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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tresiba 200units/ml FlexTouch solution for injection in a pre-filled pen

insulin degludec

Read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Tresiba is and what it is used for
2. What you need to know before using 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 in adults, adolescents, and children from 1 year of age onwards to treat diabetes mellitus. Tresiba helps the body to lower blood sugar levels. It is administered once daily. When the usual administration time cannot be followed, the timing of administration may be varied because Tresiba has a prolonged glucose-lowering effect (see section 3, “Flexibility in administration timing”). Tresiba may be used in combination with fast-acting insulins taken in relation to meals. In patients with type 2 diabetes mellitus, Tresiba may be used in combination with oral antidiabetic tablets or with injectable antidiabetic medicines other than insulin.

In patients with type 1 diabetes mellitus, Tresiba must always be used in combination with fast-acting insulins taken in relation to meals.

2. What you need to know before using Tresiba

Do not use Tresiba

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Tresiba. It is important that you are aware of the following information:

• Low blood sugar level (hypoglycaemia) – If your blood sugar level is too low, follow the instructions in section 4.
• High blood sugar level (hyperglycaemia) – If your blood sugar level is too high, follow the instructions in section 4.
• Switching from other insulins – You may need an adjustment in your insulin dose if you switch from another type, brand, or manufacturer of insulin. Speak with your doctor.
• Use of pioglitazone together with insulin – See the “Pioglitazone” section below.
• Vision changes – A rapid improvement in blood sugar control may cause a temporary worsening of diabetes-related vision problems. If you experience any vision problems, talk to your doctor.
• Using the correct insulin – Always check the label of your insulin before each injection to avoid confusion between different concentrations of Tresiba and with other insulins.

If you have reduced vision, see section 3.

Skin changes at the injection site

You should rotate your injection site to help prevent changes in fatty tissue, such as thickening of the skin, skin shrinkage, or lumps under the skin. Insulin may not work as well if injected into a lumpy, shrunken, or thickened area (see section 3 “How to use Tresiba”). Inform your doctor if you notice any changes at the injection site. Inform your doctor if you are currently injecting into these affected areas before switching to a different injection site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin or the dose of your other antidiabetic medications.

Children and adolescents

Tresiba can be used in adolescents and children from 1 year of age. 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 need to take any other medicines. Some medicines affect blood sugar levels, which may require a change in your insulin dose.

The main medicines listed below may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycaemia) if you take:

• other diabetes medicines (oral and injectable)
• sulphonamides, used to treat infections
• anabolic steroids, such as testosterone
• beta-blockers, used to treat high blood pressure. These may make it harder to recognize warning signs of low blood sugar (see section 4 “Warning symptoms of low blood sugar”)
• acetylsalicylic acid (and other salicylates), used for pain and mild fever
• monoamine oxidase inhibitors (MAO), used to treat depression
• angiotensin-converting enzyme (ACE) inhibitors, used to treat certain heart problems or high blood pressure.

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

• danazol, used to treat endometriosis
• oral contraceptives (birth control pills)
• thyroid hormones, used to treat thyroid gland problems
• growth hormone, used to treat growth hormone deficiency
• glucocorticoids, such as cortisone, used to treat inflammation
• sympathomimetics, such as epinephrine (adrenaline), salbutamol, or terbutaline, used to treat asthma
• thiazides, used to treat high blood pressure or if your body retains too much fluid.

Octreotide and lanreotide: used to treat acromegaly, a rare disorder characterized by excessive growth hormone production. These medicines may increase or decrease your blood sugar levels.

Pioglitazone: an oral antidiabetic used to treat type 2 diabetes mellitus. Some patients with long-standing type 2 diabetes mellitus and heart disease or prior 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 (edema).

If you are in any of the above situations (or are unsure), consult your doctor, pharmacist, or nurse.

Use of Tresiba with alcohol

Drinking alcohol may alter your need for insulin, as it can either increase or decrease your blood sugar level. Therefore, you should monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your insulin dose may need to be adjusted during pregnancy and after childbirth. Careful diabetes control is necessary during pregnancy. Avoiding low blood sugar (hypoglycaemia) is especially important for your baby’s health.

Driving and using machines

Low or high blood sugar levels can affect your ability to drive or operate tools or machinery. If your blood sugar level is too low or too high, your concentration and reaction ability may be impaired. This could endanger your life or the lives of others. Ask your doctor if you are allowed to drive if:

• you experience frequent episodes of hypoglycaemia;
• you have difficulty recognizing the signs of hypoglycaemia.

Important information about some of the 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

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without help. Ask for assistance from a person with normal vision who has been trained in the use of the prefilled pen FlexTouch.

Tresiba in prefilled pen is available in two strengths. “Tresiba 100 units/ml” or “Tresiba 200 units/ml”, clearly indicated on the pen label and packaging. Additionally, the packaging and label for Tresiba 100 units/ml are light green, while the packaging and label for Tresiba 200 units/ml are dark green with stripes and a red box highlighting the strength.

For both strengths, the required dose is selected in units. However, the dose units differ between the two Tresiba strengths.

The prefilled pen with 200 units/ml can deliver a dose of 2–160 units in one injection, in 2-unit increments. The dose counter on the prefilled pen displays the number of insulin units to be injected. Do not perform any dose calculations.

Your doctor will decide together with you:

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

Flexibility in administration timing

• Always follow your doctor's usage recommendations.
• Use Tresiba once daily, preferably at the same time every day.
• Occasionally, if it is not possible to use Tresiba at the same time each day, you may use it at a different time. Ensure that at least 8 hours pass between doses. There is no experience with flexible administration timing of Tresiba in children and adolescents.
• If you wish to change your usual diet, consult your doctor, pharmacist, or nurse beforehand, as a dietary change may alter your insulin requirement.

Depending on your blood sugar level, your doctor may adjust your dose.

When using 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. Talk to your doctor about possible dose adjustments.

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. Talk to your doctor about possible dose adjustments.

Medication injection

Before using Tresiba for the first time, your doctor or nurse will show you how to use the prefilled pen.

• Check the name and strength on the pen label to ensure it is Tresiba 200 units/ml.
• The dose counter on your pen shows the exact number of insulin units. Do not recalculate the dose.

Do not use Tresiba

• in insulin infusion pumps.
• if the pen has been damaged or not stored properly (see section 5 “Storage of Tresiba”).
• if the insulin does not appear clear and colourless.

How to inject yourself

• Tresiba is injected under the skin (subcutaneous injection). Do not inject into a vein or muscle.
• The best injection sites are the front of the thigh, the upper arm, and the front of the waist (abdomen).
• Change the injection site daily within the area to reduce the risk of developing lumps or dents in the skin (see section 4).
• Always use a new needle for each injection. Reusing needles may increase the risk of needle blockage, leading to inaccurate dosing. Dispose of the needle safely 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 side 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 “Blood sugar level too low”.

If you forget to use Tresiba

If you forget to administer a dose, inject the missed dose as soon as you remember, ensuring at least 8 hours between doses. If you realize you missed a dose at the time of your next scheduled dose, do not inject a double dose; instead, inject your usual daily dose.

If you stop using Tresiba

Do not stop using your insulin without consulting your doctor. Discontinuing insulin administration may lead to very high blood sugar levels and diabetic ketoacidosis (a condition involving excessive acid in the blood); see advice in section 4 “Blood sugar level too high”.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When being treated with insulin, hypoglycaemia (blood sugar level too low) may occur very commonly (may affect more than 1 in 10 people). It can be very serious. If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be potentially fatal. If you experience symptoms of low blood sugar, take immediate action to raise your blood sugar level. See the advice on “Blood sugar level too low”.

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

• local reactions spreading to other parts of the body
• sudden feeling of being unwell with sweating
• dizziness (vomiting)
• difficulty breathing
• palpitations or feeling dizzy.

Skin changes at the injection site:

If you inject insulin in the same place repeatedly, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also occur due to accumulation of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work well if injected into a lumpy, shrunken or thickened area. Change your injection site regularly to help prevent these skin changes.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

Local reactions: localized reactions at the injection site may occur. Symptoms may include pain, redness, rash, swelling, and itching. These reactions usually disappear after a few days. If symptoms do not disappear after a few weeks, consult your doctor. If reactions worsen, stop treatment with Tresiba and contact your doctor immediately. For more information, see “severe allergic reaction” above.

Uncommon (may affect up to 1 in 100 people)

Joint swelling: when starting treatment, your body may retain more fluid than normal. This causes swelling of the ankles and other joints. This effect usually disappears quickly.

Rare (may affect up to 1 in 1,000 people)

This medicine may cause allergic reactions such as rash, swelling of the tongue and lips, diarrhoea, nausea, tiredness and pruritus.

General effects of diabetes treatment

• Blood sugar level too low (hypoglycaemia)

Low blood sugar levels may occur if you:

drink alcohol, inject too much insulin, exercise more than usual, eat too little or skip a meal.

Warning signs of low blood sugar level, which may appear suddenly:

headache, difficulty speaking, palpitations, cold sweating, cold and pale skin, dizziness, excessive hunger, trembling, nervousness or anxiety, unusual tiredness, weakness and drowsiness, confusion, difficulty concentrating, and temporary changes in vision.

What to do if your blood sugar level is too low

• Take glucose tablets or a sugary product such as sweets, biscuits, or fruit juice (always carry glucose tablets or sugary products with you, in case you need them).
• Check your blood sugar level if possible, then rest. You may need to check your blood sugar level more than once, as recovery may be delayed, as with all basal insulins.
• Wait until the signs of hypoglycaemia have disappeared or your blood sugar level has stabilized. Then continue your insulin treatment as usual.

What other people should do if you lose consciousness

Inform people you spend time with that you have diabetes. Tell them about the possible consequences of low blood sugar, including the risk of losing consciousness.

Inform them that if you become unconscious, they should:

• lay you on your side
• seek immediate medical assistance
• not give you anything to eat or drink, as you could choke.

You may regain consciousness more quickly if given glucagon. This should only be administered by someone who knows how to do it.

• If glucagon is administered, you should take glucose or a sugary product as soon as you regain consciousness.
• If you do not respond to glucagon treatment, you will need to be treated in a hospital.
• If severe hypoglycaemia is not treated, it may over time cause brain injury. This may be transient or permanent. It can lead to death.

Talk to your doctor if:

• your blood sugar has been so low that you lost consciousness
• you have needed glucagon
• you have had several episodes of low blood sugar recently.

You may need to adjust the dose or frequency of your insulin injections, your diet, or your exercise.

• Blood sugar level too high (hyperglycaemia)

High blood sugar levels may occur if you:

eat more or exercise less than usual, drink alcohol, have an infection or fever, have not injected enough insulin, repeatedly inject less insulin than you need, forget to inject insulin, or stop insulin treatment without talking to your doctor.

Warning signs of high blood sugar level, which usually appear gradually:

dry and flushed skin, drowsiness or tiredness, dry mouth, fruity breath odour (acetone), increased need to urinate, thirst, loss of appetite, nausea or vomiting.

These may be symptoms of a very serious condition called ketoacidosis. This is a build-up of acid in the blood due to the body metabolizing fat instead of sugar. If untreated, it could lead to diabetic coma and death.

What to do if your blood sugar level is too high

• Check your blood sugar level.
• Check for ketones in your urine or blood.
• Seek immediate medical assistance.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tresiba

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and on the carton of the pen after “EXP”. The expiry date refers to the last day of the month indicated.

Before first use

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer. Store the pen with the cap on to protect it from light.

After opening or when carried as a spare

You may carry your Tresiba (FlexTouch) pre-filled pen with you and store it either at room temperature (not above 30°C) or in the refrigerator (between 2°C and 8°C) for up to 8 weeks.

Always keep the pen with the cap on when not in use to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tresiba

• The active substance is insulin degludec. Each ml of solution contains 200 units of insulin degludec. Each pre-filled pen contains 600 units of insulin degludec in 3 ml of solution.

• The other components are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections (see section 2).

Appearance of the product and contents of the pack

Tresiba is presented as a clear, colourless injectable solution in a pre-filled pen (600 units per 3 ml).

Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles), and multipack of 6 (2 x 3) (without needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novo Nordisk A/S
Novo Alle 1
DK-2880 Bagsvaerd, Denmark

Manufacturer

Novo Nordisk A/S
Novo Alle 1
DK-2880 Bagsvaerd
Denmark

Novo Nordisk Production SAS
45 Avenue D Orleans
28000 Chartres
France

Date of the most recent revision of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for use of Tresiba 200 units/ml FlexTouch injectable solution in pre-filled pen

Read these instructions carefully before using your FlexTouch pre-filled pen. If you do not follow the instructions carefully, you may inject too little or too much insulin, which could result in blood sugar levels that are too high or too low.

Do not use the pen without proper training from your doctor or nurse.

Start by checking the pen to ensure it contains Tresiba 200 units/ml, then review the illustrations to become familiar with the different parts of the pen and the needle.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from a person with good eyesight who has been trained in the use of the FlexTouch pre-filled pen.

Your pen is a pre-filled insulin dosing pen containing 600 units of insulin. You can select a maximum of 160 units per administration, in 2-unit increments. The pen's dose counter displays the exact number of insulin units. Do not recalculate the dose. The pen is designed to be used with NovoTwist or NovoFine disposable needles up to 8 mm in length, for single use only.

Important information

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

1. Preparing the pen

• Check the name and concentration on the label of your pen to ensure it contains Tresiba 200 units/ml. This is especially important if you use more than one type of insulin. Using the wrong type of insulin may cause your blood sugar level to become too high or too low.

• Remove the pen cap.

• Check that the insulin in the pen appears clear and colourless.

Look through the insulin window. Do not use the pen if the insulin appears cloudy.

• Take a new needle and remove the paper tab.

• Place the needle straight onto the pen and screw it on tightly.

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

• Remove the inner needle cap and discard it. If you try to reattach it, you may accidentally prick yourself with the needle.

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

Always use a new needle for each injection.

This reduces the risk of contamination, infection, insulin leakage, blocked needles, and inaccurate dosing.

Never use bent or damaged needles.

2. Checking insulin flow

• Always check insulin flow before starting.

This helps ensure you receive the full insulin dose.

• Turn the dose selector to select 2 units. Make sure a 2 appears in the dose counter.

• Hold the pen with the needle pointing upwards.

Gently tap the upper part of the pen several times to allow any air bubbles to rise.

• Press and hold the dose button until the dose counter returns to 0.

The 0 must align with the dose marker.

A drop of insulin should appear at the tip of the needle.

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 still no drop appears, replace the needle and repeat steps 2A to 2C once more.

If, despite this, no drop of insulin appears, discard the pen and use a new one.

Always ensure a drop appears at the tip of the needle before injecting. This confirms that insulin is flowing.

If no drop appears, no insulin will be injected, even if the dose counter moves. This may indicate that the needle is blocked or damaged.

Always check the flow before injecting. If you do not check the flow, you may receive an insufficient or no insulin dose, which could result in blood sugar levels that are too high.

3. Selecting the dose

• Ensure the dose counter shows 0 before starting.

The 0 must align with the dose marker.

• Turn the dose selector to select the dose you need, following your doctor's or nurse's instructions.

• The dose counter displays the selected dose in units. Do not recalculate the dose.

If you select an incorrect dose, you can turn the dose selector forward or backward to correct it.

The pen can select up to a maximum of 160 units.

The dose selector changes the number of units. Only the dose counter and dose marker show how many units you have selected for each administration.

You can select up to 160 units per administration. When less than 160 units remain in the pen, the dose counter stops when it reaches the number of units left.

The dose selector clicks differently when turned forward, backward, or beyond the number of units remaining. Do not count the clicks of the pen.

Before injecting insulin, always use the dose counter and dose marker to verify how many units you have selected.

Do not count the clicks of the pen. If you inject an incorrect dose, your blood sugar level may become too high or too low.

Do not use the insulin scale, as it only shows the approximate amount of insulin remaining in the pen.

4. Injecting the dose

• Insert the needle under the skin as instructed by your doctor or nurse.

• Ensure you can see the dose counter.

Do not touch the dose counter with your fingers. This could interrupt the injection.

• Press and hold the dose button until the dose counter returns to 0.

The 0 must align with the dose marker.

You may hear or feel a click at this point.

• Keep the needle under the skin for at least 6 seconds to ensure the full dose is delivered.

• While keeping the needle and pen straight, remove them from the skin.

If bleeding occurs at the injection site, apply light pressure with a cotton ball. Do not rub the area.

A drop of insulin may appear at the needle tip after injection. This is normal and does not affect the dose.

Always watch the dose counter to confirm how many units you are injecting.

The dose counter shows the exact number of units. Do not count the pen's clicks.

Press and hold the dose button until the dose counter returns to 0 after injection. If the dose counter stops before reaching 0, the full dose has not been administered, which could result in blood sugar levels that are too high.

5. After injection

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

• When the needle is covered, press the outer cap fully and carefully onto the needle.

• Unscrew the needle and dispose of it carefully.

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

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 inaccurate dosing. If the needle is blocked, no insulin will be injected.

When the pen is empty, discard it without the needle attached, following instructions from your doctor, nurse, pharmacist, or local authorities. Do not dispose of used needles in household waste.

Never attempt to reattach the inner needle cap. You may prick yourself.

Always remove the needle after each injection and store your pen without a needle attached.

This reduces the risk of contamination, infection, insulin leakage, blocked needles, and inaccurate dosing.

6. How much insulin is left?

• The insulin scale shows the approximate amount of insulin remaining in the pen.

• To determine the exact amount of insulin remaining, use the dose counter:

Turn the dose selector until the dose counter stops.

If it shows 160, at least 160 units remain in the pen.

If it shows less than 160, the number indicates the exact units remaining.

• Turn the dose selector back until the dose counter shows 0.

• If you need more insulin than remains in the pen, you may split the dose between two pens.

Be very careful when calculating if splitting your dose.

If in doubt, inject the full dose using a new pen. Incorrectly splitting the dose may result in too little or too much insulin being injected, leading to blood sugar levels that are too high or too low.

Additional important information

• Always carry the pen with you.

• Always carry a spare pen and new needles with you in case of loss or damage.

• 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 could cause infections.

• Never share the pen with other people. Your medication could be harmful to their health.

• People caring for patients should exercise great caution when handling used needles to reduce the risk of accidental needlestick injuries and infections.

Pen care

Handle your pen carefully. Rough handling or misuse may lead to inaccurate dosing, which could result in blood sugar levels that are too high or too low.

• Do not leave the pen in the car or in any place where it could become too hot or too cold.

• Do not expose the pen to dust, dirt, or liquids.

• Do not wash, soak, or lubricate the pen. If necessary, clean it with a cloth dampened with mild detergent.

• Avoid dropping the pen or letting it hit hard surfaces.

If the pen is dropped or you suspect it may be damaged, attach a new needle and check insulin flow before injecting.

• Do not attempt to refill the pen. Once empty, it must be discarded.

• Do not attempt to repair or disassemble the pen.