InfoCons Consumer Protection informs you – Kyinsu – Package Leaflet

Before anything else

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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Kyinsu is and what it is used for

Kyinsu is a diabetes medicine contain ing two active substances:

• Insulin icodec: a re placement insulin that acts in the same way as naturally produced insulin , but works for a longer time . It helps to control the amount of blood sugar in your body.
• Semaglutide: a substance that acts like the hormone GLP -1 in your body. It reduce s your blood sugar level when it is too high.

Kyinsu is used to control high blood sugar levels in adults with type 2 diabetes who are not controlled on basal insulin or glucagon-like peptide 1 (GLP-1). Kyinsu is used to gether with diet, exercise and oral ( taken by mouth) medicines to treat diabetes.

⚠️ 2. What you need to know before you use Kyinsu

Do not use Kyinsu

• if you are allergic to insulin icodec, semaglutide 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 Kyinsu if:

• you have type 1 diabetes – a condition where your body does not produce enough insulin.
• you have diabetic ketoacidosis – a complication of diabetes causing excess acid in the blood.
• you have low blood sugar. This may occur when your dose of Kyinsu is too high, if you miss a meal, or if you did any unplanned and strenuous physical exercise – follow the advice at the end of this leaflet under ‘ Too low blood sugar (hypoglycaemia) ’.
• you have high blood sugar – follow the advice at the end of this leaflet under ‘ Too high blood sugar (hyperglycaemia) ’.
• you have severe heart failure.

38 • you are taking pioglitazone . When pioglitazone is used together with insulin it needs special attention – see ‘ Other medicines and Kyinsu’ below.

• you have e ye problems . Sudden improvements in blood sugar control may lead to temporary worsening of diabetic eye retinopathy. This eye condition can cause loss of vision and blindness in people with diabetes. Talk to your doctor if you have eye problems.

Ensure that you use the right medicine. Always check the pen label before each injection to avoid mix- ups between Kyinsu and other medicines. Users who are blind or with poor eyesight should get help from a person w ith good eyesight who is trained in using the pre-filled pen.

Talk to your doctor, pharmacist or nurse during treatment with Kyinsu if you have:

• severe and ongoing pain in your stomach area. This could be a sign of inflamed pancreas (acute pancreatitis).
• loss of fluids from your body (dehydration) e.g. in case of vomiting and diarrhoea. It is important to drink plenty of fluids, especially during the first weeks of treatment with Kyinsu. This is especially important if you have kidney problems.
• skin changes at the injection site. The injection site should be changed regularly to help prevent changes to the fatty tissue under the skin . Such changes include skin thickening or shrinking, or lumps under the skin. Kyinsu may not work very well if you inject into a lumpy area (s ee section 3 ‘How to use Kyinsu ’). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may advise to check your blood sugar more closely and adjust Kyin su dose or other diabetes medicine.

Switching from other injectable diabetes medicines It is important that you always check that you inject your prescribed dose when you switch from a daily or other once weekly injectable diabetes medicine to once weekly Kyinsu . Always follow your doctor’s recommendation on how much medicine you should inject ( see section 3 ). Talk to your doctor, pharmacist or nurse if you are uncertain about how to use Kyinsu.

Food or liquid getting into the lungs during anaesthesia Some patients taking medicines like semaglutide (one of the active substances in Kyinsu) have had problems with food or liquid from their stomach getting into their lungs while under general anaesthesia or deep sedation. Tell your healthcare professional that you are taking Kyinsu before you have a procedure that requires general anaesthesia or deep sedation.

Antibodies to Kyinsu Treatment with Kyinsu can cause the body to produce antibodies to insulin or the GLP -1 hormone.

Very rarely, this may require you to change your dose of Kyinsu .

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age. No experience exists with using Kyinsu in this age group.

Other medicines and Kyinsu

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. Some medicines affect your blood sugar level, this may mean your dose of Kyin su has to be changed.

If you use basal insulin or GLP -1 receptor agonist treatment , discuss with your doctor when you should stop the basal insulin and GLP -1 receptor agonist treatment prior to starting on Kyinsu.

Listed below are the most common medicines that may affect your treatment with Kyinsu.

You may need a lower dose of Kyinsu if you take :

• other medicines for diabetes (by mouth or injection)
• sulphonamides – for bacterial infections
• anabolic steroids (such as testosterone) 39 • beta-blockers – for high blood pressure, heart disease or other illnesses. The se medicines may make it harder to recognise the warning signs of low blood sugar (see information in the box at the end of this leaflet under Warning signs of too low blood sugar ).
• acetylsalicylic acid and medicines called ‘salicylates’ – for pain and mild fever
• monoamine oxidase inhibitors – for depression or Parkinson’s disease
• angiotensin -converting enzyme inhibitors – for some heart problems or high blood pressure.

These medicines may cause your blood sugar levels to fall (hypoglycaemia) when you use them in combination with Kyinsu.

You may need a higher dose of Kyinsu if you take:

• danazol – medicine affecting ovulation
• oral contraceptives
• thyroid hormones – for thyroid problems
• growth hormone – for growth hormone deficiency
• glucocorticoids ( such as cortisone ) – for inflammation
• sympathomimetics, such as epinephrine (adrenaline), salbutamol or terbutaline – for asthma
• thiazides – for high blood pressure or if your body keeps too much water (water retention).

These medicines may cause your blood sugar level to rise (hyperglycaemia) when you take them together with Kyinsu.

Warfarin and other similar medicines t aken by mouth to reduce blood clotting . You may need frequent blood tests to check how quickly your blood clots.

Octreotide and lanreotide – for acromegaly, a rare illness involving excess growth hormone. They may increase or decrease your blood sugar level. Pioglitazone – a diabetes medicine given by mouth for type 2 diabetes. Some patients with long – standing type 2 diabetes, heart disease or previous stroke, develop ed heart failure when treated with pioglitazone and insulin. Inform your doctor immediately upon signs of heart failure, such as shortness of breath, tiredness, fluid retention, weight gain, ankle swelling.

Kyinsu with alcohol Your blood sugar level may either rise or fall if you drink alcohol. You need to check your blood sugar level more often than usual when you drink alcohol.

Pregnancy and breast -feeding This medicine should not be used during pregnancy, as it is not known if it affects an unborn baby. Therefore, use of effective contraception is recommended while using this medicine. If you wish to become pregnant, discuss with your doctor how to change your treatment , as you should stop using this medicine at least 2 months in advance.

It is not known if this medicine is excreted in breast milk and a risk for the baby cannot be excluded.

Therefore, Kyinsu is not recommended while breast -feeding. The doctor will decide if you should stop treatment with this medicine or breast -feeding.

Driving and using machines

Kyinsu is unlikely to affect your ability to drive or use machines, but it changes your blood sugar levels. Having too low or too high blood sugar can affect your ability to drive or use machines. It may also reduce your ability to concentrate or react, which may pose a danger to you or others. Ask your doctor or nurse for guidance if:

• you often get low blood sugar
• you find it hard to recognise low blood sugar.

Kyinsu contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, t hat is to say essentially ‘sodium – free’.

💊 3. How to use Kyinsu

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Kyinsu is given once a week .

• Inject Kyinsu on the same day of the week. To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday in a calendar.
• You can us e the medicine at any time of the day.

How much to inject Your doctor will decide together with you:

• how much Kyinsu you will need each week
• when to check your blood sugar level
• when you need to change your dose – your doctor may change your dose based on your blood sugar level
• if your treatment needs to be adjusted when using other medicines.

The maximum recommended weekly dose is 350 dose steps.

How Kyinsu is given Kyinsu is a pre -filled dial -a-dose pen.

• Kyinsu is given as an injection under the skin (subcutaneous injection) . Do not inject it into a vein or muscle. o The best places to inject are the front of your thighs, upper arms or your belly. o Change the area where you inject each time to reduce the risk of developing lumps and skin pitting (see section s 2 and 4). o Always use a new needle for each injection. Re- use of needles increases the risk of blocked needles leading to inaccurate dosing. Dispose of the needle safely after each use. o Do not use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.
• Kyinsu is given in ‘dose steps’. The dose counter on the pen shows the number of dose steps.
• The pre-filled pens of Kyinsu can provide the following doses:
• The pre-filled pen of 0.43 mL can provide from 10 to 300 dose steps in one injection, in increments of 10 dose steps.
• The pre-filled pen of 1 mL can provide from 10 to 350 dose steps in one injection, in increments of 10 dose steps.
• The pre-filled pen of 1.5 mL can provide from 10 to 350 dose steps in one injection, in increments of 10 dose steps.
• 10 dose steps contain 10 units of insulin icodec and 0.029 mg of semaglutide.

Always check the pen label before inject ing your medicine to ensure you are using the correct pen.

If you are blind or have difficulty reading the dose counter on the pen, you must not use this pen without help. Get help from a person with good eyesight who is trained to use the pre- filled pen.

Before you use Kyinsu for the first time your doctor or nurse will show you how to inject.

Carefully read the ‘Instructions for use’ on the other side of this leaflet and use the pen as described.

Do not use Kyinsu

• in insulin infusion pumps
• if the pen is damaged or has not been stored correctly (see section 5 )
• if there are visible particles – the solution should be clear and colourless.

If you have kidney or liver problems You may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.

If you us e more Kyinsu than you should Your blood sugar may get low or you may have nausea or vomiting. If your blood sugar gets low, see advice at the end of this leaflet under ‘Too low blood sugar (hypoglycaemia) ’.

If you forget to use Kyinsu

• If it is 3 days or less after you should have injected Kyinsu , inject as soon as you remember.

Then inject your next dose on your usual injection day.

• If it is more than 3 days since you should have injected Kyinsu, inject it as soon as you remember. You should inject your next dose of Kyinsu one week after you have injected the missed dose. If you wish to return to your usual injection day, you may do so in agreement with your doctor by extending the time between your next doses.

Do not use a double dose to make up for a forgotten dose.

If you stop using Kyinsu

Do not stop using Kyinsu without agreement of your doctor. If you stop using Kyinsu your blood sugar levels may increase (hyperglycaemia) and you may develop ketoacidosis. S ee advice at the end of this leaflet under ‘Too high blood sugar (hyperglycaemia)’. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

❗ 4. Possible side effects

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

Serious side effects

• low blood sugar (hypoglycaemia) – very common (may affect more than 1 in 10 people) – Low blood sugar can be very serious.
• If your blood sugar level falls too much, you may pass out.
• Serious low blood sugar level may cause brain damage and may be life -threatening.

Try to increase your blood sugar level immediately i f you have signs of low blood sugar (s ee advice under ‘ Too l ow blood sugar (hypoglycaemia)’ at the end of this leaflet ).

• damage to the retina of the eyes ( diabetic retinopathy complications) , which may cause vision problems – common (may affect up to 1 in 10 people) Tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.
• skin changes where the injection is given (lipodystrophy, cutaneous amyloidosis) – rare (may affect up to 1 in 1 000 people) If you inject this medicine too often at the same place:
• the skin may shrink or thicken
• lumps under the skin may also be caused by build-up of a protein called amyloid.

This medicine may not work very well if you inject into a lumpy, shrunken or thickened area.

Change the injection site with each injection to help prevent these skin changes.

• severe allergic reactions (anaphylactic reactions) – rare (may affect up to 1 in 1 000 people) You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

42 Other side effects

Very common (may affect more than 1 in 10 people)

• feeling sick ( nausea)
• diarrhoea

Common (may affect up to 1 in 10 people)

• hypersensitivity reactions, such as rash or itching
• reduced appetite
• headache
• dizziness
• fast heartbeat
• vomiting
• belly (abdominal) pain
• bloating (distention) of the belly
• constipation
• indigestion (dyspepsia)
• inflamed stomach (gastri tis)
• reflux or heartburn ( ‘gastroesophageal reflux disease’ )
• burping
• wind (flatulence)
• tiredness
• increase of pancreatic enzymes

Uncommon (may affect up to 1 in 100 people)

• change in the way food or drink tastes (dysgeusia)
• inflammation of the pancreas (acute pancreatitis )
• a delay in the emptying of the stomach
• gall stones (cholelithiasis)
• injection site reactions
• swelling due to fluid retention, especially of the ankles and feet (peripheral oedema )

Not known (frequency cannot be estimated from the available data)

• bowel (intestinal) obstruction
• swelling of face, lips, tongue and/or throat with difficulty swallowing ( angioedema )

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Kyinsu

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 carton, after ‘EXP’.

The expiry date refers to the last day of that month.

Before first opening Store in a refrigerator (2 °C ‑ 8 °C).

Do not freeze. Keep away from the freezing element. Keep the cap on the pen in order to protect from light.

43 After first opening or if carried as a spare You can keep Kyinsu pre-filled pen at room temperature (below 30 °C) or in a refrigerator (2 °C ‑ 8 °C) for up to :

• 6 weeks (pre -filled pen of 0.43 mL) or
• 8 weeks (pre -filled pens of 1 mL and 1.5 mL).

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

Do not use this medicine if it has been frozen.

Always keep the cap on the pen when you are not using it in order to protect from light.

This medicin e is for use by one person only.

A new needle must always be attached before each injection.

Needles must not be reused. Needles must be discarded immediately after use. In the event of blocked needles, you must follow the instructions described in the instructions for use at the end of this leaflet .

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Kyinsu contains

• The active substances are insulin icodec and semaglutide. E ach mL of solution contains 700 units of insulin icodec and 2 mg of semaglutide.
• Kyinsu (700 units + 2 mg)/mL (0.43 mL) contains 300 units of insulin icodec and 0.86 mg of semaglutide.
• Kyinsu (700 units + 2 mg)/mL (1 mL) contains 700 units of insulin icodec and 2 mg of semaglutide.
• Kyinsu (700 units + 2 mg)/mL (1.5 mL) contains 1 050 units of insulin icodec and 3 mg of semaglutide.
• The other ingredients are zinc acetate, glycerol (E 422), phenol, metacresol, sodium chloride, sodium hydroxide (for pH adjustment) (E 524), hydrochloric acid (for pH adjustment) (E 507)

and water for injections (s ee section 2 ‘Kyinsu contains sodium’).

What Kyinsu looks like and contents of the pack

Kyinsu is presented as a clear and colourless or almost colourless solution for injection in a pre- filled pen.

The pre-filled pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.

The outer packaging is pink rose with the formulation strength indicated in a blue- coloured box. The pen body is green, the pen label is pink rose with a blue-coloured box highlighting the formulation strength.

Pack sizes

• Pack size of 1 pre-filled pen of 0.43 mL (without needles) .
• Pack size of 1 pre-filled pen of 0.43 mL (with 6 disposable NovoFine Plus needles) .
• Pack size of 1 pre -filled pen of 1 mL (without needles).
• Pack size of 1 pre -filled pen of 1 mL (with 9 disposable NovoFine Plus needles).
• Pack size of 1 pre -filled pen of 1.5 mL (without needles).

44 • Pack size of 1 pre -filled pen of 1.5 mL (with 9 disposable NovoFine Plus needles).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S Novo Alle 1 2880 Bagsvaerd Denmark

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

45 HYPOGLYCAEMIA AND HYPERGLYCAEMIA General effects from diabetes treatment Too low blood sugar (hypoglycaemia) This may happen if you:

• drink alcohol
• use too much Kyinsu
• exercise more than usual
• eat too little or miss a meal.

Warning signs of too low blood sugar – these may come on suddenly:

• headache
• fast heartbeat
• feeling sick or very hungry
• cold sweat or cool pale skin
• short-lasting changes in your sight
• tremor or feeling nervous or worried
• feeling unusually tired, weak and sleepy
• slurred speech, feeling confused, difficulty in concentrating.

What to do if you get too low blood sugar:

• Eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case).
• Measure your blood sugar if possible and rest. You may need to measure your blood sugar more than once. This is because improvement in your blood sugar may not happen straight away .
• Then wait until the signs of too low blood sugar have gone or when your blood sugar level has settled. Then carry on with your insulin as usual.

What others need to do if you pass out Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood sugar gets too low, including the risk of passing out.

Let them know that if you pass out, they must:

• turn you on your side
• get medical help straight away
• not give you any food or drink because you may choke.

You may recover more quickly from passing out with administration of glucagon. This can only be given by someone who knows how to use it.

• If you are given glucagon, you will need sugar or a sugary snack as soon as you come round.
• If you do not respond to glucagon, you will have to be treated in a hospital.

If severe low blood sugar is not treated over time, it can cause brain damage. This can be short or long- lasting. It may even cause death.

Talk to your doctor if:

• your blood sugar got so low that you passed out
• you have used glucagon
• you have had too low blood sugar a few times recently.

This is because the dosing of your Kyinsu injections, food or exercise may need to be changed.

Too high blood sugar (hyperglycaemia) This may happen if you:

• drink alcohol
• get an infection or a fever
• have not used enough Kyinsu
• eat more or exercise less than usual
• keep using less Kyinsu than you need
• forget to use your Kyinsu or stop using Kyinsu without talking to your doctor.

Warning signs of too high blood sugar – these normally appear gradually:

• feeling thirsty
• flushed or dry skin
• losing your appetite
• feeling sleepy or tired
• passing water more often
• dry mouth or fruity (acetone) breath
• feeling or being sick (nausea or vomiting).

These may be signs of a very serious condition called ketoacidosis. This is a build -up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death.

What to do if you get too high blood sugar:

• test your blood sugar level.
• test your urine or blood for ketones.
• get medical help straight away.

47 Instructions for use Before you begin using your needle and Kyinsu pen, always read these instructions carefully , and talk to your doctor, nurse or pharmacist about how to inject Kyinsu correctly.

Kyinsu is a pre -filled disposable pen containing a solution for injection of insulin icodec and semaglutide (700 units + 2 mg)/mL .

Kyinsu is administered as ´dose steps´.

Your pen delivers doses in increments of 10 dose steps.

In a single injection, the pre- filled pen can deliver doses:

• from 10 dose steps equal to 10 units of insulin icodec + 0.029 mg of semaglutide
• up to 350 dose steps equal to 350 units of insulin icodec + 1 mg of semaglutide Do not do any conversion of your dose. The dose steps dialled equal the number shown on the dose counter.

Always start by checking your pen label to make sure that it contains Kyinsu

(700 units + 2 mg )/mL.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.

Once -weekly injection Kyinsu pen Please note : Your pen may differ from the pen example shown in the pictures. The se instructions apply to all Kyinsu pens.

Pen cap Pen window Dose counter Dose pointer Dose selector Dose button EXP:

Batch:

Kyinsu FlexTouch (700 units + 2 mg)/mL About your needles Always use a new needle for each injection. Check the flow as described in ‘S tep 2 ’ and use a new needle for each injection. Always remove the needle after each use.

NovoFine Plus Needle (example) Outer needle cap Inner needle cap Needle Paper tab Step 1 Prepare your pen with a new needle

• Check the name and concentration on the pen label to make

sure that your pen contains Kyinsu (700 units + 2 mg)/mL.

• Pull off the pen cap. See Figure A.
• Always check that the solution in the pen is clear and colourless or almost colourless.
• Look through the pen window. If the solution looks cloudy or contains particles, do not use the pen. See Figure B.

B

• Alwa ys use a new needle for each injection .
• Check the paper tab and the outer needle cap for damages. If you see any damage, this could affect sterility. Throw out the needle and use a new one.
• Take a new needle and tear off the paper tab.
• Do not attach a new needle to your pen until you are ready to give your injection . See Figure C.

C

• Push the needle straight onto the pen . Turn until it is on tight .

See Figure D.

D A 49 • The needle is covered by two caps . You must remove both caps . If you forget to remove both caps, you will not inject any medicine.

• Pull off the outer needle cap and keep it for later . You will need it to safely remove the needle from the pen after the injection . See Figure E.
• Pull off the inner needle cap and throw it away . See Figure F.
• A drop of the solution may appear at the needle tip. This is normal, but you must still check the solution flow before each injection. See ‘Step 2 ’.
• Never use a bent or damaged needle.

E F Step 2 Check the flow before each injection

• Always check the flow before each injection . This helps you to ensure that you will get your full Kyinsu dose.
• Turn the dose selector clockwise until you see the first mark (10 dose steps) on the dose counter. See Figure G.
• Make sure that the mark lines up with the dose pointer. See Figure H.

G 10 dose steps selected H 50 • Hold the pen with the needle pointing up.

• Press and hold in the dose button until the dose counter shows . The must line up with the dose pointer.
• A drop of the solution should appear at the needle tip. This drop indicates that your pen is ready for use. See Figure I.
• If a drop does not appear, check the flow again. This should only be done six times in total.
• If there is still no drop, you might have a blocked needle. Change the needle as described in ‘Step 5 ’ and ‘Step 1’.
• Then, check the flow once more.
• Do not use the pen if a drop of the solution still does not appear.

I Step 3 Set your dose

• Check that the dose pointer is set at . See Figure J.
• Turn the dose selector to select your intended dose as directed by your nurse or doctor. The dose counter shows the dose dialled in dose steps.
• The numbers shown on the dose counter will guide you to your dose.

J

• Your pen delivers doses in increments of 10 dose steps, this means that the dose can be increased by 10 dose steps at a time .
• You may hear a ‘click’ every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear.
• If you select a wrong dose, you can turn the dose selector forward or backwards to the correct dose.
• When your dose lines up with the dose pointer, you have selected your dose. Make sure you select your intended dose.
• The pictures show examples of how to choose your dose correctly. See Figure K.

51 • If the dose counter stops before you reach your prescribed dose while dialling, see the section ‘Do you have enough medicine? ’ below these instructions.

70 dose steps selected 270 dose steps selected K Choose your injection site

• Choose an injection site on your stomach (keep a 5 cm distance from your belly button), upper legs, or upper arms.
• You may inject in the same body area each week, but make sure it is not in the same spot that was used for your last injection.

Upper arms Stomach Upper legs Step 4 Inject your dose

• Fully insert the needle into your skin. See Figure L.
• Make sure you can see the dose counter. Do not cover the dose counter or touch it with your fingers. This could stop the injection.

L 52 • Press and hold down the dose button until the dose counter shows .

• Continue pressing the dose button with the needle in your skin and slowly count to 6 . The must line up with the dose pointer. See Figure M. You may hear or feel a click when the dose counter returns to .

Count slowly 1-2-3-4-5-6 M

• Remove the needle from your skin , you can then release the dose button. See Figure N.
• If the needle is removed earlier, a stream of the solution might come from the needle tip and the full dose will not be delivered.
• If blood appears at the injection site, press lightly on the area to stop the bleeding.
• You may see a drop of the solution at the needle tip after injecting. This is normal and does not affect your dose.

N Step 5 After your injection

• Carefully insert the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap. See Figure O.
• Once the needle is covered, carefully push the outer needle cap completely on. Not covering the needle with the outer needle cap could lead to needle stick injuries.

O 53 • Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities. See Figure P.

• Never try to put the inner needle cap back on the needle . You may stick yourself with the needle.
• Always remove and dispose of the needle immediately after each injection to prevent blocked needles, contamination, infection and inaccurate dosing.
• Never store your pen with the needle attached.

P

• Put the pen cap on your pen after each use to protect the solution from light. See Figure Q.
• When the pen is empty, dispose of the pen without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
• The package leaflet and the empty carton can be disposed of in your household waste.

Q Do you have enough medicine?

• If the dose counter stops before you reach your prescribed dose while dialling, there is not enough medicine left for a full dose. The number shown in the dose counter is the amount of medicine left in your pen.
• If you need more medicine than what is left in your pen, you can split your dose between two pens. Be sure that you calculate correctly if you are splitting your dose. If you are in doubt, dispose of the used pen and take the full dose with a new pen.
• If you split the dose incorrectly, you will inject too little or too much medicine, which can lead to too high or too low blood sugar level .

Example:

100 dose ste ps needed , dose counter stops at 70 dose steps .

54 Important information

• Needles are for single -use only. Never reuse your needles as it may lead to blocked needles, contamination, infection, leakage of medicine and inaccurate dosing.
• Treat your pen with care. Rough handling or misuse may cause inaccurate dosing which can lead to too high or too low blood sugar level .
• Caregivers must be very careful when handling needles to prevent accidental needle stick injuries and infection.
• Do not use this pen without help if you are blind or have poor eyesight and cannot follow these instructions. Get help from a person with good eyesight who is trained to use the Kyinsu pen.
• Always keep pen, and needles out of sight and reach of others, especially children .
• Inject Kyinsu once weekly. If you do not use your Kyinsu as prescribed, this can lead to too high or too low blood sugar level.
• If you use more than one type of injectable medicine, it is very important to check the name and concentration of your pen label before use.
• Never share your pen or your needles with other people.

Caring for your pen

• Do not freeze Kyinsu . Do not use Kyinsu if it has been frozen. Dispose of the pen .
• Do not drop your pen or knock it against hard surfaces.
• Avoid exposing Kyinsu to direct sunlight .
• Keep Kyinsu away from heat, microwaves and out of the light.
• Do not try to repair your pen or pull it apart.
• Do not expose your pen to dust, dirt, or liquid .
• Do not wash, soak, or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
• See the back of this leaflet to read the storage conditions for your pen .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Kyinsu (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1992).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.