2 mg injection , transdermal suspension for injection pen
exenatide
1. What Bydureon is and what it is used for
Bydureon contains the active substance exenatide. It is a drug to be injected and used to improve blood sugar control in adults with type 2 diabetes mellitus.
This medicine is used in combination with the following diabetes medicines: metformin, sulphonylureas, thiazolidinediones, SGLT2 inhibitors, and/or long-acting insulin. You are now being prescribed this medicine as a supplement, in order to better control your blood sugar level. Continue to follow the diet and exercise program you have been given.
You have diabetes because your body does not produce enough insulin to control your blood sugar level or because your body cannot use insulin properly. This medicine helps your body increase insulin production when your blood sugar is high.
2. What you need to know before using Bydureon
Do not use Bydureon
- If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Before using Bydureon, talk to your doctor, pharmacist, or diabetes nurse about the following:
- If you are taking this medicine with a sulphonylurea, hypoglycemia (too low blood sugar) may occur. Check your blood sugar level regularly. If you are not sure if any of your other medicines contain a sulphonylurea, ask your doctor, pharmacist, or diabetes nurse.
- If you have type 1 diabetes or diabetic ketoacidosis, this medicine should not be used.
- How to inject this medicine. It should be injected into the skin and not into a vein or muscle.
- If you have severe stomach problems (eg gastroparesis) or indigestion, this medicine is not recommended. The active substance in this medicine delays the emptying of the stomach, which causes the food to pass more slowly through the stomach.
- If you have had inflammation of the pancreas ( pancreatitis ) (see section 4).
- Talk to your doctor if you lose weight too fast (more than 1.5 kg per week), as it can cause problems such as gallstones ar.
- If you suffer from severe kidney disease or if you are receiving dialysis treatment, this medicine is not recommended.
Bydureon is not insulin and should therefore not be used as a replacement for insulin.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age as there is no experience with this medicine in that age group.
Other medicines and Bydureon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:
- medicines used to treat type 2 diabetes, such as medicines that work in the same way as Bydureon (eg liraglutide or other exenatide-containing medicines), as concomitant use of these medicines with Bydureon is not recommended.
- blood-thinning drugs (anticoagulants) e.g. warfarin, as you will need further monitoring for changes in INR (a measure of blood thinness) during the start of treatment with this medicine.
- a medicine containing a sulphonylurea, as low blood sugar (hypoglycemia) may occur in combination with Bydureon.
- if you are taking insulin, your doctor will tell you how to lower your insulin dose and recommend that you check your blood sugar more often to avoid hyperglycemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough a lot of insulin ).
Pregnancy and breastfeeding
It is not known if this medicine can harm your fetus and therefore it should not be used during pregnancy, and no later than 3 months before a planned pregnancy.
It is not known if exenatide passes into breast milk. This medicine should not be used if you are 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 there is a possibility that you may become pregnant during treatment with this medicine.
Driving and using machines
If you use this medicine with a sulphonylurea, hypoglycemia (too low blood sugar) may occur. Hypoglycemia may impair the ability to concentrate. Keep this in mind in all situations where you may put yourself and others at risk (eg while driving or using machines).
3. How to use Bydureon
BCise is the name of the pre-filled pen used to inject your Bydureon medicine
Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you. If you are not sure, talk to your doctor, pharmacist, or diabetes nurse.
You should inject this medicine once a week, at any time of the day, with or without food.
You should inject this medicine under the skin ( subcutaneously ) in the abdomen, upper leg (thigh), or back of the upper arm. Do not inject into a vein or muscle.
You can inject into the same area of your body every week. Be sure to choose a new injection site in the area of your choice.
Check your blood sugar level regularly, especially if you are also taking a sulphonylurea.
Inject Bydureon BCise according to the instructions in the package
Your doctor or diabetes nurse must teach you how to inject this medicine before using it for the first time.
Remove a pen from the refrigerator and leave it on a level surface for 15 minutes. Mix suspension one by shaking vigorously for at least 15 seconds. Use suspension one 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 pencil window, the medicine has NOT been mixed properly. Shake vigorously again until well blended.
You should inject this medicine immediately after mixing one.
Use a new pen for each injection. Dispose of the pen when you have used it safely, according to the instructions of your doctor or diabetes nurse.
If you use more Bydureon than you should
If you have used too much of this medicine, talk to your doctor first, as you may need medical attention. Too much of this medicine may cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).
If you forget to use Bydureon
Choose a day when you always take your Bydureon‑ injection.
If you miss a dose and it is 3 days or more until the next dose, take the missed dose soon as possible. At the next injection, you can return to your chosen injection day.
If you miss a dose and it is only 1-2 days until the next dose, do not take the missed dose but instead take the next dose as usual, on your chosen injection day. You can also change the injection day, as long as your last dose was taken 3 days earlier or more.
Do not take two doses of Bydureon within the same 3-day period
If you are not sure if you have taken a full dose of Bydureon
If you are not sure if you have taken the full dose, do not take another dose of this medicine, but take the next dose next week as planned.
If you stop using Bydureon
If you feel that you want to stop using this medicine, you should consult your doctor first. If you stop using this medicine, it may affect your blood sugar levels.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or diabetes nurse.
4. Possible side effects
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 a doctor immediately if you get symptoms like
- Swelling of the face, tongue, or throat ( angioedema )
- Hypersensitivity (rash, itching, and rapid swelling of the tissues of the throat, face, mouth, or throat)
- Difficulty swallowing
- Hives and difficulty breathing
Inflammation of the pancreas ( pancreatitis ) has in less common cases been reported for this drug (may occur in up to 1 in 100 users). Pancreatitis can be a serious, potentially life-threatening medical condition.
- Tell your doctor if you have had pancreatitis, gallstones, alcohol problems, or very high triglyceride levels. These medical conditions may increase the risk of getting pancreatitis or getting it again, regardless of whether you are taking this medicine or not.
- Stop taking this medicine and call your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you may have suffered from inflammation of the pancreas ( pancreatitis ).
The very common side effect is (can occur in more than 1 in 10):
- hypoglycemia (low blood sugar) when co-administering a medicine containing a sulphonylurea.
When this medicine is used in combination with medicines containing a sulphonylurea, episodes of low blood sugar (hypoglycemia, usually mild to moderate) may occur. The dose of sulphonylurea may need to be reduced when you use this medicine. Signs and symptoms of low blood sugar can include headaches, drowsiness, weakness, dizziness, confusion, irritation, hunger, palpitations, sweating and nervousness. Your doctor will tell you how to treat low blood sugar.
Common side effects are (may affect up to 1 in 10):
- hypoglycemia (low blood sugar) with concomitant use of insulin
- headache
- dizziness
- nausea (nausea is most common at the beginning of treatment with this medicine, but decreases with time in most patients)
- diarrhea
- vomiting
- constipation
- indigestion
- heartburn
- bloating
- pain in the abdomen
- injection site reactions ( itching or redness )
- fatigue
Uncommon side effects are
- hypoglycemia (low blood sugar) when using a medicine that does not contain a sulphonylurea.
- Decreased appetite
This medicine may reduce your appetite, the amount of food you eat, and your weight.
If you lose weight too fast (more than 1.5 kg per week), talk to your doctor, as it can cause problems such as gallstones ar. - dehydration
- unusual taste in the mouth
- somnolence
- weather stresses
- belching
- intestinal obstruction (blockage in the intestine)
- hives
- increased sweating
- rash, itching
- hair loss
- impaired renal function
- injection site reactions
If you get a reaction at the injection site ( redness, rash, or itching ), you can ask your doctor for something to relieve the discomfort. You may see or feel a small lump under the skin after injection. This usually disappears after 4 to 8 weeks. You should not stop your treatment. - loss of energy and power
Rare side effects are :
- nervousness
No known frequency (frequency can not be calculated from available data)
In addition, some second adverse event is reported:
- bleeding or easier than normal to get bruises due to low levels of platelets .skin reactions at the injection site after injection of exenatide. It can be a cavity that contains var (abscess) and a swollen or red area of skin that feels hot or tender ( cellulite ).
- Changes in INR (a measure of how thin the blood is) have been reported when used with warfarin.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bydureon
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 carton after EXP. The expiration date is the last day of the specified month.
Storage BYDUREON BCise pen
- Store in a refrigerator (2 ° C to 8 ° C).
- The pen can be stored for up to 4 weeks at a maximum of 30 ° C before use.
- Store in the original package. Sensitive to light.
- The pen must be stored on a level surface.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is exenatide. Each pre-filled pen contains 2 mg exenatide.
- The other ingredients are DL-lactide-glycolide copolymer, sucrose, and medium-chain triglycerides.
What the medicine looks like and the contents of the pack
Injection prolonged-release suspension in pre-filled pen (BCise).
White to off-white, opaque suspension.
Each pre-filled pen gives 2 mg exenatide in a volume of 0.85 ml suspension.
This medicine is available in a pack size of 4 pre-filled single-dose pens (BCise) and in a multi-pack containing 12 (3 packs of 4) pre-filled single-dose pens (BCise). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
AstraZeneca UK Limited
Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
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