Levemir – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Levemir, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet careful ly before you start using this medicine because it contains important in formation for y ou.
- Keep this l eaflet. You may need to read it ag ain.
- If you hav e any further questions, ask your doctor, nurse or pharmac ist.
- This m edicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if the ir signs of illne ss are the same a s yours.
- If you get any side effects, talk to your doctor , nurse or pharmac ist. This includes any possible side effects not listed in this leaflet. See section 4.
What is i n this leaflet 1. What Levemir is and what it is used for 2. What you need to know b efore you us e Levem ir 3. H ow to use Levemir 4. Possible side effects 5. How to store Levemir 6. Contents of the pack a nd other information 1. Wha t Levemir is and what it is used for Levemi r is a modern insulin (insuli n analogue) with a long- acting e ffect. Modern insulin products are improved versions of hum an insul in.
Levemir is used to reduce the high bl ood sugar lev el in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes) . Diab etes is a disease where your body does not produce enough insuli n to control the level of you r blood sugar.
Levemir can be used with meal- related rapid act ing insulin medicines.
In tre atment of type 2 diabetes mellitus, Levemir may also be used in combinati on with tablets for diabetes and/ or with injecta ble anti- diabe tic products, other t han insulin.
Levemir has a long and steady blood-sugar- lowering action within 3 to 4 hours after in jection.
Levemir provides up to 24 hours of basal insulin coverage.
2. What you need t o know b efore you use Levemir Do not us e Levem ir ► If you are alle rgic to insulin detemir or any of the other ingredients in this medicin e, see section 6, Contents of the pack and other information. ► If you suspect hypoglycaemia (low bl ood sugar) is sta rting , see a) Summary of serious and very common side effects in sec tion 4. ► I n insulin infusion pumps. ► If the cartridge or the device containing the cartridge is dropped, damaged or crushed. ► If it has not b een stored correctly or bee n frozen , see section 5, How to store Levemir. ► If the insulin does not appear water clear , colourless and aqueous.
If any of these applies, do not use Levemir. Talk to your doctor, nurse or pharmacist for advice.
Before using Levemir ► Check the label t o make sure it is the right type of insulin. ► Always check the ca rtridge, including th e rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the r ubber plunger has been drawn above the white label band at the bottom of the cartridge . This could be the result of an insulin leakage . If you suspect that the cart ridge is damaged, take it back to your supplier. See your pen m anual for further instructions. ► Always use a new needle for each injection to prevent contamination. ► Needles and Levemir Penfil l must not be shared. ► Levemir Penfi ll is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.
Warnings and p recautions Some conditions and activities c an affect your need for insulin. Consult your docto r: ► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands. ► If you exercis e more than usual or if you want to chang e 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. ► I f you have very low albumin you need to care fully monitor you r blood sugar level. Discuss this with your doctor.
Skin changes at the injection site The injection site should be rotated to help prevent changes to t he fa tty tissue under the skin, such as skin thickening, skin shrink ing or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use Levemi r). Tell your doctor if you notice a ny skin changes at the injection site. Te ll your doctor if you are cur rently injectin g into these affected areas before you start injecting in a di fferent area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Children and adolescents
Levemir can be used in adolescents and children aged 1 year and above.
The safety and efficacy of L evemir in children be low 1 year of age have not been established.
No data are available.
Other medicines and Lev emir
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 this may mean that your i nsulin dose has to change.
Listed bel ow ar e the most common medi cines which may affect your insulin treat ment.
Your blood sugar level may fall (hypoglycaemia) if you take:
- Other medicines for the treatme nt of diabetes
- Monoamine oxidase inhibitors (MAOI) (used to treat depression)
- Beta-block ers (used to treat hig h blood pressu re)
- Angiotensin converting enzyme (ACE) in hibitors (used to treat certain heart conditions or high blood pressure)
- Salicylat es (used to relieve pain and lower fever)
- Anabolic steroids (such as testosterone)
- Sulphonamides (used to trea t infections).
43 Your blood sugar level ma y rise (hyperglyc aemia) if you take:
- Oral contraceptives (birth control pi lls)
- Thiazides (used to treat high blood pre ssure or excessive fluid retention)
- Glucocorticoids (such as ‘cortiso ne’ used to treat infl ammation)
- Thyroid ho rmones (used to tre at thyroid gland disorders)
- Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbu taline used to treat asthma)
- Growth hormone (medicine for stimulation of skeletal and som atic growth and pronounced influence on the body’s metabolic pr ocesses)
- Danazo l (medicine acting on ovulation).
Octreotide and lanreotide (used for treatment of acromegaly, a rare ho rmonal disorder that usually occurs in middle- aged adults, caused by the pituitary gland producing excess growth ho rmone) may either i ncrease or decrease your blood sugar level.
Beta-blockers (used to treat hi gh blood pressure) may we aken or suppress enti rely the first warning symptoms which help you to recognise low blood s ugar.
Pioglitazone (t ablets used fo r the tr eatment of type 2 dia betes) Some pat ients with long -standing type 2 diabetes and heart disease or previous stroke who wer e treated with piogl itazone 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 (oed ema).
If you have taken any of the medicines listed here, tell your doctor, nurse or pharm acist.
Drinking alcohol and taking Levemir ► 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 ► If you are pregnant , think you may be pregnant or are planning to have a baby, a sk your doctor for advice before ta king this medicine . Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particula rly prevention of hypoglycaemi a, is important for the health of your baby. ► If you are breast- feeding consult your doctor as you may require adjustments in your insulin doses.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast – feeding.
Driving and using machines
► Please ask you r doctor whether you ca n drive a car or operate a machine:
- If you have frequent hypoglycaemia. • If you find it hard to recognise hypoglycaemia.
If your blood sugar is low or high, it might affect your concentration and ability to react and therefore a lso your ability to dri ve a car or opera te a machine. Bear in mind that you could endanger yourself or others.
Important information about som e of the ingredients in Levemir Levemir contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir is essen tially ‘sodium- free’.
44 3. How to use Le vemir Dose and when to take your insulin Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
Levemir can be used with meal -related rapid acti ng insulin medici nes.
In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti- diabeti c products, other than insulin.
Do not change your insulin unless your doctor tells you to .
Your dose may have to be adjusted by your doctor if:
- your doctor has switched you from one type or brand of insulin to another, or
- your doctor has added another medicine for the treatment of diabetes, in addition to your Levemi r treatment.
Use in children and adoles cents Levemir can be used in adolescents and children aged 1 year and above.
There is no experience with the use of Levemir in children below the age of 1 year.
Use in special patient groups If you have reduced kidne y or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How often to inject When Levemir is used in combination with tablets for diabetes and/or in combination wi th injectable anti-diabetic products, other than insulin, 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 pa tients’ needs. Dose of Leve mir should be adj usted 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 sugar control, the evening dose can be administe red in the evening or a t bedtime.
How a nd where to inject Levemir is for injection under the skin (subcutaneously). You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly). Levemir Penfill is only suitable for inje cting under the skin usi ng a reusable pen. Speak to your doctor if you need to inject your insulin by another method.
With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4, Poss ible 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 sugar regularly. ► Do not re fill the cartridge. ► Levemir Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles. ► If you are treated with Levemir Penfill and another insulin Penfill cartridge, you should us e two insul in delivery systems, one for each type of insulin. ► A lways carry a spare Penfill cartridge in case the one in use is lost or damaged.
45 How to inject Levemir ► Inject the insulin under your skin. Use the injection technique advised by your doct or or nurse and as described in your pen manual. ► Keep the needle under your skin for at least 6 seconds. Keep the push- button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir. ► 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.
If you take more insulin than you should
If you take too much insulin your blood sugar gets too low (hypoglycaemia) . See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin your blood sugar may get too high (hype rglycaemia ). See c) E ffects from diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar ( severe h yperglycaem ia) and ketoacidosis. See c) Effects from 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, al though no t everybody gets them. a) Summary of serious and very common side effects Low blood sugar (hypoglycaemia) is a very common side effect. It may a ffect more than 1 in 10 people.
Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in visi on; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it ca n cause bra in damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar s nack as soo n as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar: ► If you experience low blood sugar, eat glucose tablets or another high sugar snack ( e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
46 ► When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual. ► If you have such low blood sugar that makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becom ing unconscious) due to low blood sugar. Let them know 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 because you may choke .
Serious allergic reaction to Levemir or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 people.
Seek medical advice immediately:
- If signs of allergy spread to other parts of your body. • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
► If you notice any of these signs, seek medical advice immediately.
Skin c hanges at the injection site : If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 1 00 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area . Chang e the injection s ite with each inj ection to help prevent these skin changes. b) List of other side effects
Uncommon side effects
May a ffect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, sw elling and itching) at t he injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Seri ous allergic reaction abo ve.
Visio n problems: Wh en you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, contact your doctor.
Diabetic ret inopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.
Rare side effe cts May a ffect less th an 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.
Reporting of side e ffects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side ef fects you can help provide more information on the safety of this medicine. c) E ffects from diabetes High blood sugar (hyperglycaemia) High blood sugar may occur if you:
- Have not injected enough insulin.
- Forget to take your insulin or stop taking insulin.
- Repeatedly take less insulin than you need.
- Get an infection and/or a fever.
- Eat more than usual.
- Exercise less than usual.
Warning signs of high blood sugar:
The warning signs appear gradua lly. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flush ed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
What to do if you experience high blood sugar: ► If you get any of above signs: tes t your blood sugar level, test your urine for ketones if you can, then s eek medical advice immediately. ► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood bec ause the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.
5. How to store Levemir Keep thi s medicine out of the sight and reach of children.
Do not use thi s medicine after the ex piry date which is stated on the cartridge label and carton after ‘EXP ’. The expiry date refers to the last day of that month.
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.
Before opening: Levemir Penfill that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
During use or when carried as a spare: Levemir Penfill that is bein g used or carried as a spare should not 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use . These measures will help protect the environment.
6. Contents of the pack 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 solution for injection. 1 unit insulin detemir corresponds to 1 international unit of human insulin.
- The other ingredients are glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What Levemir looks like and contents of the pack
48 Levemir is presented as a solution for injection.
Pack sizes of 1, 5 and 10 cartridges of 3 ml. Not all pack sizes may be m arketed.
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 slip of the carton 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 Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .
49 Package leaflet: I nformation for the user Levemir 100 units /ml s olution for injection in pre -filled pen insulin detemir Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharma cist.
- This medicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if the ir signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is i n 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 anal ogue) with a long- acting effect. Modern insulin products are improved versions of human insulin. Levemir is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes) . Diab etes is a d isease where your body does not produce enough insulin to control the level of your blood sugar.
Levemir can be used with meal- related rapid acting insulin medicines.
In treatment of type 2 diabetes mellitus, Levemir may also be used in combina tion wit h tab lets for diabetes and/or with injectable anti- diabetic products, other than insulin .
Levemir has a long and steady blood-sugar-lowering action within 3 to 4 hours after injection.
Levemir provides up to 24 hours of basal insulin coverage.
2. What you ne ed to know b efore you use Levemir
Do not use Levemir
► If you are allergic to ins ulin detemir or any of the other ingredients in this medicine , see section 6, Contents of the pack and other information. ► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common si de effects in section 4. ► In insulin infusion pumps. ► If FlexPen is dropped, damaged or crushed. ► If it has not been stored correctly or been frozen , see section 5, How to store Levemir . ► If the insulin does not appear water clear, colourless and aqueous.
If any of these applies, do not use Levemir. Talk to your doctor, nurse or pharmacist for advice.
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 contaminat ion. ► Needles and Levemir FlexPen must not be shared. ► Levemir FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.
Warnings and precautions
Some conditions and activities can affect your need for insulin. Consult your doctor : ► 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. ► If you have very low albumin you need to carefully monitor your blood sugar level. Discuss this with your doctor.
Skin changes at the injection site The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the s kin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use Levemi r). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a di fferent area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Children and adolescents
Levemir can be used in adolescents and children aged 1 year and above.
The safety and efficacy of Levemir in children below 1 year of age have not been establish ed.
No data are available.
Other medicines an d 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 this may mean that your i nsulin dose h as to change.
Listed below are the most common medicines which may affect your insulin treatment.
Your blood su gar level may fall (hypoglycaemia) if you take:
- Other medicines for the treatment of diabetes
- Monoamine oxidase inhibitors (MAOI) (used to t reat depression)
- Beta-blockers (used to treat high blood pressure)
- Angiotensin converting enzyme (ACE) inhib itors (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).
Your blood sugar level may rise (hyperglycaem ia) if you take:
- Oral contraceptives (birth control pills)
- Thiazides (used to treat high blood pressure or excessive fluid retention)
- Gluc ocorticoids (such as ‘cort isone’ used to treat inflammation)
- Thyroid hormones (used to treat thyroid gland dis order s) 51 • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
- Growth hormone (medicine for st imulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
- Danazol ( medic ine 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 blood sugar level.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.
Pioglitazo ne (tablets used for the treatment of type 2 diabetes) Some patien ts wi th long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the develo pment of heart failure. In form 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).
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.
Drinking alcohol and taking Levemir ► If you drink alcohol, your need for insul in may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.
Pregnancy and breast -feeding ► If you are pregnant, think you may be pregnant or are planning to have a baby, a sk your doctor for advice before takin g this medicine . Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for th e health of your baby. ► If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast- feeding.
Driving and using machines
► Please ask you r doctor whether you can drive a car or ope rate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.
If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive a car or operate a mach ine. Bear in mind that you could endanger yourself or others.
Important information about some of the ingredients in Levemir Levemir contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir is essent ially ‘sodium- free’.
3. How to use Levemi r Dose and when to take your insulin Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 52 doctor, nurse or pharmacist if you are not sure .
Levemir can be used with m eal-related rapid acting insulin medicines.
In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti- diabeti c products, other than insulin.
Do not change your insulin unless your doctor tells you to.
Your dose may have to be adjusted by your doctor if:
- your doctor has switched you from one type or brand of insulin to another, or
- your doctor has added another medicine for the treatment of diabetes, in addition to your Levemir treatment .
Use in children and adolescent s Levemir can be used in adolescents and children aged 1 year and above.
There is no experience with the use of Levemir in children below the age of 1 year.
Use in special patient groups If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How often to inject When Levemir is used in combination with tablets for diabetes an d/or in combination with injectable anti-diabeti c products, other than insulin, 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 patient s’ needs. Dose of Levemir should be adjuste d ind ividually. 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 sugar control, the evening dose can be administered in the evening or at bedtime.
How and w here to inject Levemir is for injection under the skin (subcutaneously). You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly). Levemir FlexPen is only suitable for inject ing under the skin. Speak to your doctor if you need to inject your insulin by another method.
With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (se e section 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 sugar regularly.
How to handle Levemir FlexPen Levemir FlexPen is a pre-filled, colour-coded, disposable pen containing insulin detemir.
Read carefully the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for use.
Always ensure you use the corr ect pen before you inject your insulin.
If you take more insulin than you should
If you take too much insulin your blood sugar gets too low (hypoglycaemia) . See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia) . See c) E ffects from diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very hi gh blood sugar ( severe hyperglycaemia) and ketoacidosis . See c) Effects from 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 med icine can cause side effects, although not everybody gets them. a) Summary of serious and very common side effects Low blood sugar (hypoglycaemia) is a very common side effect. It may a ffect more than 1 in 10 people.
Low blood sugar may occur if you:
- Injec t too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Signs of low blood sugar: Cold sweat; cool pale skin; hea dache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood su gar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar: ► If you expe rience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case. ► When the symptoms of low blood sugar have disappeared or when your bloo d sugar level is stabilised, continue insulin treatment as usual. ► If you have such low blood sugar that makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar. Let them know th at 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 because you may choke.
Serious allergic reaction to Levemir or one of its ingr edients (called a systemic allergic reactio n) is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 people.
Seek medical advice immediately:
- If signs of allergy spread to other parts of your body. • If you suddenly feel unwell, and you: start swe ating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
► If you notice any of these signs, seek medical advice immediately.
Skin c hanges at the injection site : If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 100 people ). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area . Chang e the injection s ite with each injection to help prevent these skin changes. b) List of other side effects
Uncommon side effects
May a ffect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, s welling an d itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Seri ous allergic reaction ab ove.
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, contact your doctor .
Diabetic re tinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.
Rare side e ffects May a ffect less than 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy an d is usually transient.
Reporting of si de effects If you get an y side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporti ng system listed in Appendix V . By repor ting side effects you can help provide more information on the safety of this medicine. c) E ffects from diabetes High blood sugar (hyperglycaemia) High blood sugar may occur if you:
- Have not injected enough insulin.
- Forget to take your insulin or stop taking insulin.
- Repeatedly take less insulin than you need.
- Get an infection and/or a fever. • Eat more than usual.
- Exercise less than usual.
55 Warning signs of high blood sugar:
The warning signs appear grad ually. They include: increased urination; feeling thirsty; losin g your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flush ed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
What to do if you experience high blood sugar: ► If you get any of above signs: t est your blood sugar level, test your urine for ketones if you can, then s eek medical advice immediately. ► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this 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 which is stated on the FlexPen label and carton after ‘EXP ’. The expiry date refers to the last day of that month.
Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light.
Levemir must be protected fr om exc essive heat and light.
Before opening: Levemir FlexPen that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
During use or when carried as a spare: You can carry your Levemir FlexPen with you and keep it at a temperature below 30°C or in a refrigerator (2°C to 8°C) for up to 6 weeks. If refrigerated, keep away from the cooling element. Do not freeze.
Do not throw away any m edicines via wastewater or household waste. Ask your pharmac ist ho w to throw away medicines you no longer use . These measures will help protect the environment.
6. Contents of the pack and other information
What Levemir contains
- The active substance is insulin detemir. Each ml contains 100 units of insulin de temir. Each pre- filled pen contains 300 units of insulin detemir in 3 ml solution for injection. 1 unit insulin detemir corresponds to 1 international unit of human insulin.
- The other ingredients are glycerol, phenol, metacresol, zinc acetate, disodium p hospha te dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What Levemir looks like and contents of the pack
Levemir is presented as a solution for injection.
Pack sizes of 1 (with or without needles), 5 (without ne edles) and 10 (without needles) pre -filled pens of 3 ml. Not all pack sizes may be mar keted.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Novo Nordisk A/S , Novo Allé , DK- 2880 Bagsværd, Denmark
Manufacturer
56 The manufac turer can be identified by the batch number printed on the slip of the carton and on the label:
- If the second an d 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 s econd and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.
Now turn over for information on how to use your FlexPen.
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .
57 Instructions on how to use LEVEMIR solution for injection in a FlexPen Read the followi ng ins tructions carefully before using your FlexPen. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Your FlexPen is a pre-filled dial -a-dose ins ulin pen. You can select doses from 1 to 60 units in increments of 1 unit. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen in use is lost or damaged.
Levemir FlexPen Pen cap Cartridge Residual scale Pointer Dose selector Push – button Big outer needle cap Inner needle cap Paper tab Needle Needle (example) Caring for your pen Your FlexPen must be handled with care.
If it is dropped , damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can le ad to too high or too low blood sugar level.
You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash or lubrica te it as it may damage the pen.
Do not refill your FlexPen.
Preparing your Levemir FlexPen Check the name and c oloured label of your pen to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you take the wrong type of insulin, your blood sugar level may get too high or too low.
A Pull off the pen cap.
A B Remove the paper tab from a new disposable needle.
Screw the needle straight and tightly onto your FlexPen.
B C Pull off the big outer needle cap and keep i t for la ter.
C D Pull off the inner needle cap and dispose of it.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
D Always use a new needle for eac h injection . This reduces the risk of contamination , infection, leakage of insulin, blocked needles and inaccurate dosing.
Be careful not to bend or damage the needle before use.
Checking the insulin flow Prior to each injection small amounts of air m ay col lect in the cartridge during normal use. To avoid injection of air and ensure proper dosing:
E Turn the dose selector to select 2 units.
E 2 units selected F Hold your FlexPen with the needle pointing upwards and tap the cartridge gent ly wi th your finger a few times to make any air bubbles collect at the top of the cartridge.
F G Keeping the needle upwards, press the push -button all the way in. 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 pen is defective, and you must use a new one.
G Always make sure that a drop appea rs at the needle tip before you inject. This makes sure that the insulin flows. If no drop appears, you will not inject any insulin, even though the dose selector may move. This may indicate a blocked or damaged needle.
Always check the fl ow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.
Selecting your dose Check that the dose selector is set at 0.
H Turn the dose selector to select the nu mber of units you need to inject.
The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer. When turning the dose selector be careful not to push the push-button as insul in will come o ut.
You cannot select a dose larger than the number of units left in the cartridge.
H 5 units selected 24 units selected Always use the dose selector and the pointer to see how many units you have selected before injecting the insulin.
Do n ot count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low. Do not use the residual scale, it only shows approximately how much insulin is left in your pen.
Making the injection Insert the needle into your skin. Use the injection technique shown by your doctor or nurse.
I Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting.
Turning the dose selector w ill not i nject insulin.
I J Keep the push- button fully depressed and let the needle remain under the skin for at least 6 seconds.
This will make sure you get the full dose.
Withdraw the needle from the skin then release the pressure on t he push-button.
Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
J K Lead the needle into the big outer needle cap without touching it. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
Dispose of it carefully and put the pen cap back on you r FlexPe n.
K Always remove the needle after each injection and store your FlexPen without the needle attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Further i mport ant information Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks and cross- infection .
Dispose of your used FlexPen carefully without the needle attached.
Never share your pen or your nee dles wi th oth er people. It might lead to cross-infection.
Never share your pen with other people. Your medicine might be harmful to their health.
Always keep your pen and needles out of sight and reach of others, especially children.
61 Package leafle t: Info rmatio n for the user Levemir 100 units /ml solution for injection in pre -filled pen insulin detemir Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may nee d to r ead it again.
- If you have any further questions, ask your doctor, nurse or pharma cist.
- This medicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- I f you ge t any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is i n this leaflet 1. What Levemir is and what it is used for 2. What you need to know before you use Le vemi r 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 long- acting effect. Moder n insul in products are improved versions of human insulin. Levemir is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes) . Diabetes is a disease where your body does not produce enough i nsulin to control the level of your blood sugar.
Levemir can be used with meal- related rapid acting insulin medicines.
In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti-diabeti c products, other than insulin.
Levemir has a long and steady blood-sugar-lowering action within 3 to 4 hours after injection.
Levemir provides up to 24 hours of basal insulin coverage.
2. What you need to know b efore you use Levemir Do no t use Levemir ► If you are allergic to ins ulin detemir or any of the other ingredients in this medicine , see section 6, Contents of the pack and other information. ► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very commo n side effects in section 4. ► In insulin infusion pumps. ► If InnoLet is dropped, damaged or crushed. ► If it has not been stored correctly or been frozen , see section 5, How to store Levemir . ► If the insulin does not appear water clear, colourless and aqueous.
If any of these applies, do not use Levemir. Talk to your doctor, nurse or pharmacist for advice.
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 contaminat ion. ► Needles and Levemir InnoLet must not be shared. ► Levemir InnoLet is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.
Warnings and precautions
Some conditions and activities can affect your need for insulin. Consult your doctor : ► 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. ► If you have very low albumin you need to carefully monitor your blood sugar level. Discuss this with your doctor.
Skin changes at the injection site The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the s kin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use Levemi r). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a di fferent area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Children and adolescents
Levemir can be used in adolescents and children aged 1 year and above.
The safety and efficacy of Levemir in children below 1 year of age have not been establish ed.
No data are available.
Other medicines an d 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 this may mean that your i nsulin dose h as to change.
Listed below are the most common medicines which may affect your insulin treatment.
Your blood sugar l evel may fall (hypoglycaemia) if you take:
- Other medicines for the treatment of diabetes
- Monoamine oxidase inhibitors (MAOI) (used to t reat 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).
Your blood sugar level may rise (hyperglycaemi a) if you take:
- Oral contraceptives (birth control pills)
- Thiazides (used to treat high blood pressure or excessive fluid retention)
- Gluc ocorticoids (such as ‘cort isone’ used to treat inflammation)
- Thyroid hormones (used to treat thyroid gland diso rders) 63 • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
- Growth hormone (medicine for st imulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
- Danazol (m edicine acting on ovulation).
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle -aged adults, caused b y the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.
Pioglitazo ne (tablets used for the treatment of type 2 diabetes) Some patient s with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the develo pment of heart failure. I nform your doctor as soon as possible if you experience signs of heart failure such as unusu al shortness of breath or rapid increase in weight or localised swelling (oedema).
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.
Drinking alcohol and taking Levemir ► If you drink alcohol, your need for i nsulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.
Pregnancy and breast -feeding ► If you are pregnant , think you may be pregnant or are planning to have a baby, a sk your doctor for advice before taki ng thi s medicine . Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for th e health of your baby. ► If you are breast-feeding consult your doc tor as you may require adjustments in your insulin doses.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast – feeding.
Driving and using machines
► Please ask you r doctor whether you can drive a car or oper ate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.
If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive a car or operate a mach ine. Bear in mind that you could endanger yourself or others.
Important information about some of the ingredients in Levemir Levemir contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir is essent ially ‘sodium- free’.
3. How to use Levem ir Dose and when to take your insulin Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 64 doctor, nurse or pharmacist if you are not sure.
Levemir can be used with m eal-related rapid acting insulin medicines.
In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti- diabeti c products, other than insulin.
Do not change your insulin unless you r doctor tells you to.
Your dose may have to be adjusted by your doctor if:
- your doctor has switched you from one type or brand of insulin to another, or
- your doctor has added another medicine 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 1 year and above.
There is no experience with the use of Levemir in children below the age of 1 year.
Use in special patient groups If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How often to inject When Levemir is used in combination with tab lets for diabetes and/or in combination with injectable anti-dia betic products, other than insulin, 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 patient s’ needs. Dose of Levemir should 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 sugar control, the evening dose can be administered in the evening or at bedtime.
How and where to inject Levemir is for injection under the skin (subcutaneously). You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly). Levemir InnoLet is only suitable for inject ing under the skin. Speak to your doctor if you need to inject your insulin by another method.
With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (se e section 4, Possible side effects). The b est 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 meas ure your blood sugar regularly.
How to handle Levemir InnoLet Levemir InnoLet is a pre -filled disposable pen cont aining insulin detemir.
Read carefully the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for use.
Always ensure you use the correct pen before you inject your insulin.
If you take more insulin than you should
If you take too much insulin your blood sugar gets too low (hypoglycaemia) . See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin your blood suga r may get too high (hyperglycaemia). See c) E ffects from diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) Effects from 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 s ide effects, al though not everybody gets them. a) Summary of serious and very common side effects Low blood sugar (hypoglycaemia) is a very common side effect. It may a ffect more than 1 in 10 people.
Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid hea rtbeat; feeling sick; feeling very hungry; t empo rary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar: ► If you experience low blood sugar, eat glucose tablets or another hig h suga r snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case. ► When the symptoms of low blood sugar ha ve disappeared or when your blood sugar leve l is stabilised, continue insulin treatment as usual. ► If you have such low blood sugar that makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar. Let them know that if you pa ss out, they must turn you on your side and get medical help straight away. They must not give you any food or drink because you may choke.
Serious allergic reaction to Levemir or one of its ingredients (called a systemic allergic reaction) is a very ra re sid e effect but can potentially be life threatening. It may affect less than 1 in 10,000 people.
66 Seek medical advice immediately:
- If signs of allergy spread to other parts of your body.
- If you suddenly feel unwell, and you: start sweating; start being si ck (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
► If you notice any of these signs, seek medical advice immediately.
Skin c hanges at the injection site : If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 100 people ). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area . Chang e the injection s ite with each injection to help prevent these skin changes. b) List of other side effects
Uncommon side effects
May a ffect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, sw elling and itching) at t he injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Seri ous allergic reaction abo ve.
Visio n problems: Wh en you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Swollen joints : When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, contact your doctor.
Diabetic ret inopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.
Rare side effe cts May affect less t han 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.
Reporting of sid e effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By report ing side e ffects you can help provide more information on the safety of this medicine. c) E ffects from diabetes High blood sugar (hyperglycaemia) High blood sugar may occur if you:
- Have not injected enough insulin.
- Forget to take your insulin or stop taking insulin.
- Repe atedly take less insulin than you need.
- Get an infection and/or a fever. • Eat more than usual.
- Exercise less than usual.
Warning signs of high blood sugar:
67 The warning signs appear gradu ally. They include: increased urination; f eeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flush ed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
What to do if you experience high blood sugar: ► If you get any of above signs: te st your blood sugar level, test your urine for ketones if you can, then s eek medical advice immediately. ► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood be cause the body is breaking down fat instead of sugar). If you do not treat it, this 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 which is stated on the InnoLet label and carton after ‘EXP ’. The expiry date refers to the last day of that month.
Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light.
Levemir must be protected fro m exc essive heat and light.
Before opening: Levemir InnoLet that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
During use or when carried as a spare: Levemir InnoLet that is being used or ca rried as a spare should not 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw awa y medicines you no longer use . These measures will help protect the environment.
6. Contents 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 pe n contains 300 units of insulin detemir in 3 ml solution for injection. 1 unit insulin detemir corresponds to 1 international unit of human insulin.
- The other ingredients are glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What Levemir looks like and contents of the pack
Levemir is presented as a solution for injection.
Pack sizes of 1, 5 and 10 pre -filled pens of 3 ml. Not all pack s izes may b e ma rketed.
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 revised in
Other sources of information 68 Detailed inform ation on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .
Instructions on how to use LEVEMIR so lution for injection in InnoLet Read the instructions careful ly befor e using your InnoLet. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 un its in incr ements of 1 unit.
InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet in use is lost or damaged.
Push -button Dose selector Dose scale Compartment for needles Residual scale Insulin cartridge Disposable needle (example) Pen cap Paper tab Needle Inner needle cap Big outer needle cap Getting started Check the name and coloured label of your InnoLet to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you take the wrong type of insulin , your blood sugar level may get too high or too low. Take off the pen cap.
Attaching the needle
- Always use a new needle for each injection. This reduces the risk of contamination , infection, leakage of insulin, blocked needles and inaccurate d osing.
- Be careful not to bend or damage the needle before use.
- Remove the paper tab from a new disposable needle.
- Screw the needle straight and tightly onto your InnoLet (picture A ).
- Pull off the big outer needle cap and the inner needle cap. You m ay want to store the big outer needle cap in the compartment.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
A Priming to expel air prior 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 InnoLet 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.
- Always make sure that a drop appear s at the needle tip before injection (picture B). Thi s make s sure the insulin flows . 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.
- If no drop appears, you will not inject any insulin, even th ough the dose selector may move.
This may indicate a blocked or damaged needle.
- Always prime InnoLet before you inject. If you do not prime InnoLet, you may get too little insulin or no insulin at all. This may lead to too high blood sugar le vel.
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).
- You will hear a cli ck for e very s ingle unit dialled . The dose can be corrected by turning the dial either way. Make sure not to turn the dial or correct the dose when the needle is inserted in the skin. This may lead to inaccurate dosing that can make your blood sugar level too high or too low.
Always use the dose scale and the dose selector to see how many units you have selected before 71 injecting the insulin. Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low. Do not use the residual scale, it only shows approximately how much insulin is left in your pen.
You cannot set a dose larger than the number of units remaining in the cartridge.
C Injecting the insulin
- Insert the needle i nto 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. Always make sure that the dose selector re turns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
- Discard the needle after each injection.
D Removin g the needle
- Replace the big outer needle cap and unscrew the needle (picture E ). Dispose of it carefully.
- Put the pen cap back on your InnoLet to protect the insulin from light.
E Always use a new needle for each inje ction.Always remove and discard the needle after each injection and store your InnoLet without the needle attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Further important inf ormation Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks and cross -infection Dispose of your used InnoLet careful ly without the needle attached.
Never share your pen or your needles with other people. It might le ad to cross-infection.
Never share your pen with other people. Your medicine might be harmful to their health.
Always keep your InnoLet and needles out of sight and reach of others, especially children.
Caring for your pen Your InnoLet is designed to work a ccurately and safely. It must be handled with care. If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
You can clean your InnoLet by wiping i t with a medicinal swab. Do not soak, wash or lubricate it.
This may damage the mechanism and may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Do not refill your InnoLet.
73 Package leaflet: Information fo r the user Levemi r 100 units /ml s olution for injection in pre -filled pen insulin detemir Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again .
- If yo u have any further questions, ask your doctor, nurse or pharma cist.
- This medicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any sid e effect s, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is i n 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 u se Levemi r 4. Possible side effects 5. How to store Levemir 6. Contents of the pack and other information
ℹ️ 1. What Levemir is and what it is used for
Levemir is a modern insulin (insulin analogue) with a long- acting effect. Modern insulin produc ts are improved versions of human insulin.
Levemir is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes) . Diabetes is a disease where your body does not produce enough insulin to c ontrol the level of your blood sugar.
Levemir can be used with meal- related rapid acting insulin medicines.
In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti-dia betic pr oduc ts, other than insulin.
Levemir has a long and steady blood-sugar-lowering action within 3 to 4 hours after injection.
Levemir provides up to 24 hours of basal insulin coverage.
⚠️ 2. What you need to know b efore you use Levemir
Do not use Lev emir
► If you are allergic to ins ulin detemir or any of the other ingredients in this medicine , see section 6, Contents of the pack and other information. ► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common si de effects in section 4. ► In insulin infusion pumps. ► If FlexTouch is dropped, damaged or crushed. ► If it has not been stored correctly or been frozen , see section 5, How to store Levemir . ► If the insulin does not appear water clear, colourless and aqueo us.
If any of these applies, do not use Levemir. Talk to your doctor, nurse or pharmacist for advice.
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 contaminat ion. ► Needles and Levemir FlexTouch must not be shared. ► Levemir Flex Touch is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.
Warnings and precautions
Some conditions and activitie s can affect your need for insulin. Consult your doctor : ► 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 you r blood suga r 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. ► If you have very low albumin you need to ca refully monitor your blood sugar level. Discuss this with your doctor.
Skin changes at the injection site The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the s kin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use Levemi r). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a di fferent area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Children and adolescents
Levemir can be use d in adolescents and children aged 1 year and above.
The safety and efficacy of Levemir in children below 1 year of age have not been established.
No data are availabl e.
Other medicines and Levemir
Tell your doctor, nurse or pharmacist if you are t aking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level and this may mean that your i nsulin dose has to change.
Listed below are the most common medicines which may affect your insulin treatment.
Your blood sug ar level may fall (hypoglycaemia) if you take:
- 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) in hibitors (used to treat certain heart conditions or high blood pressure)
- Salicylates (used to relieve pain and lower fever)
- Anabolic steroids (such as testosterone)
- Sul phonamides (used to treat infections).
Your blood sugar level may rise (hypergl ycaemi a) if you take:
- Oral contraceptives (birth control pills)
- Thiazides (used to treat high blood pressure or excessive fluid retention)
- Glucocortic oids (such as ‘cor tisone’ used to treat inflammation)
- Thyroid hormones (used to treat thyroid gland disorders ) 75 • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
- Growth hormone (medicine for stimulat ion of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
- Dana zol (medici ne acting on ovulation).
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle- aged adults, caused b y the pituitary gland producing excess growth hormone) may either increase or decrea se your b lood sugar level.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you t o recognise low blood sugar.
Pioglitazo ne (tablets used for the treatment of type 2 diabetes) Some p atients wit h long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. I nform your doctor as soon as possible if you experience signs of heart failure such as u nusua l shortness of breath or rapid increase in weight or localised swelling (oedema).
If you have taken any of the medicines listed here, tell your doctor, nurse or pha rmacist.
Drinking alcohol and taking Levemir ► If you drink alcohol, your need f or insuli n may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.
Pregnancy and breast -feeding ► If you are pregnant , think you may be pregnant or are planning to have a baby, a sk your doctor for advice before taking this medicine . Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly preventi on of hypoglycaemia, is important for the health of your baby. ► If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breast – feeding.
Driving and using machines
► Please ask you r doctor whether you can drive a car o r operate a machine:
- If you have frequent hypoglycaemia.
- If you find it hard to recognise hypoglycaemia.
If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive a car or oper ate a machi ne. Bear in mind that you could endanger yourself or others.
Important information about some of the ingredients in Levemir Levemir contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir is essent ially ‘sodium- free’.
💊 3. How to use L evemir
Dose and when to take your insulin Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 76 doctor, nurse or pharmacist if you are not sure.
Levemir can be used with m eal-related rapid acting insulin medic ines.
In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti- diabeti c products, other than insulin.
Do not change your insulin unless your doctor tells you to.
Your dose may ha ve to be adjusted by your doctor if:
- your doctor has switched you from one type or brand of insulin to another, or
- your doctor has added another medicine for the treatment of diabetes, in addition to your Levemir treatment.
Use in children and adole scents Levemir can be used in adolescents and children aged 1 year and above.
There is no experience with the use of Levemir in children below the age of 1 year.
Use in special patient groups If you have reduced ki dney or liver function, or if you are above 65 ye ars of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How often to inject When Levemir is used in combination with tablets for diabetes and/or in combination with injectable anti-diabetic products, other than insulin, 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 patient s’ ne eds. Dose of Levemir should be ad justed 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 sugar control, the evening dose can be administer ed in the evening or at bedtime.
How an d where t o inject Levemir is for injection under the skin (subcutaneously). You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly). Levemir FlexTouch is only suitable for inje cting under the skin. Speak to your doctor i f you need to inject your insulin by another method.
With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting ( see section 4, Possible side effects). The b est 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 sugar regularly.
How to handle Levemir FlexTouch Leve mir FlexTouch is a pre -filled, colour -coded, disposable pen containing insulin detemir.
Read carefully the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for use.
Always ensure you use th e correct pen before you inject your i nsuli n.
If you take more insulin than you should
If you take too much insulin your blood sugar gets too low (hypoglycaemia) . See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your i nsulin your blood sugar may get too high (hyperglycaemia) . See c) E ffects from diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to ve ry high blood sugar ( severe hyperglycaemia) and ketoacidosis . See c) Effects from 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 medicine s, this med icine can cause side effects, although not everybody gets them. a) Summary of serious and very common side effects Low blood sugar (hypoglycaemia) is a very common side effect. It may a ffect more than 1 in 10 people.
Low blood sugar may occur if you:
- Inject too much insulin.
- Eat too little or miss a meal.
- Exercise more than usual.
- Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Signs of low blood sugar: Cold sweat; cool pal e skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Severe low blood sugar ca n lea d to unconsciousness. If prolonged sev ere low blo od sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone w ho knows h ow to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar: ► If yo u experience low blood sugar, eat gluc ose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case. ► When the sym ptoms of low blood sugar have disappeared or whe n your blood sugar level is stabilised, continue insulin treatment as usual. ► If you have such low blood sugar that makes you pass out, if you have had the need for an injection of glucagon, or if you have e xperi enced many incidents of low blood suga r, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (bec oming unco nscious) due to low blood sugar. Let them kn ow 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 because you may choke.
Serious allergic reaction to Levemir or one of it s ing redients (called a systemic aller gic reactio n) is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 people.
Seek medical advice immediately:
- If signs of allergy spread to other parts of your body. • If you suddenly feel unwell, and you : start swe ating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
► If you notice any of these signs, seek medical advice immediately.
Skin c hanges at the injection site : If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 1 00 people ). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area . Chang e the injection s ite with each injection to help prevent these skin changes. b) List of other side effects
Uncommon side effects
May a ffect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, sw elling and itching) at t he injection site may occur. These usually di sappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Seri ous allergic reaction abo ve.
Visio n problems: Wh en you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Swollen joints : When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, contact your doctor.
Diabetic ret inopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.
Rare side ef fects May a ffect less th an 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.
Reporting of side e ffects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side ef fects you can help provide more information on the safety of this medicine. c) E ffects from diabetes High blood sugar (hyperglycaemia) High blood sugar may occur if you:
- Have not injected enough insulin.
- Forget to take your insulin or stop taking insulin.
- Repeatedly take less insulin than you need.
- Get an infection and/or a fever.
- Eat more than usual.
- Exercise less than usual.
79 Warning signs of high blood sugar:
The warning signs appear gradua lly. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flush ed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
What to do if you experience high blood sugar: ► If you get any of above signs: tes t your blood sugar level, test your urine for ketones if you can, then s eek medical advice immediately. ► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood bec ause the body is breaking down fat instead of sugar). If you do not treat it, this 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 ex piry date which is stated on the FlexTouch label and carton after ‘EXP ’. The expiry date refers to the last day of that month.
Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light.
Levemir must be protected from excessive heat and light.
Before opening: Levemir FlexTouch that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
During use or when carried as a spare: You can carry your Levemir Fle xTouch with you and keep it at a temperature below 30°C or in a refrigerator (2°C to 8°C) for up to 6 weeks. If refrigerated, keep away from the cooling element. Do not freeze.
Do not t hrow away any m edicines via wastewater or household waste. Ask your ph arma cist how to throw away medicines you no longer use . These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Levemir contains
- The active substance is insulin detemir. Each ml contains 100 units of insul in detemir. Each pre- filled pen contains 300 units of insulin detemir in 3 ml solution for injection. 1 unit insulin detemir corresponds to 1 international unit of human insulin.
- The other ingredients are glycerol, phenol, metacresol, zinc acetate, disod ium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What Levemir looks like and contents of the pack
Levemir is presented as a solution for injection.
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 (without needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S , Novo Allé , DK- 2880 Bagsværd, Denmark Now turn over for information on how to use your FlexTouch.
This leaflet was last revised in
80 Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .
81 Instructions on how to use Levemir 100 units/ml solution for injection in pre- filled pen (FlexTouch) Please read these instructions carefully before using your FlexTouch pre -filled pen. If you do not follow the instructions carefully, you may get too little o r too much insulin, which can lead to too high or too low blood sugar level.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Levemir 100 units/ml, then look at the illustra tions to the right to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is tr ained to use the FlexTouch pre-filled pen.
Your Levemir FlexTouch pen is a pre -filled insulin pen Levemir FlexTouch contains 300 units of insulin and delivers doses from 1 to 80 units, in increments of 1 unit.
Levemir FlexTouch is designed to be used with NovoFin e or NovoTwist single -use disposable needles up to a length of 8 mm.
Pen cap Insulin scale Insulin window Pen label Dose counter Dose pointer Dose selector Dose button Levemir® FlexTouch® Levemir FlexTouch Outer needle cap Inner needle cap Needle Paper tab Needle (example) Preparing your Levemir FlexTouch pen Check the name and coloured label on your Levemir FlexTouch pen to make su re that it contains the type of insulin you need. This is especially important if you take more than one type of 82 insulin. If you take a wrong type of insulin, your blood sugar level may get too high or too low.
A. Pull off the pen cap.
A B. Check that the insulin in your pen is clear and colourless.
Look through the insulin window. If the insulin looks cloudy, do not use the pen.
B C. Take a new disposable needle and tear off the paper tab.
C D. Screw the needle straight onto the pen. Make sure the needle is on tight.
D E. Pull off the outer needle cap and save it. You will need it after the injection, to correctly remove the need le from the pen.
Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.
A drop of insulin may appear at the needle tip. This is normal.
E Always use a ne w needle for each injection . This reduces the risk of contamination , infection, leakage of insulin, blocked needles and inaccurate dosing.
Never use a bent or damaged needle.
Checking the insulin flow Make sure that you receive your full d ose by a lway s checking the insulin flow before you select and inject your dose.
F. Turn the dose selector to select 2 units.
F 2 units selected G. Hold the pen with the needle pointing up.
Tap the top of the pen a few times to let any air bubbles ris e to the top.
G H. Press the dose button with your thumb until the dose counter returns to 0. The 0 must line up with the dose pointer. A drop of insulin will appear at the needle tip.
If no drop appears, repeat steps F to H up to 6 times. If no drop appears after these new attempts, change the needle and repeat steps F to H once more.
Do not use the pen if a drop of insulin still does not appear.
H Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin flows. If no drop appears, you will not inject any insulin, even though the dose counter may move. This may indicate a blocked or damaged needle.
Always check the flow before you inj ect. If you do not check the flow, you may get too little insulin or no insulin at all. This may lead to too high blood sugar level.
84 Selecting your dose Use the dose selector on your Levemir FlexTouch pen to select your dose. You can select up to 80 units pe r dose.
I. Select the dose you need. You can turn the dose selector forwards or backwards. Stop when the right number of units lines up with the dose pointer.
The dose selector clicks differently when turned forwards, backwards or past the n umber of units left.
When the pen contains less than 80 units, the dose counter stops at the number of units left.
I 5 units selected 24 units selected Always use the dose counter and the dose pointer to see how many units you have selected before injecti ng the i nsulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low. Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.
How much insulin is left?
The insulin scale shows you approximately how much insulin is left in your pen.
Approx. how much insulin is left To see precisely how much insulin is left use the dose counter:
Turn the dose selector until the dose counter stops . If it shows 80, at lea st 80 units are left in your pen.
If it shows less than 80, the number shown is the number of units left in your pen.
Turn the dose selector back until the dose counter shows 0.
If you need more insulin than the units left in your pen, you can split your dose between two pens.
Dose counter stopped:
52 units left Example Be very careful to calculate correctly if splitting your dose.
If in doubt, take the full dose with a new pen. If you split the dose wrong, you will inject too little or too much insulin, which can l ead to too high or too low blood sugar level.
Injecting your dose Make sure that you receive your full dose by using the right injection technique.
J. Insert the needle into your skin as your doctor or nurse has shown you. Make sure you can s ee the dose counter. Do not touch the dose counter with your fingers. This could interrupt the injection.
Press the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer. You may then hear or feel a click.
After the dose counter has returned to 0, leave the needle under the skin for at least 6 seconds to make sure that you get your full dose.
J 6 seconds K. Remove the needle from the skin.
After that, you may see a drop of insulin at the needle t ip. This is normal and has no effect on the dose you just received.
K Always dispose of the needle after each injection . This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. I f the needle is blocked, you will not inject any insulin.
L. Lead the needle tip into the outer needle cap on a flat surface. Do not touch the needle or the cap.
Once the needle is covered, carefully push the outer needle cap completely on and then unscr ew the needle. Dispose of it carefully, and put the pen cap back on after every use.
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
L Always watch the dose counter to know how many units you inject. The dose counter will show the exact number of units. Do not count the pen clicks.
Hold the dose button down until the dose counter returns to 0 after the injection. If the dose counter stop s before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle after each injection and store your pen without the needle attached. This reduces the risk of contamination, infection , leakage of insulin , blocked needles and inaccurate dosing.
Caring for your pen Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, w hich can lead to too high or too low blood sugar level.
- Do not leave the pen in a car or other place where it can get too hot or too cold.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. If necessary, cl ean it with mild detergent on a moistened cloth.
- Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.
- Do not try to refill your pen . Once empty, it must be disposed of.
- Do not try to repair your pen or pull it apart.
Important information
- Always keep your pen with you.
87 • Always carry an extra pen and new needles with you, in case of loss or damaged.
- Always keep your p en and needles out of sight and reach of others, especially children.
- Never share your pen or your needles with other people. It might lead to cross -infection.
- Never share your pen with other people. Your medicine might be harmful to their health.
- Caregivers must be very careful when handling used needles – to reduce the risk of needle injury and cross-infection.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Levemir (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/04/278).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.