Tresiba 100 units/ml PenFill solution for injection in cartridge

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tresiba 100 units/ml Penfill 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.

• 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, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any side effects 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 glucose levels. It is administered once daily. If the usual administration time cannot be followed, the timing may be adjusted, as Tresiba has a prolonged glucose-lowering effect (see section 3, "Flexibility in administration timing"). Tresiba may be used in combination with fast-acting insulins administered 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 administered 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 to 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 (hypoglycemia) – If your blood sugar level is too low, follow the instructions in section 4.

• High blood sugar level (hyperglycemia) – If your blood sugar level is too high, follow the instructions in section 4.

• Switching from other insulins – You may need a dose adjustment 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 disturbances – A rapid improvement in blood sugar control may temporarily worsen diabetes-related vision problems. If you experience any vision problems, talk to your doctor.

• Using the correct insulin – Always check the label on your insulin before each injection to avoid confusion between Tresiba and other insulins.

In case of reduced vision, see section 3.

Skin changes at the injection site

Injection sites should be rotated 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 effectively 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 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 dose 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 under 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 that may affect your insulin treatment are listed below.

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

• other diabetes medicines (oral and injectable)
• sulfonamides, 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 inhibitors), 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 (hyperglycemia) 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 existing 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 insulin requirements, 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 essential during pregnancy. Avoiding low blood sugar (hypoglycemia) 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 whether you can drive if:

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

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 insulin without help. Ask a person with normal vision who has been trained in the use of the pen to assist you.

Your doctor will decide together with you:

• how much Tresiba you will 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 instructions for use.
• Use Tresiba once daily, preferably at the same time every day.
• Occasionally, when it is not possible to use Tresiba at the same time of day, you may use it at a different time. Ensure that at least 8 hours elapse 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 first, as a change in diet may alter your insulin requirement.

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

When taking 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. However, if you are elderly, you may need to check 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.

Injection of the medicine

Before using Tresiba for the first time, your doctor or nurse will show you how to do it.

• Read the instructions provided with the insulin delivery system.
• Check the name and concentration on the label to ensure it is Tresiba 100 units/ml.

Do not use Tresiba

• in insulin infusion pumps.
• if the cartridge or delivery system you are using is damaged. Return them to your supplier. See further instructions in the delivery system's instruction manual.
• if the cartridge 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 it 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.

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 take 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 you are due to take your next dose, do not inject a double dose; instead, take your usual daily dose.

If you stop using Tresiba

Do not stop using your insulin without consulting your doctor. Stopping insulin treatment could 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 gets them.

When you are 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 action immediately to raise your blood sugar level. See the advice under “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 Tresiba 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 the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work as 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 may occur at the injection site. Symptoms may include pain, redness, rash, swelling, and itching. These reactions usually disappear after a few days. If symptoms do not resolve within a few weeks, consult your doctor. If reactions worsen, stop using 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 you start using this medicine, 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 itching.

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 very little, or skip a meal.

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

headache, difficulty speaking, palpitations, cold sweating, cold and pale skin, dizziness, excessive hunger, trembling, nervousness or anxiety, unusual tiredness, weakness, 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 others should do if you lose consciousness

Inform people you spend time with that you have diabetes. Let them know what the consequences of low blood sugar may be, including the risk of losing consciousness.

Tell them that if you become unconscious, they should:

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

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

• If glucagon is given, 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, which can be temporary or permanent, and may even lead to death.

Talk to your doctor if:

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

You may need to adjust your insulin dose or injection frequency, your diet, or your level of physical activity.

• 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, do not inject 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, 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 not treated, 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 help.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 Penfill packaging following "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.

After first use or when carried as a spare

Do not refrigerate. The Tresiba Penfill cartridge may be carried with you and stored at room temperature (not above 30 °C) for up to 8 weeks.

Always keep Tresiba Penfill in its outer packaging 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 unused medicines and their packaging. This helps 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 100 units of insulin degludec. Each cartridge contains 300 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).

Nature and contents of the container

Tresiba is presented as a clear, colourless injectable solution in a cartridge (300 units in 3 ml).

Pack sizes of 5 and 10 cartridges of 3 ml. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Alle 1

DK-2880 Bagsvaerd, Denmark

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