Soliqua 100 units Solution

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.

Do not use SOLIQUA:

• if you are hypersensitive (allergic) to insulin glargine, lixisenatide or any of the other ingredients of SOLIQUA (listed in section 6)
• if you are pregnant or breastfeeding (see Pregnancy and breastfeeding)
• if you are experiencing episodes of hypoglycaemia (see Hypoglycaemia)
• if you have sudden inflammation of your pancreas including symptoms such as severe stomach pain, fever, rapid pulse, nausea and vomiting
• if you have severe kidney problems or kidney disease
• if you have type 1 diabetes, as SOLIQUA is used for type 2 diabetes and this medicine will not be right for you
• if 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
• if 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 (see Other medicines and SOLIQUA)
• if you are on dialysis as the use of this medicine will not be recommended.

Warnings and precautions

Special care should be taken with SOLIQUA:

• Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia (see Hypoglycaemia).
• Too high blood sugar (hyperglycaemia). If your blood sugar is too high, follow the guidance for hyperglycaemia (see Hyperglycaemia).
• 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.

• Severe pain in your stomach area (abdomen) that will not go away. This could be a sign of inflamed pancreas (acute pancreatitis). Also, tell your doctor if you have a history of pancreatitis.
• Loss of fluid 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.
• If you develop 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.
• Gallbladder inflammation or gallstones have been seen in people who took medicines belonging to the same family of antidiabetic medicines as lixisenatide as in SOLIQUA. If you have stomach pain, fever, nausea or yellowing of the skin and eyes, talk to your doctor.

• 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.

Other medicines and SOLIQUA

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Some medicines can change your blood sugar level. This may mean your SOLIQUA dose has to change. So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take.

Do not share medicines prescribed for you with any person. Always use SOLIQUA exactly as your doctor has told you. You should check with your doctor or pharmacist 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.

• 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 0,5 micrograms of lixisenatide and 1 unit of insulin glargine
• this pen is for the daily injection of 10 to 40 dose steps of SOLIQUA.

• 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 0,33 micrograms of lixisenatide and 1 unit of insulin glargine
• this pen is for the daily injection of 30 to 60 dose steps of SOLIQUA.

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 time.

Before injecting SOLIQUA

• always follow the “Instructions for Use” that come with this package insert • 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 if you are not sure.

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. • If you think your pen is damaged, do not use it. Get a new one. Do not try to repair the pen.

SOLIQUA can have side effects. Not all side effects reported for SOLIQUA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using SOLIQUA, please consult your health care provider for advice. If any of the following happens, stop using SOLIQUA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

Other side effects

Tell your doctor if you notice any of the following: Frequent:

• feeling dizzy
• feeling sick (nausea)
• vomiting
• diarrhoea.

• cold, runny nose, sore throat
• hives (urticaria)
• headache
• indigestion (dyspepsia)
• stomach ache
• tiredness
• changes where the injection is given: if you injection SOLIQUA too often in the same place, you may develop dents at the site, caused by a loss of fat under the skin (lipoatrophy) or you may develop lumps, caused by a build-up of fat under the skin (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (localised cutaneous amyloidosis). SOLIQUA may not work very well. Change the injection site with each injection to help prevent these changes
• 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.
• A delay in the emptying of the stomach.

• Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Reporting of side effects:

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SOLIQUA. Side effects can be reported directly to Sanofi’s Pharmacovigilance Unit at [email protected] (email) or 011 256 3700 (tel).

Store all medicines out of 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 the month. Before first use Store between 2 °C – 8 °C (in refrigerator). 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 or if carried as a spare The pen may be stored for a maximum of 28 days out of the refrigerator, but at or below 25 °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 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 use if you notice visible particles. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).