Bydureon 2 mg prolonged release suspension for injection in pre-filled pen (BCise)

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or diabetes nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or diabetes nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Bydureon is and what it is used for
2. What you need to know before you use Bydureon
3. How to use Bydureon
4. Possible side effects
5. How to store Bydureon
6. Contents of the pack and other information

• If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist, or diabetes nurse before using Bydureon about the following:

• If you use this medicine in combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can occur. Test your blood glucose levels regularly. Ask your doctor, pharmacist, or diabetes nurse if you are not sure if any of your other medicines contain a sulphonylurea.
• If you have type 1 diabetes or diabetic ketoacidosis, as this medicine should not be used.
• How to inject this medicine. It should be injected into the skin and not into a vein or into the muscle.
• If you have severe problems with your stomach emptying (including gastroparesis) or food digestion, as the use of this medicine is not recommended. The active substance in this medicine slows stomach emptying so food passes more slowly through your stomach.
• If you have ever had inflammation of the pancreas (pancreatitis) (see section 4).
• If you lose weight too quickly (more than 1.5 kg per week) talk to your doctor about it since this may cause problems such as gallstones.
• If you have severe kidney disease or you are on dialysis, as the use of this medicine is not recommended.

Bydureon is not an insulin and should therefore not be used as a substitute for insulin.

Bydureon can be used in adolescents and children aged 10 years and above. There is no data available for use of this medicine in children below 10 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly:

• other medicines that are used to treat type 2 diabetes, such as medicines that work like Bydureon (for example: liraglutide or other exenatide containing products, as taking these medicines with Bydureon is not recommended.
• medicines used to thin the blood (anticoagulants), e.g. Warfarin, as you will require additional monitoring of changes in INR (measurement of blood thinning) during initiation of therapy with this medicine.
• a medicine that contains a sulphonylurea, as low blood sugar (hypoglycaemia) can occur when combined with Bydureon.
• if you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend that you monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).

It is not known if this medicine may harm your unborn child, therefore you should not use it during pregnancy and for at least 3 months before a planned pregnancy.

It is not known if exenatide passes into your milk. You should not use this medicine while breast-feeding.

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.

You should use contraception if you could potentially become pregnant during treatment with this medicine.

If you use this medicine in combination with a sulphonylurea, low blood sugar (hypoglycaemia) can occur. Hypoglycaemia may reduce your ability to concentrate. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).

Your doctor or diabetes nurse should teach you how to inject this medicine before you use it for the first time.

Remove one pen from the refrigerator and rest it flat for at least 15 minutes. Mix the suspension by shaking hard for at least 15 seconds. Use the suspension only if it is evenly mixed, white to off-white and cloudy. If you see white medicine on the sides, bottom or top of the pen window, the medicine is NOT mixed well. Shake hard again until well mixed.

You should inject this medicine immediately after mixing the suspension.

Use a new pen for each injection. You should dispose of the pen safely after each use, as instructed by your doctor or diabetes nurse.

If you use more of this medicine than you should, please consult your doctor first as you may need medical treatment. Using too much of this medicine can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).

You might like to choose a day that you always plan to make your Bydureon injection.

If you miss a dose and there are 3 days or more until your next dose is due, then take the missed dose as soon as it is possible to do so. For your next injection you can return to your chosen injection day.

If you miss a dose and there are only 1 or 2 days until your next dose is due, skip the missed dose and take the next one as usual, on the day it is due. You can also change your chosen injection day, as long as your last dose was given 3 or more days before.

Do not take two doses of Bydureon within 3 days of each other.

If you are not sure if you have taken all of your dose, do not inject another dose of this medicine, just take it next week as planned.

If you feel you should stop using this medicine, please consult your doctor first. If you stop using this medicine this can affect your blood sugar levels.

If you get any side effects, talk to your doctor, pharmacist or diabetes nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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.

• The active substance is exenatide. Each pre-filled pen contains 2 mg of exenatide.
• The other ingredients are: poly (D,L-lactide-co-glycolide), sucrose and medium chain triglyceride.

Prolonged-release suspension for injection in pre-filled pen (BCise).

White to off-white opaque suspension.

Each pre-filled pen delivers 2 mg of exenatide in a volume of 0.85 mL.

This medicine is available in a pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise). Not all pack sizes may be marketed.