Soliqua 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.

Soliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high, it is an adjunct to diet and exercise.

It is given, with metformin with or without sodium-glucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when other medicines are not enough on their own to control your blood sugar levels.

Do not use Soliqua:
- 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 Soliqua if:

• you have type 1 diabetes, as Soliqua 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 Soliqua 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 Soliqua”.

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

Take Special care with Soliqua

Talk to your doctor, pharmacist or nurse before using Soliqua if

·               you have type 1 diabetes, as Soliqua 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 Soliqua may cause stomach side effects, 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 Soliqua.

·               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 Soliqua 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 Soliqua:

• 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 Soliqua.

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 Soliqua). 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 Soliqua in children and adolescents aged less than 18 years; therefore, the use of Soliqua is not recommended in this age group.

Other medicines and Soliqua:
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 Soliqua.

Some medicines can change your blood sugar level. This may mean your doctor may need to change your Soliqua 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 Soliqua. 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 Soliqua 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.

Soliqua 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: 
Soliqua should not be used during pregnancy. It is not known if Soliqua harms your unborn child.
Soliqua should not be used if breast-feeding. It is not known if Soliqua 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.

Soliqua contains sodium:

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

Soliqua contains metacresol:
This medicine contains metacresol which may cause allergic reactions.

Always use this medicine exactly as your doctor has told you. Your doctor may tell you to use a different dose of Soliqua 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 Soliqua 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 Soliqua with other medicines for high blood sugar.

How much to use:

The Soliqua 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 Soliqua 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, Soliqua 100 units/ml + 50 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 Soliqua:
Use Soliqua once a day, within 1 hour before a meal. Preferably inject Soliqua before the same meal every day, when you have chosen the most convenient meal.

Before injecting Soliqua:

• 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 Soliqua.

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:

• Soliqua 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 Soliqua:
• If there are particles in the Soliqua. 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 Soliqua 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 Soliqua 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 Soliqua:

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

When needed, Soliqua 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 Soliqua:
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.

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 canspread around the injection site. Most minor reactions to insulins usually disappear in afew 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

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

•A delay in the emptying of the stomach

To report any side effect(s):

• Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)SFDA call center : 19999
E- mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.s
Sanofi- Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

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
The pen may be stored for a maximum of 14 days out of the refrigerator, but below 30°C. 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.