Levemir100 U/ml solution for injection in pre-filled pen

Levemiris a modern insulin (insulin analogue) with a long-acting effect. Modern insulins are improved versions of insulin human.

Levemir is used to treat diabetes mellitus in adults, adolescents and children aged 6 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of your blood sugar. Levemir may be used in combination with oral antidiabetic medicines or with meal-related rapid acting insulin medicines.

Levemir has a long and steady blood-sugar-lowering action starting within a few hours (3-4). Levemir provides 24 hours of basal insulin coverage after injection.

Do not use Levemir

If you are allergic hypersensitive to insulin detemir or any of the other ingredients in Levemir see 6 Further information. If you suspect hypoglycaemia low blood sugar is starting see 3 How to use Levemir. In insulin infusion pumps. If InnoLet is dropped, damaged or crushed. If it has not been stored correctly or been frozen see 5 How to store Levemir. If the insulin does not appear water clear and colourless.

Before using Levemir

Check the label to make sure it is the right type of insulin. Always use a new needle for each injection to prevent contamination. Needles and Levemir InnoLet must not be shared.

Take special care with Levemir

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands. If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level. If you are ill, carry on taking your insulin and consult your doctor. If you are going abroad travelling over time zones may affect your insulin needs and the timing of your injections. Consult your doctor if you are planning such travelling. If you have very low albumin you need to carefully monitor your blood sugar level. Discuss this with your doctor.

Using other medicines

Some medicines affect the way glucose works in your body and this may influence your insulin dose. Listed below are the most common medicines, which may affect your insulin treatment. Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, you should tell your doctor if you are using any medicine as mentioned below that affects your blood sugar level.

If you take any of the medicines below, your blood sugar level may fall (hypoglycaemia):

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

If you take any of the medicines below, your blood sugar level may rise (hyperglycaemia):

• 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)
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body?s metabolic processes)
• Danazol (medicine acting on ovulation)

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

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

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

Taking Levemir with food and drink

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
- If you are pregnant, planning a pregnancy or breast-feedingplease contact your doctor for advice. Your insulin dose may need to be changed during pregnancy particularly after delivery. Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.

Driving and using machines

If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.

Important information about some of the ingredients in Levemir

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

Dose

Talk about your insulin dose with your doctor and nurse. Make sure you get Levemir InnoLet as your doctor and nurse have told you to use and follow their advice carefully .
If your doctor has switched youfrom one type or brand of insulin to another, your dose may have to be adjusted by your doctor. Do not change your insulin unless your doctor tells you to.

Use in children

Levemir can be used in children and adolescents 6 years and above.

There is no experience with the use of Levemir in children below the age of 6 years. Therefore, only use Levemir in children below this age, if your doctor has specifically told you to.

Use in special populations

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

Frequency of administration

When Levemir is used in combination with an oral antidiabetic medicine, Levemir should be administered once a day. When Levemir is used as part of a basal-bolus insulin regimen Levemirshould be administered once or twicedaily depending on patients? needs. Dose of Levemirshould be adjusted individually. The injection can be given at any time during the day, but at the same time each day. For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.

Method of administration

Levemiris for injection under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscular). Always vary the sites you inject within the same region, to avoid lumps (see 4 Possible side effects). The best places to give yourself an injection are: the front of your thighs, the front of your waist (abdomen), or the upper arm. You should always measure your blood glucose regularly.

If you take more Levemir than you should

If you take too much insulin your blood sugar gets too low (this is called hypoglycaemia or hypo). This may also happen:

• If you eat too little or miss a meal.
• If you exercise more than usual.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you feel a hypo coming on: take a high sugar snack and then measure your blood sugar. If your blood sugar is too low: eat glucose tablets or another high sugar snack (sweets, biscuits, fruit juice), then rest.
Always carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

When the symptoms of hypoglycaemia have disappeared or when your blood glucose level is stabilised continue insulin treatment.
Tell relevant people you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to a hypo.
Tell relevant people that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink. It could choke you.

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
- If prolonged severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
- If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

If you forget to take Levemir

If you forget to take your insulinyour blood sugar may get too high (this is called hyperglycaemia). This may also happen:

• If you repeatedly take less insulin than you need.
• If you get an infection or a fever.
• If you eat more than usual.
• If you exercise less than usual.

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
If you get any of these signs:test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
These may be signs of a very serious condition called diabetic ketoacidosis. If you do not treat it, this could lead to diabetic coma and eventually death.

If you stop taking Levemir

This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop taking your insulin without speaking to a doctor, who will tell you what needs to be done.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

How to handle Levemir InnoLet

Levemir InnoLet is a pre-filled disposable pen containing insulin detemir.

Read the Levemir InnoLet instructions for use included in this package leaflet carefully. You must use the pen as described in the Instructions for Use.

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

Side effects may occur with certain frequencies, which are defined as follows:

• Very common: affects more than 1 user in 10
• Common: affects 1 to 10 users in 100
• Uncommon: affects 1 to 10 users in 1,000
• Rare: affects 1 to 10 users in 10,000
• Very rare: affects less than 1 user in 10,000
• Not known: frequency cannot be estimated from the available data

Very common side effects

Low blood sugar (hypoglycaemia). See the advice in ?If you take more Levemir than you should? under 3 How to use Levemir.

Common side effects

Injection sitereactions (pain, redness, hives, inflammation, bruising, swelling and itching). These usually disappear after a few weeks of taking your insulin. If they do not disappear see your doctor. If you have serious or continuing reactions, you may need to stop using Levemir and use another insulin.

Allergic reactions, potentially allergic reactions, see below*

Uncommon side effects

Signs of allergy (allergic reactions, potentially allergic reactions). Hives and rash may occur. *Allergic reactions and potentially allergic reactions are uncommon side effects when Levemir is used in combinations with a rapid acting insulin (basal-bolus). However, when used in combination with oral antidiabetic medicines, three clinical studies have shown a frequency of common. Seek medical advice immediately:
- If the above signs of allergy appear, or - If you suddenly feel unwell and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.

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

Changes at the injection site (lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears.

Rare side effects

Disturbed sensation ( peripheral neuropathy). Fast improvement in blood glucose control may cause disturbed sensation (numbness, weakness or pain) in legs or arms. These symptoms normally disappear.

Very rare side effects

Serious allergic reaction to Levemiror one of its ingredients (called a generalised allergic reaction). See also the warning in 2 Before you use Levemir .

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

Keep out of the reach and sight of children.
Do not use Levemirafter the expiry date which isstated on the InnoLet label and carton after ?EXP.? The expiry date refers to the last day of that month.
LevemirInnoLet that is not being used is to be stored in the refrigerator at 2°C - 8°C, away from the cooling element. Do not freeze .
LevemirInnoLet that is being used or carried as a spare is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks. Always keep the cap on your InnoLet when you are not using it in order to protect it from light. Levemirmust be protected from excessive heat and light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Levemir contains

The active substance is insulin detemir. Each ml contains 100 U of insulin detemir. Each pre-filled pen contains 300 U of insulin detemir in 3 ml solution for injection. 1 unit U insulin detemir corresponds to 1 international unit IU of insulin human. The other ingredients are glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What Levemir looks like and contents of the pack

Levemir comes as a clear, colourless, aqueous solution.

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

Marketing Authorisation Holder and Manufacturer

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

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

This leaflet was last approved in

LEVEMIR solution for injection in a pre-filled pen. InnoLet. INSTRUCTIONS FOR USE

Please read the following instructions carefully before using your LevemirInnoLet.

Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. Be sure you are not using any counterfeit needles. Ask your pharmacist. Always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Push-button Dose selector dial Residualscale Dose scale Insulin cartridge Compartment for needles Rubber membrane Disposable needle exampleNeedlePen capProtective tabInner needle cap Big outerneedle cap

Preparing for injection

Check the label to be sure that your InnoLet contains the correct type of insulin. Take off the cap (as shown by the arrow).

Attaching the needle

• Always use a new needle for each injection to prevent contamination.
• Remove the protective tab from a new disposable needle.
• Screw the needle straight and tightly onto yourInnoLet (picture A).
• Always use a new disposable needle for each injection. Do not bend or damage the needle before use.
• Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.

A

Priming to expel airprior to each injection

Small amounts of air may collect in the needle and cartridge during normal use.
To avoid injection of air and ensure proper dosing:

• Dial 2 units by turning the dose selector clockwise.
• Hold yourInnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture B) to make any air bubbles collect at the top of the cartridge.
• Keeping the needle upwards, press the push-button and the dose selector returns to 0.
• A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

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

B

Setting the dose

• Always check that the push-button is fully depressed and the dose selector is set to 0.
• Dial the number of units required by turning the dose selector clockwise (picture C). Do not use the residual scale to measure your dose of insulin.
• You will hear a click for every single unit dialled. The dose can be corrected by turning the dial either way. Do not turn the dial to correct the dose when the needle is inserted in the skin.

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

C

Injecting the insulin

• Insert the needle into your skin. Use the injection technique advised by your doctor.
• Deliver the dose by pressing the push-button fully down (picture D). You will hear clicks as the dose selector returns to 0.
• After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the full dose has been delivered.
• Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to 0 when you press the push-button.
• Discard the needle after each injection.

D

Removing the needle

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

Use a new needle for each injection.
Be sure to remove and discard the needle after each injection and store your InnoLet without the needle attached. Otherwise the liquid may leak out which can cause inaccurate dosing. Healthcare professionals, relatives and other carers should follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration. Dispose of your used InnoLet carefully without the needle attached.
Needles and Levemir InnoLet must not be shared.

E

Maintenance

Your InnoLet is designed to work accurately and safely. It should be handled with care. If it is dropped, damaged or crushed, there is a risk of leakage of insulin.

Do not refill yourInnoLet.
You can clean your InnoLet by wiping it with a medicinal swab. Do not soak it in surgical spirit or wash or lubricate it. This may damage the mechanism.