Active ingredient
- insulin glargine
- lixisenatide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 04425/0839.
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen
Package leaflet: information for the user
SULIQUA® 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen
Insulin glargine + lixisenatide
Is this leaflet hard to see or read? Phone 0800 035 2525 for help
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Suliqua is and what it is used for
2. What you need to know before you use Suliqua
3. How to use Suliqua
4. Possible side effects
5. How to store Suliqua
6. Contents of the pack and other information
1. What Suliqua is and what it is used for
Suliqua is an injectable diabetes medicine that contains two active substances:
Suliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high, it is an adjunct to diet and exercise.
It is given with metformin with or without sodium-glucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when other medicines are not enough on their own to control your blood sugar levels.
2. What you need to know before you use Suliqua
Do not use Suliqua:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Suliqua if:
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:
While using this medicine be aware of the following and talk to your doctor, pharmacist or nurse before using Suliqua:
Skin changes at the injection site
The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Suliqua). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medicine dose.
Travel
Talk to your doctor before travelling. You may need to talk about:
Children and adolescents
There is no experience with Suliqua in children and adolescents aged less than 18 years; therefore, the use of Suliqua is not recommended in this age group.
Other medicines and Suliqua
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
If you use another anti diabetic medicine, discuss with your doctor whether you should stop using that medicine when starting Suliqua.
Some medicines can change your blood sugar level.
This may mean your doctor may need to change your Suliqua dose. So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take. You also need to be careful when you stop taking a medicine.
The effect of some medicines you swallow might be affected by Suliqua. Some medicines such as antibiotics, oral contraceptives, statins (medicines like atorvastatin to lower cholesterol), gastro-resistant tablets or capsules or granules or oral powder or suspensions that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Suliqua injection.
Your blood sugar level may fall (hypoglycaemia) if you take:
Your blood sugar level may rise (hyperglycaemia) if you take:
Your blood sugar level may either rise or fall if you take:
Medicine that may reduce warning signs of low blood sugar
Beta-blockers and some other medicines (such as clonidine, guanethidine, reserpine – for high blood pressure) may make it harder to recognise warning signs of your low blood sugar levels (hypoglycaemia).
It can even hide or stop the first signs that your blood sugar is too low.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
Warfarin or other anticoagulants
Tell your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent clotting of the blood) as you might need to have more frequent blood tests (called ‘International Normalised Ratio’ or INR test) to check your blood clotting.
Suliqua with alcohol
Your blood sugar level may either rise or fall if you drink alcohol. You should check your blood sugar level more often.
Pregnancy and breast-feeding
Suliqua should not be used during pregnancy. It is not known if Suliqua harms your unborn child.
Suliqua should not be used if breast-feeding. It is not known if Suliqua passes into your milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Having too low or too high blood sugar (see information in the box at the end of this leaflet) can affect your ability to drive and use tools or machines.
Your concentration may be affected. This could be dangerous to yourself and others.
Ask your doctor whether you can drive if:
Suliqua contains
3. How to use Suliqua
Always use this medicine exactly as your doctor has told you. Your doctor may tell you to use a different dose of Suliqua compared to your previous insulin dose or glucose lowering medicine, if any. Check with your doctor, pharmacist or nurse if you are not sure.
Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you:
Your doctor may tell you to use Suliqua with other medicines for high blood sugar.
How much to use
Your dose of Suliqua is administered as ‘dose steps’.
The dose window on the pen shows the number of dose steps.
Do not inject a dose lower than 10 dose steps. Do not inject a dose higher than 40 dose steps.
If a dose greater than 40 dose steps is needed, your doctor will prescribe a different strength. For dose steps from 30-60 units, Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen is available.
Many factors may affect your blood sugar level. You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low. See the box at the end of this leaflet for more information.
Use in elderly patients (65 years and older)
If you are 65 years or older, talk to your doctor as you may need a lower dose.
If you have kidney or liver problems
If you have kidney or liver problems, talk to your doctor as you may need a lower dose.
When to inject Suliqua
Use Suliqua once a day, within 1 hour before a meal.
Preferably inject Suliqua before the same meal every day, when you have chosen the most convenient meal.
Before injecting Suliqua
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
Do not use Suliqua:
Other important information about using the pre-filled pens
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:
If you use more Suliqua than you should
If you have injected too much of this medicine, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar and eat more food to prevent your blood sugar getting too low (hypoglycaemia). If your blood sugar gets too low, see the advice in the box at the end of this leaflet.
If you forget to use Suliqua
If you have missed a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):
If you stop using Suliqua
Do not stop using this medicine without talking to your doctor. If you do, it could lead to very high blood sugar (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (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)
Uncommon (may affect up to 1 in 100 people)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Suliqua
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”. The expiry date refers to the last day of that month.
Before first use
Store in a refrigerator (2-8 °C).
Do not freeze or place next to the freezer compartment or a freezer pack.
Keep the pen in the outer carton in order to protect from light.
After first use
Store your pen in use below 25°C for a maximum of 28 days. Discard the pen after this period.
Do not return the pen to a refrigerator and do not freeze. Store the pen away from direct heat or direct light. Always keep the cap on the pen when you are not using it in order to protect it from light.
Do not leave the pen in a car on an exceptionally warm or cold day.
Do not store the pen with the needle attached.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Suliqua contains
What Suliqua looks like and contents of the pack
Suliqua is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen (SoloStar).
Pack sizes of 3, 5 and 10 pre-filled pens.
Not all pack sizes may be marketed.
Needles are not included in the pack.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in March 2022
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
If you use insulin, you should always carry the following things with you:
Hyperglycaemia (high blood sugar levels)
If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Reasons why hyperglycaemia may happen:
Examples include:
Warning signs of hyperglycaemia
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and urine test showing glucose and ketone bodies. Stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
What to do if you experience hyperglycaemia
Hypoglycaemia (low blood sugar levels)
If your blood sugar level falls too much you may pass out (become unconscious). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should learn to recognise the signs when your blood sugar is falling – so you can take action to stop it getting worse.
Reasons why hypoglycaemia may happen:
Examples include:
Hypoglycaemia is also more likely to happen if:
Warning signs of hypoglycaemia
The first signs may be in your body generally.
Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations. These signs often develop before the signs of a low sugar level in the brain.
Other signs include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.
When the signs of hypoglycaemia may be less clear: The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:
In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
What to do if you experience hypoglycaemia?
1. Do not inject Suliqua. Take about 15 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary drink. Drink or foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.
2. You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due. Ask your doctor or nurse if you are not sure which foods you should eat.
With Suliqua, it may take longer to recover from low blood sugar because it contains a long-acting insulin (insulin glargine).
3. Test your blood glucose levels after 10-15 minutes after taking sugar. If blood glucose levels are still too low (< 4 mmol/L) or hypoglycaemia comes back take another 15 to 20 grams of sugar.
4. Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes back again.
What other people should do if you have hypoglycaemia
Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious). You will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections should be given even if it is not certain that you have hypoglycaemia.
You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.
<MAT>843393
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525