Product Details

What you need to know before you use Levemir

Do not use Levemir® ► If you are allergic to insulin 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 side 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 contamination. ► 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 skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use Levemir®). 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 different 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 established. No data are available. Other medicines and Levemir® Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment. Your blood sugar 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) 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 (hyperglycaemia) if you take: • Oral contraceptives (birth control pills) • Thiazides (used to treat high blood pressure or excessive fluid retention) • Glucocorticoids (such as ‘cortisone’ used to treat inflammation) • Thyroid hormones (used to treat thyroid gland disorders) • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma) • Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes) • Danazol (medicine acting on ovulation). Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your 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. Pioglitazone (tablets used for the treatment of type 2 diabetes) Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). 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 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, ask 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 prevention 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 breastfeeding. Driving and using machines ► Please ask your doctor whether you can 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 also your ability to drive a car or operate a machine. 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 essentially ‘sodiumfree’.