Active ingredient
- insulin degludec
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 04668/0411.
Tresiba 100 units/mL Cartridge (Penfill)
Package leaflet: Information for the patient
Tresiba® 100 units/mL Solution for injection in cartridge
insulin degludec
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Tresiba® is and what it is used for
2. What you need to know before you use Tresiba®
3. How to use Tresiba®
4. Possible side effects
5. How to store Tresiba®
6. Contents of the pack and other information
1. What Tresiba® is and what it is used for
Tresiba® 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. Tresiba® 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 Tresiba® has a long blood sugar-lowering effect (see section 3 for ‘Flexibility in dosing time’). Tresiba® can be used with meal-related rapid-acting insulin products. In type 2 diabetes mellitus, Tresiba® may be used in combination with tablets for diabetes or with injectable antidiabetic medicines, other than insulin.
In type 1 diabetes mellitus, Tresiba® must always be used in combination with meal-related rapid-acting insulin medicines.
2. What you need to know before you use Tresiba®
Do not use Tresiba®
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tresiba®. Be especially aware of the following:
If you have poor eyesight, please see section 3.
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 Tresiba®’). 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
Tresiba® can be used in adolescents and children aged 1 year and above. There is no experience with the use of Tresiba® in children below the age of 1 year.
Other medicines and Tresiba®
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level, this may mean your insulin dose has to be changed.
Listed below are the most common medicines which may affect your insulin treatment.
Your blood sugar level may fall (hypoglycaemia) if you take:
Your blood sugar level may rise (hyperglycaemia) if you take:
Octreotide and lanreotide: used to treat a rare condition involving too much growth hormone (acromegaly). They may increase or decrease your blood sugar level.
Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse.
Tresiba® with alcohol
If you drink alcohol, your need for insulin may change. Your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.
Pregnancy and breast-feeding
It is not known if Tresiba® affects the baby in pregnancy or during breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes is needed in pregnancy. Avoiding too low blood sugar (hypoglycaemia) is particularly important for the health of your baby.
Driving and using machines
Having too low or too high blood sugar can affect your ability to drive or use any tools or machines. If your blood sugar is too low or too high, your ability to concentrate or react might be affected. This could be dangerous to yourself or others. Ask your doctor whether you can drive if:
Important information about some of the ingredients of Tresiba®
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is essentially ‘sodium-free’.
3. How to use Tresiba®
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this insulin product without help. Get help from a person with good eyesight who is trained to use the pen.
Your doctor will decide together with you:
Flexibility in dosing time
Based on your blood sugar level, your doctor may change your dose.
When using other medicines, ask your doctor if your treatment needs to be adjusted.
Use in elderly (≥65 years old)
Tresiba® can be used in elderly, but if you are elderly, you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.
If you have kidney or liver problems
If you have kidney or liver problems, you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.
Injecting your medicine
Before you use Tresiba® for the first time, your doctor or nurse will show you how to use it.
Do not use Tresiba®
How to inject
If you use more Tresiba® than you should
If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 4 ‘Too low blood sugar’.
If you forget to use Tresiba®
If you forget a dose, inject the missed dose when discovering the mistake, ensuring a minimum of 8 hours between doses. If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not inject a double dose, but resume your once-daily dosing schedule.
If you stop using Tresiba®
Do not stop using your insulin without talking to your doctor. If you stop using your insulin, this could lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood), see advice in section 4 ‘Too high blood sugar’.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much, you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. See advice in ‘Too low blood sugar’ below.
If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Tresiba®, stop using Tresiba® and see a doctor straight away. The signs of a serious allergic reaction are:
Skin changes at the injection site:
If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 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. Change the injection site with each injection to help prevent these skin changes.
Other side effects include:
Common (may affect up to 1 in 10 people)
Local reactions: Local reactions at the place you inject yourself may occur. The signs may include: pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. See your doctor if they do not disappear after a few weeks. Stop using Tresiba® and see a doctor straight away if the reactions become serious. For more information, see ‘serious allergic reaction’ above.
Uncommon (may affect up to 1 in 100 people)
Swelling around your joints: When you first start using your medicine, your body may keep more water than it should. This causes swelling around your ankles and other joints. This is usually only short-lasting.
Rare (may affect up to 1 in 1,000 people)
This medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, nausea, tiredness and itching.
General effects from diabetes treatment
Too low blood sugar may happen if you:
drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.
Warning signs of too low blood sugar – these may come on suddenly:
Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, difficulty in concentrating; short-lasting changes in your sight.
What to do if you get too low blood sugar
What others need to do if you pass out
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.
Let them know that if you pass out, they must:
You may recover more quickly from passing out with an injection of glucagon. This can only be given by someone who knows how to use it.
Talk to your doctor if:
This is because the dosing or timing of your insulin injections, food or exercise may need to be changed.
Too high blood sugar may happen if you:
eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin without talking to your doctor.
Warning signs of too high blood sugar – these normally appear gradually:
Flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting). These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.
What to do if you get too high blood sugar
Reporting of side 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
Ireland
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tresiba®
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 Penfill® label and carton, after
‘EXP’. The expiry date refers to the last day of that month.
Before first use
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezing element.
After first opening or if carried as a spare
Do not refrigerate. You can carry your Tresiba® cartridge (Penfill®) with you and keep it at room temperature (not above 30°C) for up to 8 weeks.
Always keep Tresiba® Penfill® in the outer carton when you are not using it in order to protect it from light.
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 Tresiba® contains
What Tresiba® looks like and contents of the pack
Tresiba® is presented as a clear and colourless solution for injection in a cartridge (300 units per 3 mL).
Pack sizes of 5 and 10 cartridges of 3 mL. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 09/2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Tresiba® and Penfill® are trademarks owned by Novo Nordisk A/S, Denmark
© 2020
Novo Nordisk A/S
Tresiba Penfill PIL – UK/IE – version 9
3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA
+44 (0)1293 613555
+44 (0)800 023 2573
+44 (0)800 023 2573
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