What it is and what it is used for

for

Trurapi is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with insulin aspart helps to prevent complications from your diabetes. Insulin aspart will start to lower your blood sugar 10-20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3-5 hours. Due to this short action insulin aspart should normally be taken in combination with intermediate‐acting or long‐acting insulin preparations.

What you need to know before you take it

e Trurapi Do not use Trurapi

• If you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).
• If you suspect hypoglycaemia (low blood sugar) is starting (see "Summary of serious and very common side effects" in section 4)
• If the pre-filled pen is dropped, damaged or crushed.
• If it has not been stored correctly or been frozen (see "How to store Trurapi" in section 5).
• If the insulin does not appear clear and colourless. If any of these applies, do not use Trurapi. Talk with your doctor, nurse or pharmacist for advice. Before using Trurapi
• Check the label to make sure it is the right type of insulin.
• Always use a new needle for each injection to prevent contamination.
• Needles and the pre-filled pen must not be shared.
• Trurapi is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method. Warnings and precautions Record the brand name ("Trurapi") and Lot number (included on the outer cartons and labels of each pre-filled pen) of the medicine you are using and provide this information when reporting any side effects.

Some conditions and activities can affect your need for insulin. Consult your doctor:

• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
• If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
• If you are ill, carry on taking your insulin and consult your doctor.
• If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections. Children and adolescents Do not give this medicine to children below 1 year of age since no clinical trials have been carried out in children below the age of 1 year.

Ask your doctor, nurse or pharmacist for advice before using this medicine while pregnant or breast-feeding. Driving and using machines Please ask your doctor whether you can drive a car or use a machine:

• If you have frequent hypoglycaemia.
• If you find it hard to recognise hypoglycaemia. If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or use a machine. Bear in mind that you could endanger yourself or others.

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

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOI) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

3. How to use Trurapi

Pioglitazone (tablets used for the treatment of type 2 diabetes) Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist. Insulin aspart and alcohol If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

4. Possible side effects

Uncommon (may affect up to 1 in 100 people)

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

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of using your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately (see also "Serious allergic reactions" above).

If you stop using your insulin Do not stop using your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis (see "Effects from diabetes" in section 4).

Trurapi contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially "sodiumfree".

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

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

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

Skin changes at the injection site: If you inject insulin too often at the same place, the fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

There are no restrictions on treatment with insulin aspart during breast-feeding.

Trurapi has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.

5. How to store Trurapi

If you use more insulin than you should If you use too much insulin your blood sugar gets too low (hypoglycaemia) (see "Summary of serious and very common side effects" in section 4).

Other medicines and Trurapi Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as 'cortisone' used to treat inflammation)
• Thyroid hormones (used to treat thyroid gland disorders)
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body's metabolic processes)
• Danazol (medicine acting on ovulation).

Other side effects

Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Insulin aspart can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

Dose and when to use your insulin Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. Insulin aspart is generally used immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, insulin aspart can be given soon after a meal (see "How and where to inject" below for information). Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor. Use in children and adolescents Insulin aspart can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in relation to meals. Use in special patient groups If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How to take it

and where to inject Trurapi is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). Trurapi is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method. With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4 "Possible side effects"). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if you inject into the front of your waist (abdomen). You should always measure your blood sugar regularly. How to handle Trurapi pre‐filled pen Trurapi is available in a pre-filled disposable pen (called SoloStar) containing insulin aspart. Each SoloStar pen delivers 1-80 units in increments of 1 unit. Read carefully the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for Use.

If you forget to use your insulin If you forget to use your insulin your blood sugar may get too high (hyperglycaemia) (see "Effects from diabetes" in section 4).

Summary of serious and very common side effects Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people. Low blood sugar may occur if you:

• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol (see "Insulin aspart and alcohol" in section 2). Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating. Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. What to do if you experience low blood sugar:
• If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
• When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
• If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. The amount or timing of insulin, food or exercise may need to be adjusted. Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation. Serious allergic reactions to Trurapi or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening. It may affect up to 1 in 10,000 people. Seek medical advice immediately:
• If signs of allergy spread to other parts of your body.
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy. If you notice any of these signs, seek medical advice immediately.

Always ensure you use the correct pen before you inject your insulin.

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Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary. Swollen joints: When you start using insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor. Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this. Rare (may affect up to 1 in 1,000 people) Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient. Reporting of side effects If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. Effects from diabetes High blood sugar (hyperglycaemia)

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Before the first use store your Trurapi in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light. Keep your Trurapi pre‐filled pen in use at room temperature (below 30°C) for a maximum of 4 weeks. Do not keep the pre‐filled pen that you are using in the fridge. The pre‐filled pen should not be stored with the needle attached. Always keep the cap on the pre‐filled pen when you are not using it in order to protect from light. Do not use Trurapi pre-filled pen if the solution is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself. 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 to protect the environment.

How to store it

and care for your pen

Handling needles

If you see air bubbles

Units of insulin in your pen

If you find it hard to press the button in:

• Take care when handling needles – this is to prevent needle injury and cross-infection.

• You may see air bubbles in the insulin. This is normal, they will not harm you.

• Your pen contains a total of 300 units of insulin. You can select doses from 1 to 80 units in steps of 1 unit. Each pen contains more than one dose.
• You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.

• Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
• If you still find it hard to press in, get a new pen.
• Never use a syringe to remove insulin from your pen.

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• You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not soak, wash or lubricate your pen – this may damage it.
• Remove and throw away your used pen as told by your pharmacist or local authority.
• For further information on the storage and use of your pen please refer to sections 2 and 5 of the package leaflet.

Contents of the pack and other information

What Trurapi contains

• The active substance is insulin aspart. One ml of the solution contains 100 units (equivalent to 3.5 mg) of insulin aspart. Each pre-filled pen (SoloStar) contains 3 ml of solution for injection, equivalent to 300 units of insulin aspart. Each pre-filled pen (SoloStar) delivers 1 – 80 units in steps of 1 unit.
• The other ingredients are: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride, hydrochloric acid/sodium hydroxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity (see "Trurapi contains sodium" in section 2). What Trurapi looks like and contents of the pack Trurapi solution for injection is a clear, colourless solution. Each pre-filled pen (SoloStar) contains 3 ml. Only use needles that are compatible for use with Trurapi. Trurapi in pre-filled pen (SoloStar) comes in a pack of 1, 5 or 10 pre-filled pens. Not all pack sizes may be marketed. Marketing Authorisation Holder Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Tel: 0800 035 2525 Email: [email protected]

High blood sugar may occur if you:

• Have not injected enough insulin.
• Forget to inject your insulin or stop using insulin.
• Repeatedly inject less insulin than you need.
• Get an infection and/or a fever.
• Eat more than usual.
• Exercise less than usual.

Manufacturer Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

Warning signs of high blood sugar: The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.

This leaflet was last revised in February 2026

What to do if you experience high blood sugar

• If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
• These may be signs of a very serious condition called diabetic ketoacidosis (buildup of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist

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Trurapi is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

Skin changes at the injection site The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see "How to use Trurapi"). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Trurapi solution for injection in pre-filled pen (SoloStar) INSTRUCTIONS FOR USE Important information

✗ Never share your pen – it is only for you. ✗ Never use your pen if it is damaged or if you are not sure that it is working

✓ Take a new pen out of the fridge at least 1 hour

✓ Always use a new sterile needle for each injection.

✓ Always do a safety test before each injection – this is

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Rubber seal Insulin scale

to: check your pen and the needle are working properly. make sure that you get the correct insulin dose.

Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.

Never select a dose or press the injection button without a needle attached. This may damage your pen.

Make sure a needle is attached and the dose is set to '0'.

STEP 5: Inject your dose

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If you find it hard to press the injection button in, do not force it as this may break your pen. See the section below for help.

Choose a place to inject as shown in the picture

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Turn the dose selector until the dose pointer lines up with your dose.

• If you turn past your dose, you can turn back down.
• If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
• If you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose.

Press the injection button all the way in.

• When insulin comes out of the needle tip, your pen is working correctly.

Push the needle into your skin as shown by your doctor, pharmacist or nurse.

• Do not touch the injection button yet.

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✓ Take care when handling needles – this is to prevent ✗

needle injury and cross-infection. Never put the inner needle cap back on.

Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.

• To reduce the risk of accidental needle injury, never replace the inner needle cap.
• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
• Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases. Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local authority.

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Place your thumb on the injection button. Then press all the way in and hold.

• Do not press at an angle – your thumb could block the dose selector from turning.

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Pull off the outer needle cap. Keep this for later.

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Keep the needle straight and screw it onto the pen until fixed. Do not overtighten.

Check that the insulin is clear.

• Do not use the pen if the insulin looks cloudy, coloured or contains particles.

Injection button

Plunger*

STEP 6: Remove the needle

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Pull off the pen cap.

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STEP 4: Select the dose

Take a new needle and peel off the protective seal.

Dose pointer

• You will not see the plunger until you have injected a few doses.

STEP 3: Do a safety test

Check the name and expiry date on the label of your pen.

• Make sure you have the correct insulin. This is especially important if you have other injector pens.
• Never use your pen after the expiry date.

Dose window

Dose selector Pen cap

STEP 2: Attach a new needle This helps stop blocked needles, contamination and infection. Only use needles that are compatible for use with Trurapi

Insulin name

Cartridge holder

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• a new sterile needle (see STEP 2).
• a puncture resistant container for used needles and pens (see Throwing your pen away).

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If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call the Sanofi number on the front of this leaflet.

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• Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
• Ask for help if you have problems handling the pen, for example if you have problems with your sight.
• Read all package leaflet information and instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little insulin.

STEP 1: Check your pen before you inject. Cold insulin is more painful to inject.

Get to know your pen

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Extra items you will need:

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properly. ✓ Always perform a safety test. ✓ Always carry a spare pen and spare needles in case they get lost or stop working. ✗ Never re-use needles. If you do you might not get your dose (underdosing) or get too much (overdosing) as the needle could block.

Need help?

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Learn to inject

How to read the dose window Even numbers are shown in line with the dose pointer:

Put the pen cap back on.

• Do not put the pen back in the fridge.

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If no insulin appears:

• You may need to repeat this step up to 3 times before seeing insulin.
• If no insulin comes out after the third time, the needle may be blocked. If this happens:
• change the needle (see STEP 6 and STEP 2),
• then repeat the safety test (STEP 3).
• Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
• Never use a syringe to remove insulin from your pen. 220

Pull off the inner needle cap and throw away.

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Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.

• This will make sure you get your full dose.

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After holding and slowly counting to 10, release the injection button. Then remove the needle from your skin.