TRESIBA PEN 100 IU / ml. 3 ml. 5 pen

What is Tresiba and what it is used
Tresiba is a long-acting basal insulin called insulin degludek. It is used to treat diabetes mellitus in adults, adolescents and children aged 1 and older. Tresiba helps your body to reduce blood sugar levels. Used for once daily administration. In cases where you can not keep your usual schedule of application, you can change the time of application, as Tresiba a lasting blood glucose-lowering effect (see section 3 "Flexibility in terms of time of application"). Tresiba can be used with fast-acting insulin products related to nutrition. In type 2 diabetes mellitus, Tresiba can be used in combination with tablets for diabetes or injectable antidiabetic agents other than insulin.
In type 1 diabetes Tresiba should always be combined with diet-related rapid acting insulin products.

2. What you should know before using Tresiba
Do not use Tresiba:
if you are allergic to insulin degludek or 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.
Especially watch out for the following:
low blood sugar (hypoglycaemia) - If your blood sugar is too low, follow the instructions to lower blood sugar in section 4 "Possible Side Effects";
high blood sugar (hyperglycemia) - If your blood sugar is too high, follow the instructions to high blood sugar in section 4 "Possible Side Effects";
Transfer from other insulin products - may need a change of insulin dose, if you are switching from another type, brand or manufacturer of insulin. Talk to your doctor;
Pioglitazone used together with insulin, see 'Pioglitazone' below;
eye disorders - rapid improvement in glycemic control may cause temporary worsening of diabetic eye disorder. If you get eye disorder, talk to your doctor;
ensuring that you use the correct type of insulin - always check the label of the insulin before each injection to avoid accidental confusion between different concentrations of Tresiba and other insulin products.
If you have poor eyesight, please see section 3 "How to use Tresiba".

Children and adolescents
Tresiba can be used in adolescents and children aged 1 and older. There is no experience with the use of Tresiba in children under 1 year.

Other medicines and Tresiba
Tell your doctor, pharmacist or nurse if you are taking, you have recently taken or might take any other medicines. Some medicines affect your blood sugar - it may mean that your dose of insulin should be changed.

Below are listed the drugs most frequently may affect your insulin treatment with insulin.
Your blood sugar may fall (hypoglycaemia) if you take:
other medicines for diabetes (oral and injectable);
sulfonamides - for infections;
Anabolic steroids - such as testosterone;
Beta-blockers - for high blood pressure. They can hinder the recognition of the warning signs of too low blood sugar (see section 4 "Warning signs of too low blood sugar");
acetylsalicylic acid (and other salicylates) - for pain and mild fever;
monoamine oxidase inhibitors (MAOI) - Depression;
angiotensin converting enzyme (ACE) inhibitors - for certain heart conditions or high blood pressure.
Your blood sugar may increase (hyperglycaemia) if you take:
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;
sympathomimetic such as epinephrine (adrenaline), salbutamol and terbutaline - asthma;
thiazides - for high blood pressure or excessive fluid retention in the body (water retention).
Octreotide and lanreotide - used to treat a rare condition with high levels of growth hormone (acromegaly). They can increase or decrease your blood sugar.

Pioglitazone - oral antidiabetic medicine used for the treatment of diabetes mellitus type 2. Some patients with long-standing type 2 diabetes mellitus and heart disease or stroke treated with pioglitazone and insulin develop heart failure. Tell your doctor immediately if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling (edema).
If any of the above applies to you (or you are not sure), tell your doctor, pharmacist or nurse.

Tresiba alcohol
If you consume alcohol, your need for insulin may change. Your blood sugar may rise or fall. Therefore, you should monitor your blood sugar more often than usual.

Pregnancy and lactation
It is not known whether Tresiba affect the baby during pregnancy. If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. You may need to change your insulin dosage during pregnancy and after birth.
You take a careful control of your diabetes during pregnancy. Preventing excessively low blood sugar (hypoglycemia) is particularly important for the health of your baby.

Driving and using machines
Too low or too high blood sugar can affect your ability to drive or use tools or machines. If your blood sugar is too low or high, your concentration and ability to react might be affected. So you can put yourself or others in danger. Please ask your doctor whether you can drive if:
often get too low blood sugar;
too hard to recognize low blood sugar.
Important information about some of the ingredients of Tresiba
Tresiba contains less than 1 mmol sodium (23 mg) per dose. This means that the drug is essentially sodium.

3. How to use Tresiba
Always use this medicine exactly as prescribed by your doctor. If you're not sure, ask your doctor, pharmacist or nurse.
If you are blind or have poor eyesight and can not read the dose counter on the pen, do not use this pen unaided. Seek help from a person with good eyesight who is trained to use the pen FlexTouch.
The pre-filled pen can deliver a dose of 1-80 units per injection in increments of 1 unit.

Your doctor will work with you to decide:
Tresiba how much you need each day;
when to check your blood sugar if you have a higher or lower dose.
Flexibility in terms of time of application
Always follow your doctor's recommendations for dosage;
Use Tresiba once daily, preferably at the same time each day;
Where the use at the normal time of the day are not possible, Tresiba can be used at different times of the day. Provide at least 8 hours between doses;
If you want to change your usual diet, first ask your doctor, pharmacist or nurse as a change in diet can lead to a change in your need for insulin.
Based on your blood sugar doctor may change your dose.
When using other medications, 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 check your blood sugar 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 more often. Talk to your doctor about changes in your dose.

Injecting your medicine
Before using Tresiba for the first time, your doctor or nurse will show you how to use the pre-filled pen.
Check the name and concentration of the pen label to make sure it is Tresiba 100 units / ml.

Do not use Tresiba:
In insulin infusion pumps;
If the pen is damaged or not properly stored (see section 5 "How to store Tresiba");
If the insulin does not appear clear and colorless.
How to inject
Tresiba is injected under the skin (subcutaneous injection). Do not inject it into a vein or muscle;
The best places to inject are front thighs, armpits or front of your waist (abdomen);
Change the injection site in the designated area of ​​skin that you use every day to reduce the risk of forming lumps and hollows of the skin (see section 4).
Detailed instructions for use are given on the other side of this leaflet.

If you use more than the amount of Tresiba
If you use too much insulin your blood sugar may become too low (hypoglycaemia), see advice in section 4 'Too low blood sugar. "

If you forget to use Tresiba
If you miss a dose, inject the missed dose when you discover your mistake, making sure that between doses have a minimum of eight hours. If you find that you missed the previous dosage when it is time to apply the next regularly scheduled dose, do not double dose and resume your schedule once daily administration.

If you stop using Tresiba
Do not stop using your insulin without talking to your doctor. If you stop taking your insulin This could lead to very high blood sugar 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) can occur very frequently during treatment with insulin (may affect more than 1 in 10 people). It can be very severe. If your blood sugar drop too much, you may lose consciousness. Severe hypoglycaemia may cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, immediately take measures to raise blood sugar. See the advice in "Too low blood sugar" below.
If you experience a serious allergic reaction (rarely seen) to insulin or any of the ingredients of Tresiba, stop applying Tresiba and see a doctor immediately. Signs of a serious allergic reaction include:
Local reactions spread to other parts of the body;
suddenly feel unwell, and sweat;
You begin to vomit;
feel difficulty in breathing;
have a rapid heart beat and feel dizzy.
Other side effects include:
Common (may affect up to 1 in 10 people):
Local effects can be obtained local reactions at the injection site.
Signs may include: pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. Consult your doctor if you do not disappear after a few weeks. Stop applying Tresiba and consult your doctor immediately if the reactions become serious. For more information, see section "Serious allergic reaction" above.

Uncommon (may affect up to 1 in 100 people):
Skin changes at the injection site (lipodystrophy): fatty tissue under the skin may shrink (lipoatrophy) or thicken (lipohypertrophy). When every time the injection is changed, the risk of the formation of these skin changes can be reduced. If you notice any skin changes with your doctor or nurse. If you continue to inject the same place, these reactions can become more severe and change the amount of medicine that your body gets from the pen;
Swelling around the joints: When you start using the drug for the first time, your body can hold more water than normal. This causes swelling around your ankles and other joints. It is usually short-lived.
Rare (may affect up to 1 in 1000 people):
This medicine may cause allergic reactions such as hives, swelling of the tongue and lips, diarrhea, nausea, fatigue and itching.
Common effects from diabetes
Too low blood sugar (hypoglycemia).
Too low blood sugar can get if: consume alcohol; too much insulin; do more physical activity than usual; Food is too little or miss a meal.
Warning signs of too low blood sugar - they can come on suddenly: headache; slurred speech, rapid heart beat; cold sweat, cool pale skin; nausea, feelings of hunger; tremor or nervousness; anxiety; unusual tiredness, weakness and drowsiness; confusion; difficulty in concentrating, short-term changes in vision.

What to do if you experience low blood sugar
Accept glucose (tablets) or other breakfast high in sugar such as sweets, biscuits or fruit juice (always carry a glucose (tablets) or snack high in sugar case);
Measure your blood sugar if possible and rest. You may need to measure blood sugar more than once, because as with all basal insulin products, improvement of low blood sugar may be delayed;
Wait until the symptoms of low blood sugar have disappeared or when blood sugar levels are stabilized. Then continue insulin treatment as usual.
What should other people if you pass out
Tell everyone around you that you have diabetes. Tell them what could happen, including the risk of loss of consciousness when your blood sugar gets too low.

Tell them that if you pass, they must:
turn you on your side;
immediately seek medical attention;
do not give you anything to eat or drink because of the risk of suffocation.
You may come to mind quickly after injection of glucagon. It can be set only by a person who knows how to use it.
If you are given glucagon soon as you awake, you will need glucose or a sugary snack;
If injection of glucagon you do not work, you should be treated in hospital;
If very low blood sugar is not treated in time, it can cause brain damage. It can be short or long. It may even lead to death.
Talk to your doctor if you:
your blood sugar level has dropped so much that you have lost consciousness;
You have used an injectable glucagon;
several times recently had very low blood sugar.
You may need to change the amount of insulin or hours of injection, food or exercise.
Too high blood sugar (hyperglycemia).
Too high blood sugar can get if: eat more food or doing less exercise than usual; drinking alcohol; you have an infection or fever; you have not injected enough insulin; continue to use less insulin than you need; remember to apply insulin or you stop applying it without talking to your doctor.
5. How to store Tresiba
Keep out of reach of children.
Do not use this medicine after the expiry date 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). Keep away from the freezer element. Do not freeze. Keep the pen cap to protect from light.

After first opening or when carried as a spare
You can wear your pre-filled pen Tresiba (FlexTouch) with you and keep it at room temperature (no more than 30 ° C) or refrigerated (2 ° C - 8 ° C) to 8 weeks.
Always keep the pen cap on when not in use to protect from light.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Tresiba
The active substance is insulin degludek. Each ml solution contains 100 units (U) insulin degludek. Each pre-filled pen (3 ml) containing 300 units (U) insulin degludek.
Other ingredients are: glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.

Tresiba looks like and contents of the pack
Tresiba is a clear and colorless solution for injection in pre-filled pen (300 units of 3 ml).
Packs of 1 (with or without needles), 5 (without needles) and 10 (2 x 5) (without needles) pre-filled pens of 3 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Novo Nordisk A / S, Denmark.

Instructions for using the Tresiba 100 units / ml solution for injection in pre-filled pen (FlexTouch)
Please read these instructions carefully before using your pre-filled pen FlexTouch. If you do not follow instructions carefully, you may get too much or too little insulin, which can lead to too high or too low blood sugar.
Do not use a pen without adequate training by your doctor or nurse.
Start by checking the stylus to make sure that it contains Tresiba 100 units / ml, then look at the illustration below to familiarize yourself with the different parts of your pen and needle.
If you are blind or have poor eyesight and can not read the dose counter on the pen, do not use this pen unaided. Seek help from a person with good eyesight who is trained to use the pen FlexTouch.
Your pen is prefilled insulin pen with the possibility of raising the dose containing 300 units of insulin. You can dial up to 80 units per dose in steps of 1 unit. Your pen is designed for use with disposable needles NovoFine or NovoTwist a length of 8 mm.

Important information
Pay special attention to those comments because they are important for the proper use of the pen.

Tresiba prefilled pen and needle (example) (FlexTouch)
Pen cap;
Outer needle cap;
Inner needle cap;
needle;
Paper label;
Insulin scale;
Window for insulin;
Tag pen;
Dosage button;
Arrow dose;
Dose selector;
Dose counter;
Button dose smooth.
1. Prepare your pen
Check the name and concentration of the label on the pen to make sure that it contains Tresiba 100 units / ml. This is extremely important if you receive more than one type of insulin. If wrong insulin, your blood sugar may become too high or too low.
Remove the cap of the pen.
Check that the insulin in the pen is clear and colorless. Look through the window of insulin. If the insulin looks cloudy, do not use the pen.
Take a new needle and remove the paper label.

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