LEVEMIR 100 U/ML Инъекционный раствор

Содержание инструкции

1. Levemir 100 units/ml injectable solution in cartridge
   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. Package Contents and Other Information
2. Levemir 100 units/ml injectable solution in prefilled pen
   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. Content of the pack and other information
3. Levemir 100 units/ml injectable solution in prefilled pen
   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. Package Contents and Other Information
4. Levemir 100 units/ml injectable solution in prefilled pen
   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. Content of the pack and other information

Levemir 100 units/ml injectable solution in cartridge

insulin detemir

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use 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 insulin (insulin analogue) with prolonged action. Modern insulin medicines are an improved version 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 can be used with rapid-acting mealtime insulin medicines.
In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with
tablets for diabetes and/or injectable antidiabetic medicines, other than insulin.
Levemir has a prolonged and consistent action of reducing blood sugar levels
within 3-4 hours after the injection. Levemir provides a 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 any of the other ingredients of this medicine,
see section 6, Contents of the pack and other information.
► If you experience the warning signs of hypoglycaemia (low blood sugar),
see a) Summary of serious and very common adverse effects in section 4.
► In microinfusors.
► If the cartridge or the device containing the cartridge is leaking, damaged or has
cracks.
► 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 water.
Do not use Levemir if any of these occur. Talk to your doctor, nurse or pharmacist for
advice.

Before using Levemir
► Check the label to make sure it is the correct type of insulin.
► Always check the cartridge, including the rubber stopper at the bottom of the
cartridge. Do not use it if it appears damaged or if the rubber stopper has been pulled up above the
white band at the bottom of the cartridge. This could lead to insulin leakage. If
you suspect the cartridge is damaged, return it to the supplier. Consult the
pen manual for further information.
► Always use a new needle for each injection to prevent contamination.
► Needles and Levemir Penfill must not be shared with others.
► Levemir Penfill is only suitable for subcutaneous injections with a reusable pen. Talk to your
doctor if you need to inject the insulin in another way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, abnormalities of the adrenal gland, pituitary gland or
thyroid
► If there has been an increase in your physical activity or a change in your usual diet,
as this may vary your blood sugar level
► If you become ill, continue to take your insulin and consult your doctor
► If you intend to travel abroad, travelling to countries with a different time zone may
vary your insulin requirements and the time of your injection.
► If you have very low albumin levels, you should carefully monitor your blood sugar level.
Talk to your doctor about this.

Skin changes at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, an area
thinned or an area thickened (see section 3, How to use Levemir). Tell your doctor if
you notice skin changes at the injection site. If you are currently injecting into one of these
affected areas, consult your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin or other
diabetes 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 under 1 year of age have not been established.
Data not available.

Other medicines and Levemir
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines affect your blood sugar level and may vary your insulin needs. The most important medicines that can affect insulin treatment are listed below.
Your blood sugar level may decrease (hypoglycaemia) if you take:

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

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

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

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder
usually occurring in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise a low blood
sugar level.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid increase in weight or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

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

Pregnancy and breastfeeding
► If you are pregnant or suspect you may be pregnant, ask your doctor for advice before taking this medicine. Your insulin dose may need to be
adjusted during pregnancy and after delivery. It is important to carefully control
your diabetes, especially to prevent hypoglycaemic episodes for the health of the 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
► Ask your doctor whether it is safe to drive or use machines:

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

High or low blood sugar levels can affect your ability to concentrate and react, and consequently also your ability to drive a vehicle or use machines. Be aware that you may 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, which means that Levemir is
essentially “sodium-free”.

3. How to use Levemir

Dosage and when to administer insulin
Always use insulin and adjust the dose exactly as your doctor has told you. If you are not sure,
consult your doctor, nurse or pharmacist.
Levemir can be used with rapid-acting prandial insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with
tablets for diabetes and/or injectable antidiabetic medications, other than insulin.
Do not change your insulin unless your doctor tells you to do so.
A dose adjustment by your doctor may be necessary if:

• your doctor has changed the type or brand of insulin, or
• your doctor has added another medication to your diabetes treatment, in addition to treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children starting from 1 year of age.
No clinical studies with Levemir have been conducted in children under 1 year of age.

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

How often to inject
Levemir should be administered once daily when used in combination with
tablets for diabetes and/or in combination with injectable antidiabetic medications, other than
insulin. When Levemir is used as part of a basal-bolus insulin regimen, it should be
administered one or two times a day according to need. The dose of Levemir should be
adjusted individually. The injection can be made at any time of the day,
but at the same time each day. In cases where two daily doses are needed to optimize
blood sugar control, the evening dose can be administered in the evening or before going to
bed.

How and where to inject
Levemir is administered by injection under the skin (subcutaneous use). You must never inject Levemir
directly into a vein (intravenously) or into the muscle (intramuscularly). Levemir Penfill is
suitable only for subcutaneous injections with a reusable pen. Talk to your doctor if you need to
inject insulin using another method.
With each injection, vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin indentations (see section 4, 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.
► 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, you must use two insulin delivery devices, one for each type of insulin.
► Always carry a Penfill cartridge with you as a spare in case the one in use is lost or
damaged.

How to inject 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 you have injected the entire dose.
Keep the injection button pressed down until the needle is withdrawn from the skin.
This will ensure correct administration and limit blood flow within the needle
or residual insulin.
► After each injection, make sure to remove and discard the needle and store Levemir without the needle
attached. Otherwise, the liquid may leak causing 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 insulin, your blood sugar level becomes too high (hyperglycemia).
See c) Effects of diabetes in section 4

If you stop taking insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a very high blood sugar level (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 everybody gets them.

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

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

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; racing heartbeat; feeling unwell; excessive hunger; temporary vision disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) leading to death. You may regain consciousness more quickly with a glucagon injection 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 is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets or a sugary snack with you, to be used if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilised, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have frequent episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the dose, timing of your insulin, food and physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you should faint, they should turn you onto your side and request immediate medical assistance. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto Levemir or any of its ingredients (called a systemic allergic reaction) is a very rare side effect but can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

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

Changes to the skin at the injection site:If you inject insulin in the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by a build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is unknown). Insulin may not work as well if you inject into an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Serious allergic reaction.
Vision problems: Vision disturbances may occur at the start of insulin treatment, however, these are usually temporary.
Swollen joints: Fluid retention may cause swelling around the ankles and other joints at the start of insulin treatment. This is a phenomenon that soon disappears. If it does not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar improves very rapidly, retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1000 people.
Peripheral neuropathy (pain due to nerve damage): a rapid improvement in blood sugar levels can cause nerve pain, this is called peripheral neuropathy and disappears spontaneously.

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

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

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

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, itchy skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact a doctor immediately.
► These may be the symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolising fat instead of sugar).
If left untreated, this may lead to diabetic coma and eventually to 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 cartridge label and on the
pack after ‘EXP’. The expiry date refers to the last day of the month indicated.
When not in use, always keep the cartridge in the outer packaging to protect it from
light.
Levemir must be protected from excessive heat and light.

Before opening:Unused Levemir Penfill must be stored in a refrigerator at 2°C - 8°C,
away from refrigerating elements. Do not freeze .

During use or when carried with you as a spare:Levemir Penfill in use or that is being carried with
you as a spare must not be stored in a refrigerator. It can be carried with you at room
temperature (below 30°C) for up to 6 weeks.
When not in use, always keep the cartridge in the outer packaging to protect it from
light.
Levemir must be protected from excessive heat and light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of unused medicines. 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 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 presented as an injectable solution.
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 flap of the pack and
on the label:

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

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

Levemir 100 units/ml injectable solution in prefilled pen

insulin detemir

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use 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 insulin (insulin analogue) with a prolonged action. Modern insulin medications are an improved version 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 can be used with rapid-acting prandial insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with tablets for diabetes and/or injectable antidiabetic medications, other than insulin.
Levemir has a prolonged and consistent action in reducing blood sugar levels within 3-4 hours after injection. Levemir provides a 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 any of the other ingredients of this medicine,
see section 6, Contents of the pack and other information.
► If you experience the warning signs of hypoglycaemia (low blood sugar)
see a) Summary of serious and very common adverse reactions in section 4.
► In microinfusers.
► If 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 water.
Do not use Levemir if any of these apply. Talk to your doctor, nurse or pharmacist for
advice.

Before using Levemir
► Check the label to make sure it is the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and Levemir FlexPen must not be shared with others.
► Levemir FlexPen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject
insulin in a different way.

Warnings and precautions
Some conditions and activities can affect your insulin needs. Consult your doctor:
► If you have kidney or liver problems, abnormalities affecting the adrenal gland, pituitary gland or
thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as
this may vary your blood sugar level.
► If you become ill, continue to take your insulin and consult your doctor.
► If you plan to travel abroad, travelling to countries with a different time zone may
vary your insulin needs and the time of your injection.
► If you have very low albumin levels, you should carefully monitor your blood sugar level.
Talk to your doctor about it.

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

Children and adolescents
Levemir can be used in adolescents and children from 1 year of age.
The safety and efficacy of Levemir in children under 1 year of age have not been established.
No data available.

Other medicines and Levemir
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines affect your blood sugar level and can vary your insulin needs. The most important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

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

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

• oral contraceptives (birth control pills)
• thiazides (used to treat high blood pressure or excessive fluid retention)
• glucocorticoids (such as “cortisone”) used to treat inflammation
• thyroid hormones (used to treat thyroid conditions)
• 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 that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning signs that can help you recognise a low level of
blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

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

Pregnancy and breastfeeding
► If you are pregnant or planning to become pregnant, ask your
doctor for advice before taking this medicine. Your insulin dose may require an
adjustment during pregnancy and after delivery. It is important to carefully control
diabetes, especially to prevent hypoglycaemic episodes for the health of the 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
► Ask your doctor whether it is safe to drive or use machines:

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

If your blood sugar is high or low, this can affect your ability to concentrate and react and consequently also your ability to drive a vehicle or use machines. Be aware that you could put yourself or others at risk.
Important information about some ingredients of Levemir
Levemir contains less than 1 mmol of sodium (23 mg) per dose, which means that Levemir is
essentially “sodium-free”.

3. How to use Levemir

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

• your doctor has changed the type or brand of insulin, or
• your doctor has added another medication to your diabetes treatment, in addition to treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children starting from 1 year of age.
No clinical studies with Levemir have been conducted in children under 1 year of age.

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

How often to inject
Levemir should be administered once daily when used in combination with
diabetes tablets and/or in combination with injectable antidiabetic medications, other than
insulin. When Levemir is used as part of a basal-bolus insulin regimen, it should be
administered one or two times daily according to need. The dose of Levemir should be
adjusted individually. The injection can be made at any time of the day,
but at the same time each day. In cases where two daily doses are needed to optimize
blood sugar control, the evening dose can be administered in the evening or before going
to bed.

How and where to inject
Levemir is administered by injection under the skin (subcutaneous use). You must never inject
Levemir directly into a vein (intravenously) or into a muscle (intramuscularly). Levemir FlexPen is
only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin using another
method.
With each injection, vary the injection site within the particular area of skin that you usually use.
This can reduce the risk of developing nodules and skin depressions (see section 4, Possible
undesirable effects). The best areas for injecting 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, prefilled pen, colour-coded, which contains insulin
detemir.
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 will become too low (hypoglycemia). See a)
Summary of serious and very common adverse effects in section 4.

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

If you stop taking insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a very high blood sugar level (severe hyperglycemia
) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions on 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 will experience them.

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

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

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; extreme hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) up to death. You may regain consciousness more quickly with an injection of glucagon hormone by someone who knows how to use it. If glucagon is administered to you, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another high-sugar snack (candies, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets or a high-sugar snack with you, to be used if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount, timing of insulin, food and physical activity.
Inform people close to you that you have diabetes and what the consequences may be, including the risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should turn you on your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto Levemir or any of its ingredients (called a systemic allergic reaction) is a very rare side effect but can be life-threatening. It can occur in less than 1 in 10,000 people.
Contact your doctor immediately:

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

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which it occurs is unknown). Insulin may not work as well as it should if you inject into an area with lumps, an area that has thinned, or an area that has thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but are usually temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints at the beginning of insulin treatment. This is a phenomenon that soon disappears. If not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to vision loss): if you have diabetic retinopathy and your blood sugar improves very rapidly, retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1000 people.
Peripheral neuropathy (pain due to nerve damage): a rapid improvement in blood sugar levels can induce nerve pain, this is called peripheral neuropathy and disappears spontaneously.

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

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

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

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

5. How to store 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
pack after ‘EXP’. The expiry date refers to the last day of the month indicated.
When not in use, always keep the FlexPen cap on the pen 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 freezing agents. Do not freeze .

During use or when carried with you as a spare:You can carry Levemir FlexPen with you and
store it at a temperature below 30°C or in a refrigerator (2°C - 8°C) for up to 6 weeks. If
stored in a refrigerator, keep it away from freezing agents. Do not freeze .
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of unused medicines. This will help protect the environment.

6. Content of the pack and other information

What Levemir contains

• The active ingredient 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 content of the pack
Levemir is presented as an injectable solution.
Packs of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled 3 ml 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 package tab and
on the label:

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

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

Instructions on how to use LEVEMIR injectable solution in FlexPen.
Read the following instructions carefully before using your FlexPen.If you do not follow
the instructions carefully, you may inject too much or too little insulin, which can lead to a level of
blood sugar that is too high or too low.
FlexPen is a pre-filled pen for administering variable-dose insulin.
It is possible to 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 carry a spare device for administering
insulin in case the FlexPen in use is lost or damaged.

Taking care of the pen
Your FlexPen must be handled with care. If it leaks or has been knocked or is damaged, there is
a risk that insulin may leak. This can cause incorrect dosages, which can lead to a
blood sugar level that is too high or too low.
You can clean the outside of your FlexPen with a disinfectant wipe. Do not immerse, wash or lubricate
the pen to avoid damaging the mechanism.
Do not refill your FlexPen.

Preparing Levemir FlexPen
Check the name and coloured label of your pen to make sure it contains the correct
type of insulin.This is particularly important if you use more than one type of insulin. If
you administer 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 on firmly and perpendicularly to your FlexPen.

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

D
Remove the inner cap from the needle and discard it.
Never try to put the inner cap back on the needle. You could injure yourself with the needle.

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

Checking the insulin flow
Small amounts of air may accumulate in the cartridge during normal use. Before each injection, to avoid injecting air and to administer the correct dose of insulin:
E
Rotate the dose selector and select 2 units.

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

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

Always make sure a drop appears at the tip of the needle before injecting. This
ensures the flow of insulin. 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 injecting. If you do not check the flow, you may inject a
too low amount of insulin or may not inject any at all. This can lead to a
blood sugar level that is too high.

Selecting the dose
Check that the dose selector is at 0.
H
Rotate the dose selector to select the number of units to be injected.
The dose can be increased or decreased by rotating the selector in both directions until
the indicator shows the correct dose. When rotating the dose selector, be careful not to
press the injection button to avoid insulin leakage.
You cannot select a dose higher than the number of units remaining in the cartridge.

Before injecting insulin, always use the dose selector and indicator to see how many
units have been selected.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar
level may become too high or too low. Do not use the scale, which only
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 dose of insulin by pushing the injection button all the way down until the indicator reaches
0. Be careful to press only the injection button.
Rotating the dose selector will not inject insulin.

J
Keep the injection button pressed down and leave the needle under the skin for at least 6 seconds. This
will ensure complete administration of the dose.
Withdraw the needle from the skin after releasing pressure on the injection button.
Always make sure the dose selector returns to 0 after the injection. If the dose selector
stops before reaching 0, the full dose has not been administered and may
cause a blood sugar level that is too high.

K
Insert the tip of the needle into the outer cap without touching the cap itself. When the needle is
covered, press the outer cap fully and then unscrew the needle.
Dispose of the needle carefully and replace the cap on the FlexPen.

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

Other important information
Anyone caring for you should be very careful when handling used needles to reduce
the risk of needle stick injuries and cross-infection.
Dispose of the used FlexPen with due caution, making sure to remove the needle.
Never share the pen and needles with other people. This can lead to cross-infection.
Never share the pen with other people. The medicine may be dangerous to their
health.
Always keep the pen and needles out of the sight and reach of others, especially
children.

Levemir 100 units/ml injectable solution in prefilled pen

insulin detemir

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use 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 insulin (insulin analogue) with a prolonged action. Modern insulin medications are an improved version 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 condition in which the body does not produce enough insulin to control blood sugar levels.
Levemir can be used with rapid-acting mealtime insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with tablets for diabetes and/or injectable antidiabetic medications, other than insulin.
Levemir has a prolonged and consistent action in reducing blood sugar levels within 3-4 hours after injection. Levemir provides a 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 any of the other ingredients of this medicine,
see section 6 Contents of the pack and other information.
► If you experience the warning signs of hypoglycaemia (low blood sugar
see a) Summary of serious and very common side effects in section 4.
► In microinfusors.
► If InnoLet 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 water.
Do not use Levemir if any of these occur. Talk to your doctor, nurse or pharmacist for
advice.

Before using Levemir
► Check the label to make sure it is the correct type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and Levemir InnoLet must not be shared with others.
► Levemir InnoLet is only suitable for subcutaneous injections. Talk to your doctor if you need to inject
the insulin in a different way.

Warnings and precautions
Some conditions and activities can influence your insulin needs. Consult your doctor:
► If you have kidney or liver problems, abnormalities affecting the adrenal gland, pituitary gland or
thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as
this may change your blood sugar level.
► If you become ill, continue to take your insulin and consult your doctor.

►If you are planning to travel abroad, travelling to countries with a different time zone may change
your insulin requirements and the time of your injection.
► If you have very low albumin levels, you should carefully monitor your blood sugar level. Talk to your doctor.

Changes to the skin at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, in a thinned area or in a thickened area (see section 3, How to use Levemir). Tell your doctor if
you notice changes to the skin at the injection site. If you are currently injecting into one of these
affected areas, consult your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your dose of insulin or other
diabetes 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 under 1 year of age have not been established.
No data available.

Other medicines and Levemir
Tell your doctor, nurse or pharmacist if you are taking or have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels and may change your insulin requirements. The most important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

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

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

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

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

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

Pregnancy and breastfeeding
.
► If you are pregnant or suspect you may be pregnant, ask your doctor for advice before taking this medicine. Your insulin dose may need to be
adjusted during pregnancy and especially after delivery. It is important to control
your diabetes carefully, especially to prevent hypoglycaemic episodes for the health of
the 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
► Ask your doctor whether it is safe for you to drive or use machines:

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

If your blood sugar is high or low, this can affect your ability to concentrate and react and consequently also your ability to drive a vehicle or use machines. Be aware that you could put yourself or others at risk.
Important information about some ingredients of Levemir
Levemir contains less than 1 mmol of sodium (23 mg) per dose, which means that Levemir is
essentially “sodium-free”.

3. How to use Levemir

Dose and when to administer insulin
Always use the insulin and adjust the dose exactly as your doctor has told you. If you are not sure
consult your doctor, nurse or pharmacist.
Levemir can be used with rapid-acting prandial insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with
tablets for diabetes and/or injectable antidiabetic medications, other than insulin.
Do not change the insulin unless your doctor tells you to do so.
A dose adjustment by your doctor may be necessary if:

• your doctor has changed the type or brand of insulin, or
• your doctor has added another medication for the treatment of diabetes, in addition to treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children starting from 1 year of age.
No clinical studies with Levemir have been conducted in children under 1 year of age.

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

How often to inject
Levemir should be administered once a day when used in combination with
tablets for diabetes and/or in combination with injectable antidiabetic medications, other than
insulin. When Levemir is used as part of a basal-bolus insulin regimen, it should be
administered one or two times a day according to need. The dose of Levemir should be
adjusted individually. The injection can be made at any time of the day,
but at the same time each day. In cases where two daily doses are needed to optimize
blood sugar control, the evening dose can be administered in the evening or before going
to bed.

How and where to inject
Levemir is administered by injection under the skin (subcutaneous use). You must never inject Levemir
directly into a vein (intravenous route) or into the muscle (intramuscular route). Levemir InnoLet is suitable
only for subcutaneous injections. Talk to your doctor if you need to inject insulin using another method.
With each injection, vary the injection site within the particular area of skin that you usually use.
This can reduce the risk of developing nodules and skin indentations (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 InnoLet
Levemir InnoLet is a disposable prefilled pen containing detemir insulin.
as described in the Instructions for Use.
Always make sure to use the correct pen before injecting your insulin.

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

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

If you stop taking insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a very high blood sugar level (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 everybody gets them.

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

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

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; very hungry; temporary vision problems; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) up to death. You can regain consciousness more quickly with a glucagon hormone injection 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 will need to be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets or a sugary snack with you, to be used if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar, have needed a glucagon injection, or have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the amount, timing of your insulin, food and physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you were to faint, they should turn you on your side and seek immediate medical attention. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto Levemir or any of its ingredients (called a systemic allergic reaction) is a very rare side effect but can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

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

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known). Insulin may not work as well as it should if you inject into an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Vision problems: vision problems may occur at the start of insulin treatment, but are usually temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints at the start of insulin treatment. This is a phenomenon that will soon disappear. If it does not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar level improves very rapidly, the retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1000 people.
Peripheral neuropathy (pain due to nerve damage): a rapid improvement in blood sugar control can induce nerve pain, this is called peripheral neuropathy and disappears spontaneously.

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

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

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

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

5. How to store Levemir

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the InnoLet label and on the
pack after ‘EXP’. The expiry date refers to the last day of the month indicated.
When not in use, always keep the FlexPen cap on the pen to protect it from
light.
Levemir must be protected from excessive heat and light.

Before opening:Unused Levemir InnoLet must be stored in a refrigerator at 2°C - 8°C,
away from refrigerating agents. Do not freeze .

During use or when carried with you as a spare:Levemir InnoLet in use or which is being carried
with you as a spare must not be stored in a refrigerator. It can be carried with you at room
temperature (below 30°C) for up to 6 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of unused medicines. This will help protect the environment.

6. Package Contents and Other Information

What Levemir contains

• The active ingredient is insulin detemir. Each ml contains 100 units of insulin detemir. Each prefilled 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 Levemir and package contents
Levemir is presented as an injectable solution.
Packs of 1, 5 and 10 prefilled 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 the leaflet over for information on how to use your InnoLet.
This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the European Agency website

Instructions on how to use LEVEMIR injectable solution in InnoLet
Read the following instructions carefully before using yourInnoLet.If you do not follow
the instructions carefully, you may inject too much or too little insulin, which can lead to a level of
blood sugar that is too high or too low.
InnoLet is a simple and compact prefilled pen capable of delivering from 1 to 50 units of insulin in
1-unit increments. InnoLet is specifically designed to be used with NovoFine or NovoTwist disposable needles of up to 8 mm in length. As a precaution, always carry
a spare device for administering insulin in case your InnoLet in use
is lost or damaged.

To get started
Check the name and colored labelof your InnoLet to make sure it contains the correct type
of insulin. This is especially important if you are using more than one type of insulin. If you administer
the wrong type of insulin, your blood sugar level may 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 dosage.
• Be careful not to bend or damage the needle before use.
• Remove the protective sealfrom a new disposable needle.
• Screw the needle on firmly and perpendicularly to InnoLet (figureA).
• Remove the large outer needle protection cap and the inner needle cap.It may be helpful to keep the large outer needle cap in the designated compartment.
• Never try to put the inner needle cap back on the needle itself. You could injure yourself with the needle.

Preparing the pen to eliminate air before each injection
Small amounts of air may accumulate in the needle and insulin cartridge during normal use.
To avoid injecting air and to administer the correct dose of insulin:

• Select 2 unitsby turning the dose selector clockwise
• Hold InnoLet with the needle pointing upwards and gently tapthe insulin cartridgeseveral times with your fingers (figure B). This will cause air bubbles to collect at the top of the cartridge.
• Still holding the needle pointing upwards, fully depress the injection button.The dose selector will return to 0.
• Always make sure a drop of insulin comes out of the needle tipbefore the injection (figure B). This ensures insulin flow. If this does not happen, replace the needle and repeat the procedure no more than 6 times.

Further failure to dispense insulin indicates that the device is 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 the injection. If you do not check your InnoLet, you may inject too little insulin or not inject any at all. This can lead to a blood sugar level that is too high.

Selecting the dose

• Always make sure the injection button is fully depressed and the dose selector is positioned at 0.
• Select the number of unitsto be injected by rotating the selector clockwise (figure C).
• You will feel a click for each single unit selected.The dose can be corrected by rotating the selector in both directions. Make sure not to rotate the knob or correct the dose when the needle is inserted into the skin. This can lead to inaccurate dosages that can cause your blood sugar level to become too high or too low.

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

Injecting the insulin

• Insert the needle into the skin.Use the injection technique recommended by your doctor.
• Administer the dose of insulin by fully depressing the injection button (figureD).You will feel clicks as the selector returns to 0.
• After the injection, wait at least 6 seconds before removing the needleto ensure complete delivery of the dose.
• Make sure you do not block the dose selector during the injectionas it must be free to return to 0 when the injection button is pressed. Always make sure the dose selector returns to 0 after the injection. If the dose selector stops before reaching 0, the full dose has not been administered and may cause a blood sugar level that is too high.
• Dispose of the needle after each injection.

Removing the needle

• Put the large outer protection cap on and unscrew the needle (figureE). Dispose of the needle with

due caution.

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

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

Further important information
Anyone caring for you should be very careful when handling used needles to reduce
the risk of needle stick injuries and cross-infection.
Dispose of the used InnoLet with due caution, making sure to remove the needle.
Never share the pen and needles with other people. This can lead to cross-infection.
Never share the pen with other people. The medicine may be dangerous to their health.
Always keep the InnoLet pen and needles out of sight and reach of others, especially
children.

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

Do not refill InnoLet.

Levemir 100 units/ml injectable solution in prefilled pen

insulin detemir

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use 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 insulin (insulin analogue) with a prolonged action. Modern insulin medications are an improved version 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 can be used with rapid-acting mealtime insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with tablets for diabetes and/or injectable antidiabetic medications, other than insulin.
Levemir has a prolonged and consistent action in reducing blood sugar levels within 3-4 hours after injection. Levemir provides a 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 any of the other ingredients of this medicine,
see section 6 Contents of the pack and other information.
► If you experience the warning signs of hypoglycemia (low blood sugar)
see a) Summary of serious and very common adverse effects in section 4.
► In microinfusors.
► 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 water.
Do not use Levemir if any of these occur. Talk to your doctor, nurse or pharmacist for
advice.

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

Warnings and precautions
Some conditions and activities can influence your insulin needs. Consult your doctor:
► If you have kidney or liver problems, abnormalities of the adrenal gland, pituitary gland or
thyroid.
► If there has been an increase in physical activity or a change in your usual diet, as
this may change your blood sugar levels.
► If you become ill, continue to take your insulin and consult your doctor.
► If you are planning to travel abroad, travelling to countries with a different time zone may
change your insulin requirements and the time of your injection. Consult your doctor if you are
planning such trips.
► If you have very low albumin levels, you should carefully monitor your blood sugar level.
Talk to your doctor about this.

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

Children and adolescents
Levemir can be used in adolescents and children from 1 year of age.
The safety and efficacy of Levemir in children under 1 year of age have not been established.
No data available.

Other medicines and Levemir
Tell 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 your blood sugar level and may change your insulin needs. The most important medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycemia) if you take:

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

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

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

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise low blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure such as unusual shortness of breath or a
rapid weight gain or localised swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

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

Pregnancy and breastfeeding
► If you are pregnant or suspect you may be pregnant, ask your doctor for advice before taking this medicine. Your insulin dose may need to be
adjusted during pregnancy and after delivery. It is important to control your diabetes carefully, especially to prevent hypoglycemic episodes for the health of the 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
► Ask your doctor whether it is safe for you to drive or use machines:

• If you have frequent episodes of hypoglycemia.
• If you have difficulty recognising the warning signs of hypoglycemia.

High or low blood sugar can affect your ability to concentrate and react, and consequently your ability to drive or use machines. Be aware that
you may put yourself or others at risk.

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

3. How to use Levemir

Dose and when to administer insulin
Always use insulin and adjust the dose exactly as your doctor has told you. If you are not sure
consult your doctor, nurse or pharmacist.
Levemir can be used with rapid-acting prandial insulin medications.
In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with
diabetes tablets and/or injectable antidiabetic medications, other than insulin.
Do not change your insulin unless your doctor tells you to do so.
A dose adjustment by your doctor may be necessary if:

• your doctor has changed the type or brand of insulin, or
• your doctor has added another medication for the treatment of diabetes, in addition to treatment with Levemir.

Use in children and adolescents
Levemir can be used in adolescents and children starting from 1 year of age.
No clinical studies with Levemir have been conducted in children under 1 year of age.

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

How often to inject
Levemir should be administered once a day when used in combination with
diabetes tablets and/or in combination with injectable antidiabetic medications, other than
insulin. When Levemir is used as part of a basal-bolus insulin regimen, it should be
administered one or two times a day according to need. The dose of Levemir should be
adjusted individually. The injection can be made at any time of the day,
but at the same time each day. In cases where two daily doses are needed to optimize
blood sugar control, the evening dose can be administered in the evening or before going
to bed.

How and where to inject
Levemir is administered by injection under the skin (subcutaneous use). You should never inject
insulin directly into a vein (intravenously) or into the muscle (intramuscularly). Levemir
FlexTouch is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin with
another method.
With each injection, vary the injection site within the particular area of skin that you usually use.
This can reduce the risk of developing nodules and skin depressions (see section 4, Possible
undesirable 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 FlexTouch
Levemir FlexTouch is a disposable pre-filled pen, colour-coded, containing insulin
detemir.
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 will become too low (hypoglycemia). See a)
Summary of serious and very common adverse effects in section 4.

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

If you stop taking insulin
Do not stop taking insulin without talking to your doctor, who will tell you what
you need to do. This could lead to a very high level of 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 everybody gets them.

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

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

Warning signs of low blood sugar: cold sweat; cold and pale skin; headache; fast heartbeat; feeling unwell; being very hungry; temporary vision problems; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe hypoglycemia is prolonged and not treated, it can cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly with a glucagon injection given by someone who knows how to use it. If glucagon is given to you, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you should be taken to hospital.
What to do if your blood sugar is low:
► If your blood sugar is too low, eat glucose tablets or another sugary snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets or a sugary snack with you, to be used if needed.
► When the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue your insulin treatment.
► If you have low blood sugar and have needed a glucagon injection, or if you have frequent episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the dose, timing of your insulin, food or physical activity.
Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting due to hypoglycemia. Explain that, if you should faint, they should turn you onto your side and call for immediate medical help. You should not be given food or drink as this could cause you to choke.

Serious allergic reactionto Levemir or any of its ingredients (called a systemic allergic reaction) is a very rare side effect but can be life-threatening. It may affect less than 1 in 10,000 people.
Contact your doctor immediately:

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

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

b)List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If the symptoms do not disappear or spread to other parts of the body, see your doctor immediately. See also Serious allergic reaction.
Vision problems: vision problems may occur at the start of insulin treatment, but are usually temporary.
Swollen joints: fluid retention may cause swelling around the ankles and other joints at the start of insulin treatment. This usually disappears quickly. If it does not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to blindness): if you have diabetic retinopathy and your blood sugar improves rapidly, the retinopathy may worsen. Ask your doctor.

Rare side effects
May affect less than 1 in 1000 people.
Peripheral neuropathy (pain due to nerve damage): a rapid improvement in blood sugar levels can cause nerve pain, this is called peripheral neuropathy and disappears spontaneously.

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

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

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

Warning signs of high blood sugar:
The warning signs appear gradually. They include: passing more urine than usual; thirst; loss of appetite; feeling unwell (nausea or vomiting); feeling sleepy or tired; dry, itchy skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high:
► If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact your doctor immediately.
► These may be the symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar).
If not treated, this can 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 FlexTouch label and on the
pack after ‘EXP’. The expiry date refers to the last day of the month indicated.
When not in use, always keep the FlexPen cap on the pen to protect it from
light.
Levemir must be protected from excessive heat and light.

Before opening:Unused Levemir FlexTouch must be stored in a refrigerator at 2°C -
8°C, away from freezing agents. Do not freeze .

During use or when carried with you as a spare:You can carry Levemir FlexTouch with you
and store it at a temperature below 30°C or in a refrigerator (2°C - 8°C) for up to 6 weeks. If
stored in a refrigerator, keep it away from freezing agents. Do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of unused medicines. This will help protect the environment.

6. Content of the pack 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 Levemir and content of the pack
Levemir is presented as an injectable solution.
Packs of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 pens
pre-filled with 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 the leaflet over for information on how to use your FlexTouch.
This leaflet was last revised in
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency (EMA): http://www.ema.europa.eu/.

Instructions on how to use Levemir 100 units/ml injectable solution in pre-filled pen
(FlexTouch)
Read the following instructions carefully before using your FlexTouch pre-filled pen.If you do not follow the instructions carefully, you may inject too much or too little insulin which
may lead to a blood sugar level that is too high or too low.

Do not use the pen without receiving adequate instructionfrom 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 impairment and are unable to read the pen dose counter,
do not use this pen without help.Ask someone with good
vision who is trained in the use of the FlexTouch pre-filled pen for assistance.
Levemir FlexTouch is a pre-filled pen with insulin. Levemir FlexTouch contains 300 units of
insulin and it is possible to select a dose between 1 and 80 units in 1-unit increments.
Levemir FlexTouch is designed to be used with single-use needles NovoFine or NovoTwist
with a length of up to 8 mm.

Preparing your Levemir FlexTouch pen
Check the name and coloured label to make sure your Levemir FlexTouch contains the
correct type of insulin.This is particularly important if you use more than one type of insulin. If
you administer 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 screwed on tightly.

• E.Remove the outer needle cap and keep it. You will need it after the injection to remove the needle from the pen correctly.

Remove the inner needle cap and discard it. If you try to put it back on, you could accidentally prick yourself
with the needle.
A drop of insulin may appear at the needle tip. This is normal.

Always use a new needle for each injection. This reduces the risk of contamination,
insulin leakage, needle blockage and incorrect dosage.

Never use a bent or damaged needle.
Checking the insulin flow
Before each injection, always check the insulin flow to make sure you are delivering the correct dose of insulin:

• F.Rotate the dose selector and select 2 units.

• G.Hold the pen with the needle pointing upwards.

Tap the side of the pen 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 will appear at the needle tip.

If this does not happen, repeat steps Fto Hup to 6 times. If a drop of insulin does not appear
after these attempts, change the needle and repeat steps Fto Hagain.
Do not use the pen if a drop of insulin still does not appear.

Always make sure a drop appearson the needle tip before the injection. This
ensures the insulin is flowing. If this does not happen, do notinject the insulin, even if
the dose counter moves. This may indicate a blocked or
damaged needle.

Always check the flow before the injection.If you do not check the flow, you may not inject
any insulin at all or you may inject too little. This can lead to a
blood sugar level that is too high.

Selecting the dose
Use the dose selector on your Levemir FlexTouch pen to select the dose. It is possible to
select up to 80 units per dose.

• I.Select the dose you need .You can rotate the dose selector forwards and backwards. Stop when the correct number of units is aligned with the dose indicator.

The dose selector makes a different sound (click) if rotated forwards, backwards or if it passes over the
number of remaining units.
When the pen contains less than 80 units, the dose counter displays the number of remaining units.

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

How much insulin is left?
The insulin scaleshows approximatelyhow much insulin is left in
the pen.

To see precisely how much insulin is leftin the pen use the dose counter:
Rotate the dose selector until the dose counter stops.If it shows 80,
there are at least 80 unitsleft in the pen.
If it shows less than 80the number shown is the number of units remaining in the pen.
Rotate the dose selector back until the dose counter shows 0.
If you need a number of insulin doses greater than those remaining in the pen, you can
split the dose between two pens.

Be very careful to calculate the correct number if you split the dose.
If you are unsure, inject the full dose using a new pen. If you split the dose
incorrectly, you will inject too low or too high a dose of insulin, which can lead to a
blood sugar level that is too high or too low.

Injecting the dose
Use the correct injection technique to make sure you deliver the entire dose.

• J.Insert the needle into the skin as shown to you by your doctor or nurse. Make sure you can see the dose counter. Do not touch the dose counter with your fingers, otherwise the injection may be blocked.

Push the injection button until the dose counter reaches 0. The 0 must
align with the dose indicator and you may feel or hear a click.

After the dose counter has returned to 0, leave the needle under the skin for at least6 seconds
to make sure you have injected the entire dose.

• K.Remove the needle from the skin.

After this, you may see a drop of insulin on the needle tip. This is normal and has
no effect on the dose delivered.

Always discard the needle after each injection. This reduces the risk of contamination, infection,
insulin leakage, needle blockage and incorrect dosage .If the needle is blocked, do not
inject the insulin.

• L.Bring the needle tip into the outer needle cap placed on a flat surface. Do not touch the needle or the cap.

When the needle is covered, press the outer cap fully and then
unscrew the needle. Discard 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 look at the dose counter to see how many units you are injecting.
The dose counter shows the exact number of units. Do not count the pen clicks. Hold
the injection button pressed until the dose counter returns to 0 after
the injection. If the dose counter stops before reaching 0, the full dose has not
been delivered and this may lead to a blood sugar level that is too high.

Never try to put the inner needle cap back on. You could prick yourself with the needle.

Always remove the needle from the pen after each injectionand store the pen without the needle
attached. This reduces the risk of contamination, infection, insulin leakage, needle blockage and incorrect dosage.

Pen maintenance
Treat the pen with care. Incorrect or improper use can cause incorrect dosages, which can lead
to a blood sugar level that is too high or too low.

• Do not leave the pen in the caror in other places where it could get 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 mild detergent on a damp cloth.

• Do not drop orknock the penagainst hard surfaces. If you drop it or suspect a problem, always screw on a new needle and check the insulin flow before the injection.
• Do not try to refill the pen. When it is empty, it must be discarded.
• Do not try to repairor disassemble the pen.

Important information

• Always carry the pen with you.
• Always carrywith you an extra pen and new needlesin case you lose or damage the pen or the needles.
• Always keep the pen and the needles out of sight and reach of others, especially children.
• Never share the pen and needles with other people. This can lead to cross-infection.
• Never sharethe pen with other people. The medicine may be dangerous to their health.
• Anyone caring for you must take great care when handling used needlesto reduce the risk of needle injury and cross-infection.