Package leaflet: Information for the patient

Ryzodeg 100 units/mL FlexTouch solution for injection in a pre-filled pen

70% insulin degludec / 30% insulin aspart
Please 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 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 Ryzodeg is and what it is used for
What you need to know before using Ryzodeg
How to use Ryzodeg
Possible side effects
How to store Ryzodeg
Contents of the pack and other information

1. What Ryzodeg is and what it is used for

Ryzodeg is used to treat diabetes mellitus in adults, adolescents, and children from the age of 2 years.
It helps the body to reduce blood sugar levels.
This medicine contains two types of insulin:

Basal insulin called insulin degludec, which has a prolonged effect on lowering blood sugar levels.
Rapid-acting insulin called insulin aspart, which reduces blood sugar levels shortly after injection of the medicine.

2. What you should know before using Ryzodeg

Do not use Ryzodeg

if you are allergic to insulin degludec, insulin aspart, 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 Ryzodeg. 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 adjust 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, consult 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 Ryzodeg and other insulin medicines.

If you have vision problems, 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 effectively if injected into an area with lumps, thinning, or thickening of the skin (see section 3 ‘How to use Ryzodeg’).
Inform your doctor if you notice any skin changes at the injection site. If you currently inject into one of these affected areas, consult your doctor before switching to a new injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or that of other antidiabetic medicines.
Children and adolescents
Ryzodeg can be used in adolescents and children with diabetes mellitus from the age of 2 years.
Ryzodeg should be used with particular caution in children aged 2 to 5 years. The risk of very low blood sugar levels may be higher in this age group. There is no experience with the use of this medicine in children under 2 years of age.
Other medicines and Ryzodeg
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. Some medicines affect blood sugar levels, which may require an adjustment in your insulin dose.
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 medicines for diabetes (oral and injectable)
sulfonamides, 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 ‘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 fluid retention.

Octreotide and lanreotide: used to treat a rare disease characterised by excessive growth hormone production (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 with heart disease 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 (oedema).
If any of these situations apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse.
Ryzodeg with alcohol
Alcohol may alter your insulin requirements, as it can cause blood sugar levels to increase or decrease. You should therefore monitor your blood sugar levels more frequently than usual.
Pregnancy and breastfeeding
It is not known whether Ryzodeg affects the fetus during pregnancy or during breastfeeding. If you are pregnant, suspect 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 management is essential during pregnancy, and it is particularly important for the health of the baby to prevent low blood sugar levels (hypoglycaemia).
Driving and using machines
Low or high blood sugar levels can impair your ability to drive or operate machinery. If your blood sugar level is too low or too high, your concentration and reaction ability may be affected. This could endanger yourself and others. Ask your doctor whether you can 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 Ryzodeg
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is practically ‘sodium-free’.

3. How to use Ryzodeg

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without assistance. Have someone with good eyesight who has been trained to use the pre-filled FlexTouch pen help you.
The pre-filled pen can deliver doses from 1–80 units in a single injection, in 1-unit increments.

Your doctor will decide together with you:

how much Ryzodeg you need each day and with which meal(s) it should be taken
when to check your blood sugar levels and whether a higher or lower dose is needed.

Flexibility in administration timing

Always follow the dose recommended by your doctor.
Ryzodeg can be used once or twice daily.
Use the medicine with your main meal; you may choose a different time, provided Ryzodeg is administered with your main meal(s).
If you wish to change your usual diet, consult your doctor, pharmacist, or nurse first, as dietary changes may alter your insulin requirements.

Depending on your blood sugar levels, your doctor may adjust your dose.
When using Ryzodeg together with other medicines, ask your doctor whether your treatment needs to be adjusted.

Use in elderly (≥ 65 years)
Ryzodeg can be used in elderly patients, but more frequent monitoring of blood sugar levels may be necessary. 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 levels more frequently. Discuss any dose adjustments of Ryzodeg with your doctor.

Injecting the medicine
Before using Ryzodeg 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 make sure it is Ryzodeg 100 units/mL.

Do not use Ryzodeg

in insulin infusion pumps.
if the pen is damaged or has not been stored correctly (see section 5, 'How to store Ryzodeg').
if the insulin does not appear clear and colourless.

How to inject

Ryzodeg is administered by subcutaneous injection (under the skin). Do not inject it into a vein or into a muscle.
The best injection sites are the front of the waist (abdomen), the upper arms, or the front of the thighs.
Rotate the injection site daily within the chosen area to reduce the risk of developing lumps or hollows under the skin (see section 4, 'Possible side effects').
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 the solution from the pen, to avoid dosing errors and potential overdosing.

Detailed instructions for use are provided on the back of this leaflet.

If you use more Ryzodeg 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 Ryzodeg
If you miss a dose, inject the missed dose at the next main meal of that day, then resume your usual dosing schedule. Do not inject a double dose if you remember that you missed a previous dose.

If you stop using Ryzodeg
Do not stop treatment with insulin without first talking 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, 'Blood sugar level too high'.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With insulin treatment, hypoglycaemia (blood sugar level too low) is very common (may affect more than 1 in 10 people). It can become very severe. If your blood sugar level drops very low, you may lose consciousness. Severe hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, take immediate action to raise it. See advice in the section “Low blood sugar level” below.
If you experience a severe allergic reaction (which has occurred rarely) to insulin or to any of the ingredients in this medicine, stop using Ryzodeg and contact a doctor immediately. Signs of a severe allergic reaction include:

Local reactions spread to other parts of the body
You suddenly feel unwell and start sweating
You start to feel sick (vomiting)
You have difficulty breathing
Your heartbeat is fast or you feel dizzy.

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, urticaria (hives), swelling, and itching. Reactions usually disappear within a few days. If they do not disappear within a few weeks, contact your doctor.
If reactions become severe, stop using Ryzodeg and contact a 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 with this medicine, your body may retain more water than it should. 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 urticaria, swelling of the tongue and lips, diarrhoea, nausea, fatigue, and itching.
Frequency not known (cannot be estimated from the available data)
Changes in the skin at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis).
Insulin may not work as well as it should if you inject into an area with lumps, into a thinned area, or into a thickened area. Change your injection site with each injection to prevent these skin changes.

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; do more physical activity than usual; eat too little or skip a meal.
Warning signs of low blood sugar level, which may occur suddenly:
headache; confused speech; fast heartbeat; cold sweat; cold and pale skin; feeling unwell; strong hunger; trembling or shakiness, 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).
Measure your blood sugar if possible, then rest. You may need to measure 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 faint, they must:

turn you onto your side
call a doctor immediately
not give you food or drink, as this could cause choking.

You may regain consciousness more quickly if given glucagon, 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 glucagon treatment, you will need to be taken to hospital.
If severe hypoglycaemia is not treated promptly, it can cause temporary or permanent brain damage and may even lead to death.

Contact your doctor if:

your blood sugar level became so low that you fainted
you received glucagon
you have recently had several episodes of low blood sugar. Your insulin dose, injection times, diet, or exercise may need to be adjusted.
High blood sugar level (hyperglycaemia)

Your blood sugar level may become too high if:
you eat or exercise more than usual; drink alcohol; have an infection or fever; have not used enough insulin; continue to use less insulin than you need; forget to use insulin or stop using insulin without talking to your doctor.
Warning signs of high blood sugar level, which usually occur gradually:
Dry, flushed skin; feeling drowsy or tired; 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 left untreated, it may lead to diabetic coma and possibly death.
What to do if your blood sugar level is too high

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Ryzodeg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen label and on the carton 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.
Do not freeze. Keep the cap on the pen to protect it from light.
After first opening or carried as a spare
You may carry the pre-filled Ryzodeg (FlexTouch) pen with you as a spare and store it at room temperature (not above 30 °C) or in the refrigerator (2°C-8°C) for up to 4 weeks.
When not in use, keep the pen with the cap on to protect the medicine from light.
Do not dispose of any medicine 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 Ryzodeg contains

The active substances are insulin degludec and insulin aspart. Each mL of solution contains a total of 100 units of insulin degludec/insulin aspart in a 70/30 ratio (equivalent to 2.56 mg of insulin degludec and 1.05 mg of insulin aspart). Each unused pre-filled pen (3 mL) contains 300 units of insulin degludec/insulin aspart in 3 mL of solution.
The other ingredients are glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections (see section 2).

Description of the appearance of Ryzodeg and contents of the pack
Ryzodeg is a clear, colourless injectable solution in a 3 mL pre-filled pen.
Pack sizes: 1 pen (with or without needles), 5 pens (without needles), and a multiple pack of 10 (2 x 5) (without needles), each pen containing 3 mL.
Not all pack sizes may be marketed.

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

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
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 Ryzodeg 100 units/mL FlexTouch pre-filled pen injectable solution

Read these instructions carefully before using the Ryzodeg FlexTouch pen. If you do not follow these instructions exactly, you may inject too little or too much insulin, which could lead to blood sugar levels that are too high or too low.

Do not use the pen without first receiving adequate training from your doctor or nurse.

Begin by checking the pen to ensure it contains Ryzodeg 100 units/mL, then refer to the illustrations below to familiarize yourself with the different parts of the pen and the needle.

If you are blind or have severe visual problems, do not use this pen without help. Ask a person with good vision who has been trained to use the Ryzodeg FlexTouch pen to assist you.

The pen is a pre-filled insulin pen with adjustable dosing, containing 300 units of insulin. You can select a maximum dose of 80 units per injection in increments of 1 unit. The pen is designed to be used with NovoTwist or NovoFine disposable needles up to 8 mm in length.

Important information

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

Exploded diagram of a medical injection pen with blue and white components separated by horizontal guide lines on a white background

Ryzodeg
1. Preparing the pen

Check the name and strength on the pen label to ensure the pen contains Ryzodeg 100 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.

Two hands holding and rotating a cylindrical blue and white medical device to the right, indicated by a thick blue arrow

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

A hand holding horizontally a blue and white medical injection pen on a light blue background

Take a new needle and remove the protective seal.

Two hands holding and rotating a transparent plastic cap to the left, indicated by a dark blue arrow on a light background

Push the needle onto the pen and rotate it until it is securely attached.

A hand rotating the top part of an injection pen downward following the direction indicated by a curved light blue arrow

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

A hand rotating a protective cap to the right to detach it from a pen-shaped medical device with a cylindrical tip

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 tip of the needle. This is normal, but you must still check the insulin flow.

Two hands removing a protective cap from a blue medical device following the direction indicated by an arrow pointing to the right

Two orange triangles side by side, each with a white exclamation mark at the center, on a white background

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

2. Checking insulin flow

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

Two hands holding a blue medical device with a numeric display showing zero, and a curved arrow indicating rotational movement

A
2 units
selected

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

A hand gripping a cylindrical blue and white medical device emitting sound signals or vibrations indicated by curved lines

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

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

Two orange triangles with thin borders and a white exclamation mark at the center, positioned side by side

A small air bubble may remain at the needle tip, but it will not be injected.
If no drop appears, repeat steps 2 A to 2 C up to six times. If still no drop appears, replace the needle and repeat steps 2 A to 2 C 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 insulin flow before injection. Failure to do so may result in no insulin being injected or an incomplete dose, 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 pointer.
Turn the dose selector to set the required dose, as prescribed by your doctor or nurse.

If you select the wrong dose, you can correct it by turning the dose selector forwards or backwards. The maximum dose you can select on the pen is 80 units.

Two hands holding a blue medical device with a display showing a numerical sequence from 0 to 4, 6, and finally 24 units

A
Example
5 units
selected
24 units
selected
The dose selector changes the number displayed. Only the dose counter and dose pointer 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 remaining units.
The dose selector makes a different click sound when turned forwards, backwards, or when exceeding the remaining units. Do not count the clicks of the pen.
Before injecting insulin, always use the dose counter and dose pointer

An orange triangle with a thin border containing a white exclamation mark at the center, next to a solid gray rectangle on a white background

to verify the number of units selected.
Do not count pen clicks to determine the dose. Selecting and injecting the wrong dose may cause your blood sugar level to become too high or too low.
Do not rely on 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 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 pointer. You may hear or feel a click.
Keep the needle under the skin for at least 6 seconds to ensure the full dose is delivered.

A hand holding a blue injection pen with a downward arrow and a dosage detail indicating zero and a timer 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 with a blue arrow pointing downward

Hazard symbol composed of an orange triangle with a white exclamation mark at the center, next to a solid gray square

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 you are injecting.
The dose counter shows the exact number of units. Do not count pen clicks.
Keep the injection button pressed until the dose counter returns to 0 after injection. If the 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.

Medical illustration showing a blue arrow indicating the movement of a protective cap toward the tip of a blue medical device

When the needle is covered, press the outer cap firmly into place.
Unscrew the needle and dispose of it carefully.

Hands holding a syringe with blue liquid and an arrow indicating the movement of insertion or pushing downward

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

Two hands holding a cylindrical blue and black medical device, with an arrow indicating rotational or central part insertion movement

C
Always dispose of the needle after each injection in an appropriate sharps container. This reduces the risk of contamination, infection, insulin leakage, needle blockage, 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 accidentally prick yourself with the needle.

Three orange triangles with a white exclamation mark at the center

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

An orange triangle with a white exclamation mark at the center, next to a solid gray rectangle on a white background

This reduces the risk of contamination, infection, insulin leakage, needle blockage, and incorrect dosing.

6. How much insulin is left?

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

Pre-filled syringe with a blue body and white graduations on a light background, needle pointing downward

A
Approximately
how much
insulin is
left

To see how much insulin remains, use the dose counter: Turn 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 actual number of units remaining.

B
Example
Dose counter
stopped:
52 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 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 too little or too much insulin being injected, leading to high or low blood sugar levels.

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-infections.
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 needlestick injuries and cross-infections.

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

Do not leave the pen in a car or other places where it may 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 subject it to hard impacts. If dropped or if you suspect damage, attach a new needle and check 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

Ryzodeg 100 units/mL FlexPen solution for injection in a pre-filled pen

70% insulin degludec / 30% insulin aspart
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 give it to other people, even if they have the same symptoms as yours, because it could 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 Ryzodeg is and what it is used for
What you need to know before using Ryzodeg
How to use Ryzodeg
Possible side effects
How to store Ryzodeg
Contents of the pack and other information

1. What Ryzodeg is and what it is used for

Ryzodeg is used to treat diabetes mellitus in adults, adolescents, and children from the age of 2 years.
It helps the body to reduce blood sugar levels.
This medicine contains two types of insulin:

Basal insulin called insulin degludec, which has a prolonged effect in reducing blood sugar levels.
Rapid-acting insulin called insulin aspart, which reduces blood sugar levels shortly after injection of the medicine.

2. What you need to know before using Ryzodeg

Do not use Ryzodeg

if you are allergic to insulin degludec, insulin aspart, 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 Ryzodeg. 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 sugar 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 Ryzodeg and other insulin medicines.

If you have vision problems, see section 3.
Skin changes at the injection site
You should rotate your injection sites to help prevent changes in the fatty tissue beneath the skin, such as thickening of the skin, thinning of the skin, or the appearance of lumps under the skin. Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening of the skin (see section 3 ‘How to use Ryzodeg’).
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 sugar more closely and possibly adjust your insulin dose or other antidiabetic medicines.
Children and adolescents
Ryzodeg can be used in adolescents and children with diabetes mellitus from the age of 2 years.
Ryzodeg should be used with particular caution in children aged 2 to 5 years. The risk of very low blood sugar levels may be higher in this age group. There is no experience with the use of this medicine in children under 2 years of age.
Other medicines and Ryzodeg
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. Some medicines affect blood sugar levels, 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)
sulfonamides, 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 ‘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 fluid retention.

Octreotide and lanreotide: used to treat a rare disease characterised 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 (oedema).
If any of these situations apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse.
Ryzodeg and alcohol
If you consume alcohol, your insulin requirement may change because blood sugar levels may rise or fall. Therefore, you should check your blood sugar level more frequently than usual.
Pregnancy and breastfeeding
It is not known whether Ryzodeg affects the fetus during pregnancy or during 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 childbirth. 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
Blood sugar levels that are too low or too high can affect your ability to drive or operate 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 whether you may drive if:

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

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