Label: information for the user

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

detemir insulin

Read this label carefully before starting to use this medicine because it contains important information for you.

•Keep this label, as you may need to read it again.

•If you have any questions, consult your doctor, nurse, or pharmacist.

•This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

•If you experience any adverse effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this label. See section 4.

1.What is Levemir and how is it used

2.What you need to know before starting to use Levemir

3.How to use Levemir

4.Adverse effects

5.Storage of Levemir

6.Contents of the package and additional information

Levemir is a modern insulin (insulin analog) with prolonged action. Modern insulins are improved versions of human insulin.

Levemir is used to reduce high blood sugar levels in adults, adolescents, and children 1 year of age and older with 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 insulins administered in relation to meals.

In the treatment of type 2 diabetes mellitus, Levemir can also be used in combination with oral diabetes medications and/or non-insulin injectable antidiabetic drugs.

Levemir has a prolonged and constant action of reducing sugar 3 or 4 hours after injection. Levemir provides basal insulin coverage for up to 24 hours.

No use Levemir

?If you are allergic to detemir insulin or any of the other components of this medication, see section 6, Contents of the pack and additional information.

?If you suspect that you are going to have hypoglycemia (low blood sugar), see a) Summary of very common and serious adverse reactions in section 4.

?In insulin infusion pumps.

• If FlexPen has fallen, been damaged or broken.
• If it has not been stored properly or has been frozen, see section 5, Storage of Levemir.
• If the insulin does not have a transparent, colorless and watery appearance like water.

If any of these circumstances affect you, do not use Levemir. Consult your doctor, nurse or pharmacist.

Before using Levemir

Warnings and precautions

Some conditions and activities may affect your insulin requirement. Consult your doctor:

?If you have kidney, liver, adrenal gland, pituitary gland or thyroid gland problems.

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

?If you are ill, continue insulin treatment and consult your doctor.

?If you are traveling abroad, time zone differences between countries may affect your insulin requirement and administration timing.

?If your albumin levels are very low, carefully control your blood sugar levels. Discuss this with your doctor.

Changes in skin at the injection site

Rotate the injection site to help prevent changes in the fatty tissue, such as skin thickening, skin shrinking or lumps under the skin. Insulin may not work well if injected in a swollen, shrunk or thickened area (see section 3, How to use Levemir). Inform your doctor if you detect any changes in the injection site. Inform your doctor if you are currently injecting in these affected areas, before starting to inject in a different area. Your doctor may instruct you to check your blood sugar levels more closely, and adjust the insulin or your other antidiabetic medications.

Children and adolescents

Levemir can be used in adolescents and children aged 1 year and older.

The safety and efficacy of Levemir in children under 1 year of age have not been established.

No data are available.

Other medicines and Levemir

Inform your doctor, nurse or pharmacist if you are using, have used recently or may need to use any other medicine.

Some medicines affect your blood sugar level and this may mean that your insulin dose needs to be adjusted. The following are the main medicines that may affect your insulin treatment:

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

•Other medicines for diabetes treatment

•Monamine oxidase inhibitors (MAOIs) (used to treat depression)

•Beta-blockers (used to treat high blood pressure)

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

•Salicylates (used to relieve pain and reduce fever)

•Anabolic steroids (such as testosterone)

•Sulfonamides (used to treat infections)

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

•Oral contraceptives (birth control pills)

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

•Glucocorticoids (such as "cortisone" used to treat inflammation)

•Thyroid hormones (used to treat thyroid gland disorders)

•Adrenergic agonists (such as epinephrine [adrenaline] or salbutamol or terbutaline for asthma)

•Growth hormone (medication to stimulate somatic and skeletal growth, which has a pronounced effect on metabolic processes)

•Danazol (medication that acts on ovulation)

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

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

Pioglitazone (tablets used to treat type 2 diabetes)

Some patients with long-standing type 2 diabetes and pre-existing heart disease or stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as unusual shortness of breath, rapid weight gain or localized inflammation (edema).

If you have taken any of the medicines mentioned above, inform your doctor, nurse or pharmacist.

Alcohol and use of Levemir

?If you drink alcohol, it may change your insulin requirement as your blood sugar level may be increased or decreased. It is recommended to have a careful control.

Pregnancy and breastfeeding

?If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine. You may need to adjust your insulin dose while pregnant and after delivery. It is essential for the health of your baby to have a careful control of your diabetes, especially to prevent hypoglycemia.

?If you are breastfeeding, consult your doctor as you may need to adjust your insulin dose.

Consult your doctor, nurse or pharmacist before using any medicine while pregnant or breastfeeding.

Driving and operating machinery

?Please ask your doctor if you can drive or operate machinery:

•If you have frequent hypoglycemia.

•If you find it difficult to recognize hypoglycemia.

If your blood sugar levels are low or high, they may affect your concentration and reaction time and therefore also your ability to drive a car or operate machinery. Note that you may put your life or the lives of others at risk.

Important information about some of the components of Levemir

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

Posology and when to administer insulin

Always use the insulin and adjust the dose exactly as recommended by your doctor. If in doubt, consult your doctor, nurse or pharmacist again.

Levemir can be used with rapid-acting insulins administered in relation to meals.

In the treatment of type 2 diabetes, Levemir can also be used in combination with oral diabetes medications and/or non-insulin injectable antidiabetic drugs.

Do not change insulin unless your doctor tells you to.

Your doctor may need to adjust your dose if:

•your doctor changesyou from one type or brand of insulin to another, or

•your doctor has added another medication for the treatment of diabetes, in addition to your Levemir treatment.

Use in children and adolescents

Levemir can be used in adolescents and children aged 1year and older.

There is no experience with the use of Levemir in children under 1year of age.

Use in special patient groups

If you have kidney or liver dysfunction (renal or hepatic insufficiency), or if you are over 65years old, you must monitor your blood sugar more frequently and consult with your doctor about changes in your insulin dose.

How often to inject

When used in combination with oral diabetes medications and/or in combination with non-insulin injectable antidiabetic drugs, Levemir should be administered once a day. When used as part of a basal-bolus regimen, Levemir should be administered once or twice a day, depending on the patient's needs. The Levemir dose should be adjusted individually. The injection can be administered at any time of the day, but at the same time every day. In patients who need two doses a day to optimize their blood sugar control, the evening dose can be administered in the evening or before bedtime.

How and where to inject

Levemir is injected under the skin(subcutaneous administration). Levemir should never be injected directly into a vein (intravenous administration) or muscle (intramuscular administration). LevemirFlexPenis only indicated for subcutaneous injection. Consult your doctor if you need to inject insulin by another method.

In each injection, change the injection site within the specific area of skin that you usually use. This may reduce the risk of developing lumps or depressions in the skin (see section4, Possible adverse effects). The best areas for injection are the following: the front of the thigh, the abdominal area and the outer upper arm. Regularly measure your blood sugar level.

How to handle Levemir FlexPen

Levemir FlexPen is a pre-filled, disposable pen with a color code containing detemir insulin.

Read the usage instructions included in this leaflet carefully. You must use the pen as described in the usage instructions.

Always make sure you use the correct pen before injecting insulin.

If you use more insulin than you should

If you use too much insulin, your blood sugar level may become very low (hypoglycemia). See a) Summary of serious and very frequent adverse effects in section 4.

If you forget to use your insulin

If you forget to inject insulin, your blood sugar level may become very high (hyperglycemia). See c) Effects of diabetes in section 4.

If you interrupt your insulin treatment

Do not stop taking your insulin without consulting your doctor, he will tell you what to do. This could produce very high blood sugar levels (severe hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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 may affect more than 1 in 10 people.

Symptoms of low blood sugar may appear if:

•Too much insulin is injected.

•Very little food is eaten or a meal is skipped.

•More exercise than usual is done.

•Alcohol is consumed (see section 2, Alcoholic beverages and use of Levemir).

Warning signs of low blood sugar:chills, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary changes in vision, drowsiness, fatigue and weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

A severe drop in blood sugar can lead to loss of consciousness. If a severe and prolonged drop in blood sugar is not treated, it may cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly if someone who knows how to do it administers a glucagon injection. If glucagon is administered, you should take glucose or a sweet product as soon as you regain consciousness. If you do not respond to glucagon treatment, you should be treated in a hospital.

What to do if your blood sugar level is low:

?If your blood sugar level is low, take glucose tablets or a sweet product (caramels, cookies, fruit juice). Measure your blood sugar level if possible and then rest. Always carry glucose tablets or sweet foods with you in case you need them.

?When the symptoms of hypoglycemia have disappeared or when your blood sugar levels have stabilized, continue treatment with insulin as usual.

?If you have had blood sugar levels so low that you have lost consciousness, if you have needed someone to administer a glucagon injection, or if you have had many drops in blood sugar levels, talk to your doctor. You may need to adjust the amount or schedule of insulin, food, or exercise.

Inform others that you have diabetes and what the consequences may be, including the risk of losing consciousness due to a drop in blood sugar levels. Inform them that if you become unconscious, they should lay you on your side and seek immediate medical attention. Do not give you anything to eat or drink as you may choke.

Severe allergic reactionto Levemir or one of its components (called systemic allergic reaction) is a very rare but potentially fatal side effect. It may affect up to 1 in 10,000 people.

Consult your doctor immediately:

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

•If you suddenly feel sick and have sweating, vomiting, difficulty breathing, palpitations, and dizziness.

?If you notice any of these symptoms, consult your doctor immediately.

Changes in skin at the injection site: If insulin is injected in the same place, the fatty tissue may shrink (lipatrophy) or become thicker (lipohypertrophy) (it may affect up to 1 in 100 people). Bumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work well if injected in a thickened, shrunk, or swollen area. Change the injection site to help prevent these skin changes.

b)List of other side effects

Uncommon side effects

They may affect up to 1 in 100 people.

Allergic signs:Allergic reactions may occurin the injection site (pain, redness, rashes, inflammation, hematomas, swelling, and itching). These reactions usually disappear after a few weeks of treatment. If symptoms do not disappear or spread to your body, consult your doctor immediately. See also Severe allergic reaction above.

Visual problems:You may have visual problems when starting insulin treatment, but this alteration is usually temporary.

Swollen joints::When starting insulin treatment, fluid accumulation may cause inflammation of the ankles and other joints. This effect usually disappears quickly. If not, consult your doctor.

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

Rare side effects

They may affect up to 1 in 1,000 people.

Painful neuropathy:(pain due to nerve damage): If your blood sugar level improves rapidly, you may experience nerve-related pain, which is usually temporary.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

c)Diabetes effects

High blood sugar (hyperglycemia)

Symptoms of high blood sugar may appear if:

•Not enough insulin is injected.

•Insulin is forgotten or interrupted.

•Repeatedly less insulin is injected than needed.

•An infection or fever is present.

•More food is eaten than usual.

•Less physical exercise than usual is done.

Warning signs of high blood sugar:

These warning signs appear gradually. They include: increased need to urinate, thirst, loss of appetite, feeling of dizziness (nausea or vomiting), drowsiness or fatigue, dry and red skin, feeling of dryness in the mouth, and breath with a fruity odor (acetone).

What to do if your blood sugar level is very high:

?If you notice any of the described symptoms: check your blood sugar level, check your urine ketone level if possible, and consult your doctor immediately.

?These may be symptoms of a severe condition called diabetic ketoacidosis (acid accumulates in the blood due to the body breaking down fat instead of sugar). If not treated, it may cause diabetic coma and death.

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

Do not use this medication after the expiration date that appears on the label of the FlexPen and on the packaging after CAD. The expiration date is the last day of the month indicated.

Always keep the cap of the pen on your FlexPen when not in use to protect it from light.

Levemir must be protected from excessive heat and light.

Before opening:Unused Levemir FlexPenmust be stored in the refrigerator between 2°C and 8°C, away from the refrigerator element. Do not freeze.

During use or when carrying as a spare:You may carry your Levemir FlexPen with you and store it at a temperature below 30°C or in the refrigerator (between 2°C and 8°C) for 6weeks. If refrigerated, keep away from the refrigerator element. Do not freeze.

Medications should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Levemir

•The active ingredient is insulin detemir. Each ml contains 100units of insulin detemir. Each pre-filled pen contains 300units of insulin detemir in 3ml of injectable solution. 1unit of insulin detemir corresponds to 1unit of international standard of human insulin.

•The other components are glycerol, phenol, metacresol, zinc acetate, dihydrate disodium phosphate, sodium chloride, hydrochloric acid, sodium hydroxide, and injection water.

Appearance of the product and contents of the package

Levemir is presented as an injectable solution.

Packages containing 1 (with or without needles), 5 (without needles), and 10 (without needles) pre-filled pens of 3ml. It may not be all presentations marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Responsible for manufacturing

The manufacturer can be identified by the batch number printed on the carton lid 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.

The back includes the instructions for use of FlexPen.

Last review date of this leaflet:

Other sources of information

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

Instructions for use of LEVEMIR injectable solution in FlexPen

Read these instructions carefully before using your FlexPen.If you do not follow the instructions carefully, you may administer too little or too much insulin, which could produce a level of blood sugar that is too high or too low.

FlexPen is a pre-filled insulin dosing pen.Doses of 1 to 60units can be selected in increments of 1unit. FlexPen is designed to be used with the disposable needles NovoFine or NovoTwist up to 8mm long. As a precaution, always carry a spare insulin administration device in case the FlexPen you are using is lost or damaged.

Care of the pen

You must handle your FlexPen with care.

If it falls, is damaged, or is hit, there is a risk of insulin leakage. This could cause an inaccurate dose, which may produce a level of blood sugar that is too high or too low.

You can clean the outer part of your FlexPen with an alcohol-soaked cotton swab. Do not submerge it, wash it, or lubricate it, as the pen may be damaged.

Do not refill your FlexPen.

Preparation of Levemir FlexPen

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

A

Remove the pen cap.

B

Remove the paper tab from a new disposable needle.

Twist the straight needle firmly onto your FlexPen.

C

Remove the large outer needle cap and save it for later.

D

Remove the inner needle cap and discard it.

Do not attempt to put the inner needle cap back on. You may prick yourself with the needle.

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

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

Insulin flow check

Before each injection, small amounts of air may be present in the cartridge during normal use. To avoid injecting air and ensure proper dosing:

E

Turn the dose selector to select 2units.

F

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

G

Keeping the needle pointing upwards, press the plunger all the way down. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure up to 6times.

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

Always make sure a drop appears at the needle tip before injecting. This ensures that the insulin flows. If no drop appears, no insulin will be injected, although the dose selector may move. This may indicate that the needle is blocked or damaged.

Always check the flow before injecting. If you do not check the flow, you may receive an insufficient or non-existent dose of insulin, which could produce a level of blood sugar that is too high.

Dose selection

Check that the dose selector indicates 0.

H

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

The dose can be corrected forward and backward by turning the dose selector in either direction until the corrected dose is aligned with the dose marker. When turning the dose selector, be careful not to press the plunger, as insulin may leak out.

You cannot select a dose greater than the number of units remaining in the cartridge.

Before injecting insulin, always use the dose selector and dose marker to see how many units you have selected.

Do not count the clicks of the pen. If you select an incorrect dose and inject it, your blood sugar level may become too high or too low. Do not use the remaining insulin scale, as it only shows the approximate amount of insulin remaining in the pen.

Injection

Insert the needle under the skin. Use the injection technique indicated by your doctor or nurse.

I

Inject the dose by pressing the plunger all the way down so that 0 is aligned with the dose marker. Be careful to press the plunger only when injecting.

Turning the dose selector will not inject insulin.

J

Keep the plunger pressed down and keep the needle under the skin for at least 6seconds. This ensures that the full dose is injected.

Remove the needle from the skin and once you have done so, release the plunger.

Always make sure the dose selector returns to 0 after injection. If the dose selector stops before reaching 0, the full dose has not been administered, which could result in a level of blood sugar that is too high.

K

Cap the needle with the large outer needle cap without touching it. When the needle is covered, press the large outer needle cap gently and then twist it off.

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

Always remove the needle after each injection and store your FlexPen without the needle. This reduces the risk of contamination, infection, insulin loss, needle blockage, and inaccurate dosing.

Other important information

People caring for these patients must be very careful when handling used needles to reduce the risk of accidental punctures and infections.

Dispose of your used FlexPen carefully without leaving the needle attached.

Never share the pen or needles with others. This could cause infections.

Never share the pen with others. Your medicine could be harmful to their health.

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