B. PACKAGE LEAFLET

Package leaflet: information for the user

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Insulin glargine + lixisenatide

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 or 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.

What is in this leaflet

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

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

• 3. How to use Suliqua

• 4. Possible side effects

• 5. How to store Suliqua

• 6. Contents of the pack and other information

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 sodiumglucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when other medicines are not enough on their own to control your blood sugar levels.

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, as Suliqua is used for type 2 diabetes and this medicine will not be right for you.
• you have 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. Since Suliqua may cause stomach side effects (see section 4), the medicine has not been studied in patients with severe stomach or gut problems. Please see the information regarding medicines that should not stay too long in your stomach in the section “Other medicines and Suliqua”.

you have severe kidney disease or you are on dialysis as the use of this medicine will not be recommended.

Follow closely your doctor’s instruc­tions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique.

Be especially aware of the following:

• Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
• Too high blood sugar (hyperglycaemia). If your blood sugar is too high, follow the guidance for

hyperglycaemia (see information in the box at the end of this leaflet).

• Ensure that you use the right medicine. You must always check the label before each injection to avoid mix-ups between Suliqua and other insulins.
• If you have poor eyesight, please see section 3.

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

• 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 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 Suliqua). 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 medicine dose.

Travel

Talk to your doctor before travelling. You may need to talk about:

• If your medicine is available in the country you are visiting.
• How to arrange the supply of your medicine, needles and other items.
• How to correctly store your medicine while travelling.
• The time you eat meals and use your medicine.
• 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.

Other medicines and Suliqua

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. If you use another antidiabetic medicine, discuss with your doctor whether you should stop using that medicine when starting Suliqua.

Some medicines can change your blood sugar level. This may mean your doctor may need to change your Suliqua dose. So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take. You also need to be careful when you stop taking a medicine.

The effect of some medicines you swallow might be affected by Suliqua. Some medicines such as antibiotics, oral contraceptives, statins (medicines like 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.

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

• Any other medicine to treat diabetes.
• Disopyramide, for some heart problems.
• Fluoxetine, for depression.
• Sulphonamide antibiotics, to treat infections.
• Fibrates, for lowering high levels of blood fats.
• Monoamine oxidase inhibitors (MAOIs), for depression or Parkinson's di­sease.
• Angiotensin converting enzyme (ACE) inhibitors, for heart problems or high blood pressure.
• Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates (such as acetylsalicylic a­cid).
• Pentamidine, for some parasite infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar.

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

• Corticosteroids such as cortisone and prednisolone, for inflammation.
• Danazol, for endometriosis.
• Diazoxide, for high blood pressure.
• Protease inhibitors, for HIV.
• Diuretics, for high blood pressure or fluid retention.
• 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).
• 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.

Medicine that may reduce warning signs of low blood sugar

Beta-blockers and some other medicines (such as clonidine, guanethidine, reserpine – for high blood pressure) may make it harder to recognise warning signs of your low blood sugar levels (hypoglycaemia). It can even hide or stop the first signs that your blood sugar is too low.

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

Warfarin or other anticoagulants

Tell your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent clotting of the blood) as you might need to have more frequent blood tests (called ‘International Normalised Ratio’ or INR test) to check your blood clotting.

Suliqua with alcohol

Your blood sugar level may either rise or fall if you drink alcohol. You should check your blood sugar level more often.

Pregnancy and breast-feeding

Suliqua should not be used during pregnancy. It is not known if Suliqua harms your unborn child.

Suliqua should not be used if breast-feeding. It is not known if Suliqua passes into your milk.

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

Driving and using machines

Having too low or too high blood sugar (see information in the box at the end of this leaflet) can affect your ability to drive and use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others.

Ask your doctor whether you can drive if:

• Your blood sugar is often too low.
• You find it hard to recognise when your blood sugar is too low.

Suliqua contains sodium

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

Suliqua contains metacresol

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

Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you:

• 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.

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

How much to use

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen:

• This pen provides a dose of 10 to 40 dose steps in one injection, in steps of 1 dose step.
• Each dose step you dial contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.

Your dose of Suliqua is administered as ‘dose steps’. The dose window on the pen shows the number of dose steps.

Do not inject a dose lower than 10 dose steps. Do not inject a dose higher than 40 dose steps.

If a dose greater than 40 dose steps is needed, your doctor will prescribe a different strength. For dose steps from 30–60 units, Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen is available.

Many factors may affect your blood sugar level. You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low. See the box at the end of this leaflet for more information.

Use in elderly patients (65 years and older)

If you are 65 years or older, talk to your doctor as you may need a lower dose.

If you have kidney or liver problems

If you have kidney or liver problems, talk to your doctor as you may need a lower dose.

When to inject 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

• Always follow the “Instructions for use” that come with this package leaflet and use the pen as described.
• If you do not follow all of these instructions, you may get too much or too little of Suliqua.

To avoid mistakes, always check the medicine pack and label on the pen before each injection to make sure you have the correct pen, especially if you inject more than one medicine.

Ask your doctor or pharmacist if you are not sure.

How to inject

• Suliqua is injected under the skin (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 you inject each day. This will reduce the risk of developing

dents or lumps at the site (for more information, see “Other side effects” in section 4).

Do not use Suliqua

• If there are particles in the Suliqua. The solution should be clear, colourless and water-like.

Other important information about using the pre-filled pens

• Always use a new needle for each injection. The re-use of needles increases the risk of blocked needles which may cause under- or overdosing. Dispose of the needle safely after each use.
• To prevent infection being passed from one person to another, pens should never be used for more than one person, even when the needle is changed.
• Only use needles that are compatible with Suliqua pen (see “Instructions for Use”).
• A safety test must be performed before each injection.
• Throw away the used needle in a sharps container, or as told by your pharmacist or local authority.

Never use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.

If the pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:

• Throw the pen away and use a new one.
• Talk to your doctor, pharmacist or nurse if you think you have a problem with your pen.

If you use more Suliqua than you should

If you have injected too much of this medicine, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar and eat more food to prevent your blood sugar getting too low (hypoglycaemia). If your blood sugar gets too low, see the advice in the box at the end of this leaflet.

If you forget to use Suliqua

If you have missed a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):

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.
• For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.

If you stop using Suliqua

Do not stop using this medicine without talking to your doctor. If you do, it could lead to very high blood sugar (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).

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.

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straightaway (see the box at the end of this leaflet).

Hypoglycaemia can be very serious and is very common with medicines containing insulin (may affect more than 1 in 10 people).

Low blood sugar means that there is not enough sugar in your blood.

If your blood sugar falls too low, you may pass out (become unconscious).

If blood sugar remains very low for too long it may cause brain damage and may be life-threatening. For more information, see the box 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 at the injection site

If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). This is not known how often these skin changes occur. 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.

Common ( may affect up to 1 in 10 people)

• Feeling dizzy
• Feeling sick (nausea)
• Vomiting
• Diarrhoea
• Skin and allergic reactions at the injection site: 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 in 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

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 inBy 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

Store your pen in use below 25°C for a maximum of 28 days. Discard the pen after this period.

Do not return the pen to a refrigerator and do not freeze. Store the pen away from direct heat or direct light. Always keep the cap on the pen when you are not using it in order to protect it from light.

Do not leave the pen in a car on an exceptionally warm or cold day.

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 150 micrograms lixisenatide in 3 ml of solution.

Each ml contains 100 units insulin glargine and 50 micrograms lixisenatide.

• Each dose step of Suliqua contains 1 unit of insulin glargine and 0.5 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 “What you need to know before you use Suliqua” for information on sodium and metacresol.

What Suliqua looks like and contents of the pack

Suliqua is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen (SoloStar).

Pack sizes of 3, 5 and 10 pre-filled pens.

Not all pack sizes may be marketed.

Needles are not included in the pack.

Marketing Authorisation Holder

sanofi-aventis groupe

54, rue La Boétie

75008 Paris

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

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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.

Hyperglycaemia (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Reasons why hyperglycaemia may happen:

Examples include:

• You have not injected your Suliqua or not injected enough.
• Your medicine has become less effective – for example because it was not stored properly.
• Your pen does not work properly.
• You are doing 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 are taking or have taken certain other medicines (see section 2, "Other medicines and

Suliqua").

Warning signs of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and urine test showing glucose and ketone bodies. 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 experience hyperglycaemia

• Test your blood sugar level and, if it is high, as agreed with your doctor or nurse, test 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.

Hypoglycaemia (low blood sugar levels)

If your blood sugar level falls too much you may pass out (become unconscious). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should learn to recognise the signs when your blood sugar is falling – so you can take action to stop it getting worse.

Reasons why hypoglycaemia may happen:

Examples include:

• You inject too much Suliqua.
• You miss meals or delay them.
• 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 are doing 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 are taking or have stopped taking certain other medicines (see section 2, "Other medicines

and Suliqua").

Hypoglycaemia is also 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 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.

Warning signs of hypoglycaemia

The first signs may be in your body generally. Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations. These signs often develop before the signs of a low sugar level in the brain.

Other signs include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.

When the signs of hypoglycaemia may be less clear:

The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:

• You are elderly.
• You have had diabetes for a long time.
• You have a certain type of nerve damage (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 diabetes control has greatly improved

recently.

• You have recently changed from animal insulin to a manufactured insulin, like there is in Suliqua.
• You are taking or have taken certain other medicines (see section 2, „Other medicines and Suliqua“).

In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.

What to do if you experience hypoglycaemia?

• 1. Do not inject Suliqua. Take about 15 to 20 grams sugar straight away – such as glucose, sugar cubes or a sugary drink. Drink or foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.

• 2. You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due. Ask your doctor or nurse if you are not sure which foods you should eat.

With Suliqua, it may take longer to recover from low blood sugar because it contains a long-acting insulin (insulin glargine).

• 3. 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 gram of sugar.

• 4. Speak to a doctor straightaway if you are not able to control the hypoglycaemia, or it comes back again.

What other people should do if you have hypoglycaemia

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 an injection of glucose or glucagon (a medicine which increases blood sugar). These injections should be given even if it is not certain that you have hypoglycaemia.

You should test your blood sugar straightaway after taking glucose to check that you really have hypoglycaemia.

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen (10–40).

INSTRUCTIONS FOR USE

Read the Package Leaflet and these Instructions for Use before first use of Suliqua

Suliqua (10–40) SoloStar pen contains insulin glargine and lixisenatide. The combination of medicinal products in this pen is for the daily injection of 10 to 40 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 medicine from your pen. If you do, you may not get the correct amount of medicine.

Keep these Instructions For 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 STEP 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).

*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 cold medicine is more painful. After first use the pen will be stored at temperatures below 25°C.

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

• Make sure you have the correct medicine. This pen is peach coloured with an orange injection button.
• Do not use this pen if you need a daily dose less than 10 dose steps or if you need more than 40 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.

• 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.

• 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 10 to 40 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 10 dose steps. Always use another Suliqua (10–40 ) 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.
• Do not use the pen if your single daily dose is less than 10 dose steps, shown as white

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 10 dose steps, or more than 40 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.

• 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: information for the user

Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen Insulin glargine + lixisenatide

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 or 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.

What is in this leaflet

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

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

• 3. How to use Suliqua

• 4. Possible side effects

• 5. How to store Suliqua

• 6. Contents of the pack and other information

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 sodiumglucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when other medicines are not enough on their own to control your blood sugar levels.

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, as Suliqua is used for type 2 diabetes and this medicine will not be right for you.
• you have 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. Since Suliqua may cause stomach side effects (see section 4), the medicine has not been studied in patients with severe stomach or gut problems. Please see the information regarding medicines that should not stay too long in your stomach in the section “Other medicines and Suliqua”.
• you have severe kidney disease or you are on dialysis as the use of this medicine will not be recommended.

Follow closely your doctor’s instruc­tions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique.

Be especially aware of the following:

• Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
• Too high blood sugar (hyperglycaemia). If your blood sugar is too high, follow the guidance for

hyperglycaemia (see information in the box at the end of this leaflet).

• Ensure that you use the right medicine. You must always check the label before each injection to avoid mix-ups between Suliqua and other insulins.
• If you have poor eyesight, please see section 3.

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

• 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 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 Suliqua). 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 medicine dose.

Travel

Talk to your doctor before travelling. You may need to talk about:

• If your medicine is available in the country you are visiting.
• How to arrange the supply of your medicine, needles and other items.
• How to correctly store your medicine while travelling.
• The time you eat meals and use your medicine.
• 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.

Other medicines and Suliqua

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. If you use another antidiabetic medicine, discuss with your doctor whether you should stop using that medicine when starting Suliqua.

Some medicines can change your blood sugar level. This may mean your doctor may need to change your Suliqua dose. So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take. You also need to be careful when you stop taking a medicine.

The effect of some medicines you swallow might be affected by Suliqua. Some medicines such as antibiotics, oral contraceptives, statins (medicines like 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.

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

• Any other medicine to treat diabetes.
• Disopyramide, for some heart problems.
• Fluoxetine, for depression.
• Sulphonamide antibiotics, to treat infections.
• Fibrates, for lowering high levels of blood fats.
• Monoamine oxidase inhibitors (MAOIs), for depression or Parkinson's di­sease.
• Angiotensin converting enzyme (ACE) inhibitors, for heart problems or high blood pressure.
• Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates (such as acetylsalicylic a­cid).
• Pentamidine, for some parasite infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar.

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

• Corticosteroids such as cortisone and prednisolone, for inflammation.
• Danazol, for endometriosis.
• Diazoxide, for high blood pressure.
• Protease inhibitors, for HIV.
• Diuretics, for high blood pressure or fluid retention.
• 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).
• 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.

Medicine that may reduce warning signs of low blood sugar

Beta-blockers and some other medicines (such as clonidine, guanethidine, reserpine – for high blood pressure) may make it harder to recognise warning signs of your low blood sugar levels (hypoglycaemia). It can even hide or stop the first signs that your blood sugar is too low.

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

Warfarin or other anticoagulants

Tell your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent clotting of the blood) as you might need to have more frequent blood tests (called ‘International Normalised Ratio’ or INR test) to check your blood clotting.

Suliqua with alcohol

Your blood sugar level may either rise or fall if you drink alcohol. You should check your blood sugar level more often.

Pregnancy and breast-feeding

Suliqua should not be used during pregnancy. It is not known if Suliqua harms your unborn child.

Suliqua should not be used if breast-feeding. It is not known if Suliqua passes into your milk.

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

Driving and using machines

Having too low or too high blood sugar (see information in the box at the end of this leaflet) can affect your ability to drive and use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others.

Ask your doctor whether you can drive if:

• Your blood sugar is often too low.
• You find it hard to recognise when your blood sugar is too low.

Suliqua contains sodium

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

Suliqua contains metacresol

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

Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you:

• 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.

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

How much to use

The Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen :

• 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.

Your dose of Suliqua is administered as ‘dose steps’. The dose window on the pen shows the number of dose steps.

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 dose steps from 10–40 units, Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen.

Many factors may affect your blood sugar level. You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low. See the box at the end of this leaflet for more information.

Use in elderly patients (65 years and older)

If you are 65 years or older, talk to your doctor as you may need a lower dose.

If you have kidney or liver problems

If you have kidney or liver problems, talk to your doctor as you may need a lower dose.

When to inject 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

• Always follow the “Instructions for use” that come with this package leaflet and use the pen as described.
• If you do not follow all of these instructions, you may get too much or too little of Suliqua.

To avoid mistakes, always check the medicine pack and label on the pen before each injection to make sure you have the correct pen, especially if you inject more than one medicine. Ask your doctor or pharmacist if you are not sure.

How to inject

• Suliqua is injected under the skin (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 you inject each day. This will reduce the risk of developing

dents or lumps at the site (for more information, see “Other side effects” in section 4).

Do not use Suliqua

• If there are particles in the Suliqua. The solution should be clear, colourless and water-like.

Other important information about using the pre-filled pens

• Always use a new needle for each injection. The re-use of needles increases the risk of blocked needles which may cause under- or overdosing. Dispose of the needle safely after each use.
• To prevent infection being passed from one person to another, pens should never be used for more than one person, even when the needle is changed.
• Only use needles that are compatible with Suliqua pen (see “Instructions for Use”).
• A safety test must be performed before each injection.
• Throw away the used needle in a sharps container, or as told by your pharmacist or local authority.

Never use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.

If the pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:

• throw the pen away and use a new one.
• talk to your doctor, pharmacist or nurse if you think you have a problem with your pen.

If you use more Suliqua than you should

If you have injected too much of this medicine, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar and eat more food to prevent your blood sugar getting too low (hypoglycaemia). If your blood sugar gets too low, see the advice in the box at the end of this leaflet.

If you forget to use Suliqua

If you have missed a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):

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.
• For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.

If you stop using Suliqua

Do not stop using this medicine without talking to your doctor. If you do, it could lead to very high blood sugar (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).

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.

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straightaway (see the box at the end of this leaflet).

Hypoglycaemia can be very serious and is very common with medicines containing insulin (may affect more than 1 in 10 people).

Low blood sugar means that there is not enough sugar in your blood.

If your blood sugar falls too low, you may pass out (become unconscious).

If blood sugar remains very low for too long it may cause brain damage and may be life-threatening. For more information, see the box 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 at the injection site

If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). This is not known how often these skin changes occur. 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.

Common (may affect up to 1 in 10 people)

• Feeling dizzy
• Feeling sick (nausea)
• Vomiting
• Diarrhoea
• Skin and allergic reactions at the injection site: 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 in 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

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 inBy 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

Store your pen in use below 25°C for a maximum of 28 days. Discard the pen after this period.

Do not return the pen to a refrigerator and do not freeze. Store the pen away from direct heat or direct light. Always keep the cap on the pen when you are not using it in order to protect it from light.

Do not leave the pen in a car on an exceptionally warm or cold day.

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

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 “What you need to know before you use Suliqua” for information on sodium and metacresol.

What Suliqua looks like and contents of the pack

Suliqua is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen (SoloStar).

Pack sizes of 3, 5 and 10 pre-filled pens.

Not all pack sizes may be marketed.

Needles are not included in the pack.

Marketing Authorisation Holder

sanofi-aventis groupe

54, rue La Boétie

75008 Paris

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.

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site

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.

Hyperglycaemia (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Reasons why hyperglycaemia may happen:

Examples include:

• You have not injected your Suliqua or not injected enough.
• Your medicine has become less effective – for example because it was not stored properly.
• Your pen does not work properly.
• You are doing 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 are taking or have taken certain other medicines (see section 2, "Other medicines and

Suliqua").

Warning signs of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and urine test showing glucose and ketone bodies. 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 experience hyperglycaemia

• Test your blood sugar level and, if it is high, as agreed with your doctor or nurse, test 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.

Hypoglycaemia (low blood sugar levels)

If your blood sugar level falls too much you may pass out (become unconscious). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should learn to recognise the signs when your blood sugar is falling – so you can take action to stop it getting worse.

Reasons why hypoglycaemia may happen:

Examples include:

• You inject too much Suliqua.
• You miss meals or delay them.
• 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 are doing 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 are taking or have stopped taking certain other medicines (see section 2, „Other medicines and Suliqua“).

Hypoglycaemia is also 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 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.

Warning signs of hypoglycaemia

The first signs may be in your body generally. Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations. These signs often develop before the signs of a low sugar level in the brain.

Other signs include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.

When the signs of hypoglycaemia may be less clear:

The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:

• You are elderly.
• You have had diabetes for a long time.
• You have a certain type of nerve damage (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 diabetes control has greatly improved

recently.

• You have recently changed from animal insulin to a manufactured insulin, like there is in Suliqua.
• You are taking or have taken certain other medicines (see section 2, „Other medicines and Suliqua“).

In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.

What to do if you experience hypoglycaemia?

• 1. Do not inject Suliqua. Take about 15 to 20 grams sugar straight away – such as glucose, sugar cubes or a sugary drink. Drink or foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.

• 2. You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due. Ask your doctor or nurse if you are not sure which foods you should eat.

With Suliqua, it may take longer to recover from low blood sugar because it contains a long-acting insulin (insulin glargine).

• 3. 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 gram of sugar.

• 4. Speak to a doctor straightaway if you are not able to control the hypoglycaemia, or it comes back again.

What other people should do if you have hypoglycaemia

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 an injection of glucose or glucagon (a medicine which increases blood sugar). These injections should be given even if it is not certain that you have hypoglycaemia.

You should test your blood sugar straightaway after taking glucose to check that you really have hypoglycaemia.

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

INSTRUCTIONS FOR USE

Read the Package Leaflet 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 medicine from your pen. If you do, you may not get the correct amount of medicine.

Keep these Instructions For 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 STEP 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).

*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 cold medicine is more painful. After first use the pen will be stored at temperatures below 25°C.

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

• Make sure you have the correct medicine. This pen is olive coloured 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.

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.

• 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.

10 secs^

• 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.

• 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: information for the user

Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen Insulin glargine + lixisenatide

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 or 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.

What is in this leaflet

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

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

• 3. How to use Suliqua

• 4. Possible side effects

• 5. How to store Suliqua

• 6. Contents of the pack and other information

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 sodiumglucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when other medicines are not enough on their own to control your blood sugar levels.

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, as Suliqua is used for type 2 diabetes and this medicine will not be right for you.
• you have 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. Since Suliqua may cause stomach side effects (see section 4), the medicine has not been studied in patients with severe stomach or gut problems. Please see the information regarding medicines that should not stay too long in your stomach in the section “Other medicines and Suliqua”.
• you have severe kidney disease or you are on dialysis as the use of this medicine will not be recommended.

Follow closely your doctor’s instruc­tions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique.

Be especially aware of the following:

• Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
• Too high blood sugar (hyperglycaemia). If your blood sugar is too high, follow the guidance for

hyperglycaemia (see information in the box at the end of this leaflet).

• Ensure that you use the right medicine. You must always check the label before each injection to avoid mix-ups between Suliqua and other insulins.
• If you have poor eyesight, please see section 3.

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

• 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 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 Suliqua). 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 medicine dose.

Travel

Talk to your doctor before travelling. You may need to talk about:

• If your medicine is available in the country you are visiting.
• How to arrange the supply of your medicine, needles and other items.
• How to correctly store your medicine while travelling.
• The time you eat meals and use your medicine.
• 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.

Other medicines and Suliqua

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. If you use another antidiabetic medicine, discuss with your doctor whether you should stop using that medicine when starting Suliqua.

Some medicines can change your blood sugar level. This may mean your doctor may need to change your Suliqua dose. So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take. You also need to be careful when you stop taking a medicine.

The effect of some medicines you swallow might be affected by Suliqua. Some medicines such as antibiotics, oral contraceptives, statins (medicines like 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.

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

• Any other medicine to treat diabetes.
• Disopyramide, for some heart problems.
• Fluoxetine, for depression.
• Sulphonamide antibiotics, to treat infections.
• Fibrates, for lowering high levels of blood fats.
• Monoamine oxidase inhibitors (MAOIs), for depression or Parkinson's di­sease.
• Angiotensin converting enzyme (ACE) inhibitors, for heart problems or high blood pressure.
• Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates (such as acetylsalicylic a­cid).
• Pentamidine, for some parasite infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar.

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

• Corticosteroids such as cortisone and prednisolone, for inflammation.
• Danazol, for endometriosis.
• Diazoxide, for high blood pressure.
• Protease inhibitors, for HIV.
• Diuretics, for high blood pressure or fluid retention.
• 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).
• 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.

Medicine that may reduce warning signs of low blood sugar

Beta-blockers and some other medicines (such as clonidine, guanethidine, reserpine – for high blood pressure) may make it harder to recognise warning signs of your low blood sugar levels (hypoglycaemia). It can even hide or stop the first signs that your blood sugar is too low.

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

Warfarin or other anticoagulants

Tell your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent clotting of the blood) as you might need to have more frequent blood tests (called ‘International Normalised Ratio’ or INR test) to check your blood clotting.

Suliqua with alcohol

Your blood sugar level may either rise or fall if you drink alcohol. You should check your blood sugar level more often.

Pregnancy and breast-feeding

Suliqua should not be used during pregnancy. It is not known if Suliqua harms your unborn child.

Suliqua should not be used if breast-feeding. It is not known if Suliqua passes into your milk.

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

Driving and using machines

Having too low or too high blood sugar (see information in the box at the end of this leaflet) can affect your ability to drive and use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others.

Ask your doctor whether you can drive if:

• Your blood sugar is often too low.
• You find it hard to recognise when your blood sugar is too low.

Suliqua contains sodium

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

Suliqua contains metacresol

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

Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you:

• 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.

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

How much to use

The Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen :

• 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.

Your dose of Suliqua is administered as ‘dose steps’. The dose window on the pen shows the number of dose steps.

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 dose steps from 10–40 units, Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen.

Many factors may affect your blood sugar level. You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low. See the box at the end of this leaflet for more information.

Use in elderly patients (65 years and older)

If you are 65 years or older, talk to your doctor as you may need a lower dose.

If you have kidney or liver problems

If you have kidney or liver problems, talk to your doctor as you may need a lower dose.

When to inject 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

• Always follow the “Instructions for use” that come with this package leaflet and use the pen as described.
• If you do not follow all of these instructions, you may get too much or too little of Suliqua.

To avoid mistakes, always check the medicine pack and label on the pen before each injection to make sure you have the correct pen, especially if you inject more than one medicine. Ask your doctor or pharmacist if you are not sure.

How to inject

• Suliqua is injected under the skin (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 you inject each day. This will reduce the risk of developing

dents or lumps at the site (for more information, see “Other side effects” in section 4).

Do not use Suliqua

• If there are particles in the Suliqua. The solution should be clear, colourless and water-like.

Other important information about using the pre-filled pens

• Always use a new needle for each injection. The re-use of needles increases the risk of blocked needles which may cause under- or overdosing. Dispose of the needle safely after each use.
• To prevent infection being passed from one person to another, pens should never be used for more than one person, even when the needle is changed.
• Only use needles that are compatible with Suliqua pen (see “Instructions for Use”).
• A safety test must be performed before each injection.
• Throw away the used needle in a sharps container, or as told by your pharmacist or local authority.

Never use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.

If the pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:

• throw the pen away and use a new one.
• talk to your doctor, pharmacist or nurse if you think you have a problem with your pen.

If you use more Suliqua than you should

If you have injected too much of this medicine, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar and eat more food to prevent your blood sugar getting too low (hypoglycaemia). If your blood sugar gets too low, see the advice in the box at the end of this leaflet.

If you forget to use Suliqua

If you have missed a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):

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.
• For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.

If you stop using Suliqua

Do not stop using this medicine without talking to your doctor. If you do, it could lead to very high blood sugar (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).

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.

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straightaway (see the box at the end of this leaflet).

Hypoglycaemia can be very serious and is very common with medicines containing insulin (may affect more than 1 in 10 people).

Low blood sugar means that there is not enough sugar in your blood.

If your blood sugar falls too low, you may pass out (become unconscious).

If blood sugar remains very low for too long it may cause brain damage and may be life-threatening. For more information, see the box 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 at the injection site

If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). This is not known how often these skin changes occur. 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.

Common (may affect up to 1 in 10 people)

• Feeling dizzy
• Feeling sick (nausea)
• Vomiting
• Diarrhoea
• Skin and allergic reactions at the injection site: 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 in 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

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 inBy 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

Store your pen in use below 25°C for a maximum of 28 days. Discard the pen after this period.

Do not return the pen to a refrigerator and do not freeze. Store the pen away from direct heat or direct light. Always keep the cap on the pen when you are not using it in order to protect it from light.

Do not leave the pen in a car on an exceptionally warm or cold day.

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 micrograms 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 “What you need to know before you use Suliqua” for information on sodium and metacresol.

What Suliqua looks like and contents of the pack

Suliqua is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen (SoloStar).

Pack sizes of 3, 5 and 10 pre-filled pens.

Not all pack sizes may be marketed.

Needles are not included in the pack.

Marketing Authorisation Holder

sanofi-aventis groupe

54, rue La Boétie

75008 Paris

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.

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site

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.

Hyperglycaemia (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Reasons why hyperglycaemia may happen:

Examples include:

• You have not injected your Suliqua or not injected enough.
• Your medicine has become less effective – for example because it was not stored properly.
• Your pen does not work properly.
• You are doing 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 are taking or have taken certain other medicines (see section 2, "Other medicines and

Suliqua").

Warning signs of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and urine test showing glucose and ketone bodies. 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 experience hyperglycaemia

• Test your blood sugar level and, if it is high, as agreed with your doctor or nurse, test 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.

Hypoglycaemia (low blood sugar levels)

If your blood sugar level falls too much you may pass out (become unconscious). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should learn to recognise the signs when your blood sugar is falling – so you can take action to stop it getting worse.

Reasons why hypoglycaemia may happen:

Examples include:

• You inject too much Suliqua.
• You miss meals or delay them.
• 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 are doing 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 are taking or have stopped taking certain other medicines (see section 2, „Other medicines and Suliqua“).

Hypoglycaemia is also 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 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.

Warning signs of hypoglycaemia

The first signs may be in your body generally. Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations. These signs often develop before the signs of a low sugar level in the brain.

Other signs include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.

When the signs of hypoglycaemia may be less clear:

The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:

• You are elderly.
• You have had diabetes for a long time.
• You have a certain type of nerve damage (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 diabetes control has greatly improved

recently.

• You have recently changed from animal insulin to a manufactured insulin, like there is in Suliqua.
• You are taking or have taken certain other medicines (see section 2, „Other medicines and Suliqua“).

In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.

What to do if you experience hypoglycaemia?

• 1. Do not inject Suliqua. Take about 15 to 20 grams sugar straight away – such as glucose, sugar cubes or a sugary drink. Drink or foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.

• 2. You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due. Ask your doctor or nurse if you are not sure which foods you should eat.

With Suliqua, it may take longer to recover from low blood sugar because it contains a long-acting insulin (insulin glargine).

• 3. 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 gram of sugar.

• 4. Speak to a doctor straightaway if you are not able to control the hypoglycaemia, or it comes back again.

What other people should do if you have hypoglycaemia

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 an injection of glucose or glucagon (a medicine which increases blood sugar). These injections should be given even if it is not certain that you have hypoglycaemia.

You should test your blood sugar straightaway after taking glucose to check that you really have hypoglycaemia.

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

INSTRUCTIONS FOR USE

Read the Package Leaflet 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 medicine from your pen. If you do, you may not get the correct amount of medicine.

Keep these Instructions For 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 STEP 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).

*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 cold medicine is more painful. After first use the pen will be stored at temperatures below 25°C.

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

• Make sure you have the correct medicine. This pen is olive coloured 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.

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.

• 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.

10 secs^

• 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.

• 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.