AWIQUI

Patient Information Leaflet

Awiqli 700 units/mL solution for injection in pre-filled pen

insulin icodec
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Awiqli is and what it is used for
2. What you need to know before using Awiqli
3. How to use Awiqli
4. Possible side effects
5. How to store Awiqli
6. Contents of the pack and other information

1. What Awiqli is and what it is used for

Awiqli contains 'insulin icodec' used to treat diabetes in adults. It is a type of insulin called a "long-acting basal insulin".
Diabetes is a condition in which the body does not produce enough insulin (a hormone that controls the amount of sugar in the blood). The active substance in Awiqli, insulin icodec, is a replacement insulin that works similarly to naturally produced insulin but over a longer period of time. This means it provides a long and steady blood-glucose-lowering effect. Therefore, it must be injected only once a week.

2. What you need to know before using Awiqli

Do not use Awiqli

• if you are allergic to insulin icodec 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 Awiqli.
Important things to know before using Awiqli:

• Hypoglycaemia (low blood glucose levels) may occur if your dose of Awiqli is too high, or if you skip a meal or perform unplanned, intense physical exercise. Other factors that may increase the risk of hypoglycaemia include changing the injection site, illness (such as vomiting, diarrhoea, or fever), alcohol consumption, and use of other medicines. Symptoms of hypoglycaemia usually appear suddenly (see information in the box at the end of this leaflet). Severe hypoglycaemia can lead to loss of consciousness and/or seizures and may result in temporary or permanent impairment of brain function or even death. If you experience hypoglycaemia, follow the instructions provided in the box at the end of this leaflet for low blood sugar levels.

• If you have type 1 diabetes, your risk of hypoglycaemia may be higher.

• Hyperglycaemia (high blood glucose levels) may occur if your dose of Awiqli is insufficient and/or if treatment is interrupted, or if you have an associated illness, particularly an infection. Symptoms of hyperglycaemia usually develop gradually over several hours or days (see information in the box at the end of this leaflet). Untreated hyperglycaemia may lead to diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood). If you experience hyperglycaemia, follow the instructions provided in the box at the end of this leaflet for high blood sugar levels.

• Switching from other insulin medicines: Your doctor may need to adjust your insulin dose if you switch from once- or twice-daily basal insulin to once-weekly Awiqli. It is important to always ensure you inject the correct dose, especially for the first and second injections of Awiqli, as your doctor may prescribe a higher dose for the first injection followed by a lower dose. Always follow your doctor’s recommendations regarding the amount of medicine you should take. See section 3.

• If you are taking pioglitazone with Awiqli, contact your doctor if you develop signs or symptoms of congestive heart failure (when the heart does not pump blood as it should), such as shortness of breath, fatigue, fluid retention, weight gain, or swelling in the ankles.

• Eye problems: Rapid improvement in blood glucose control may temporarily worsen diabetic retinopathy (an eye condition that can lead to vision loss and blindness in people with diabetes). If you experience eye problems, consult your doctor.

• Make sure you are using the correct type of insulin: Always check the label on the insulin pen before each injection to avoid accidental confusion with other insulin medicines. If you are blind or have visual impairments, ensure you receive assistance from another person with good vision who has been trained in the use of the pre-filled pen.

Skin changes at the injection site
The injection site should be rotated regularly to help prevent changes in the fatty tissue under the skin. These changes include thickening or thinning of the skin or subcutaneous nodules.
This medicine may not work properly if you inject into an area with nodules, thinning, or thickening of the skin (see section 3, “How to use Awiqli”). Consult your doctor, pharmacist, or nurse if you notice any skin changes at the injection site or if you are currently injecting into affected areas before switching to a new injection site. Your doctor, pharmacist, or nurse may advise you to monitor your blood glucose more closely and adjust the dose of Awiqli or other antidiabetic medicines, if necessary.

Anti-insulin antibodies
Treatment with Awiqli may cause your body to produce antibodies against insulin (molecules that may affect insulin treatment). Very rarely, this may require a change in insulin dose.

Children and adolescents
Do not administer this medicine to children and adolescents aged 0 to 18 years. This is because there is no experience with the use of Awiqli in children or adolescents.

Other medicines and Awiqli
Inform 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 dose of Awiqli needs to be adjusted.
Below are listed the most common medicines that may affect treatment with Awiqli.

You may need a lower dose / your blood sugar level may decrease (hypoglycaemia) if you use:

• other diabetes medicines (oral or injectable)
• sulphonamides, for infections
• anabolic steroids, such as testosterone
• beta-blockers, for high blood pressure. These may make it difficult to recognize warning signs of low blood sugar (see information in the box at the end of this leaflet, “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.

You may need a higher dose / 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 excessive fluid retention.

Octreotide and lanreotide (for a rare disease involving excess growth hormone (acromegaly)) may increase or decrease blood sugar levels.
Pioglitazone (an oral antidiabetic medicine for type 2 diabetes).
Some patients with long-standing type 2 diabetes and heart problems or a history of stroke treated with pioglitazone and insulin have developed heart failure.

• Inform your doctor immediately if you develop signs of heart failure such as shortness of breath, fatigue, fluid retention, weight gain, or swelling in the ankles.

If you fall under any of the above conditions (or if you have any doubts), consult your doctor, pharmacist, or nurse before injecting Awiqli, as dose adjustment of a weekly insulin in relation to interactions with other medicines may differ.

Awiqli and alcohol
If you drink alcohol, your required dose of Awiqli may change. Your blood sugar level may increase or decrease. This means you need to monitor your blood sugar levels more frequently than usual when consuming alcohol.

Pregnancy and breastfeeding
It is not known whether or how Awiqli may affect the fetus. Therefore, if you are a woman of childbearing potential who is trying to become pregnant, you must discontinue treatment with this medicine. If you become pregnant while using this medicine, contact your doctor for advice.
It is not known whether this medicine is excreted in breast milk, and a risk to the infant cannot be excluded. Therefore, Awiqli must not be used during breastfeeding, and a decision must be made whether to discontinue treatment with this medicine or to avoid breastfeeding.

Driving and using machines
Awiqli has no or negligible effects on the ability to drive and use machines, but it affects blood sugar levels. Low blood sugar (hypoglycaemia) or high blood sugar (hyperglycaemia) 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. Consult your doctor or nurse if:

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

Important information on some ingredients of Awiqli
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Awiqli

Awiqli is administered once weekly.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
Awiqli is a long-acting insulin. It may be used together with short-acting or rapid-acting insulins.
In type 2 diabetes:

• Awiqli may be used in combination with oral antidiabetic tablets or injectable medications, including short-acting or rapid-acting insulins. In type 1 diabetes:
• Awiqli must always be used in combination with short-acting or rapid-acting insulins.
• If you have recently been diagnosed with type 1 diabetes (and are not already being treated with insulin), Awiqli is not suitable for you.

If you are blind or have visual impairments and cannot read the dose counter on the pen, do not
use this pen without assistance. Ask for help from someone with good eyesight who has been trained
in the use of the pre-filled pen.
Contents of the pens
The pre-filled pen can deliver a dose from 10 to 700 units per injection in increments
of 10 units.

• Awiqli 700 units/mL (1 mL) contains 700 units
• Awiqli 700 units/mL (1.5 mL) contains 1,050 units
• Awiqli 700 units/mL (3 mL) contains 2,100 units

The dose counter on the pre-filled pen indicates the number of insulin units to be injected.
Therefore, do not recalculate the dose. The 700 units/mL pre-filled pen can deliver a dose
of 10–700 units per injection in increments of 10 units.
When to use Awiqli
Awiqli is a basal insulin to be used once weekly.

• The Awiqli injection should be administered on the same day each week.
• You may take the medicine at any time of day.

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

• how much Awiqli you will need each week
• when to monitor your blood sugar levels
• when you may need a higher or lower dose, as your doctor may adjust the dose based on your blood sugar levels
• whether your treatment needs to be adjusted when taking other medicines.

Dose when switching from a basal insulin taken once or twice daily
The weekly dose of Awiqli depends on your current basal insulin dose. Your doctor will prescribe a
dose that covers your weekly basal insulin requirement.

• For the first injection only, you may need an increased dose of Awiqli. This higher dose applies only to the first injection; do not use this dose for the second or subsequent injections. Consult your doctor about the amount to take for the first injection.
• The dose of Awiqli should be based on blood glucose measurements. Your doctor will determine with you the amount of Awiqli you will receive each week.
• Consistent blood glucose monitoring is recommended during the transition and in the following weeks.

Use in elderly patients (65 years and older)
Awiqli can be used in elderly patients.
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.
Before injecting Awiqli
Before using Awiqli for the first time, read the instructions for use provided with this package.
Check the name and label on the pen to ensure it is Awiqli 700 units/mL.
How to inject

• Inject Awiqli under the skin (subcutaneous injection). Do not inject into a vein or muscle.
• The best injection sites are the front of the thighs, upper arms, or abdomen (abdominal area).
• Rotate the injection site each time you administer this medicine to reduce the risk of developing lumps or skin depressions (see section 2).
• Always use a new needle for each injection. This reduces the risk of contamination, infection, and blocked needles, which could lead to inaccurate dosing. Dispose of needles carefully after each use.
• Do not use a syringe to withdraw solution from the pen, to avoid dosing errors and potential overdose.

Detailed instructions for use are provided on the back of this patient information leaflet.
Do not use Awiqli

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

If you use more Awiqli than you should
If you use too much of this medicine, your blood sugar level may become too low (hypoglycaemia). See the advice provided in the box at the end of this leaflet – Low blood sugar level (hypoglycaemia).
If you forget to use Awiqli
If you are a patient with type 1 diabetes

• Inject it as soon as you remember. You should then continue injecting Awiqli once weekly, with the next dose administered on the same day of the week as the missed dose. This day will become your new weekly injection day for Awiqli. Continue weekly injections thereafter.
• If you wish to return to your original injection day, you may do so in agreement with your doctor by extending the interval between doses.
• If you are unsure when to take the medicine, consult your doctor or pharmacist.

If you are a patient with type 2 diabetes

• If less than or equal to 3 days have passed since you should have injected Awiqli, inject it as soon as you remember. Then administer the next dose on your usual injection day.
• If more than 3 days have passed since you should have injected Awiqli, inject it as soon as you remember. You must then administer the next dose of Awiqli one week after the missed dose was injected. If you wish to return to your original injection day, you may do so in agreement with your doctor by extending the interval between doses.
• Continue injecting once weekly thereafter.
• If you are unsure when to take the medicine, consult your doctor or pharmacist.

If you stop using Awiqli
Do not stop using Awiqli without first discussing it with your doctor. If you discontinue this
medicine, you may develop very high blood sugar levels (hyperglycaemia) and ketoacidosis (a condition characterized by excess acid in the blood). See the advice provided in the box at the end of this leaflet – High blood sugar level (hyperglycaemia).

4. Possible side effects

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

Hypoglycaemia (low blood sugar level): very common (may affect more than 1 in 10 people)

• It may 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 signs of low blood sugar, act immediately to raise your blood sugar level. See the advice in the section “Low blood sugar level (hypoglycaemia)” below.

Hypersensitivity reactions: uncommon (may affect up to 1 in 100 people)
Signs of a severe allergic reaction include:

• feeling unwell (dizziness)
• breathing difficulties
• rapid heartbeat or feeling dizzy
• nausea and vomiting
• local reactions such as rash, swelling or itching spreading to other parts of the body
• sweating and loss of consciousness.

If you experience a severe allergic reaction to Awiqli, stop using this medicine and seek immediate medical help. A severe allergic reaction can be life-threatening if swelling of the throat blocks the airways.

Skin changes at the injection site: rare (may affect up to 1 in 1,000 people)

• If you inject this medicine too often in the same spot, the skin may become thinner (lipoatrophy) or thicker (lipohypertrophy).
• Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis) if you inject insulin frequently in the same area. The frequency of this occurrence is unknown.
• This medicine 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 help prevent these skin changes.

Other side effects include:
Common (may affect up to 1 in 10 people)

• Skin problems at the injection site such as bruising, bleeding, pain or discomfort, redness, swelling, itching.
• Peripheral oedema (swelling, especially of the ankles and feet, due to fluid retention).

Reporting of side effects
If you get 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 Awiqli

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the box after "Exp.". The expiry date refers to the last day of that month.
Before opening
Store in the refrigerator (2 °C – 8 °C).
Do not freeze. Keep away from refrigerating elements.
Keep the cap on the pen to protect it from light.
After first opening or when carried as a spare
You may carry the Awiqli pre-filled pen (FlexTouch) as a spare and store it at room temperature (below 30 °C) or in the refrigerator (from 2 °C to 8 °C) for up to 12 weeks.
When not in use, store 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Awiqli contains

• The active substance is insulin icodec. Each mL of solution contains 700 units of insulin icodec. Each pre-filled pen contains 700, 1,050 or 2,100 units of insulin icodec in 1, 1.5 or 3 mL of solution, respectively.
• The other ingredients are glycerol, metacresol, phenol, zinc acetate, sodium chloride, hydrochloric acid, sodium hydroxide (for pH adjustment) and water for injections (see section 2).

Description of the appearance of Awiqli and contents of the pack
Awiqli is a clear, colourless injectable solution contained in a pre-filled pen.
The outer packaging is green with the dosage “700 units/mL” shown in a yellow box. The pen body is green, while the pen label is dark green with a yellow box highlighting the formulation dosage.

Pack sizes

• Pack containing 1 pre-filled pen of 1 mL (without needles).
• Pack containing 1 pre-filled pen of 1 mL (with 9 or 14 NovoFine Plus disposable needles).
• Pack containing 1 pre-filled pen of 1.5 mL (without needles).
• Pack containing 1 pre-filled pen of 1.5 mL (with 13 or 14 NovoFine Plus disposable needles).
• Multipack containing 2 pre-filled pens of 1.5 mL (with 26 or 28 NovoFine Plus disposable needles).
• Pack containing 1 pre-filled pen of 3 mL (without needles).
• Pack containing 2 pre-filled pens of 3 mL (without needles).
• Pack containing 1 pre-filled pen of 3 mL (with 13 or 14 NovoFine Plus disposable needles).
• Multipack containing 2 pre-filled pens of 3 mL (with 26 or 28 NovoFine Plus disposable needles).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Alle 1
DK-2880 Bagsvaerd
Denmark
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

HYPERGLYCAEMIA AND HYPOGLYCAEMIA
General effects of diabetes treatment
Blood sugar too low (hypoglycaemia)
This can happen if:

• you drink alcohol
• you use too much insulin
• you do more physical activity than usual
• you eat too little or skip a meal.

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

• headache
• rapid heartbeat
• feeling unwell or intense hunger
• cold sweat or cold, pale skin
• temporary vision disturbances
• trembling, shakiness, nervousness or anxiety
• unusual tiredness, weakness or drowsiness
• slurred speech, confusion or difficulty concentrating.

What to do if your blood sugar is too low:

• eat glucose tablets or a sugary snack, such as sweets, biscuits or fruit juice (always carry glucose tablets or a sugary snack with you, to use if needed).
• Measure your blood sugar if possible and rest. You may need to measure your blood sugar more than once. This is because with basal insulins such as Awiqli, the rise in blood glucose may be delayed.
• Wait until the symptoms of low blood sugar have disappeared or until your blood sugar has stabilised, then continue with insulin as usual.
• If you have type 1 diabetes and experience repeated episodes of hypoglycaemia, you must consult your doctor.

What others should do if you lose consciousness
Tell everyone you spend time with that you have diabetes and what the possible consequences of low blood sugar are, including the risk of fainting. Explain to them that if you should faint, they must:

• turn you onto your side
• seek immediate medical assistance
• not give you food or drink, as this could cause choking.

You may recover more quickly from unconsciousness if glucagon is administered, which can only be given by someone who knows how to use it.

• If glucagon is administered, you will need sugar or a sweet snack as soon as you regain consciousness.
• If you do not respond to glucagon, you must be taken to hospital.

If severe hypoglycaemia is not treated promptly, it can cause brain damage, which may be temporary or permanent. It may even lead to death.

Contact your doctor if:

• your blood sugar has become so low that you fainted
• you have used glucagon
• you have recently had several episodes of low blood sugar. It may be necessary to adjust your insulin dose or injection times, your diet or your physical activity.

Blood sugar too high (hyperglycaemia)
This can happen if:

• you drink alcohol
• you have an infection or fever
• you have not used enough insulin
• you eat more or do less physical activity than usual
• you continue to use less insulin than needed
• you forget to use your insulin or stop using it without consulting your doctor.

Warning signs of high blood sugar, which usually develop gradually:

• thirst
• dry, flushed skin
• loss of appetite
• drowsiness or tiredness
• increased frequency of urination
• dry mouth or fruity (acetone) breath
• feeling unwell or malaise (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 could lead to diabetic coma and possibly death.

What to do if your blood sugar is too high:

• measure your blood sugar.
• check for the presence of ketones in your urine or blood. Seek immediate medical assistance.

Instructions for use

Before starting to use the Awiqli pen and needle, always read these instructions carefully and consult your doctor, nurse, or pharmacist to learn how to correctly inject Awiqli.
The Awiqli pen is a single-use pre-filled pen containing icodec insulin 700 units/mL. It can deliver from 10 to 700 units in a single weekly injection.
Always start by checking the pen label to make sure it contains
Awiqli 700 units/mL.
The pen is designed for use with NovoFine Plus, NovoFine, or NovoTwist disposable needles up to 8 mm in length.

Once a week
Awiqli pen
Note: the pen may differ in size from that shown in the illustration. These instructions apply to all Awiqli pens.

Needle information
Always use a new needle for each injection. Check the flow as described in 'Step 2'
and use a new needle for each injection. Always remove the needle after each use.
NovoFine Plus needle (example)

Step 1 Prepare the pen with a new needle

• Check the name and dosage on the pen label to

ensure the pen contains icodec insulin
700 units/mL.

• Remove the cap from the pen. See Figure A.
• Always check that the insulin in the pen is clear and

colourless.

• Look through the pen window. If the insulin appears cloudy or contains particles, do not use the pen. See Figure B.
• Always use a new needle for each injection.

C

• Check the protective seal and outer cap of the needle for any damage that could affect sterility. Discard the needle and use a new one.
• Take a new needle and remove the protective seal.
• Do not attach a new needle to the pen until you are ready to administer the injection. See Figure C.
• Push the needle straight onto the pen. Rotate it until it is securely

tightened. See Figure D.

• The needle is covered by two caps: both must be removed. If you forget to remove both caps, Awiqli will not be injected.
• Remove the outer needle cap and keep it aside for later. You will

need it after the injection to safely remove the needle E
from the pen. See Figure E.

• Remove the inner needle cap and discard it. See Figure F.
• A drop of Awiqli may appear at the needle tip. This is normal, but you must still check the flow of Awiqli before each injection. See ' Step 2' .
• Never use a bent or damaged needle.

Step 2 Check the flow before each injection.

• Always check the flow before each injection. This

G
helps ensure the full dose of Awiqli is delivered.

• Rotate the dose selector clockwise until the first mark (10 units) appears in the dose counter. See Figure G.
• Ensure the mark is aligned with the dose indicator. See Figure H.
• Hold the pen with the needle pointing upwards.

I

• Press and hold the injection button until the dose counter shows . It must align

with the dose indicator.

• A drop of Awiqli should appear at the needle tip. This drop indicates the pen is ready for use. See Figure I.
• If no drop appears, check the flow again. This may be done only six times in total.
• If still no drop appears, the needle may be blocked. Change the needle as described in ' Step 5' and 'Step 1'.
• Then check the flow again.
• Do not use the pen if no drop of Awiqli appears.

Step 3 Set the dose

• Verify that the dose indicator is set to . See

Figure J.

• Rotate the dose selector to select the number of units required for the injection as prescribed by your doctor or nurse. The dose counter displays the dose in units.
• Make sure you select the prescribed dose.
• The units shown in the dose counter will guide you to your dose. The dose can be increased in increments of 10 units at a time.
• You will hear a "click" each time you rotate the dose selector. Do not set the dose by counting audible clicks.
• If you select the wrong dose, you can correct it by rotating the dose selector forward or backward.
• When the dose aligns with the dose indicator, it has been selected. Make sure you select the prescribed dose.

• The illustrations show examples of how to correctly select the dose. See Figure K.
• If the dose counter stops before reaching the prescribed dose, refer to the section 'Do you have enough Awiqli?' at the end of these instructions.

Choose the injection site

• Choose an injection site on the abdomen (keeping a distance of 5 cm from the navel), the upper arms, or the upper legs.
• You may inject in the same body area each week, but ensure it is not the exact same spot used for the previous injection.

Step 4 Inject the dose

• Insert the needle completely into the skin. See Figure L.

• Make sure you can see the dose counter. Do not cover the dose counter or touch it with your fingers, otherwise the injection may be interrupted.
• Press and hold the injection button until the dose counter shows .

• Continue holding the injection button while the needle is in the skin and count slowly to 6. It must align

with the dose indicator. See Figure M. When the
dose counter returns to , you may hear a click.

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

• Remove the needle from the skin, then release the injection button. See Figure N.

N

• If the needle is removed too early, Awiqli may leak from the needle tip, and the full dose will not be delivered.
• If bleeding occurs at the injection site, apply gentle pressure to the area for several minutes to stop the bleeding.
• After injection, you may see a drop of Awiqli at the needle tip. This is normal and does not affect the dose.

Step 5 After injection

• Gently place the needle tip into the outer needle cap placed on a flat surface, without touching the needle or the cap itself. See Figure O.

• Once the needle is covered, carefully press the outer cap fully into place.
• Unscrew the needle and dispose of it carefully according to instructions from your doctor, nurse, pharmacist, or local authorities.
  See Figure P.

• Never attempt to re-cap the inner needle cap. You may accidentally prick yourself with the needle.
• Always remove and dispose of the needle immediately after each injection to avoid contamination, infection, blocked needles, and inaccurate dosing.
• Never store the pen with the needle attached.
• Replace the cap on the pen after each use to protect Awiqli from light. See Figure Q.

• When the pen is empty, dispose of it without the needle attached, as instructed by your doctor, nurse, pharmacist, or local authorities.
• The package leaflet and empty box may be disposed of in household waste.

Do you have enough Awiqli?

• If the dose counter stops before reaching your

prescribed dose, there is not enough Awiqli left for a full dose. The number shown in the dose counter indicates the number of units remaining in the pen.

• If you need more Awiqli than remains in the pen, you may split the dose between two pens. In this case, ensure you calculate correctly. If in doubt, discard the used pen and administer the full dose with a new pen.
• If you split the dose incorrectly, you may inject too low or too high a dose of Awiqli, which could lead to blood sugar levels that are too high or too low.

Important information

• Needles are for single use only. Never reuse needles. This reduces the risk of contamination, infection, insulin leakage, needle blockage, and incorrect dosing.
• Handle the pen with care. Incorrect or improper use may lead to incorrect dosing, which could result in blood sugar levels that are too high or too low.
• Anyone assisting the patient must be extremely careful when handling needles to prevent needlestick injuries and infections.
• Do not use this pen without help if you have vision problems and cannot follow these instructions. Have a person with good vision who has been trained to use the Awiqli pen assist you.
• Always keep the pen and needles out of sight and reach of others, especially children.
• Inject Awiqli once a week.
• Use Awiqli as prescribed. If you do not use Awiqli as prescribed, you may develop blood sugar levels that are too high or too low.
• If you use more than one type of injectable medicine, it is very important to check the name and concentration on the pen label before use.
• Never share the pen or needles with other people.

Pen maintenance

• Do not freeze Awiqli. Do not use Awiqli if it has been frozen. Dispose of the pen.
• Do not drop the pen or subject it to hard impacts.
• Avoid exposing Awiqli to direct sunlight.
• Keep Awiqli away from heat sources, microwaves, and light.
• Do not attempt to repair or disassemble the pen.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, immerse in liquid, or lubricate the pen. If necessary, it may be cleaned with a neutral detergent on a damp cloth.
• Refer to the back of this leaflet for storage conditions of the pen.