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 are: EU/1/12/807/001, EU/1/12/807/002, EU/1/12/807/003, EU/1/12/807/004, EU/1/12/807/005.
Tresiba 100 units/mL Pre-filled Pen (FlexTouch)
Package leaflet: Information for the patient
Tresiba® 100 units/mL solution for injection in pre-filled pen
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 pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch® pre-filled pen.
Tresiba® in a pre-filled pen is available in two strengths. “Tresiba® 100 units/mL” or “Tresiba® 200 units/mL” is clearly marked on the pen label and packaging. In addition, Tresiba® 100 units/mL packaging and label are light green, and Tresiba® 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 dialled in units. The dose steps, however, differ between the two strengths of Tresiba®.
The pre-filled pen 100 units/mL can provide a dose of 1–80 units in one injection in steps of 1 unit. The dose counter of the pre-filled pen shows the number of units of insulin to be injected. Do not make any dose re-calculation.
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 the pre-filled pen.
Do not use Tresiba®
How to inject
Detailed instructions for use are provided on the other side of this leaflet.
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 this medicine 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.
Malta:
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 pen 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. Keep the cap on the pen in order to protect it from light.
After first opening or if carried as a spare
You can carry your Tresiba® pre-filled pen (FlexTouch®) with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C to 8°C) for up to 8 weeks.
Always keep the cap on the pen 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 pre-filled pen (300 units per 3 mL).
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack of 10 (2 x 5) (without needles) pre-filled pens 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®, FlexTouch®, NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S, Denmark
© 2020
Novo Nordisk A/S
Instructions on how to use Tresiba® 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 or 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 Tresiba® 100 units/mL, then look at the illustrations below 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 trained to use the FlexTouch® pre-filled pen.
Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. You can select a maximum of 80 units per dose, in steps of 1 unit. Your pen is designed to be used with NovoTwist® or NovoFine® single-use disposable needles up to a length of 8 mm.
Important information
Pay special attention to these notes as they are important for correct use of the pen.
1 Prepare your pen
A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.
Always use a new 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.
2 Check the insulin flow
A small air bubble may remain at the needle tip, but it will not be injected.
If no drop appears, repeat steps 2A to 2C up to 6 times. If there is still no drop, change the needle and repeat steps 2A to 2C once more.
If a drop of insulin still does not appear, dispose of the pen and use a new one.
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 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.
3 Select your dose
If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
The pen can dial up to a maximum of 80 units.
The dose selector changes the number of units. Only the dose counter and dose pointer will show how many units you select per dose.
You can select up to 80 units per dose. When your pen contains less than 80 units, the dose counter stops at the number of units left.
The dose selector clicks differently when turned forwards, backwards or past the number of units left.
Do not count the pen clicks.
Always use the dose counter and the dose pointer to see how many units you have selected before 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 insulin scale, it only shows approximately how much insulin is left in your pen.
4 Inject your dose
You may see a drop of insulin at the needle tip after injecting. This is normal and does not affect your dose.
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 stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
5 After your injection
Always dispose of the needle after each injection in an appropriate sharps container. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked, you will not inject any insulin.
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities. Do not place the used needle in household waste.
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.
6 How much insulin is left?
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 lead to too high or too low blood sugar level.
Further important information
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Tresiba 100 units/ml FlexTouch PIL, UK/IE, version 10
3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA
+44 (0)1293 613555
+44 (0)845 600 5055
+44 (0)845 600 5055
+44 (0)1293 613535