2 mg powder and solvent for solution for injection , prolonged- release suspension
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 received.
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 drug helps your body increase insulin production when blood sugar levels are 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 problems with gastric emptying (eg gastroparesis) or digestion, as 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:
- other medicines used to treat type 2 diabetes, such as medicines that work in the same way as Bydureon (for example liraglutide and 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 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 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).
Important information about some of the ingredients of Bydureon
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is almost “sodium-free”.
3. How to use Bydureon
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.
Never mix insulin and Bydureon in the same injection. If you have to give yourself both medicines at the same time, you must use separate injections. You can give both injections in the same area of the body (for example the abdomen), but you should not give the injections next to each other.
Check your blood sugar level regularly, especially if you are also taking a sulphonylurea.
Inject Bydureon according to the instructions in the package leaflet
Your doctor or diabetes nurse must teach you how to inject this medicine before using it for the first time.
Make sure that the liquid in the syringe is clear and free of particles before you start. After mixing, suspension one should only be used if mixture one is white to off-white and cloudy. If you see dry lumps of powder on the sides or bottom of the vial, the medicine has NOT been mixed properly. Shake vigorously until well blended.
You should inject this medicine immediately after mixing the powder with the liquid.
Attach a new injection needle before each injection and dispose of it safely after each use as directed by 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 doses as 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, provided that your last dose has been 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 medicine (may affect up to 1 in 100 people) in patients who have received this medicine. 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 ).
Very common side effect is (can occur in more than 1 in 10)
- nausea (nausea is most common at the beginning of treatment with this medicine, but decreases with time in most patients)
- diarrhea
- 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
- dizziness
- headache
- vomiting
- loss of energy and power
- fatigue (exhaustion)
- constipation
- pain in the abdomen
- bloating
- indigestion
- weather voltage
- heartburn
- decreased appetite
This medicine can 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.
- 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.
Uncommon side effects are
- impaired renal function
- dehydration, sometimes with impaired renal function
- intestinal obstruction (blockage in the intestine)
- belching
- unusual taste in the mouth
- increased sweating
- hair loss
- somnolence
Rare side effects are
- nervousness
Not known (frequency can not be estimated 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. Changes in INR (a measure of how thin the blood is) have been reported when used with warfarin.
- 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 ).
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.
Store in a refrigerator (2 ° C to 8 ° C). Do not freeze.
The package can be stored for up to 4 weeks at a maximum of 30 ºC before use.
Store in the original package. Sensitive to light.
Discard frozen Bydureon packs.
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 vial contains 2 mg of exenatide.
- Other ingredients are:
- In the powder: poly (D, L-lactide-co-glycolide) and sucrose.
- In the diluent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, and water for injections.
What the medicine looks like and the contents of the pack
Powder and solvent for solution for injection, prolonged-release suspension.
The powder is white to off-white and the diluent is clear, colorless to pale yellow to pale brown.
Each single-dose pack consists of a vial of 2 mg exenatide powder, a pre-filled syringe of 0.65 ml of diluent, a vial connection, and two injection needles. An injection needle is an extra needle.
This medicine is available in pack sizes of 4 single doses and 3 packs of 4 single doses. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
AstraZeneca UK Limited
Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA
UK
Swords Laboratories T / A Lawrence Laboratories
Unit 12 Distribution Center, Shannon Industrial Estate, Shannon, Co. Clare
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
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