remove the needle from the pen.
Remove the inner needle cap and discard it. Do not try to reinsert it, as you may accidentally prick yourself with the needle.
A drop of insulin may appear at the tip of the needle. This is normal.

Always use a new needle for each injection. This reduces the risk of contamination, insulin leakage, blocked needles, and incorrect dosing.
Never use a bent or damaged needle.

Checking Insulin Flow
Before each injection, always check insulin flow to ensure you deliver the correct dose of insulin:
F. Turn the dose selector and select 2 units.

G. Hold the pen with the needle pointing upwards.
Tap the top of the pen gently several times with your finger so that any air bubbles collect at the top.

H. Press the injection button with your thumb until the dose counter returns to zero. The "0" must align with the dose indicator. A drop of insulin should appear at the needle tip.
If this does not happen, repeat steps F to H up to 6 times. If no drop appears after these attempts, change the needle and repeat steps F to H once more.
Do not use the pen if no drop of insulin appears.

Always make sure a drop appears at the needle tip before injection.

This ensures proper insulin flow. If no drop appears, do not inject insulin, even if the dose counter moves. This may indicate a blocked or damaged needle.
Always check insulin flow before each injection. If you do not check the flow, you may not inject any insulin or may inject too little, which could lead to high blood sugar levels.

Selecting the Dose
Use the dose selector on your Levemir FlexTouch pen to select your dose. You can select up to 80 units per dose.
I. Select the dose you need. You can turn the dose selector forwards or backwards. Stop when the correct number of units aligns with the dose indicator.
The dose selector makes different clicking sounds when turned forwards, backwards, or when exceeding the remaining insulin units.
When less than 80 units remain in the pen, the dose counter will display the number of units left.

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

How much insulin is left?
The insulin scale shows approximately how much insulin remains in the pen.

To see exactly how much insulin is left in the pen, use the dose counter:
Turn the dose selector until the dose counter stops. If it shows 80, at least 80 units remain in the pen.
If it shows less than 80, the number displayed is the exact number of units remaining.
Turn the dose selector back until the dose counter shows 0.
If you need more insulin than remains in the pen, you may split the dose between two pens.

Be very careful when calculating the correct dose if splitting.

If you are unsure, inject the full dose using a new pen. If you split the dose incorrectly, you may inject too little or too much insulin, which could lead to high or low blood sugar levels.

Injecting the Dose
Use the correct injection technique to ensure you deliver the full dose.
J. Insert the needle into the skin as shown by your doctor or nurse. Make sure you can see the dose counter. Do not touch the dose counter with your fingers, as this may interrupt the injection.
Press the injection button until the dose counter reaches 0. The "0" must align with the dose indicator, and you may hear or feel a click.

After the dose counter reaches 0, leave the needle in the skin for at least 6 seconds to ensure the full dose is delivered.

K. Remove the needle from the skin.
After this, you may see a drop of insulin at the needle tip. This is normal and does not affect the administered dose.

Always dispose of the needle after each injection. This reduces the risk of contamination, infection, insulin leakage, blocked needles, and incorrect dosing. If the needle is blocked, you will not be able to inject insulin.
L. Place the needle tip into the outer needle cap placed on a flat surface. Do not touch the needle or cap.
Once the needle is covered, press the outer cap firmly and then unscrew the needle. Dispose of the needle carefully and replace the cap after each use.
When the pen is empty, discard it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local health authority.

Always check the dose counter to know how many units you are injecting.
The dose counter shows the exact number of units. Do not count the clicks of the pen. Keep pressing the injection button until the dose counter returns to 0 after injection. If the dose counter stops before reaching 0, the full dose has not been delivered, which may lead to high blood sugar levels.
Never try to reinsert the inner needle cap. You may accidentally prick yourself with the needle.

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

Pen Maintenance
Handle the pen with care. Incorrect or improper use may lead to incorrect dosing, which could result in blood sugar levels that are too high or too low.

• Do not leave the pen in a car or in other places where it could become too hot or too cold.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent on a damp cloth.
• Do not drop or knock the pen against hard surfaces. If it is dropped or if you suspect damage, always attach a new needle and check insulin flow before injection.
• Do not refill the pen. When it is empty, it must be discarded.
• Do not attempt to repair or disassemble the pen.

Important Information

• Always carry the pen with you.
• Always carry a spare pen and new needles in case you lose or damage your pen or needles.
• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen or needles with other people. This could lead to cross-infections.
• Never share the pen with other people. The medicine may be harmful to their health.
• Anyone caring for you should exercise great caution when handling used needles to reduce the risk of needle-stick injuries and cross-infections.