Suliqua

Patient Information Leaflet: Information for the User

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

insulin glargine + lixisenatide
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Suliqua is and what it is used for
2. What you need to know before using 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 insulin, which helps control blood sugar (glucose) throughout the day.
• lixisenatide – a GLP-1 analogue, which helps the body produce additional insulin in response to increased blood sugar levels and slows down the absorption of sugar from food.

Suliqua is used to treat adults with type 2 diabetes, in addition to diet and exercise, to help control blood glucose levels when they are too high. It is administered with metformin, with or without sodium-glucose co-transporter 2 (SGLT2) inhibitors (gliflozins), when other medicines are not sufficient to control blood glucose levels.

2. What you need to know before using 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 is not suitable for you.
• you have diabetic ketoacidosis (a diabetes complication that occurs when the body cannot use glucose due to insufficient insulin); this medicine is not appropriate for you.
• you have a serious stomach or intestinal problem, such as a stomach muscle disorder called "gastroparesis," which causes delayed stomach emptying. Since Suliqua may cause stomach-related side effects (see section 4), it has not been studied in patients with severe stomach or intestinal problems. See information about

medicines that should not remain in the stomach for too long in the section “Other medicines
and Suliqua ”.

• you are scheduled for surgery under anesthesia, inform your doctor that you are taking Suliqua.
• you have severe kidney disease or are on dialysis; in these cases, use of this medicine is not recommended.

Follow your doctor’s instructions carefully regarding dosage, monitoring (blood and urine tests), diet, physical activity (exercise), and injection technique.
Pay particular attention to the following:

• Low blood sugar levels (hypoglycaemia). If your blood glucose levels are too low, follow the guidelines for hypoglycaemia (see information in the box at the end of this leaflet).
• High blood sugar levels (hyperglycaemia). If your blood glucose levels are too high, follow the guidelines for hyperglycaemia (see information in the box at the end of this leaflet).
• Make sure you are using the correct medicine. Always check the label before each injection to avoid accidental mix-ups between Suliqua and other insulins.
• If you have vision problems, see section 3.

While using this medicine, be alert to the following events and consult your
doctor, pharmacist, or nurse before taking Suliqua:

• severe, persistent pain in the stomach area (abdomen). This could be a sign of an inflamed pancreas (acute pancreatitis).
• Loss of body fluids (dehydration), e.g., due to vomiting or diarrhoea. It is important to prevent dehydration by drinking plenty of fluids, especially during the first weeks of treatment with Suliqua.

Skin changes at the injection site:
Injection sites should be rotated to prevent skin changes such as lumps under the skin. Insulin may not work as effectively if injected into an area with lumps (see section How to use Suliqua). If you currently inject into an area with lumps, consult your doctor before switching to another injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin or other antidiabetic medicine doses.

Travel
Talk to your doctor before travelling. You may need to discuss the following:

• Whether the medicine is available in the country you are visiting.
• How to arrange supply of the medicine, needles, and other materials.
• How to store the medicine properly during travel.
• Meal times and medicine administration schedules.
• Possible effects of time zone changes.
• Any health risks in the countries you will visit.
• What to do in an emergency if you feel unwell or become ill.

Children and adolescents
There are no data on Suliqua in children and adolescents under 18 years of age; therefore, use of
Suliqua is not recommended in this age group.

Other medicines and Suliqua
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. If you are taking another antidiabetic medicine, discuss with your doctor whether you should stop using it when starting Suliqua.
Some medicines may affect your blood glucose levels. This may mean your doctor needs to adjust your Suliqua dose.
Therefore, before taking any medicine, ask your doctor whether, and how, it may affect your blood glucose and whether you need to take any precautions. Also, be cautious when stopping a medicine.
The effect of some oral medicines may be influenced by Suliqua. You may need to take certain medicines, such as antibiotics, oral contraceptives, statins (medicines like atorvastatin to lower cholesterol), tablets or capsules or granules or oral powders or gastro-resistant suspensions that should not remain in the stomach for too long, at least one hour before or four hours after the Suliqua injection.

Your blood sugar levels may decrease (hypoglycaemia) if you take:

• any other medicine for diabetes.
• disopyramide – for certain heart problems.
• fluoxetine – for depression.
• sulphonamide antibiotics – to treat infections.
• fibrates – to reduce high blood fat levels.
• monoamine oxidase inhibitors (MAOIs) – for depression or Parkinson’s disease.
• angiotensin-converting enzyme (ACE) inhibitors – for heart problems or high blood pressure.
• painkillers and fever-reducing medicines such as pentoxifylline, propoxyphene, and salicylates (such as acetylsalicylic acid).
• pentamidine – for certain parasitic infections. This may cause excessive lowering of blood glucose, sometimes followed by hyperglycaemia.

Your blood sugar levels may increase (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 extremely low blood glucose levels.
• isoniazid – for tuberculosis.
• somatropin – a growth hormone.
• thyroid hormones – for thyroid gland problems.
• oestrogens and progestogens – such as in oral contraceptives used for birth control or oestrogens used for bone loss (osteoporosis).
• clozapine, olanzapine, and phenothiazine derivatives – for mental health conditions.
• sympathomimetics such as epinephrine (adrenaline), salbutamol, and terbutaline – for asthma.

Your blood sugar levels may increase or decrease if you take:

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

Medicines that may affect warning signs of hypoglycaemia
Beta-blockers and other medicines (such as clonidine, guanethidine, and reserpine – for high blood pressure) may make it harder to recognize early warning signs that help you detect low blood sugar levels (hypoglycaemia). They may even mask or suppress the initial symptoms of hypoglycaemia.

If any of these situations apply to you, or if you have any doubts, talk to your doctor, pharmacist, or nurse before using this medicine.

Warfarin or other anticoagulants
Talk to your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent blood clotting), as you may need more frequent blood tests to monitor your blood thickness (known as INR or ‘International Normalised Ratio’ test).

Suliqua and alcohol
Your blood sugar levels may increase or decrease if you drink alcohol. You should check your blood glucose levels more often than usual.

Pregnancy and breastfeeding
Suliqua must not be used during pregnancy. It is not known whether Suliqua could be harmful to the unborn baby.
Suliqua must not be used during breastfeeding. It is not known whether Suliqua passes into breast milk.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Having blood sugar levels that are too low or too high (see information in the box at the end of this leaflet) may affect your ability to drive or operate machinery. Your concentration may be impaired. This could be dangerous for you and others.
Ask your doctor whether you may drive if:

• your blood glucose levels are often too low.
• you have difficulty recognizing when your blood glucose levels are too low.

Suliqua contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

Suliqua contains metacresol
This medicine contains metacresol, which may cause allergic reactions.

3. How to use Suliqua

Take this medicine exactly as instructed by your doctor. Your doctor may prescribe a different dose of Suliqua compared to your previous insulin dose or any other blood glucose-lowering medicine you were taking. If you have any doubts, consult your doctor, pharmacist, or nurse.
Based on your lifestyle, blood glucose test results, and prior insulin use, your doctor will advise you:

• The daily dose of Suliqua you need and the time of day to take it.
• When you should check your blood glucose levels and whether urine tests are necessary.
• Whether you need a lower or higher dose.

Your doctor may instruct you to use Suliqua together with other medicines for high blood glucose.
How much to use
Suliqua 100 units/mL + 50 micrograms/mL solution for injection in a pre-filled pen:

• This pen delivers a dose between 10 and 40 single doses in one injection, in 1-single-dose increments.
• Each selected single dose contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.

The dose of Suliqua is administered in “single doses.” The dose window on the pen displays the number of single doses.
Do not inject a dose lower than 10 single doses. Do not inject a dose higher than 40 single doses.
If a dose higher than 40 single doses is required, your doctor will prescribe a different dosing option. For single doses of 30–60 units, Suliqua 100 units/mL + 33 micrograms/mL injectable solution in a pre-filled pen is available.
Many factors affect blood glucose levels. You should be aware of these factors so you can take appropriate action if your levels fluctuate, to prevent them from 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 of age or older, speak with your doctor, as you may require a lower dose.
If you have liver or kidney problems
If you have liver or kidney problems, consult your doctor, as you may require a lower dose.
When to inject Suliqua
Suliqua must be used once daily, within 1 hour before a meal. Preferably, Suliqua should be injected daily before the same meal, once you have chosen the most convenient one.
Before injecting Suliqua

• Always read the “Instructions for Use” included with this package leaflet and use the pen as described.
• If you do not follow all instructions, you may administer too much or too little Suliqua.

To avoid errors, always check the packaging and labeling of the pen before each injection to ensure you have the correct pen, especially if you use more than one injectable medicine.
If you have any doubts, consult your doctor or pharmacist.
How to perform the injection

• Suliqua is injected under the skin (subcutaneous use or “SC”).
• Inject it into the front of your thighs, the upper arms, or the front of your waist (abdomen).
• Change the injection site within the area each day. This reduces the risk of developing dents or thickening at the injection site (for more information, see “Other side effects” in section 4).

Do not use Suliqua:

• if there are particles in the solution. The solution must be clear, colourless, and watery.

Other important information about the use of pre-filled pens

• Always use a new needle for each injection. Reusing needles increases the risk of blockage, which may lead to underdosing or overdosing. Discard needles after each use.
• To prevent possible transmission of infections from one person to another, pens must never be shared between individuals, even if the needle is changed.
• Use only needles compatible with the Suliqua pen (see “Instructions for Use”).
• Before each injection, a safety test must be performed.
• Dispose of used needles in a sharps container, or as directed by your pharmacist or local authorities.

Never use a syringe to withdraw solution from the pen, to avoid errors leading to underdosing or overdosing.
If the pen is damaged, has not been stored properly, you are unsure whether it is working correctly, or you notice your blood glucose control is unexpectedly worsening:

• discard the pen and use a new one.
• Consult your doctor, pharmacist, or nurse if you believe there is a problem with the pen.

If you use more Suliqua than you should
If you have injected too high a dose of this medicine, your blood sugar levels may become too low (hypoglycaemia). Check your blood glucose and eat more substantial meals to prevent blood sugar levels from becoming too low (hypoglycaemia). If your blood sugar levels become too low, follow the advice provided in the box at the end of this leaflet.
If you forget to use Suliqua
If you miss a dose of Suliqua or do not inject a sufficient dose of insulin, your blood sugar levels may become too high (hyperglycaemia).
When necessary, Suliqua may be injected before the next meal.

• Do not inject a double dose to make up for a missed dose.
• Do not administer two injections per day.
• Check your blood glucose, then inject your next dose at the usual time.
• For information on treating hyperglycaemia, see the box at the end of this leaflet.

If you stop using Suliqua
Do not stop using this medicine without consulting your doctor. Doing so may lead to very high blood sugar levels (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice signs of abnormally low blood sugar (hypoglycaemia), take immediate action to raise your blood sugar level (see the box at the end of this leaflet).
Hypoglycaemia can be very serious and is very common with medicines containing insulin (it may affect more than 1 in 10 people).
Low blood sugar means there is not enough sugar in the blood.
If blood sugar becomes too low, you may faint (lose consciousness).
If blood sugar remains too low for too long, it may damage the brain and can potentially be fatal.
See the box at the end of this leaflet for more information.

Other side effects
Contact 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 in the same spot, the skin may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis). The frequency of these skin changes is not known. Insulin may not work properly if you inject into an area with lumps. Change your injection site with each injection to help prevent these skin changes.

Common ( may affect up to 1 in 10 people)

• Dizziness
• Feeling unwell (nausea)
• Vomiting
• Diarrhoea
• Skin and allergic reactions at the injection site: signs may include redness, unusually strong pain during injection, itching, hives, swelling, or inflammation. These reactions may also spread around the injection site. Most mild reactions to insulin usually resolve within a few days to a few weeks.

Uncommon ( may affect up to 1 in 100 people)

• Cold, runny nose, sore throat
• Hives
• Headache
• Indigestion (dyspepsia)
• Stomach ache
• Fatigue
• Gallstones
• Inflamed gallbladder
• Altered taste

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

• Delayed stomach emptying

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Suliqua

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after the word "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 and do not place near the freezer compartment or next to a cooling pack.
Keep the pen in the outer carton to protect the medicine from light.
After first use
Store the pen in use at below 25 °C for a maximum of 28 days. Dispose of the pen after this period.
Do not return the pen to the refrigerator and do not freeze. Keep the pen protected from heat and direct light.
Always keep the pen cap on the pen when not in use to protect the medicine from light.
Do not leave the pen in a car on particularly hot or cold days.
Do not store the pen with the needle attached.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Suliqua contains

• The active substances are insulin glargine and lixisenatide. Each pen contains 300 units of insulin glargine and 150 micrograms of lixisenatide in 3 mL of solution. Each mL contains 100 units of insulin glargine and 50 micrograms of lixisenatide. Each single dose of Suliqua contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
• The other excipients 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 using Suliqua” for information on sodium and metacresol.

Description of the appearance of Suliqua and contents of the pack
Suliqua is a clear, colourless solution for injection (injection) contained in a glass cartridge
inserted into a prefilled pen (SoloStar).
Packs containing 3, 5 and 10 prefilled pens.
Not all pack sizes may be marketed.
Needles are not included in the pack.

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

Manufacturer:
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst-65926 Frankfurt am Main
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika Magyarország
Sanofi s.r.o. SANOFI-AVENTIS Zrt.
Tel: +420 233 086 111 Tel.: +36 1 505 0050

Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel.: 0800 52 52 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131

Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00

Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00

France Portugal
Sanofi Winthrop Industrie Sanofi - Produtos Farmacêuticos, Lda
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger : +33 1 57 63 23 23

Hrvatska România
Swixx Biopharma d.o.o. Sanofi Romania S.R.L.
Tel: +385 1 2078 500 Tel: +40 (0) 21 317 31 36

Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00

Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 131212 (technical enquiries) Puh/Tel: +358 (0) 201 200 300
800 536389 (other enquiries)

Κύπρος Sverige
C.A. Papaellinas Ltd Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00

Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6 616 47 50 Tel: +44 (0) 800 035 2525

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

• You are recovering from injuries, surgery, or other types of stress.
• You are recovering from an illness or fever.
• You are taking or have stopped taking certain other medicines (see section 2 “Other medicines and Suliqua”).

Hypoglycaemic episodes may also occur more frequently if:

• You have just started treatment with Suliqua – if hypoglycaemia occurs, it is more likely to happen in the morning.
• Your blood sugar levels are close to normal or are unstable.
• You have changed the area of skin where you inject Suliqua, for example from the thigh to the upper arm.
• You have severe kidney or liver disease, or other conditions such as hypothyroidism.

Warning signs of hypoglycaemia
The first signs may affect the body in general. Examples of symptoms indicating that blood sugar levels are dropping too low or too quickly include: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and palpitations. These symptoms often develop before those indicating reduced sugar levels in the brain.
Other symptoms include: headache, intense hunger, feeling unwell (nausea) or actual illness (vomiting), tiredness, drowsiness, restlessness, sleep disturbances, aggression, difficulty concentrating, slow reflexes, depression, feeling confused, difficulty speaking (sometimes aphasia), visual disturbances, trembling, inability to move (paralysis), tingling sensations in the hands or arms, numbness and tingling often around the mouth, dizziness, loss of self-control, inability to care for oneself, seizures, fainting.

When warning signs of hypoglycaemia may be less evident:
The early warning signs of hypoglycaemia may vary, be less obvious, or even completely absent if:

• You are elderly.
• You have had diabetes for a long time.
• You suffer from a certain type of nerve disease (called "diabetic autonomic neuropathy").
• After a recent hypoglycaemic episode (e.g. the day before).
• If hypoglycaemia develops slowly.
• If blood glucose levels are almost always normal or if diabetes control has recently improved significantly.
• If you have recently switched from animal-sourced insulin to an insulin produced as in Suliqua.
• You are taking or have taken certain other medicines (see section 2 “Other medicines and Suliqua”).
  In these cases, you may develop severe hypoglycaemia (even with loss of consciousness) before realizing what is happening. Learn to recognize the warning signs. If necessary, check your blood glucose levels more frequently. This may help detect mild hypoglycaemic episodes. If you are unable to recognize the warning signs, avoid any activities (such as driving) that could be dangerous for you and others due to hypoglycaemia.

What to do in case of hypoglycaemia?

1. Do not inject Suliqua. Immediately take 15 to 20 g of sugar, such as glucose tablets, sugar cubes, or a sugary drink. Drinking or consuming artificially sweetened foods or drinks (such as diet beverages) will not help treat hypoglycaemia.
2. You may need to eat food that causes a prolonged rise in blood sugar (such as bread or pasta), especially if your next meal is still some time away. Consult your doctor or nurse if you are unsure about which foods to consume.
   With Suliqua, recovery from hypoglycaemia may be delayed because it contains long-acting insulin (insulin glargine).
3. Check your blood sugar levels 10–15 minutes after taking sugar. If blood sugar levels are still too low (< 4 mmol/L) or if hypoglycaemia recurs, take another 15 to 20 grams of sugar.
4. Contact your doctor as soon as you realize you are unable to control hypoglycaemia or if it recurs.

What other people should do if you have a hypoglycaemic episode
Inform your close family members, friends, and colleagues to contact a doctor immediately if you are unable to swallow or if you faint (lose consciousness).
Glucose or glucagon (a medicine that raises blood sugar levels) must be administered. These should be given even if it is not certain that a hypoglycaemic event has occurred.
It is advisable to check blood glucose levels immediately after administering sugar to confirm that a hypoglycaemic episode was indeed occurring.
Suliqua 100 units/mL + 50 micrograms/mL injectable solution 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. This combination
medicine in the pen is for daily injection of single doses ranging from 10 to 40 units of Suliqua.

• Never reuse needles. Otherwise, the full dose may not be delivered (underdosing) or too much medicine may be delivered (overdosing), as the needle could become blocked.
• Never use a syringe to withdraw medicine from the pen. Otherwise, the correct amount of medicine may not be administered.

Keep these Instructions for Use for future reference.
Important information

• Do not share your pen with anyone – it is intended for your use only.
• Never use the pen if it is damaged or if you are unsure whether it works properly.
• Always perform a safety test. See STEP 3.
• Always carry a spare pen and needles with you, as you may lose them or they may not work properly.
• Always check the label on the pen before use to make sure you have the correct pen.

Learn how to perform the injection:

• Ask your doctor, pharmacist, or nurse to show you how to inject before using the pen.
• Ask for help if you have difficulty handling the pen, for example, if you have vision problems.
• Read these instructions in full before using the pen. If you do not follow all instructions, you may administer too much or too little medicine.

Need help?
If you have questions about Suliqua, the pen, or diabetes, contact your doctor, pharmacist, or
nurse.
Additional supplies you will need:

• A new sterile needle (see STEP 2).
• A sharps container for used needles (see Disposal of the pen).

Injection sites

Upper arms
Abdomen
Thighs
Know your pen

* The plunger will only be visible after several doses have been injected
STEP 1: Check the pen
For first use of a new pen, remove it from the refrigerator at least 1 hour before injection.
Injecting cold medicine causes more pain during injection. After first use, the pen
should be stored at temperatures below 25 °C.
A. Check the name and expiry date on the pen label.

• Make sure you have the correct medicine. The pen is peach-coloured with an orange injection button.
• Do not use this pen if you require a daily dose of less than 10 units or more than 40 units. Discuss with your doctor which pen is suitable for your needs.
• Do not use the pen after the expiry date.

B. Remove the pen cap.

C. Check that the medicine is clear.

• Carefully inspect the transparent cartridge holder. Do not use the pen if the medicine appears cloudy, discoloured, or contains particles.

STEP 2: Attach a new needle

• Do not reuse needles. Always use a new sterile needle for each injection. This helps prevent blocked needles, contamination, and infections.
• Always use needles compatible for use with the Suliqua pen.

A. Take a new needle and remove the protective seal.

B. Hold the needle straight and screw it onto the pen, tightening it securely. Do not
overtighten.

C. Remove the outer needle cap. Set it aside for reuse later.

D. Remove the inner needle cap and discard it.
If you try to replace it, you may accidentally prick yourself with the needle.

How to handle needles

• Be careful when handling needles to avoid injury and transmission of infections.

STEP 3: Perform a safety test
Always perform a safety test before each injection to:

• Check the pen and needle to ensure they are working properly
• Ensure you deliver the correct dose.

A. Select 2 units by turning the dose selector until the dose indicator lines up with the 2 mark.

B. Press the injection button fully.

• When medicine appears at the tip of the needle, the pen is working correctly and the dose selector will return to “0”.

If no liquid appears

• You may need to repeat this step up to 3 times before seeing medicine.
• If medicine still does not appear after the third attempt, the needle may be blocked. In this case:
  • change the needle ( see STEP 6 and STEP 2 ),
  • then repeat the safety test ( STEP 3 ).
• Do not use the pen if medicine still does not appear at the needle tip. Use a new pen.
• Do not use a syringe to withdraw medicine from the pen.

If air bubbles are seen

• The medicine may contain air bubbles. This is normal and not harmful.

STEP 4: Select the dose

• Use this pen only to inject single daily doses from 10 to 40 units.
• Do not select a dose or press the injection button without a needle attached, as the pen may be damaged.

A. Ensure the needle is attached and the dose is set to ‘0’.

B. Turn the dose selector until the dose indicator lines up with the dose to be injected.

• If you go past your prescribed dose, you can turn the selector back.
• If there are not enough units remaining in the pen for your full dose, the dose selector will stop at the number of units remaining.
• If you cannot select the full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete the dose. Only in this case, it is allowed to inject a partial dose of less than 10 units. Always use another Suliqua (10-40) SoloStar pen to complete the dose and no other pen.

How to read the dose window

• Even numbers align with the dose indicator; odd numbers are shown as a line between even numbers.

29 units selected

• Do not use the pen if the daily single dose is less than 10 units, shown as white numbers on a black background.

Medicine units in the pen

• The pen contains a total of 300 units. Doses can be selected in 1-unit increments.
• Do not use this pen if you require a single daily dose of less than 10 units or more than 40 units. Discuss with your doctor which pen is suitable for your needs.
• Each pen is used for more than one administration.

STEP 5: Inject the dose

• If you have difficulty pressing the injection button, do not force it, as the pen may break.
• Change the needle ( see STEP 6 Remove the needle and STEP 2 Attach a new needle) then perform a safety test ( see STEP 3 ).
• If pressing remains difficult, use a new pen.
• Do not use a syringe to withdraw medicine from the pen.

A. Choose an injection site as shown in the image above.
B. Push the needle into the skin as shown by your doctor, pharmacist, or nurse.

• Do not press the injection button yet.

C. Place your thumb on the injection button, then press it fully and hold it down.

• Do not press sideways. Your thumb may prevent the dose selector from rotating.

D. Keep holding the injection button down and, when “0” appears in the dose window,
count slowly to 10.

• This ensures the device delivers the full dose.

E. After holding the button and counting slowly to 10, release the
injection button. Then remove the needle from the skin.
STEP 6: Remove the needle

• Be careful when handling needles to avoid injury and transmission of infections.
• Do not reattach the inner needle cap.

A. Grasp the wider part of the outer needle cap. Hold the needle straight and guide it
into the outer needle cap. Then press firmly to secure it.

• The needle may pierce the cap if inserted at an angle.

B. Hold and press the wider part of the outer needle cap. Rotate the pen several times using the other hand to unscrew the needle.

• Repeat if the needle does not detach the first time.

C. Dispose of the used needle in a puncture-resistant sharps container (see “ Disposal
of the pen ” at the end of these Instructions for Use).

D. Replace the pen cap.

• Do not return the pen to the refrigerator.

How to store the pen
Before first use

• Store new pens in the refrigerator at a temperature between 2 °C and 8 °C.
• Do not freeze.

After first use

• Store the pen at room temperature, below 25 °C.
• Do not return the pen to the refrigerator.
• Do not store the pen with the needle attached.
• Store the pen with the cap on.
• Use the pen within 28 days after first use.

Pen maintenance
Always handle the pen carefully

• If you think the pen may be damaged, do not attempt to repair it. Use a new pen.

Protect the pen from dust and dirt

• The outside of the pen may be cleaned with a damp cloth (water only). Do not immerse, wash, or lubricate the pen, as it may be damaged.

Disposal of the pen

• Remove the needle before disposing of the pen.
• Dispose of the used pen as instructed by your pharmacist or local authorities.

Patient Information Leaflet: Information for the user

Suliqua 100 units/mL + 33 micrograms/mL solution for injection in pre-filled pen

insulin glargine + lixisenatide
Please read this leaflet carefully before using this medicine because it contains
important information for you.

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

Contents of this leaflet

1. What Suliqua is and what it is used for
2. What you need to know before using 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 medicine for diabetes that contains two active substances:

• insulin glargine – a long-acting insulin, which helps control blood sugar (glucose) throughout the day.
• lixisenatide – a GLP-1 analogue, which helps the body produce additional insulin in response to increased blood sugar levels and slows down the absorption of sugar from food.

Suliqua is used to treat adults with type 2 diabetes, in addition to diet and exercise, to help control blood glucose levels when they are too high. It is administered together with metformin, with or without sodium-glucose co-transporter 2 (SGLT2) inhibitors (gliflozins), when other medicines are not sufficient to control blood glucose levels.

2. What you need to know before using 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 is not suitable for you.

• you have diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot process glucose due to insufficient insulin), as this medicine is not suitable for you.

• you have a serious stomach or intestinal problem, such as a stomach muscle disorder called "gastroparesis," which causes delayed stomach emptying. Since Suliqua may cause unwanted effects on the stomach (see section 4.4), this medicine
  has not been studied in patients with severe stomach or intestinal problems. Refer to
  the information about medicines that should not remain in the stomach too long in the section
  “Other medicines and Suliqua”.

• if you are undergoing surgery requiring anaesthesia (being put to sleep), inform your doctor that you are taking Suliqua.

• you have severe kidney disease or are on dialysis; in these cases, use of this medicine is not recommended.

Carefully follow your doctor's instructions regarding dosage, monitoring (blood and urine tests), diet, physical activity (exercise and physical activities), and injection technique.
Pay particular attention to the following:

• Low blood sugar levels (hypoglycaemia). If your blood sugar levels are too low, follow the guidelines for hypoglycaemia (see information in the box at the end of this leaflet).
• High blood sugar levels (hyperglycaemia). If your blood sugar levels are too high, follow the guidelines for hyperglycaemia (see information in the box at the end of this leaflet).
• Make sure you are using the correct medicine. Always check the label before each injection to avoid accidental mix-ups between Suliqua and other insulins.
• If you have vision problems, see section 3.

While using this medicine, be alert for the following events and consult your
doctor, pharmacist, or nurse before taking Suliqua:

• severe, persistent pain in the stomach area (abdomen). This could be a sign of an inflamed pancreas (acute pancreatitis).
• Loss of body fluids (dehydration), e.g., due to vomiting or diarrhoea. It is important to prevent dehydration by drinking plenty of fluids, especially during the first weeks of treatment with Suliqua.

Skin changes at the injection site:
Rotate your injection site to prevent skin changes such as the appearance of
lumps under the skin. Insulin may not work as effectively if you inject into
an area with lumps (see section How to use Suliqua). If you currently inject into
an area with lumps, consult your doctor before switching to another injection site. Your
doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or
other antidiabetic medicines.

Travel
Talk to your doctor before travelling. You may need to discuss the following:

• Whether your medicine is available in the country you are visiting.
• How to arrange supply of your medicine, needles, and other materials.
• How to properly store your medicine while travelling.
• The times at which you will eat meals and take your medicine.
• Possible effects of time zone changes.
• Any health risks in the countries you will visit.
• What to do in case of an emergency if you feel unwell or become ill.

Children and adolescents
There are no data on Suliqua in children and adolescents under 18 years of age; therefore, use of
Suliqua is not recommended in this age group.

Other medicines and Suliqua
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. If you are taking another antidiabetic medicine, discuss with your
doctor whether you should discontinue it when starting Suliqua.
Some medicines can cause changes in blood sugar levels, which may mean your doctor needs to adjust your Suliqua dose. Therefore, before taking any medicine, ask your doctor whether, and how, it may affect your blood sugar and whether precautions are needed. Also, exercise caution when stopping a medicine.
The effect of some oral medicines may be influenced by Suliqua. You may need to take certain medicines, such as antibiotics, oral contraceptives, statins (medicines like atorvastatin for lowering cholesterol), tablets, capsules, granules, oral powders, or gastro-resistant suspensions that should not remain in the stomach too long, at least one hour before or four hours after the Suliqua injection.

Your blood sugar levels may decrease (hypoglycaemia) if you take:

• any other medicine for diabetes.
• disopyramide – for certain heart conditions.
• fluoxetine – for depression.
• sulphonamide antibiotics – to treat infections.
• fibrates – to reduce high blood fat levels.
• monoamine oxidase inhibitors (MAOIs) – for depression or Parkinson’s disease.
• angiotensin-converting enzyme (ACE) inhibitors – for heart problems or high blood pressure.
• painkillers and fever-reducing medicines such as pentoxifylline, propoxyphene, and salicylates (such as acetylsalicylic acid).
• pentamidine – for certain parasitic infections. This may cause excessive lowering of blood sugar, sometimes followed by hyperglycaemia.

Your blood sugar levels may increase (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 extremely low blood sugar levels.
• isoniazid – for tuberculosis.
• somatropin – a growth hormone.
• thyroid hormones – for thyroid gland problems.
• oestrogens and progestogens – such as in birth control pills or oestrogen use for bone loss (osteoporosis).
• clozapine, olanzapine, and phenothiazine derivatives – for mental health conditions.
• sympathomimetics such as epinephrine (adrenaline), salbutamol, and terbutaline – for asthma.

Your blood sugar levels may increase or decrease if you take:

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

Medicines that may affect the warning signs of hypoglycaemia
Beta-blockers and other medicines (such as clonidine, guanethidine, and reserpine – for high blood pressure)
may make it difficult to recognize early warning signs that help you detect low blood sugar levels (hypoglycaemia). They may even mask or stop early symptoms of hypoglycaemia.

If any of these situations apply to you, or if you have any doubts, talk to your doctor, pharmacist, or nurse
before using this medicine.

Warfarin or other anticoagulants
Talk to your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent blood clotting), as you may need to have blood tests more frequently to measure your blood's clotting ability (known as the INR or 'International Normalised Ratio' test).

Suliqua and alcohol
Your blood sugar levels may rise or fall if you drink alcohol. You should check your blood sugar levels more often than usual.

Pregnancy and breastfeeding
Suliqua must not be used during pregnancy. It is not known whether Suliqua may harm the unborn baby.
Suliqua must not be used during breastfeeding. It is not known whether Suliqua passes into breast milk.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Having blood sugar levels that are too low or too high (see information in the box at the end of this leaflet) may affect your ability to drive or use machines. Your concentration may be impaired. This could be dangerous for you and others.
Ask your doctor whether you may drive if:

• your blood sugar levels are often too low.
• you find it difficult to recognize when your blood sugar levels are too low.

Suliqua contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

Suliqua contains metacresol
This medicine contains metacresol, which may cause allergic reactions.

3. How to use Suliqua

Take this medicine exactly as directed by your doctor. Your doctor may prescribe a different dose of Suliqua compared to your previous insulin dose or any other blood glucose-lowering medicine you were taking. If you have any doubts, consult your doctor, pharmacist, or nurse.

Based on your lifestyle, blood glucose test results, and prior insulin use, your doctor will advise you:

• The daily dose of Suliqua you need and the time of day to take it.
• When you should check your blood glucose and whether you need to perform additional urine tests.
• Whether you require a lower or higher dose.

Your doctor may instruct you to use Suliqua together with other medicines for high blood glucose.

How much to use
Suliqua 100 units/mL + 33 micrograms/mL solution for injection in a pre-filled pen:

• This pen delivers a dose ranging from 30 to 60 single doses in one injection, in increments of 1 single dose.
• Each selected single dose contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.

The dose of Suliqua is administered in “single doses.” The dose window on the pen displays the number of single doses.
Do not inject a dose lower than 30 single doses. Do not inject a dose higher than 60 single doses.
If a dose lower than 30 single doses is required, your doctor will prescribe a different dosing option. For single doses from 10 to 40, Suliqua 100 units/mL + 50 micrograms/mL injectable solution in a pre-filled pen is available.

Many factors affect blood glucose levels. You should be aware of these factors so you can take appropriate corrective actions if your levels fluctuate, to avoid them 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 of age or older, consult your doctor as you may require a lower dose.

If you have liver or kidney problems
If you have liver or kidney problems, consult your doctor as you may require a lower dose.

When to inject Suliqua
Suliqua should be used once daily, within 1 hour before a meal. Preferably, Suliqua should be injected daily before the same meal once you have chosen the most convenient one.

Before injecting Suliqua

• Always read the “Instructions for Use” provided with this leaflet and use the pen as described.
• If you do not follow all instructions, you may administer too much or too little Suliqua.

To avoid mistakes, always check the packaging and labeling of the pen before each injection to ensure you have the correct pen, especially if you use more than one injectable medicine.
If you have any doubts, consult your doctor or pharmacist.

How to perform the injection

• Suliqua is injected under the skin (subcutaneous use or “SC”).
• Inject it into the front of the thighs, upper arms, or the front of the waist (abdomen).
• Change the injection site within the area each day. This reduces the risk of developing dents or thickened skin at the injection site (for more information, see “Other side effects” in section 4).

Do not use Suliqua
if there are particles in the solution. The solution should be clear, colourless, and watery.

Other important information about the use of pre-filled pens

• Always use a new needle for each injection. Reusing needles increases the risk of blockage, which may lead to under- or overdosing. Discard needles after each use.
• To prevent possible transmission of infections from one person to another, pens must never be shared between individuals, even if the needle is changed.
• Use only needles compatible with the Suliqua pen (see “Instructions for Use”).
• Before each injection, a safety test must be performed.
• Dispose of used needles in a sharps container, or as directed by your pharmacist or local authorities.

Never use a syringe to withdraw solution from the pen, as this may lead to dosing errors (under- or overdosing).

If the pen is damaged, has not been stored correctly, you are unsure whether it functions properly, or you notice your blood glucose control is unexpectedly worsening:

• Discard the pen and use a new one.
• Consult your doctor, pharmacist, or nurse if you believe there is a problem with the pen.

If you use more Suliqua than you should
If you have injected too high a dose of this medicine, your blood sugar levels may become too low (hypoglycaemia). Check your blood glucose and eat more substantial meals to prevent your blood sugar from dropping too low (hypoglycaemia). If your blood sugar levels do become too low, follow the advice provided in the box at the end of this leaflet.

If you forget to use Suliqua
If you miss a dose of Suliqua or have not injected a sufficient dose of insulin, your blood sugar levels may become too high (hyperglycaemia).
When necessary, Suliqua can be injected before the next meal.

• Do not inject a double dose to make up for a missed dose.
• Do not administer two injections in one day.
• Check your blood glucose, then inject your next dose at the usual time.
• For information on managing hyperglycaemia, see the box at the end of this leaflet.

If you stop using Suliqua
Do not stop using this medicine without consulting your doctor. Doing so may lead to very high blood sugar levels (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).
If you have any doubts about using this medicine, consult 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 abnormally low blood sugar (hypoglycaemia), take immediate action to raise your blood sugar level (see the boxed information at the end of this leaflet).
Hypoglycaemia can be very serious and is very common with insulin-containing medicines (may affect more than 1 in 10 people).
Low blood sugar means there is not enough sugar in the blood.
If blood sugar becomes too low, you may faint (lose consciousness).
If blood sugar remains too low for too long, it may damage the brain and can potentially be fatal.
See the boxed information at the end of this leaflet for further details.

Other side effects
Contact your doctor, pharmacist, or nurse if you experience any of the following side effects:

• Skin changes at the injection site

If you inject insulin too often in the same spot, the skin may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis). The frequency of these skin changes is unknown. Insulin may not work as well if you inject into an area with lumps. Change the injection site with each injection to help prevent these skin changes.

Common ( may affect up to 1 in 10 people)

• Dizziness
• Feeling unwell (nausea)
• Vomiting
• Diarrhoea
• Skin and allergic reactions at the injection site: signs may include redness, unusually strong pain during injection, itching, hives, swelling, or inflammation. These reactions may also spread around the injection site. Most mild reactions to insulin usually resolve within a few days to a few weeks.

Uncommon ( may affect up to 1 in 100 people)

• Cold, runny nose, sore throat
• Hives
• Headache
• Indigestion (dyspepsia)
• Stomach ache
• Fatigue
• Gallstones
• Inflamed gallbladder
• Taste disturbance

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

• Delayed stomach emptying

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Suliqua

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following the word “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 and do not place near the freezer compartment or next to a cooling pack.
Keep the pen in its outer packaging to protect the medicine from light.
After first use
Store the pen in use at below 25 °C for up to 28 days. Dispose of the pen after this period.
Do not return the pen to the refrigerator and do not freeze. Store the pen away from direct heat or light. Always keep the pen cap on when not in use to protect the medicine from light.
Do not leave the pen in a car on particularly hot or cold days.
Do not store the pen with the needle attached.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Suliqua contains

• The active substances are insulin glargine and lixisenatide. Each pen contains 300 units of insulin glargine and 100 micrograms of lixisenatide in 3 mL of solution. Each mL contains 100 units of insulin glargine and 33 micrograms of lixisenatide. Each single dose 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 (to adjust pH), and water for injections. See also section 2 “What you need to know before using Suliqua” for information on sodium and metacresol.

Description of the appearance of Suliqua and contents of the pack
Suliqua is a clear, colourless injectable solution contained in a glass cartridge within a pre-filled pen (SoloStar).
Packs 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 Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst-65926 Frankfurt am Main
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika Magyarország
Sanofi s.r.o. SANOFI-AVENTIS Zrt.,
Tel: +420 233 086 111 Tel.: +36 1 505 0050

Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel: 0800 52 52 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131

Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00

Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00

France Portugal
Sanofi Winthrop Industrie Sanofi - Produtos Farmacêuticos, Lda
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger : +33 1 57 63 23 23

Hrvatska România
Swixx Biopharma d.o.o. Sanofi-aventis Romania S.R.L.
Tel: +385 1 2078 500 Tel: +40 (0) 21 317 31 36

Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00

Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (technical enquiries) Puh/Tel: +358 (0) 201 200 300
800 536389 (other enquiries)

Κύπρος Sverige
C.A. Papaellinas Ltd Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00

Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6 616 47 50 Tel: +44 (0) 800 035 2525

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

• You are doing more physical exercise than usual, or a different type of physical activity.
• You are recovering from injuries, surgery, or other types of stress.
• You are recovering from an illness or fever.
• You are taking or have stopped taking certain other medicines (see section 2 “Other medicines and Suliqua”).

Hypoglycaemic episodes may also be more likely if:

• You have recently started treatment with Suliqua – if hypoglycaemia occurs, it is more likely to happen in the morning.
• Your blood sugar levels are close to normal or are unstable.
• You have changed the area of skin where you inject Suliqua, for example from the thigh to the upper arm.
• You have severe kidney or liver disease, or other medical conditions such as hypothyroidism.

Warning signs of hypoglycaemia
The first signs may affect the body in general. Examples of signs indicating that blood sugar levels are dropping too low or too quickly include sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and palpitations. These signs often develop before those indicating reduced sugar levels in the brain.
Other signs include: headache, intense hunger, feeling unwell (nausea) or illness (vomiting), tiredness, drowsiness, restlessness, sleep disturbances, aggression, difficulty concentrating, slow reflexes, depression, confusion, difficulty speaking (sometimes aphasia), vision changes, trembling, inability to move (paralysis), tingling sensations in the hands or arms, numbness and tingling often around the mouth, dizziness, loss of self-control, inability to care for yourself, seizures, fainting.

When hypoglycaemia warning signs may be less evident:
Early warning signs of hypoglycaemia may vary, be less obvious, or even completely absent if:

• You are elderly.
• You have had diabetes for a long time.
• You suffer from a certain type of nerve damage (called “diabetic autonomic neuropathy”).
• You have recently experienced a hypoglycaemic episode (e.g. the day before).
• Hypoglycaemia develops slowly.
• Your blood glucose levels are almost always normal, or your diabetes control has recently improved significantly.
• You have recently switched from animal-source insulin to an insulin produced as in Suliqua.
• You are taking or have taken certain other medicines (see section 2 “Other medicines and Suliqua”).
  In these cases, you may develop severe hypoglycaemia (even leading to unconsciousness) before realizing what is happening. Learn to recognize your warning signs. If necessary, check your blood glucose levels more frequently. This may help detect mild hypoglycaemic episodes. If you are unable to recognize warning signs, avoid situations (such as driving) that could be dangerous for you and others due to hypoglycaemia.

What to do in case of hypoglycaemia?

1. Do not inject Suliqua. Immediately take 15 to 20 g of sugar, such as glucose tablets, sugar cubes, or a sugary drink. Drinking or consuming artificially sweetened foods or drinks (such as diet beverages) will not help treat hypoglycaemia.
2. You may need to eat food that causes a prolonged rise in blood sugar (such as bread or pasta), especially if your next meal is still some time away. Consult your doctor or nurse if you are unsure about which foods to consume.
   With Suliqua, recovery from hypoglycaemia may be delayed because it contains long-acting insulin (insulin glargine).
3. Check your blood sugar 10–15 minutes after taking sugar. If blood sugar levels are still too low (< 4 mmol/L) or hypoglycaemia recurs, take another 15 to 20 grams of sugar.
4. Contact your doctor as soon as possible if you are unable to control hypoglycaemia or if it recurs.

What should other people do if you have a hypoglycaemic episode?
Inform your close family members, friends, and colleagues to contact a doctor immediately if you are unable to swallow or if you faint (lose consciousness).
Glucose or glucagon (a medicine that raises blood sugar levels) must be administered, even if it is not certain that a hypoglycaemic event has occurred.
It is advisable to check blood glucose levels immediately after administering sugar to confirm that a hypoglycaemic episode was occurring.

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 pen (30-60) (SoloStar) contains insulin glargine and lixisenatide. The combination of
medicines in this pen is intended for daily injection of 30 to 60 single doses of Suliqua.

• Never reuse needles. Otherwise, the full dose may not be delivered (underdosing) or too much medicine may be delivered (overdosing), because the needle could become blocked.
• Never use a syringe to withdraw medicine from the pen. Otherwise, the correct amount of medicine may not be administered.

Keep this Instructions for Use leaflet for future reference.
Important information

• Do not share your pen with anyone else – it is intended for your use only.
• Never use the pen if it is damaged or if you are unsure whether it is working properly.
• Always perform a safety test. See STEP 3.
• Always carry a spare pen and replacement needles with you, in case you lose them or they do not work properly.
• Always check the label on the pen before use to make sure you have the correct pen.

Learn how to perform the injection:

• Ask your doctor, pharmacist, or nurse to teach you how to perform the injection before using the pen.
• Ask for help if you have difficulty handling the pen, for example, if you have vision problems.
• Read these instructions completely before using the pen. If you do not follow all instructions, you may administer too much or too little medicine.

Need help?
If you have questions about Suliqua, the pen, or diabetes, contact your doctor, pharmacist, or
nurse.
Additional materials you will need:

• A new sterile needle (see STEP 2).
• A sharps container for used needles (see Disposal of the pen).

Injection sites

Upper arms
Abdomen
Thighs
Get to know the pen

* The plunger will only be visible after several doses have been injected.
STEP 1: Check the pen
For first use of a new pen, remove it from the refrigerator at least 1 hour before injection.
Injecting cold medicine causes more pain during injection. After first use, the pen
should be stored at temperatures below 25 °C.
A. Check the name and expiry date on the pen label.

• Make sure you have the correct medicine. The pen is olive-coloured with a brown injection button.
• Do not use this pen if you require a daily dose of less than 30 single doses or more than 60 single doses. Discuss with your doctor which pen is suitable for your needs.
• Do not use the pen after the expiry date.

B. Remove the pen cap.

C. Check that the medicine is clear.

• Carefully inspect the transparent cartridge holder. Do not use the pen if the medicine appears 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 prevent blocked needles, contamination, and infections.
• Always use needles compatible for use with the Suliqua pen.

A. Take a new needle and remove the protective seal.

B. Hold the needle straight and screw it onto the pen, securing it firmly. Do not
overtighten.

C. Remove the outer needle cap. Keep it aside for reuse later.

D. Remove the inner needle cap and discard it.
If you try to replace it, you could accidentally prick yourself with the needle.

How to handle needles

• Be careful when handling needles to avoid injury and transmission of infections.

STEP 3: Perform a safety test
Always perform a safety test before each injection to:

• Check the pen and needle to ensure they are working properly.
• Ensure you deliver the correct dose.

A. Select 2 single units by rotating the dose selector until the dose indicator lines up with the “2” mark.

B. Press the injection button fully.

• When medicine appears at the tip of the needle, the pen is working correctly, and the dose selector will return to “0”.

If no liquid appears:

• You may need to repeat this step up to 3 times before seeing medicine.
• If medicine still does not appear after the third attempt, the needle may be blocked. In this case:
  • change the needle ( see STEP 6 and STEP 2 ),
  • then repeat the safety test ( STEP 3 ).
• Do not use the pen if medicine still does not appear at the needle tip. Use a new pen.
• Do not use a syringe to withdraw medicine from the pen.

If air bubbles are seen

• The medicine may contain air bubbles. This is normal and not dangerous.

STEP 4: Select the dose

• Use this pen only to inject single daily doses ranging from 30 to 60 single units.
• Do not select a dose or press the injection button without first attaching a needle, as the pen could be damaged.

A. Confirm that the needle is attached and that the dose is set to ‘0’.

B. Rotate the dose selector until the dose indicator aligns with the dose to be injected.

• If you go past the required dose, you can turn the selector backwards.
• If there are not enough single units remaining in the pen for your full dose, the dose selector will stop at the number of remaining units.
• If you cannot select the full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete the dose. Only in this case, it is acceptable to inject a partial dose of less than 30 single units. Always use another Suliqua (30-60) SoloStar pen to complete the dose and no other pen.

How to read the dose window

• Even numbers are aligned with the dose indicator; odd numbers are shown as a line between even numbers.

39 units selected

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

Medicine units in the pen

• The pen contains a total of 300 single units. You can select doses in 1-unit increments.
• Do not use this pen if you require a single daily dose of less than 30 single units or more than 60 single units. Discuss with your doctor which pen is suitable for your needs.
• Each pen is intended for multiple administrations.

STEP 5: Inject the dose

• If you have difficulty pressing the injection button, do not force it, as the pen may break.
• Change the needle (see STEP 6 Remove the needle and STEP 2 Attach a new needle), then perform a safety test (see STEP 3).
• If pressing remains difficult, use a new pen.
• Do not use a syringe to withdraw medicine from the pen.

A. Choose an injection site as shown in the image above.
B. Push the needle into the skin as shown by your doctor, pharmacist, or nurse.

• Do not press the injection button yet.

C. Place your thumb on the injection button, then press it fully and hold it down.

• Do not press sideways. Your thumb may prevent the dose selector from rotating.

D. Keep the injection button pressed down and when “0” appears in the dose window, count slowly to 10.

• This ensures the device delivers the full dose.

E. After holding the button down and counting slowly to 10, release the
injection button. Then remove the needle from the skin.
STEP 6: Remove the needle

• Be careful when handling needles to avoid injury and transmission of infections.
• Do not reattach the inner needle cap.

A. Hold the wider part of the outer needle cap. Hold the needle straight and guide it
into the outer needle cap. Then press firmly to secure it.

• The needle may pierce the cap if inserted at an angle.

B. Hold and press the wider part of the outer needle cap. Rotate the pen several times using the other hand to unscrew the needle.

• Repeat if the needle does not detach on the first attempt.

C. Dispose of the used needle in a puncture-resistant container (see “ Disposal
of the pen ” at the end of these Instructions for Use).

D. Replace the pen cap.

• Do not return the pen to the refrigerator.

How to store the pen
Before first use

• Store new pens in the refrigerator at a temperature between 2 °C and 8 °C.
• Do not freeze.

After first use

• Store the pen at room temperature, below 25 °C.
• Do not return the pen to the refrigerator.
• Do not store the pen with the needle attached.
• Store the pen with the cap attached.
• Use the pen for a maximum of 28 days after first use.

Pen maintenance
Always handle the pen carefully

• If you think the pen may be damaged, do not attempt to repair it. Use a new one.

Protect the pen from dust and dirt

• The outside of the pen may be cleaned with a damp cloth (water only). Do not immerse, wash, or lubricate the pen, as it may be damaged.

Disposal of the pen

• Remove the needle before disposing of the pen.
• Dispose of the used pen as instructed by your pharmacist or local authorities.