Tresiba: detailed information

Package leaflet: Information for the patient

Tresiba 100 units/mL solution for injection in pre-filled pen

insulin degludec
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Tresiba is and what it is used for
What you need to know before using Tresiba
How to use Tresiba
Possible side effects
How to store Tresiba
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 from the age of 1 year. Tresiba helps your body reduce blood sugar levels. It is administered once daily. Tresiba has a prolonged blood sugar-lowering effect, so if you are unable to take your regularly scheduled dose at the usual time, you may vary the time of administration (see section 3 for 'Flexibility in administration times'). Tresiba may be used together with fast-acting mealtime insulin medications.
In type 2 diabetes mellitus, Tresiba may be used in combination with oral diabetes tablets or injectable antidiabetic medicines, in addition to insulin.
In type 1 diabetes mellitus, Tresiba must always be used in combination with fast-acting mealtime insulin medications.

2. What you need to know before using Tresiba

Do not use Tresiba:

if you are allergic to insulin degludec or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tresiba. Pay particular attention to:

Low blood sugar levels (hypoglycemia) – if your blood sugar level is too low, follow the instructions for low blood sugar in section 4.
High blood sugar levels (hyperglycemia) – if your blood sugar level is too high, follow the instructions for high blood sugar in section 4.
Switching from other insulin medicines – you may need to change your insulin dose when switching from another type, brand, or manufacturer of insulin. Talk to your doctor.
Pioglitazone used with insulin – see 'Pioglitazone' below.
Eye problems – rapid improvement in blood glucose control may lead to a temporary worsening of eye disorders. If you experience eye problems, talk to your doctor.
Make sure you are using the correct type of insulin – always check the insulin label before each injection to avoid accidental confusion between different strengths of Tresiba and other insulin medicines.

If you have poor eyesight, see section 3.
Skin changes at the injection site
You should rotate your injection site to help prevent changes in the fatty tissue under the skin, such as skin thickening, skin thinning, or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area, or into a thickened area (see section 3, 'How to use Tresiba'). Inform your doctor if you notice skin changes at the injection site. If you currently inject into one of these affected areas, talk to your doctor before starting to inject in another area. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or that of your other antidiabetic medicines.
Children and adolescents
Tresiba can be used in adolescents and children aged 1 year and older. There is no experience with the use of Tresiba in children below 1 year of age.
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, which may mean that your insulin dose needs to be changed.
Below is a list of the most common medicines that may affect insulin treatment.
Your blood sugar level may decrease (hypoglycemia) if you use:

other antidiabetic medicines (oral and injectable)
sulphonamides, for infections
anabolic steroids, such as testosterone
beta-blockers, for high blood pressure. These may make it difficult to recognize warning signs of low blood sugar (see section 4 for 'Warning signs of low blood sugar').
acetylsalicylic acid (and other salicylates), for pain and mild fever
monoamine oxidase inhibitors (MAOIs), for depression
angiotensin-converting enzyme (ACE) inhibitors, for certain heart conditions or high blood pressure.

Your blood sugar level may increase (hyperglycemia) if you use:

danazol, for endometriosis
oral contraceptives, birth control pills
thyroid hormones, for thyroid problems
growth hormone, for growth hormone deficiency
glucocorticoids, such as 'cortisone', for inflammation
sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, for asthma
thiazides, for high blood pressure or fluid retention.

Octreotide and lanreotide: used to treat a rare disease characterized by excessive production of growth hormone (acromegaly). These may increase or decrease your blood sugar level.
Pioglitazone: an oral antidiabetic medicine used to treat type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes and heart problems or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
If any of these situations apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse.
Tresiba with alcohol
If you consume alcohol, your insulin requirement may change because alcohol can cause your blood sugar level to increase or decrease. Therefore, you should check your blood sugar level more frequently than usual.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Your insulin dose may need to be adjusted during pregnancy and after delivery. Careful diabetes control during pregnancy is essential, and it is particularly important for your baby's health to prevent low blood sugar (hypoglycemia).
Driving and using machines
Low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia) may affect your ability to drive or use tools or machinery. If your blood sugar level is too low or too high, your concentration or reaction ability may be impaired. This could endanger yourself or others. Ask your doctor if you are allowed to drive if:

your blood sugar level frequently becomes too low.
you have difficulty recognizing the signs of low blood sugar.

Important information about some ingredients of Tresiba
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially 'sodium-free'.

3. How to use Tresiba

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
If you are blind or have visual impairments and cannot read the dose counter on the pen, do not
use this pen without assistance. Ask a person with good eyesight, who has been trained in the use of the pre-filled FlexTouch pen, to help you.
The pre-filled Tresiba pen is available in two formulations. “Tresiba 100 units/mL” or “Tresiba
200 units/mL” is clearly marked on the pen label and packaging. Additionally, the packaging and label of Tresiba 100 units/mL are light green in color, while the packaging and label of Tresiba 200 units/mL are dark green with a red stripe highlighting the formulation.
For both strengths, the required dose is measured in units. However, the unit increments differ between the two Tresiba strengths.
The pre-filled pen with 100 units/mL can deliver a dose from 1 to 80 units in a single injection, in 1-unit increments. The dose counter on the pre-filled pen displays the number of insulin units to be injected. Do not recalculate the dose.

Your doctor will decide together with you:

how much Tresiba you need each day
when to check your blood sugar level and whether a higher or lower dose is needed.

Flexibility in administration times

Always follow the dose recommended by your doctor.
Use Tresiba once daily, preferably at the same time each day.
If it is not possible to take Tresiba at the same time every day, you may take it at a different time. Ensure that at least 8 hours pass between doses. There is no experience regarding flexibility in administration times of Tresiba in children and adolescents.
If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as changes in diet may affect your insulin requirements.

Depending on your blood sugar level, your doctor may adjust your dose.
When using Tresiba together with other medicines, ask your doctor whether your treatment needs to be adjusted.
Use in elderly patients (≥65 years)
Tresiba can be used in elderly patients, but if you are elderly, you may need to monitor your blood sugar level more frequently. Discuss dose adjustments with your doctor.
If you have kidney or liver problems
If you have kidney or liver problems, you may need to monitor your blood sugar level more frequently. Discuss dose adjustments with your doctor.
Injection of the medicine
Before using Tresiba FlexTouch for the first time, your doctor or nurse must show you how to use it.

Check the name and strength on the pen label to ensure it is Tresiba 100 units/mL.

Do not use Tresiba

in insulin infusion pumps.
if the pen is damaged or has not been stored properly (see section 5).
if the insulin does not appear clear and colourless.

How to inject

Tresiba is administered by subcutaneous injection (injected under the skin). Do not inject it into a vein or muscle.
The best injection sites are the front of the thighs, the upper arms, or the front of the waist (abdomen).
Rotate the injection site within the chosen area each day to reduce the risk of developing lumps or skin depressions (see section 4).
Always use a new needle for each injection. Reusing needles increases the risk of needle blockage, which may lead to inaccurate dosing. Dispose of the needle carefully after each use.
Do not use a syringe to withdraw solution from the pen, to avoid dosing errors and potential overdose.

Detailed instructions for use are provided on the reverse of this leaflet.
If you use more Tresiba than you should
If you use too much insulin, your blood sugar level may become too low (hypoglycaemia); see advice in section 4 ‘Low blood sugar level’.
If you forget to use Tresiba
If you miss a dose, inject the missed dose as soon as you remember, ensuring at least 8 hours between doses. If you remember the missed dose at the time you are due to take your next scheduled dose, do not inject a double dose; instead, resume your regular daily dosing schedule.
If you stop using Tresiba
Do not stop insulin treatment without speaking to your doctor. If you stop using insulin, you may develop very high blood sugar levels and ketoacidosis (a condition characterised by excess acid in the blood); see advice in section 4 ‘High blood sugar level’.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

With insulin treatment, hypoglycaemia (low blood sugar level) is very common (may affect more than 1 in 10 people). It can become very severe. If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, act immediately to raise your blood sugar level. See advice in the section “Low blood sugar level” below.

If you experience a severe allergic reaction to this medicine (which has occurred rarely) or to any of the ingredients of Tresiba, stop using Tresiba and contact a doctor immediately. Signs of a severe allergic reaction include:

local reactions spreading to other parts of the body
suddenly feeling unwell and starting to sweat
starting to feel sick (vomiting)
difficulty breathing
rapid heartbeat or dizziness.

Skin changes at the injection site:
If you inject insulin into the same spot repeatedly, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening. Rotate your 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 may occur at the injection site. Signs may include pain, redness, hives, swelling, and itching. These reactions usually disappear within a few days. If they do not disappear within a few weeks, consult your doctor. If the reactions become severe, stop using Tresiba and contact your doctor immediately. For further information, see above 'severe allergic reactions'.

Uncommon (may affect up to 1 in 100 people)
Swelling around joints: At the beginning of treatment, your body may retain more fluid than usual. This effect causes swelling around the ankles and other joints. It usually lasts only a short time.

Rare (may affect up to 1 in 1,000 people)
This medicine may cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, nausea, fatigue, and itching.

General effects of diabetes treatment

Low blood sugar level (hypoglycaemia)

Your blood sugar level may become too low if you:
drink alcohol; use too much insulin; exercise more than usual; eat too little or skip a meal.

Warning signs of low blood sugar, which may occur suddenly:
headache; confusion; rapid heartbeat; cold sweating; cold, pale skin; feeling unwell; intense hunger; trembling or nervousness or anxiety; unusual tiredness, weakness, or drowsiness; confusion; difficulty concentrating; temporary visual disturbances.

What to do if your blood sugar level is too low

Eat sugar cubes or a sugary snack such as sweets, biscuits, or fruit juice (always carry sugar cubes or a sugary snack with you, to use if needed).
Check your blood sugar level if possible, then rest. You may need to check your blood sugar level more than once, as with all basal insulins, recovery from low blood sugar may be delayed.
Wait until the symptoms of low blood sugar have disappeared or your blood sugar level has stabilised, then continue your insulin treatment as usual.

What others should do if you faint
Tell everyone you spend time with that you have diabetes and what the possible consequences are, including the risk of fainting due to low blood sugar.

Explain to them that if you do faint, they must:

turn you onto your side
seek immediate medical help
not give you food or drink, as this could cause choking.

You may regain consciousness more quickly with a glucagon injection, which should only be administered by someone who knows how to use it.

If glucagon is given to you, you will need sugar or a sweet snack as soon as you regain consciousness.
If you do not respond to the glucagon injection, you must be taken to hospital.
If severe hypoglycaemia is not treated promptly, it may cause temporary or permanent brain damage and may even lead to death.

Contact your doctor if:

your blood sugar level has become so low that you fainted
you have used a glucagon injection
you have recently had several episodes of low blood sugar. Your insulin dose, timing of injections, diet, or exercise routine may need to be adjusted.
High blood sugar level (hyperglycaemia)

Your blood sugar level may become too high if you:
eat more or exercise less than usual; drink alcohol; have an infection or fever; do not use enough insulin; continue using less insulin than you need; forget to use insulin or stop using insulin without talking to your doctor.

Warning signs of high blood sugar, which usually develop gradually:
dry, flushed skin; drowsiness or tiredness; dry mouth and fruity breath (acetone); more frequent urination; thirst; loss of appetite; feeling unwell (nausea or vomiting).

These may be signs of a very serious condition called ketoacidosis. This is an accumulation of acid in the blood because the body is metabolising fat instead of sugar. If untreated, it may lead to diabetic coma and possibly death.

What to do if your blood sugar level is too high

Check your blood sugar level.
Check for the presence of ketones in your urine or blood.
Contact a doctor immediately.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. 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 stated on the pen label and on the box after 'EXP'. The expiry date refers to the last day of that month.
Before first use
Store in a refrigerator (2 °C - 8 °C). Do not freeze. Keep away from cooling elements.
Keep the cap on the pen to protect it from light.
After first use or when carried as a spare
You may carry the pre-filled Tresiba pen (FlexTouch) as a spare and store it at room temperature (not above 30 °C) or in the refrigerator (from 2 °C to 8 °C) for up to 8 weeks.
When not in use, store the pen with the cap on to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Tresiba Contains

The active substance is insulin degludec. Each mL of solution contains 100 units of insulin degludec. Each unused pre-filled pen contains 300 units of insulin degludec in 3 mL of solution.
The other ingredients are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid, sodium hydroxide (for pH adjustment), and water for injections (see section 2).

Description of the Appearance of Tresiba and Contents of the Package
Tresiba is a clear, colourless injectable solution contained in a pre-filled pen (300 units in 3 mL).
Pack sizes: 1 pen (with or without needle), 5 pens (without needle), and a multipack of 10 (2 x 5) (without needle) 3 mL pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark

Manufacturer
The manufacturer can be identified from the batch number printed on the carton flap and label:

If the second and third characters are P5, ZF or FG, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, 28000 Chartres, France.

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for Using Tresiba 100 units/mL Solution for Injection in Pre-filled Pen (FlexTouch)
Read these instructions carefully before using the FlexTouch pre-filled pen. If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
Do not use the pen without first receiving proper instruction from your doctor or nurse.
Begin by checking the pen to ensure it contains Tresiba 100 units/mL, then refer to the illustrations below to learn about the different parts of the pen and the needle.
If you are blind or have severe vision problems, do not use this pen without help. Ask someone with good eyesight who has been trained to use the Tresiba FlexTouch pen to assist you.
The pen is a pre-filled, insulin-dosing pen containing 300 units of insulin.
You can select a maximum dose of 80 units per injection, in 1-unit increments. The pen is designed to be used with NovoTwist or NovoFine disposable needles up to 8 mm in length.

Warning symbol with a white exclamation mark inside

Important Information
Pay close attention to these notes, as they are important for the correct use of the pen.

Exploded diagram of an injection pen with separated components including a green and white main body, blue cap, and internal parts

Tresiba

1 Preparing the Pen

Check the name and strength on the pen label to make sure the pen contains Tresiba 100 units/mL. This is especially important if you use more than one type of insulin. Administering the wrong type of insulin may cause your blood sugar level to become too high or too low.
Remove the pen cap.

Two hands holding a cylindrical medical device in blue and yellow, with an arrow indicating a sliding motion to the right

Check that the insulin in the pen is clear and colourless. Look through the insulin window. Do not use the pen if the insulin appears cloudy.

A hand gripping a horizontal medical device in blue and light green with a transparent central section on a lilac background

Take a new needle and remove the protective seal.

Two hands rotating and removing a protective cap from a medical device following the direction of a blue arrow pointing to the left

Push the needle onto the pen and rotate it until it is secure.

A hand rotates the top part of a cylindrical medical device in yellow and light blue following the direction of a white arrow

Remove the outer needle cap and keep it for later. You will need it after the injection to properly remove the needle from the pen.

Medical illustration showing a hand inserting a yellow injection pen into a body part following the direction of a blue arrow

Two peach-colored triangles with a white exclamation mark in the center each on a white background

Remove the inner needle cap and discard it. Do not attempt to reinsert it, as you may accidentally prick yourself with the needle.

A small drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.

Two hands removing a protective cap from a medical injection pen with a blue arrow indicating movement to the right

Always use a new needle for each injection.
This reduces the risk of contamination, infection, insulin leakage, blocked needles, and incorrect dosing.
Never use a bent or damaged needle.

2 Checking the Insulin Flow

Always check the insulin flow before injecting. This helps ensure the full dose of insulin is delivered.
Rotate the dose selector and select 2 units. Make sure the dose counter displays 2.

Two hands holding a blue medical device with a display showing zero and a curved arrow indicating a downward rotation movement

Hold the pen with the needle pointing upwards. Gently tap the pen with your finger several times so that air bubbles rise to the top.

A hand holding a yellow and white injection pen vertically with curved lines indicating vibration or an audible signal

Press and hold the injection button until the dose counter returns to zero. The "0" must align with the dose indicator. A drop of insulin should appear at the needle tip.

A hand holding a blue and white injection pen with an arrow pointing downward

Two orange triangles with a white exclamation mark in the center each on a white background

C
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 six times. If still no drop appears, replace the needle and repeat steps 2A to 2C once more.
If no drop of insulin appears, discard the pen and use a new one.
Always ensure a drop appears at the needle tip before injection. This confirms proper insulin flow.
If no drop appears, do not inject the insulin, even if the dose counter moves. This may indicate a blocked or damaged needle.
Always check the insulin flow before each injection. If you do not check the flow, you may not inject any insulin or may inject an insufficient amount, which could lead to high blood sugar levels.

3 Selecting the Dose

Before starting, ensure the dose counter is at 0. The "0" must align with the dose indicator.
Rotate the dose selector to select the required dose, as prescribed by your doctor or nurse. If you select the wrong dose, you can correct it by rotating the dose selector forward or backward.

A maximum of 80 units can be selected on the pen.

Diagram showing the medical device with numbers 02, 46, and 24 displayed on small blue screens with arrows pointing upward

Warning symbol composed of a white exclamation mark inside

The dose selector changes the number displayed. Only the dose counter and dose indicator show how many units have been selected for each dose.
You can select up to 80 units per dose. When less than 80 units remain in the pen, the dose counter will display the number of units left.
The dose selector makes a distinct click when rotated forward, backward, or when exceeding the remaining units. Do not count the clicks of the pen.
Before injecting insulin, always use the dose counter and dose indicator to verify how many units have been selected.
Do not count the clicks of the pen. Selecting and injecting the wrong dose may result in blood sugar levels that are too high or too low.
Do not use the insulin scale, which only approximately indicates how much insulin remains in the pen.

4 Injecting the Dose

Insert the needle into the skin as shown to you by your doctor or nurse.
Ensure you can see the dose counter. Do not touch the dose counter with your fingers, as this may interrupt the injection.
Press and hold the injection button until the dose counter returns to 0. The "0" must align with the dose indicator. You may hear or feel a click.
Leave the needle under the skin for at least 6 seconds to ensure the full dose is delivered.

A hand gripping a blue and yellow medical device with an arrow pointing downward and a display showing zero and a clock with the number 6

A
6 seconds

Remove the needle and pen from the skin while keeping them vertical. If bleeding occurs at the injection site, apply light pressure with a cotton swab without rubbing the area.

Medical illustration of an injector device in green and white with a blue arrow pointing upward

B
After injection, a small drop of insulin may appear at the needle tip. This is normal and does not affect the dose.
Always check the dose counter to confirm how many units are being injected.
Do not count the clicks of the pen. The dose counter shows the exact number of units. Keep the injection button pressed until the dose counter returns to 0 after injection. If the dose counter stops before reaching 0, the full dose has not been delivered, which may result in high blood sugar levels.

5 After Injection

Place the needle tip into the outer needle cap placed on a flat surface, without touching the needle or the outer cap.

A blue arrow indicating the movement of a protective cap being removed from the device

Once the needle is covered, press the outer cap fully and carefully.
Unscrew the needle and dispose of it carefully.

A hand pressing down the cap of a syringe containing yellow liquid following the direction of a blue arrow toward the base

Two equilateral light orange triangles each with a white exclamation mark at the center on a white background

Replace the pen cap on the pen after each use to protect the insulin from light.

Two hands gripping and rotating a cylindrical medical device in blue and yellow indicated by a blue arrow for drug preparation

C
Always dispose of the needle after each injection in an appropriate sharps container. This reduces the risk of contamination, infection, insulin leakage, blocked needles, and incorrect dosing. If the needle is blocked, you will not be able to inject insulin.
When the pen is empty, discard it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities. Do not dispose of used needles in household waste.
Never attempt to reinsert the inner needle cap. You may prick yourself with the needle.
Always remove the needle from the pen after each injection and store the pen without a needle attached.
This reduces the risk of contamination, infection, insulin leakage, blocked needles, and incorrect dosing.

6 How Much Insulin is Left?

The insulin scale shows approximately how much insulin remains in the pen.

Vertical syringe with yellow liquid and blue base on a light blue background with a small blue square in the upper left corner

approximately
how much
left

To see exactly how much insulin remains, use the dose counter: rotate the dose selector until the dose counter stops. If it shows 80, at least 80 units remain in the pen. If it shows less than 80, the number displayed is the exact number of units remaining.

Two hands holding a blue injection pen with a display showing zero and an arrow indicating transition to value 52 in the lower box

Two orange triangles with pointed tops, each containing a white exclamation mark at the center

Rotate the dose selector back until the dose counter shows 0.
If you need more insulin units than remain in the pen, you may split your dose between two pens.

Be very careful when calculating the correct number if splitting the dose.
If you are unsure, inject the full dose using a new pen. Incorrectly splitting the dose may result in injecting too little or too much insulin, leading to blood sugar levels that are too high or too low.

Other Important Information

Always carry the pen with you.
Always carry a spare pen and new needles in case you lose or damage your pen or needles.
Always keep the pen and needles out of sight and reach of others, especially children.
Never share the pen or needles with other people. This may lead to cross-infection.
Never share the pen with other people. The medicine may be harmful to their health.
Exercise great care when handling used needles to reduce the risk of needle-stick injuries and cross-infection.

Pen Maintenance
Handle the pen with care. Improper or incorrect use may result in incorrect dosing, which could lead to blood sugar levels that are too high or too low.

Do not leave the pen in a car or other places where it could become too hot or too cold.
Do not expose the pen to dust, dirt, or liquids.
Do not wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent on a damp cloth.
Do not drop the pen or allow it to hit hard surfaces. If the pen is dropped or you suspect damage, attach a new needle and check the insulin flow before injection.
Do not attempt to refill the pen. When empty, it must be discarded.
Do not attempt to repair or disassemble the pen.

Patient information leaflet

Tresiba 200 units/mL solution for injection in pre-filled pen

insulin degludec
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Tresiba is and what it is used for
What you need to know before using Tresiba
How to use Tresiba
Possible side effects
How to store Tresiba
Contents of the pack and other information

1. What Tresiba is and what it is used for

In type 2 diabetes mellitus, Tresiba can be used in combination with oral antidiabetic tablets or injectable antidiabetic medicines, in addition to insulin.

In type 1 diabetes mellitus, Tresiba must always be used in combination with fast-acting prandial insulin medications.

2. What you need to know before using Tresiba

Do not use Tresiba:

if you are allergic to insulin degludec or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tresiba. Pay particular attention to:

Low blood sugar levels (hypoglycaemia) – if your blood sugar level is too low, follow the instructions for low blood sugar in section 4.
High blood sugar levels (hyperglycaemia) – if your blood sugar level is too high, follow the instructions for high blood sugar in section 4.
Switching from other insulin medicines – you may need to change your insulin dose when switching from another type, brand, or manufacturer of insulin. Talk to your doctor.
Pioglitazone used with insulin – see 'Pioglitazone' below.
Eye problems – rapid improvement in blood glucose control may lead to temporary worsening of eye disorders. If you experience eye problems, talk to your doctor.
Make sure you are using the correct type of insulin – always check the insulin label before each injection to avoid accidental mix-ups between different strengths of Tresiba and other insulin medicines.

If you have poor eyesight, see section 3.
Skin changes at the injection site
Injection sites should be rotated to help prevent changes in the fatty tissue under the skin, such as skin thickening, skin thinning, or the appearance of lumps under the skin.
Insulin may not work as well if you inject into an area with lumps, into a thinned area, or into a thickened area (see section 3, 'How to use Tresiba'). Inform your doctor if you notice skin changes at the injection site. If you are currently injecting into one of these affected areas, talk to your doctor before starting to inject in another area. Your doctor may advise you to monitor your blood glucose more closely and may adjust your insulin dose or that of your other antidiabetic medicines.
Children and adolescents
Tresiba can be used in adolescents and children aged 1 year and older. There is no experience with the use of Tresiba in children under 1 year of age.
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, which may mean that your insulin dose needs to be changed.
Below is a list of the most common medicines that may affect insulin treatment.
Your blood sugar level may decrease (hypoglycaemia) if you use:

other diabetes medicines (oral and injectable)
sulphonamides, for infections
anabolic steroids, such as testosterone
beta-blockers, for high blood pressure. These may make it difficult to recognize early warning signs of low blood sugar (see section 4 for 'Early warning signs of low blood sugar').
acetylsalicylic acid (and other salicylates), for pain and mild fever
monoamine oxidase inhibitors (MAOIs), for depression
angiotensin-converting enzyme (ACE) inhibitors, for certain heart conditions or high blood pressure.

Your blood sugar level may increase (hyperglycaemia) if you use:

danazol, for endometriosis
oral contraceptives (birth control pills)
thyroid hormones, for thyroid problems
growth hormone, for growth hormone deficiency
glucocorticoids, such as 'cortisone', for inflammation
sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, for asthma
thiazides, for high blood pressure or excessive fluid retention.

Octreotide and lanreotide: used to treat a rare condition characterized by excessive production of growth hormone (acromegaly). These may increase or decrease blood sugar levels.
Pioglitazone: an oral antidiabetic medicine used to treat type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes and heart problems or a history of stroke, who were treated with pioglitazone and insulin, developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).
If any of these situations apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse.
Tresiba with alcohol
If you consume alcohol, your insulin requirement may change because alcohol can cause your blood sugar level to rise or fall. Therefore, you should check your blood sugar level more frequently than usual.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. You may need to adjust your insulin dose during pregnancy and after delivery. Careful diabetes control during pregnancy is essential, and it is particularly important for your baby's health to prevent low blood sugar (hypoglycaemia).
Driving and using machines
Low blood sugar (hypoglycaemia) or high blood sugar (hyperglycaemia) can affect your ability to drive or operate tools or machinery. If your blood sugar is too low or too high, your concentration or reaction ability may be impaired. This could endanger yourself or others. Ask your doctor if you are allowed to drive if:

your blood sugar frequently becomes too low
you have difficulty recognizing the signs of low blood sugar.

Important information about some ingredients of Tresiba
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. this medicine is essentially 'sodium-free'.