Levemir
100 U/ml solution for injection in cartridge
Insulin detemir
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor, nurse or pharmacist
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
- 1. What Levemir is and what it is used for
- 2. Before you use Levemir
- 3. How to use Levemir
- 4. Possible side effects
- 5. How to store Levemir
- 6. Further information
What Levemir
is and what it is used for
Levemir is a modern insulin (insulin analogue) with a long-acting effect (up to 24 hours). Modern insulins are improved versions of human insulin.
Levemir is used to treat diabetes mellitus in adults, children and adolescents aged 6-17 years. It may be used in combination with oral antidiabetic medicines or with meal-related rapid acting insulin products.
Before you use Levemir
Do not use Levemir
- If you are allergic (hypersensitive) to insulin detemir or any of the other ingredients of Levemir (see 6 Further information)
- If you suspect hypoglycaemia (low blood sugar) is starting (see 4 Possible side effects)
- In insulin infusion pumps
- If the cartridge or the device containing the cartridge is dropped, damaged or crushed
- If it hasn’t been stored correctly or if it has 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 check the cartridge, including the rubber plunger (stopper). Do not use it if any damage is seen or if there is a gap between the rubber plunger and the white label band. Take it back to your supplier. See your delivery system manual for further instructions
- Disinfect the rubber membrane with a medicinal swab
- Always use a new needle for each injection to prevent contamination.
Take special care with Levemir
- If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands
- If you are exercising 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 the injections. Consult your doctor if you are planning such travelling.
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 have specifically told you to.
As with all insulin products, in elderly patients and patients with renal or heparic impairment, glucose monitoring should be intensified and insulin detemir dosage adjusted on a individual basis.
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 below medicine 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 below medicine 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 (use 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) may both 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.
Taking Levemir with food and drink
- If you are drinking alcohol your need for insulin may change, as your blood sugar level may either rise or fall. Carefull 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-feeding please contact your doctor for advice. Your insulin dosage may need to be changed during pregnancy particulary 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 hypoglycaemias
- If you find it hard to recognise hypoglycaemia.
How to use Levemir
Dosage
Talk about your insulin dose with your doctor and nurse. Do not change your insulin unless your doctor tells you to. Make sure you get the Levemir Penfill that your doctor and nurse have told you to use and follow their advice carefully. This leaflet is a general guide.
If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
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 Levemir should be administered once or twice daily depending on patients’ needs. Dosage of Levemir should be adjusted individually. 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
Levemir is 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.
- Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse and described in your delivery system manual
- Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered
- After each injection be sure to remove and discard the needle and store Levemir without the needle attached. Otherwise, the liquid may leak out, which can cause inaccurate dosing.
Do not refill the cartridge.
Levemir Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
If you are treated with Levemir Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
If you take more insulin 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 symptoms of hypoglycaemia have disappeared or when blood glucose level is stabilised continue insulin treatment.
Tell relevant people you have diabetes and what may be the consequences, including the risk of passing out due to a hypo.
Tell relevant people that if you pass out (become unconscious), 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 your insulin
If you forget to take your insulin your 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 your insulin
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 product, ask your doctor or pharmacist.
Levemir Penfill Side Effects
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.
Uncommon side effects
Signs of allergy. Hives and rash may occur.
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.
Common side effects
Low blood sugar (hypoglycaemia).
Injection site reactions (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.
Rare side effects
Disturbed sensation. 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 Levemir or one of its ingredients (called a generalised allergic reaction). See also the warning in 2 Before using Levemir.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
How to store Levemir
Keep out of the reach and sight of children.
Do not use Levemir after the expiry date which is stated on the cartridge label and carton, after EXP. The expiry date refers to the last day of that month.
Levemir Penfill 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.
Levemir Penfill 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 cartridge in the outer carton when you are not using it in order to protect it from light.
Levemir must be protected from excessive heat and light.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Levemir contains
- The active substance is insulin detemir. Each ml contains 100 U of insulin detemir. Each cartridge contains 300 U of insulin detemir in 3 ml solution for injection. 1 unit (U) insulin detemir corresponds to 1 international unit (IU) of human insulin
- The other ingredients are: glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What Levemir looks like and contents of the pack
Levemir comes as a clear, colourless, aqueous solution.
Pack sizes of 1, 5 and 10 cartridges of 3 ml.
Not all packs may be marketed.
Marketing authorisation holder
Manufacturer
The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
- If the second and third characters are W5, S6, P5, K7, or ZF
is the manufacturer
- If the second and third characters are H7 or T6
is the manufacturer.
This leaflet was last approved in 04/2009
Levemir
, Penfill and NovoFine are trademarks owned by Novo Nordisk A/S, Denmark
©2007/2009
Novo Nordisk A/S
8-0990-01-002-1
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