BYDUREON 2 mg POWDER AND SOLVENT FOR PROLONGED-RELEASE INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

Bydureon 2 mg powder and solvent for prolonged-release suspension for injection

exenatide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

Contents of the pack:

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

1. What is Bydureon and what is it used for

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 older with type 2 diabetes mellitus.

This medicine is used in combination with the following diabetes medicines: metformin, sulfonylureas, thiazolidinediones (the combination therapy with thiazolidinediones was only studied in adult patients), SGLT2 inhibitors and/or long-acting insulin. Your doctor has prescribed this medicine as an additional medicine to help you control your blood sugar level. Continue with your diet and exercise plan.

You have diabetes because your body does not produce enough insulin to control your blood sugar levels or your body is not able to use insulin properly. This medicine helps your body increase insulin production when your blood sugar is high.

2. What you need to know before you use 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 precautions

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

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

Bydureon is not an insulin, so it should not be used as a substitute for insulin.

Children and adolescents

Bydureon can be used in adolescents and children aged 10 years and older. There is no data available on the use of this medicine in children under 10 years of age.

Using Bydureon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, especially:

• other medicines used to treat type 2 diabetes, such as medicines that work like Bydureon (e.g., liraglutide or other medicines that contain exenatide), as the use of these medicines with Bydureon is not recommended.
• medicines used to thin the blood (anticoagulants), e.g., warfarin, as you will need to have regular checks for changes in your INR (a measure of blood clotting) when starting treatment with this medicine.
• a medicine that contains a sulfonylurea, as low blood sugar (hypoglycemia) may occur when combined with Bydureon.

Pregnancy and breastfeeding

It is not known if this medicine can harm your unborn baby, so you should not use it during pregnancy or for at least 3 months before a planned pregnancy.

It is not known if exenatide passes into breast milk. You should not use this medicine during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and using machines

If you use this medicine in combination with a sulfonylurea, low blood sugar (hypoglycemia) may occur. Hypoglycemia can reduce your ability to concentrate. Please be aware of this possible problem in all situations where you might put yourself or others at risk (e.g., driving a car or using machines).

Important information about some of the ingredients of Bydureon

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to use Bydureon

Follow the instructions for administration of this medicine exactly as told by your doctor, pharmacist, or diabetes nurse. If you are not sure, ask your doctor, pharmacist, or diabetes nurse.

You should inject this medicine once a week, at any time of day, with or without food.

You should inject this medicine into the skin (subcutaneous injection) in the area around your stomach (abdomen), in the upper part of your leg (thigh), or in the upper back part of your arm. Do not inject into a vein or muscle.

You can use the same area each week. Make sure to choose a different injection site within that area.

Never mix insulin and Bydureon in the same injection. If you need to administer both at the same time, use two separate injections. You can inject both in the same area (e.g., in the abdominal area) but do not inject one next to the other.

Check your blood sugar levels regularly, especially if you are using a sulfonylurea.

To inject Bydureon, follow the "Instructions for the User" included in the pack.

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

Before starting, check that the liquid in the syringe is clear and free of particles. After mixing, use the suspension only if the mixture is between white and off-white and cloudy. If you see dry powder clumps on the walls or at the bottom of the vial, the medicine is NOT properly mixed. Shake vigorously again until it is well mixed.

You should inject this medicine immediately after mixing the powder and solvent.

Use a new injection needle for each injection and dispose of it safely after each use, as instructed by your doctor or diabetes nurse.

If you use more Bydureon than you should

If you use more of this medicine than you should, talk to your doctor before taking any further action, as you may need medical treatment. Using too much of this medicine can cause nausea, vomiting, dizziness, or low blood sugar symptoms (see section 4).

If you forget to use Bydureon

You might find it helpful to set a specific day to take your Bydureon injection.

If you forget a dose and it is 3 days or more until your next scheduled dose, take the missed dose as soon as possible. For your next injection, you can go back to your usual injection day.

If you forget a dose and it is only 1 or 2 days until your next scheduled dose, skip the missed dose and take the next dose at the usual time. You can also change your injection day, as long as the last dose was given 3 or more days before.

Do not take two doses of Bydureon if it has been less than 3 days since the last dose.

If you are not sure if you have taken your full dose of Bydureon

If you are not sure if you have taken your full dose, do not inject another dose of this medicine. Simply use it the following week as scheduled.

If you stop using Bydureon

If you think you need to stop using this medicine, talk to your doctor before doing so. If you stop using this medicine, it may affect your blood sugar levels.

If you have any other questions about using this medicine, 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).

See your doctor immediately if you experience symptoms such as

• Swelling of the face, tongue, or throat (angioedema)
• Hypersensitivity (rash, itching, and rapid swelling of the tissues of the neck, face, mouth, or throat)
• Difficulty swallowing
• Hives and difficulty breathing

Cases of pancreatitishave been reported uncommonly (may affect up to 1 in 100 people) in patients treated with this medicine. Pancreatitis can be a serious medical condition that can be life-threatening.

• Tell your doctor if you have had pancreatitis, gallstones, alcoholism, or very high triglycerides. These medical conditions may increase the risk of pancreatitis or make it more likely to happen again, whether or not you are taking this medicine.

• Stop taking this medicine and contact your doctor immediatelyif you have severe and persistent stomach pain, with or without vomiting, as you may have pancreatitis.

Very common side effects(may affect more than 1 in 10 people)

• nausea (nausea is more common when starting treatment with this medicine but decreases over time in most patients)
• diarrhea
• low blood sugar (hypoglycemia) when used with a sulfonylurea.

When using this medicine with a sulfonylurea, episodes of low blood sugar (hypoglycemia, usually mild to moderate) may occur. It may be necessary to reduce the dose of your sulfonylurea medicine while using this medicine. The signs and symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, rapid heartbeat, sweating, and a feeling of nervousness. Your doctor will tell you how to treat low blood sugar.

Common side effects(may affect up to 1 in 10 people)

• low blood sugar (hypoglycemia) when used with insulin
• dizziness
• headache
• vomiting
• lack of energy and strength
• fatigue
• constipation
• stomach pain
• swelling
• indigestion
• flatulence (gas)
• heartburn
• decreased appetite

This medicine may reduce your appetite, the amount of food you eat, and your weight. Tell your doctor if you lose weight too quickly (more than 1.5 kg per week), as this can cause problems such as gallstones.

• injection site reactions.

If you experience an injection site reaction (redness, rash, or itching), you can talk to your doctor about prescribing something to help alleviate any signs or symptoms. After injection, you may see or feel a small lump under your skin; this should disappear within 4 to 8 weeks. You should not need to stop your treatment.

Uncommon side effects

• reduced kidney function
• dehydration, sometimes with reduced kidney function
• intestinal obstruction (blockage in the intestine)
• belching
• unusual taste
• increased sweating
• hair loss
• drowsiness
• delayed gastric emptying
• inflamed gallbladder
• gallstones

Rare side effects

• nervousness

Unknown frequency(cannot be estimated from the available data)

In addition, other adverse reactionshave been reported:

• bleeding or bruising more easily than normal due to a low level of platelets in the blood.
• changes in INR (a measure of blood clotting) have been reported when used with warfarin.
• skin reactions at the injection site after injection of exenatide. These include: abscess (a pocket of pus) and cellulitis (a red, swollen, and painful area of skin).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or diabetes nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 expiry date refers to the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

The kit can be stored for up to 4 weeks below 30°C before use. Store in the original packaging to protect from light.

Discard any Bydureon kit that has been frozen.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Bydureon composition

• The active ingredient is exenatide. Each vial contains 2 mg of exenatide.
• The other components are:
• In the powder: poly (D, L-lactide-co-glycolide) and sucrose.
• In the solvent: sodium carmellose; sodium chloride; polysorbate 20; sodium dihydrogen phosphate monohydrate; disodium phosphate heptahydrate and water for injectable preparations.

Appearance of Bydureon and container contents

Powder and solvent for prolonged-release injectable suspension.

The powder is white to off-white and the solvent is a clear, colorless to pale yellow, to pale brown solution.

Each single-dose kit contains a vial with 2 mg of exenatide in powder, a pre-filled syringe with 0.65 ml of solvent, a vial connector and two injection needles. One of the needles is a spare.

This medication is available in packs of 4 single-dose kits and 3 packs with 4 single-dose kits. Only some pack sizes may be marketed.

Marketing authorization holder:

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer:

AstraZeneca UK Limited

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA

United Kingdom

Swords Laboratories T/A Lawrence Laboratories

Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of last revision of this prospectus:

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website http://www.ema.europa.eu/.