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The product code(s) for this leaflet is: PLGB 17901/0315 .
Bydureon 2 mg prolonged release suspension for injection in pre-filled pen (BCise)
Bydureon® 2 mg prolonged-release suspension for injection in pre-filled pen
exenatide
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
Bydureon contains the active substance exenatide. It is an injectable medicine used to improve blood sugar control in adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus.
This medicine is used in combination with the following diabetes medicines: metformin, sulphonylureas, thiazolidinediones (combination therapy with thiazolidinedione was only studied in adult patients), SGLT2 inhibitors and/or a long-acting insulin. Your doctor is now prescribing this medicine as an additional medicine to help control your blood sugar. Continue to follow your food and exercise plan.
You have diabetes because your body does not make enough insulin to control the level of sugar in your blood or your body is not able to use the insulin properly. This medicine helps your body to increase the production of insulin when your blood sugar is high.
Talk to your doctor, pharmacist, or diabetes nurse before using Bydureon about the following:
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:
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).
BCise is the name of the pre-filled pen device used to inject your Bydureon medicine.
Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you. Check with your doctor, pharmacist, or diabetes nurse if you are not sure.
You should inject this medicine once a week, at any time of day, with or without meals.
You should inject this medicine into the skin (subcutaneous injection) of your stomach area (abdomen), upper leg (thigh), or the back of your upper arm. Do not inject into a vein or muscle.
Each week you can use the same area of your body. Be sure to choose a different injection site in that area.
Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.
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 have any further questions on the use of this medicine, ask your doctor, pharmacist, or diabetes nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1 in 1,000 people).
You should see your doctor immediately if you experience symptoms such as
Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly (may affect up to 1 in 100 people) in patients receiving this medicine. Pancreatitis can be a serious, potentially life-threatening medical condition.
Very common side effects (may affect more than 1 in 10 people)
When this medicine is used with a medicine that contains a sulphonylurea, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur. The dose of your sulphonylurea medicine may need to be reduced while you use this medicine. The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery. Your doctor should tell you how to treat low blood sugar.
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects
This medicine may reduce your appetite, the amount of food you eat, and your weight.
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 an injection site reaction (redness, rash, or itching) you may like to ask your doctor for something to help relieve any signs or symptoms. You may see or feel a small bump under the skin after your injection; it should go away after 4 to 8 weeks. You should not need to stop your treatment.
Rare side effects
Not known (frequency cannot be estimated from the available data)
In addition some other side effects have been reported:
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.
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 label and the carton after EXP. The expiry date refers to the last day of that month.
Bydureon BCise pen should be stored as follows:
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.
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.
This leaflet was last revised in November 2022
© AstraZeneca 2022
Bydureon is a registered trademark of the AstraZeneca group of companies.
CV 22 0139
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