100 U/ml Solution for injection in pre-filled pen Insulin aspart
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
What NovoRapid® is and what it is used for
NovoRapid® is a rapid-acting modern insulin (insulin analogue). Modern insulin products are improved versions of human insulin.
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of your blood sugar.
NovoRapid® will start to lower your blood sugar 10-20 minutes after you take it, a maximum effect occurs between 1 and 3 hours and the effect lasts for 3-5 hours. Due to this short action, NovoRapid® should
normally be used in combination with intermediate-acting or long-acting insulin preparations. Moreover NovoRapid® can be used for continuous infusion in a pump system.
Before you use NovoRapid®
Do not use NovoRapid®
► If you are allergic (hypersensitive) to insulin aspart or any of the other ingredients in NovoRapid® (see 6 Further information).
► If you suspect hypoglycemia (low blood sugar) is starting (see 3 How to use NovoRapid®).
► If FlexPen® is dropped, damaged or crushed.
► If it has not been stored correctly or if it has been frozen (see 5 How to store NovoRapid®).
► If the insulin does not appear clear and colorless.
Before using NovoRapid®
► 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 NovoRapid® FlexPen® must not be shared.
Take special care with NovoRapid®
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
► If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
► If you are ill: carry on taking your insulin and consult your doctor.
► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Consult your doctor if you are planning such travelling.
Using other medicines
Some medicines affect the way glucose works in your body and this may influence your insulin dose. The most common medicines which may affect your insulin treatment are listed. Tell your doctor, nurse or
pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, you should tell your doctor if you are using any medicine listed that may affect your blood sugar level.
If you take any of the following medicines, your blood sugar level may fall (hypoglycaemia):
Oral antidiabetic medicinal products, monoamine oxidase (MAOI) inhibitors, beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides.
If you take any of the following medicines, your blood sugar level may rise (hyperglycaemia):
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Octreotide and lanreotide may either increase or decrease your blood sugar level.
Beta-blockers may weaken or suppress entirely the first warning symptoms which help you to recognize a hypoglycaemia.
Thiazolidinediones (class of oral antidiabetic medicines used for treatment of type 2 diabetes mellitus)
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Taking NovoRapid® with food and drink
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, planning a pregnancy or breast-feeding, please contact your doctor for advice. NovoRapid® can be used during pregnancy and breastfeeding. Your insulin dosage 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.
Driving and using machines
If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car:
► If you have frequent hypoglycaemia.
► If you find it hard to recognise hypoglycaemia.
NovoRapid® has a rapid effect. Therefore, if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.
How to use NovoRapid®
Talk about your insulin dose with your doctor and nurse. Make sure you get the colour-coded NovoRapid® FlexPen® as your doctor and nurse have told you to use and follow their advice carefully.
If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor. Do not change your insulin unless your doctor tells you to.
Eat a meal or snack containing carbohydrates within 10 minutes of the injection to avoid hypoglycaemia.
NovoRapid® is generally given immediately before a meal. When necessary, NovoRapid® can be given soon after a meal.
Use in children
NovoRapid® can be used in children instead of soluble human insulin when a rapid onset effect is preferred. For example, when it is difficult to dose the child in relation to meals.
Use in special populations
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Method of administration
NovoRapid® is for injection under the skin (subcutaneously) or for continuous infusion in a pump system. NovoRapid® may also be given directly into a vein (intravenously) by healthcare professionals. Never inject your insulin directly into a muscle (intramuscular).
Always vary the sites you inject within the same region to reduce the risk of developing lumps or skin pitting (see 4 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); the upper arm or the front of your thighs. The insulin will work more quickly if you inject into the waist (abdomen). You should measure your blood sugar regularly.
How to handle NovoRapid® FlexPen®
Read the included NovoRapid® FlexPen® INSTRUCTIONS FOR USE carefully. You must use the pen as described in the Instructions for Use.
For use in an infusion pump system
NovoRapid® should never be mixed with any other insulin when used in a pump. Follow the instructions and recommendations from your doctor regarding the use of NovoRapid® in a pump. Before use of NovoRapid® in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump system.
• Before inserting the needle, use soap and water to clean your hands and the skin where the needle is inserted to avoid any infection at the infusion site.
• When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or the tubing.
• Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.
To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump,