Insulin degludec 100 units/mL Solution for injection in pre-filled pen

Insulin degludec 200 units/mL Solution for injection in pre-filled pen

What Insulin degludec is used for:

Insulin degludec is a long-acting basal insulin called insulin degludec. It is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. 

Insulin degludec helps your body reduce your blood sugar level. It is used for once-daily dosing. On occasions when you cannot follow your regular dosing schedule, you can change the time of dosing because Insulin degludec has a long blood sugar-lowering effect. Insulin degludec can be used with meal-related rapid-acting insulin products. 

In type 2 diabetes mellitus, Insulin degludec may be used in combination with tablets for diabetes or with injectable antidiabetic medicines, other than insulin. In type 1 diabetes mellitus, Insulin degludec must always be used in combination with meal-related rapid acting insulin medicines.

Do not use Insulin degludec if:

you are allergic to insulin degludec or any of the other ingredients of this medicine. 

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before using Insulin degludec. Be especially aware of the following: 

• Low blood sugar (hypoglycemia)
• High blood sugar (hyperglycemia) 
• Switching from another insulin 
• Pioglitazone used together with insulin
• Eye disorder – fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder. If you experience eye problems, talk to your doctor.
• Ensuring you use the right type of insulin – always check the insulin label before each injection to avoid accidental mix-ups between different strengths of Insulin degludec as well as other insulin products. 
• Skin changes at the injection site
• Insulin degludec can be used in adolescents and children aged 1 year and above. 

Possible side effects:

Insulin degludec can cause serious side effects. These side effects happen only to a small number of people and include:

• Hypoglycemia 
• Skin changes at the injection site
• Signs of allergic reactions
• Vision problems
• Swollen joints
• Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision)
• Painful neuropathy (pain due to nerve damage)

Other medicines and Insulin degludec:

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: 

• Your blood sugar level may fall (hypoglycemia) if you take medicines for: diabetes, depression, blood pressure, certain heart conditions, pain and lower fever, fertility, infections.
• Your blood sugar level may rise (hyperglycemia) if you take medicines for: birth control, fluid retention, thyroid gland disorders, asthma, growth.

How to take Insulin degludec:

• Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
• Insulin degludec in a pre-filled pen is available in two strengths. “Insulin degludec 100 units/mL” or “Insulin degludec 200 units/mL” is clearly marked on the pen label and packaging. In addition, Insulin degludec 100 units/mL packaging and label are light green, and Insulin degludec 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
• For both strengths, the needed dose is dialed in units. The dose steps, however, differ between the two strengths of Insulin degludec.
• Use Insulin degludec once each day, preferably at the same time every day.
• Insulin degludec is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). 
• 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. 
• 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 injected into the front of your waist. You should always measure your blood sugar regularly.

How to store Insulin degludec:

• 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 FlexTouch® label and carton, after ‘EXP’. Always keep the pen cap on.
• Before opening: Insulin degludec pen 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 Insulin degludec pen with you and keep it at a temperature below 30°C or in a refrigerator (2˚C to 8˚C) for up to 4 weeks. If refrigerated, keep away from the cooling element. Do not freeze. 
• 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.