InfoCons Consumer Protection informs you – Suliqua – 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Suliqua is an injectable diabetes medicine that contains two active substances

• insulin glargine : a long- acting type of insulin which helps control blood sugar (glucose) throughout the day.
• lixisenatide: a “GLP -1 analogue” that helps the body produce its own additional insulin in response to increases in blood sugar, and slows the absorption of sugar from foods.

Suliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high, it is an adjunct to diet and exercise. It is given, with metformin with or without sodium- glucose co -transporter -2 (SGLT2) inhibitors (gliflozin products) , when other medicines are not enough on their own to control your blood sugar levels .

If you use another anti -diabetic medicine, discuss with your doctor whether, you should stop using that medicine when starting Suliqua.

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

Do not use Suliqua

• if you are allergic to insulin glargine or lixisenatide 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 Suliqua if:

• you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to use glucose because there is not enough insulin) since this medicine will not be right for you.
• you have a severe stomach or gut problem such as a disease of the muscles of the stomach called “gastroparesis” which results in delayed stomach emptying .
• you are taking other oral medicines that should not stay too long in your stomach, see section “Oral medicines and Suliqua” .

62 • you have severe kidney disease or you are on dialysis, as the use of this medicine is not recommended.

• you know that you are due to have surgery where you will be under anaesthesia (sleeping), tell your doctor that you are taking Suliqua.

Closely follow your doctors instructions for how much S uliqua to use, how to monitor your blood and urine , your diet and physical activity levels and injection technique .

Important:

• If your blood sugar is too low (hypoglycaemia ) – see ‘what to do if you have low blood sugar’ at the end of this leaflet.
• If your blood sugar is too high (hyperglycaemia ) – see ‘what to do if you have high blood sugar ’ at the end of this leaflet.
• Make sure you use the right type of insulin – always check the insulin label before each injection to avoid mix- ups with other insulins.
• If you are blind or have poor eyesight, do not use the pre -filled pen without help. This is because you will not be able to read the dose window on the pen. Get help from a person with good eyesight who is trained in using the pen.

While using Suliqua be aware of the following and talk to your doctor, pharmacist or nurse :

• severe pain in your stomach area (abdomen) that will not go away. 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 avoid dehydration by drinking plenty of fluids, especially during the first weeks of treatment with Suliqua .

Skin changes where the injection is given Change where you inject regularly. This is to prevent skin changes such as thickening, shrinking or lumps. The insulin may not work well if you inject into a lumpy area

• Tell your doctor , pharmacist or nurse 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 the dose of your insulin or other anti- diabetic medications .

Antibody formation Suliqua treatment can cause the body to produce antibodies to insulin glargine and/or lixisenatide (substances that act against insulin glargine and/or lixisenatide ). However, only very rarely, this will require a change to your Suliqua dose.

Travel and Su liqua If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections. You may need to talk to your doctor about:

• If your medicine is available in the country you are visiting.
• How to arrange the supply of your insulin , needles and other items.
• How to correctly store your insulin while travelling.
• The time you eat meals and use your insulin .
• The possible effects of changing to different time zones.
• Any health risks in the countries you will visit.
• What you should do in an emergency if you feel unwell or become ill.

Children and adolescents

There is no experience with Suliqua in children and adolescents aged less than 18 years; therefore, the use of Suliqua is not recommended in this age group.

63 Other medicines and Suliqua Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. Some medicines can change your blood sugar level. Your doctor will tell you if your insulin dose has to change. You also need to be careful when you stop taking a medicine.

Oral medicines and Suliqua Because Suliqua can slow stomach emptying the effect of some medicines you swallow might be affected. Some medicines such as antibiotics, oral contraceptives, statins ( such as atorvastatin to lower cholesterol ), gastro -resistant tablets or capsules or granules or oral powder or suspensions that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Suliqua injection.

Listed below are the most common medicines which may affect your insulin treatment:

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

• any other medicine for diabetes
• disopyramide – for some heart problems
• fluoxetine – for depression
• pentamidine – for some parasit ic infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar
• sulphonamide antibiotics – for infection
• fibrates – for lowering high levels of fat in the blood
• monoamine oxidase inhibitors (MAOIs) – for depression or Parkinson´s disease
• pentoxifylline, propoxyphene and salicylates (such as aspirin) – for pain and mild fever
• angiotensin converting enzyme (ACE) inhibitors – for heart problems or high blood pressure Your blood sugar level may rise (hyperglycaemia) if you take:
• danazol – for endometriosis
• diazoxide – for high blood pressure
• glucagon – for very low blood sugar
• isoniazid – for tuberculosis
• somatropin – a growth hormone
• thyroid hormones – for thyroid gland problems
• oestrogens and progestogens – such as in the contraceptive pill , for birth control or use of oestrogens for bone loss (osteoporosis)
• corticosteroids such as cortisone and prednisolone – for inflammation
• protease inhibitors – for HIV
• diuretics – for high blood pressure or fluid retention
• clozapine , olanzapine and phenothiazine derivatives – for mental health problems
• sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline , for asthma.

Your blood sugar level may either rise or fall if you take:

• beta-blockers or clonidine – for high blood pressure.
• lithium salts – for mental health problems.

Beta-blockers

• Beta-blockers like other “Sympatholytic medicines ” (such as clonidine, guanethidine, reserpine
• for high blood pressure) can hide or stop the first signs that your blood sugar being too low (hypoglycaemia) or may make it harder to recognise warning signs .

Warfarin or other blood thinners Tell your doctor if you are taking warfarin or other blood thinners (anticoagulants) as you might need to have more frequent blood tests (called ‘International Normalised Ratio’ or INR test).

If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before using Suliqua.

Suliqua with alcohol Your blood sugar level may rise or fall if you drink alcohol – you will need to check your blood sugar level more often than usual .

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.

• Suliqua should not be used during pregnancy. It is not known if Suliqua harm s your unborn child.
• Suliqua should not be used if breast -feeding. It is not known if Suliqua passes into your milk.

Driving and using machines

Having too low or too high blood sugar can affect your ability to drive , use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others. Ask your doctor, pharmacist or nurse whether you can drive, use tools or machines if:

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

Suliqua contains sodium and metacresol

This medicine contains less than 1 mmol sodium (23 mg) sodium per dose , that is to say essentially ‘sodium -free’. This medicine contains metacresol which may cause allergic reactions.

💊 3. How to use Suliqua

Always use this medicine exactly as your doctor has told you.

Your doctor may tell you to use a different dose of Suliqua compared to your previous insulin dose or glucose lowering medicine if any.

Your doctor may tell you to use Suliqua with other medicines for high blood sugar.

Check with your doctor, pharmacist or nurse if you are not sure.

How much to use Your doctor will decide:

• how much Suliqua you need each day and at what time
• when to check your blood sugar level and if you need to carry out urine tests
• when you may need a higher or lower dose These are based on your life -style, your blood sugar (glucose) tests and your insulin use in the past.

Talk to your doctor as you may need a lower dose if:

• you are 65 years or older
• you have kidney or liver problems Your dose of Suliqua is administered as ‘dose steps’. The dose window on the pen shows the number of dose steps.

Suliqua 100 units/ ml + 33 microg rams/ ml in pre -filled pen (30 -60):

• this pen provides a dose of 30 to 60 dose steps in one injection, in steps of 1 dose step.
• each dose step you dial contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
• Do not inject a dose lower than 30 dose steps.
• Do not inject a dose higher than 60 dose steps.
• If a dose lower than 30 dose steps is needed, your doctor will prescribe a different strength. For 65 dose steps from 10 -40 units, Suliqua 100 units /ml + 50 micrograms /ml solution for injection in pre-filled pen (10-40) is available.

Make sure you have the correct pen:

• always check the medicine label before each injection to avoid mistakes, especially if you inject more than one medicine.

Many factors may affect your blood sugar level – learn what these are and what to do if your sugar level changes . This will help st op it becoming too high or too low. See ‘hyperglycaemia and hypoglycaemia’ at the end of this leaflet for more information.

When to use Suliqua

• Use Suliqua once a day, within 1 hour before a meal.
• Preferably inject Suliqua before the same meal every day, when you have chosen the most convenient meal .

Before injecting Suliqua

• Read the Instructions for use that come with this package leaflet
• If you do not follow all the instructions, you may get too much or too little of Suliqua .

How to inject

• Inject Suliqua under the skin This is called ‘ subcutaneous use ’ or ‘SC’.
• Inject it into the front of your thighs, upper arms or the front of your waist (abdomen).
• Change the place within the area where you inject each day – to reduce the risk of developing dents or lumps at the site (see section 4).
• Always use a new sterile needle for each injection – to reduce the risk of infection and blocked needles which can lead to you getting too much or too little medicine.
• Throw away the used needle in a sharps container, or as instructed by your pharmacist
• Do not share your insulin pen with anyone else, even when the needle is changed – to prevent infection.
• Do not use a syringe to remove the solution from the pen – to avoid potential overdose.
• Perform safety test before each injection.

Do not use Suliqua

• if there are particles in the Suliqua – the liquid should be clear, colourless and water -like.

Throw the pen away and use a new one if:

• you notice that your blood sugar control is unexpectedly getting worse
• the pen is damaged or has not been stored correctly Talk to your doctor, pharmacist or nurse if you are not sure your pen is working properly.

If you use more Suliqua than you should

If you use too much of this medicine, your blood sugar level may get too low – see ‘low blood sugar ’ at the end of this leaflet for advice.

If you forget to use Suliqua

• If you miss a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may get too high see ‘high blood sugar (hyperglycaemia) at the end of this leaflet for advice .
• When needed, Suliqua can be injected before the next meal.
• Do not inject a double dose to make up for a forgotten dose.
• Do not use two injections per day
• Check your blood sugar and then inject your next dose at the usual time.

66 If you stop using Suliqua Do not stop using this medicine without talking to your doctor. If you stop using this medicine, this could lead to very high blood sugar and a build- up of acid in the blood called (ketoacidosis) see ‘high blood sugar’ at the end of this leaflet for advice .

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

Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

Low blood sugar (hypoglycaemia) – very common: may affect more than 1 in 10 people

• If your blood sugar falls too much , you may pass out
• Serious low blood sugar may cause brain damage and may be life- threatening.

If you have signs of low blood sugar, try to increase your blood sugar level straight away. See advice in ‘low blood sugar’ at the end of this leaflet.

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Skin changes where the injection is given (not known: frequency cannot be estimated from the available data):

If you inject insulin too often at the same place, the skin may change which include:

• skin shrinking (lipoatrophy)
• skin thicken ing (lipohypertrophy)
• 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 area where the injection is given regularly to prevent skin changes.

Common (may affect up to 1 in 10 people )

• feeling dizzy
• feeling sick ( nausea )
• vomiting
• diarrhoea
• skin and allergic reactions where the injection is given ,the signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear within a few days to a few weeks.

Uncommon ( may affect up to 1 in 100 people )

• cold, runny nose, sore throat
• hives (urticaria)
• headache
• indigestion (dyspepsia)
• stomach ache
• tiredness
• gallstones
• inflamed gallbladder
• changed sense of taste

Rare (may affect up to 1 in 1 000 people)

• delay in the emptying of the stomach

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 Suliqua

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 carton and on the label of the pen after “EXP”. The expiry date refers to the last day of that month.

Before first use

• Store in a refrigerator, 2°C-8°C .
• Do not freeze or place next to the freezer compartment or a freezer pack.
• Keep the pen in the outer carton in order to protect from light.

After first use

• Do not store the pen in a refrigerator and do not freeze.
• Store your pen in use for a maximum of 28 days below 25°C and away from direct heat or direct light. Discard the pen after this period.
• Do not leave the pen in a car on a very warm or cold day.
• Always keep the cap on the pen when you are not using it in order to protect it from light.
• Do not store the pen with the needle attached.

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

📦 6. Contents of the pack and other information

What Suliqua contains

• The active substances are insulin glargine and lixisenatide.

Each pen contains 300 units insulin glargine and 100 micrograms lixisenatide in 3 ml of solution . Each ml contains 100 units insulin glargine and 33 m icrograms lixisenatide .

Each dose step of Suliqua contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide .

• The other ingredients are: glycerol 85% , methionine, metacresol, zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections. See also

section 2 ‘Suliqua contains sodium and ‘metacresol’.

What Suliqua looks like and contents of the pack

• Suliqua is a clear and colourless solution .
• Each pre- filled pen (SoloStar) contains 3 ml of solution for injection.
• Pack sizes of 3, 5 and 10 pre -filled pens.
• Not all pack sizes may be marketed.
• Needles are not included in the pack.

68 Marketing Authorisation Holder Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France

Manufacturer

Sanofi -Aventis Deutschland GmbH Industriepark Höchst – 65926 Frankfurt am Main Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) Česká republika Sanofi s.r.o.

Tel: +420 233 086 111 Magyarország SANOFI -AVENTIS Zrt.

Tel.: +36 1 505 0050 Danmark Sanofi A/S Tlf: +45 45 16 70 00 Malta Sanofi S.r.l.

Tel: +39 02 39394275 Deutschland Sanofi -Aventis Deutschland GmbH Tel.: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge sanofi -aventis Norge AS Tlf: +47 67 10 71 00 Ελλάδα Sanofi -Aventis Μονοπρόσωπη ΑΕΒΕ Τηλ: +30 210 900 16 00 Österreich sanofi -aventis GmbH Tel: +43 1 80 185 – 0 España sanofi -aventis, S.A.

Tel: +34 93 485 94 00 Polska Sanofi Sp. z o.o.

Tel.: +48 22 280 00 00 France Sanofi Winthrop Industrie Tél: 0 800 222 555 Appel depuis l’étranger: +33 1 57 63 23 23 Portugal Sanofi – Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400 69 Hrvatska Swixx Biopharma d.o.o.

Tel: +385 1 2078 500 România Sanofi Romania SRL Tel: +40 (0) 21 317 31 36 Ireland sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 Slovenija Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00 Ísland Vistor e hf.

Sími: +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600 Italia Sanofi S.r.l.

Tel: +39 800 536389 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.

Τηλ: +357 22 741741 Sverige Sanofi AB Tel: +46 (0)8 634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50

This leaflet was last revised in

Other source s of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ Hyperglycaemia and hypoglycaemia If you use insulin, you should always carry the following things with you:

• Foods containing sugar, such as glucose tablets or a sugary drink (at least 20 grams).
• Information so that others know you have diabetes.

High blood sugar (hyperglycaemia) Warning signs of high blood sugar:

• feeling thirsty, needing to urinate more often
• feeling tired or dry skin, reddening of the face, loss of appetite
• low blood pressure, fast heartbeat
• glucose and ketone bodies in urine
• stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.

What to do if you have high blood sugar

• Test your blood sugar level and your urine for ketones as soon as you notice any of the above signs .
• Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must always be treated by a doctor, normally in a hospital.

High blood sugar can happen if :

• you have not injected your Suliqua or not injected enough.
• your medicine is not working properly – this could be because it was not stored properly.
• your pen does not work properly.
• you do less exercise than usual.
• you are under stress – such as emotional distress or excitement.
• you have an injury, infection or fever or have had an operation.
• you take or have taken some other medicines see section 2 ‘Other medicines and Suliqua ’.

Low blood sugar (h ypoglycaemia ):

Very low blood sugar may make you pass out (unconscious), cause a heart attack or brain damage and be life -threatening. Learn to recognise the signs when your blood sugar is falling – and what to do to stop it getting worse.

Warning signs of low blood sugar

• The first signs may be in your body generally:
• feeling sweaty
• having clammy skin
• feeling anxious
• fast or irregular heartbeat, high blood pressure, palpitations Other signs in your brain may come slightly later:
• headache, trembling, feeling dizzy
• changes in your sight
• feeling very hungry, feeling sick (nausea) or vomiting
• changes in behaviour, aggression, depression
• feeling tired or sleepy, sleeping problems, feeling restless
• difficulty concentrating, confusion, slowed reactions or difficulty speaking (sometimes total loss of speech)
• not being able to move (paralysis), tingling in hands or arms, feeling numb and tingling often around the mouth
• loss of self -control, being unable to look after yourself, fits or passing out.

71 What to do if you have low blood sugar

• Do not inject Suliqua.
• Take about 15 to 20 grams sugar straight away – such as glucose, sugar cubes or a sugary drink.

Do not drink or eat foods that contain artificial sweeteners (such as diet drinks ). They do not help treat low blood sugar.

• Then eat something such as bread or pasta that will raise your blood sugar over a longer time .

Ask your doctor or nurse if you are not sure which foods you should eat , especially if your next meal is not due. With Suliqua, it may take longer to recover from low blood sugar because it contains a long- acting insulin (insulin glargine).

• Test your blood glucose levels after 10 -15 minutes after taking sugar. If blood glucose levels are still too low (<4 mmol/L) or hypoglycaemia comes back, take another 15 to 20 grams of sugar.
• Speak to a doctor straight away if you are not able to control the hypoglycaemia , or if it comes back.

What other people should do if you have low blood sugar

• Tell your relatives, friends and close colleagues to get medical help straightaway if you are not able to swallow or if you pass out (become unconscious).
• You will require glucose or glucagon (a medicine which increases blood sugar) and it should be given even if it is not certain that you have hypoglycaemia.
• You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.

Low blood sugar can happen if:

• you inject too much Suliqua.
• you miss meals or eat late.
• you do not eat enough, or eat food containing less carbohydrates than normal – artificial sweeteners are not carbohydrates.
• you drink alcohol – especially when you have not eaten much.
• you lose carbohydrates from being sick (vomiting) or diarrhoea.
• you do more exercise than usual or a different type of physical activity.
• you are recovering from an injury, operation or other stress.
• you are recovering from an illness or from fever.
• you take or have stopped taking certain other medicines, see section 2 ‘Other medicines and Suliqua’.

Low blood sugar is more likely to happen if:

• you have just started Suliqua treatment – if low blood sugar occurs, it may be more likely to happen in the morning.
• your blood sugar levels are almost normal or are unstable.
• you change the area of body where you inject Suliqua, for example from the thigh to the upper arm.
• you have severe kidney or liver disease, or some other disease such as hypothyroidism.

Signs of low blood sugar may be different, less clear or missing if:

• you are elderly.
• you have had diabetes for a long time.
• you have a nervous disease called “diabetic autonomic neuropathy”.
• you have recently had too low blood sugar, for example the day before.
• your low blood sugar comes on slowly.
• your low blood sugar is always around “normal” or your blood sugar has got much better.
• you have recently changed from animal insulin to a manufactured insulin, like Suliqua.
• you take or have taken some other medicines, see section 2, ‘Other medicines and Suliqua’ .

In such cases, you may get very low blood sugar and even pass out before you know what is happening. Know your warning signs. You may need to test your blood sugar more often – to help you 72 spot low blood sugar. If you find it difficult to spot your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by low blood sugar .

73 Suliqua 100 units/ ml + 33 micrograms /ml solution for injection in pre -filled pen (30-60).

INSTRUCTIONS FOR USE Read the Package Leaf let and these Instructions for Use before first use of Suliqua Suliqua (30- 60) SoloStar pen contains insulin glargine and lixisenatide. The combination of medicinal products in this pen is for the daily injection of 30 to 60 dose steps of Suliqua.

• Never re- use needles. If you do, you might not get your full dose (underdosing) or get too much (overdosing) as the needle could block.
• Never use a syringe to remove medicin e from your pen. If you do, you may not get the correct amount of medicine .

Keep these I nstructions F or Use for future reference.

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 properly.
• Always perform a safety test. See S TEP 3.
• Always carry a spare pen and spare needles in case they get lost or stop working.
• Always check the label of the pen before use to make sure you have the correct pen .

Learn to inject

• Talk with your doctor or 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 of these instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little medicine .

Need help?

If you have any questions about Suliqua , the pen or about diabetes, ask your doctor, pharmacist or nurse.

Additional items you will need

• a new sterile needle (see STEP 2 ).
• a sharps container for used needles. (see Throwing your pen away ).

74 Places to inject Get to know your pen *You will not see the plunger until you have injected a few doses STEP 1: Check your pen For first use of a new pen take it out of the refrigerator at least 1 hour before you inject. Injecting c old medicine is more painful. After first use the pen will be stored at temperatures below 25°C.

A. Check the name and expir y date on the label of your pen.

• Make sure you have the correct medicine . This pen is olive colo ured with a brown injection button.
• Do not use this pen if you need a daily dose less than 30 dose steps or if you need more than 60 dose steps. Discuss with your doctor which pen is suitable for your needs.
• Do not use your pen after the expiry date.

B. Pull off the pen cap.

Upper arms Stomach Thighs Cartridge holder Plunger* Dose window Dose pointer Dose selector Product name Scale Rubber seal Pen cap Injection button 75 C. Check that the medicine is clear.

• Look at the transparent cartridge holder . Do not use the pen if the medicine looks

cloudy, coloured or contains particles.

STEP 2: Attach a new needle

• Do not reuse needles. Always use a new sterile needle for each injection. This helps stop blocked needles, contamination, and infection.
• Always use needles that are compatible for use with Suliqua pen.

A. Take a new needle and peel off the protective seal.

B. Keep the needle straight and screw it onto the pen until fixed. Do not over- tighten.

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

76 D. Pull off the inner needle cap and throw away.

If you try to put it back on, you may accidentally stick yourself with the needle.

Handling needles

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

STEP 3: Do a safety test Always do a safety test before each injection to:

• Check your pen and the needle to make sure they are working properly
• Make sure that you get the correct dose.

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

B. Press the injection button all the way in.

• When medicine comes out of the needle tip, your pen is working correctly, the dose selector will be reset to “0”.

If no liquid appears

• You may need to repeat this step up to 3 times before seeing medicine .
• If no medicine 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 medicine coming out of the needle tip. Use a new pen.
• Do not use a syringe to remove medicine from your pen.

If you see air bubbles

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

STEP 4: Select the dose

• Use this pen only to inject single daily doses from 30 to 60 dose steps.
• Do not select a dose or press the injection button without a needle attached. This may damage your pen.

A. Make sure a needle is attached and the dose is set to ‘0’.

B. 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 dose steps left in your pen for your dose, the dose selector will stop at the number of dose steps left.
• If you cannot select your full prescribed dose, use a new pen or inject the remaining dose steps and use a new pen to complete your dose. Only in this case, it is okay to inject a partial dose of less than 30 dose steps. Always use another Suliqua (30- 60) Solostar pen to complete your dose and no other pen.

How to read the dose window

• Even numbers are presented in line with the dose pointer and odd numbers are presented as a line between even numbers.

39 units selected

• Do not use the pen if your single daily dose is less than 30 dose steps , shown as white numbers on a black background.

Units of medicine in your pen

• Your pen contains a total of 300 dose steps . You can select your dose in steps of 1 dose step .
• Do not use this pen if you need a single daily dose that is less than 30 dose steps , or more than 60 dose steps. Discuss with your doctor which pen is suitable for your needs.
• Each pen contains more than 1 dose.

STEP 5: Inject the dose

• If you find it hard to press the injection button in, do not force it as this may break your pen .
• Change the needle ( see STEP 6 Remove the needle and STEP 2 Attach a new needle) then do a safety test ( see STEP 3 ).
• If you still find it hard to press in, get a new pen.
• Do not use a syringe to remove medicine from your pen.

A. Choose a place to inject as shown in the picture above.

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

• Do not touch the injection button yet.

C. 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.

D. 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.

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

STEP 6: Remove the needle

• Take care when handling needles to prevent needle injury and cross -infection.
• Do not put the inner needle cap back on.

A. Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap back. Then push firmly on.

• The needle can puncture the cap if it is recapped at an angle.

B. Grip and squeeze the widest part of the outer needle cap. Turn your pen several times with your other hand to remove the needle.

• Try again if the needle does not come off the first time.

10 secs 80 C. Throw away the used needle in a puncture resistant container (see “Throwing your pen away ” at the end of these Instructions for Use).

D. Put your pen cap back on.

• Do not put the pen back in the refrigerator.

How to store your pen Before first use

• Keep new pens in the refrigerator between 2°C to 8°C .
• Do not freeze.

After first use

• Keep your pen at room temperature, below 25°C.
• Do not put your pen back in the refrigerator.
• Do not store your pen with the needle attached.
• Store the pen with your pen cap on.
• Only use your pen for up to 28 days after its first use.

How to care for your pen Handle your pen with care

• If you think that your pen may be damaged, do not try to fix it. Use a new one.

Protect your pen from dust and dirt

• You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not soak, wash or lubricate the pen. This may damage it.

Throwing your pen away

• Remove the needle before throwing your pen away.
• Throw away your used pen as instructed by your pharmacist or local authority.

📄 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 Suliqua (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1157).

⚠️ 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.