Bydureon - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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.

What is in this leaflet

• 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

1. What Bydureon is and what it is used for

Bydureon contains the active substance exenatide. It is an injectable medicine 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 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.

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 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.

Children and adolescents

Do not give this medicine to children and adolescents less than 18 years, as there is no experience with this medicine in this age group.

Other medicines and Bydureon

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).

Pregnancy and breast-feeding

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.

Driving and using machines

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).

Important information about some of the ingredients of Bydureon

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Bydureon

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.

Never mix insulin and Bydureon together in the same injection. If you need to give yourself both at the same time, use two separate injections. You may give both injections in the same body area (for example, your stomach area), but you should not give the injections next to each other.

Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.

Follow the “Instructions for the User” provided in the carton to inject Bydureon

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

Check that the liquid in the syringe is clear and free of particles before you begin. After mixing, use the suspension only if the mixture is white to off white and cloudy. If you see clumps of dry powder on the sides or bottom of the vial, the medicine is NOT mixed well. Shake vigorously again until well mixed.

You should inject this medicine immediately after mixing the powder and the 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, please consult with 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).

If you forget to use Bydureon

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 you have taken the full dose of Bydureon

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 stop using Bydureon

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.

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 your doctor immediately if you experience symptoms such as

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

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.

• Tell your doctor if you have had pancreatitis, gallstones, alcoholism or very high triglycerides. These medical conditions can increase the risk of getting pancreatitis, or getting it again, whether or not you are taking this medicine.
• STOP taking this medicine and contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).

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

• nausea (nausea is most common when first starting this medicine, but decreases over time in most patients)
• diarrhoea
• hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea.

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)

• hypoglycaemia (low blood sugar) when taken with an insulin
• dizziness
• headache
• vomiting
• loss of energy and strength
• tiredness (fatigue)
• constipation
• pain in the stomach area
• bloating
• indigestion
• flatulence (passing gas)
• heartburn
• reduced appetite

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.

• injection site reactions

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.

Uncommon side effects

• decrease in kidney function
• dehydration, sometimes with a decrease in kidney function
• intestinal obstruction (blockage in intestine)
• burping
• unusual taste in the mouth
• increased sweating
• hair loss
• sleepiness
• a delay in the emptying of the stomach

Rare side effects

• feeling jittery

Not known (frequency cannot be estimated from the available data)

In addition some other side effects have been reported:

• bleeding or bruising more easily than normal due to low level of blood platelets.
• changes in INR (measurement of blood thinning) have been reported when used together with warfarin.
• skin reactions at the injection site following injection of exenatide. These include: cavity containing pus (abscess) and swollen, or red area of skin that feels hot and tender (cellulitis).

Reporting of side effects

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 national reporting system listed in. By reporting side effects, you can help provide more information on the safety of this medicine.

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 the carton after EXP.

The expiry date refers to the last day of that month.

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

The kit may be kept for up to 4 weeks below 30 °C prior to use.

Store in the original package in order to protect from light.

Throw away any Bydureon kit that has been frozen.

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.

6. Contents of the pack and other information

What Bydureon contains

• – The active substance is exenatide. Each vial contains 2 mg of exenatide.

• – The other ingredients are:

• – In the powder: poly (D,L-lactide-co-glycolide) and sucrose.

• – In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate and water for injection.

What Bydureon looks like and contents of the pack

Powder and solvent for prolonged-release suspension for injection.

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

Each single-dose kit consists of one vial containing 2 mg exenatide powder, one pre-filled syringe containing 0.65 mL solvent, one vial connector, and two injection needles. One needle is a spare.

This medicine is available in pack sizes of 4 single-dose kits and 3 packs of 4 single-dose kits. Not all pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Sodertalje

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11	Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550
Efcnrapua Acmpa3eHeKa Etnrapua EOOfl Ten.: +359 (2) 44 55 000	Luxembourg/Lu­xemburg AstraZeneca S.A./N.V. Tel/Tel: +32 2 370 48 11
Česká republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111	Magyarorszag AstraZeneca Kft. Tel.: +36 1 883 6500
Danmark AstraZeneca A/S Tlf: +45 43 66 64 62	Malta Associated Drug Co. Ltd Tel: +356 2277 8000
Deutschland AstraZeneca GmbH Tel: +49 41 03 7080	Nederland AstraZeneca BV Tel: +31 79 363 2222
Eesti AstraZeneca Tel: +372 6549 600	Norge AstraZeneca AS Tlf: +47 21 00 64 00

EXXáSa AstraZeneca A.E. Tql: +30 210 6871500	Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100	Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777
Italia AstraZeneca S.p.A. Tel: +39 02 9801 1	Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Kúnpog AXéKTop Oap^aKeuTiK^ At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000
Latvija SIA AstraZeneca Latvija Tel: +371 67377100	United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency

Package Leaflet: Information for the user

Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen

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.

What is in this leaflet

• 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

1. What Bydureon is and what it is used for

Bydureon contains the active substance exenatide. It is an injectable medicine 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 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.

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 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.

Children and adolescents

Do not give this medicine to children and adolescents less than 18 years, as there is no experience with this medicine in this age group.

Other medicines and Bydureon

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).

Pregnancy and breast-feeding

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.

Driving and using machines

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).

Important information about some of the ingredients of Bydureon

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Bydureon

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.

Never mix insulin and Bydureon together in the same injection. If you need to give yourself both at the same time, use two separate injections. You may give both injections in the same body area (for example, your stomach area), but you should not give the injections next to each other.

Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.

Follow the “Instructions for the User” provided in the carton to inject Bydureon

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 let it stand at room temperature for at least 15 minutes. Check that the liquid in the pen is clear and free of particles before you begin. After mixing the liquid with the powder, use the suspension only if the mixture is white to off white and cloudy. If you see clumps of dry powder on the sides of the pen, the medicine is NOT mixed well. Tap vigorously again until well mixed.

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

Use a new pen for each injection. You should dispose of the pen safely, with the needle still attached, after 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, please consult with 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).

If you forget to use Bydureon

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 you have taken the full dose of Bydureon

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 stop using Bydureon

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.

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 your doctor immediately if you experience symptoms such as

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

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.

• Tell your doctor if you have had pancreatitis, gallstones, alcoholism or very high triglycerides.

These medical conditions can increase the risk of getting pancreatitis, or getting it again, whether or not you are taking this medicine.

• STOP taking this medicine and contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).

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

• nausea (nausea is most common when first starting this medicine, but decreases over time in most patients)
• diarrhoea
• hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea 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)

• hypoglycaemia (low blood sugar) when taken with an insulin
• dizziness
• headache
• vomiting
• loss of energy and strength
• tiredness (fatigue)
• constipation
• pain in the stomach area
• bloating
• indigestion
• flatulence (passing gas)
• heartburn
• reduced appetite

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.

• injection site reactions

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.

Uncommon side effects

• decrease in kidney function
• dehydration, sometimes with a decrease in kidney function
• intestinal obstruction (blockage in intestine)
• burping
• unusual taste in the mouth
• increased sweating
• hair loss
• sleepiness
• a delay in the emptying of the stomach

Rare side effects

• feeling jittery

Not known (frequency cannot be estimated from the available data)

In addition some other side effects have been reported:

• bleeding or bruising more easily than normal due to low level of blood platelets.
• changes in INR (measurement of blood thinning) have been reported when used together with warfarin.
• skin reactions at the injection site following injection of exenatide. These include: cavity containing pus (abscess) and swollen, or red area of skin that feels hot and tender (cellulitis).

Reporting of side effects

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 national reporting system listed in. By reporting side effects, you can help provide more information on the safety of this medicine.

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 the carton after EXP. The expiry date refers to the last day of that month.

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

The pen may be kept for up to 4 weeks below 30 °C prior to use.

Store in the original package in order to protect from light.

Throw away any Bydureon pen that has been frozen.

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.

6. Contents of the pack and other information

What Bydureon contains

• – The active substance is exenatide. Each pre-filled pen contains 2 mg of exenatide. After suspension, the delivered dose is 2 mg/0.65 mL.

• – The other ingredients are:

• – In the powder: poly (D,L-lactide-co-glycolide) and sucrose.

• – In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, water for injection and sodium hydroxide (for pH adjustment).

What Bydureon looks like and contents of the pack

This medicine is provided as a powder and solvent (liquid) for suspension for injection in a pre-filled pen. The powder (2 mg) in one chamber, is white to off-white and the solvent (0.65 mL) in the other chamber, is a clear, colourless to pale yellow to pale brown solution. Each single-dose pre-filled pen is provided with one custom needle. Each carton also contains one spare needle.

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

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Sodertalje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

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

For any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Efcarapua

Acmpa3eHeKa Etarapua EOOfl

Tea.: +359 (2) 44 55 000

Česká republika

AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

Danmark AstraZeneca A/S Tlf: +45 43 66 64 62	Malta Associated Drug Co. Ltd Tel: +356 2277 8000
Deutschland AstraZeneca GmbH Tel: +49 41 03 7080	Nederland AstraZeneca BV Tel: +31 79 363 2222
Eesti AstraZeneca Tel: +372 6549 600	Norge AstraZeneca AS Tlf: +47 21 00 64 00
EXXáSa AstraZeneca A.E. Tql: +30 210 6871500	Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100	Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777
Italia AstraZeneca S.p.A. Tel: +39 02 9801 1	Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Kúnpog AXéKTop Oap^aKeuTiK^ At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000
Latvija SIA AstraZeneca Latvija Tel: +371 67377100	United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency

Package Leaflet: Information for the user

Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen 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.

What is in this leaflet

• 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

1. What Bydureon is and what it is used for

Bydureon contains the active substance exenatide. It is an injectable medicine 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 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.

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 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.

Children and adolescents

Do not give this medicine to children and adolescents less than 18 years, as there is no experience with this medicine in this age group.

Other medicines and Bydureon

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).

Pregnancy and breast-feeding

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.

Driving and using machines

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).

3. How to use Bydureon

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.

Follow the “Instructions for the User” provided in the carton to inject Bydureon BCise

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 Bydureon than you should

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).

If you forget to use Bydureon

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 you have taken the full dose of Bydureon

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 stop using Bydureon

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.

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 your doctor immediately if you experience symptoms such as

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

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.

• Tell your doctor if you have had pancreatitis, gallstones, alcoholism or very high triglycerides.

These medical conditions can increase the risk of getting pancreatitis, or getting it again, whether or not you are taking this medicine.

• STOP taking this medicine and contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).

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

• hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea

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)

• hypoglycaemia (low blood sugar) when taken with an insulin
• headache
• dizziness
• nausea (nausea is most common when starting this medicine, but decreases over time in most patients)
• diarrhoea
• vomiting
• constipation
• indigestion
• heartburn
• bloating
• pain in the stomach area
• injection site itchiness or redness
• tiredness (fatigue)

Uncommon side effects

• hypoglycaemia (low blood sugar) when this medicine is used with a medicine that does not contain a sulphonylurea
• reduced appetite

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.

• dehydration
• unusual taste in the mouth
• sleepiness
• flatulence (passing gas)
• burping
• intestinal obstruction (blockage in intestine)
• hives
• increased sweating
• rash, itching
• hair loss
• decrease in kidney function
• injection site reactions

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.

• loss of energy and strength
• a delay in the emptying of the stomach

Rare side effects

• feeling jittery

Not known (frequency cannot be estimated from the available data)

In addition some other side effects have been reported:

• bleeding or bruising more easily than normal due to low level of blood platelets.
• skin reactions at the injection site following injection of exenatide. These include: cavity containing pus (abscess) and swollen, or red area of skin that feels hot and tender (cellulitis).
• changes in INR (measurement of blood thinning) have been reported when used together with

warfarin.

Reporting of side effects

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 national reporting system listed in. By reporting side effects, you can help provide more information on the safety of this medicine.

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 the carton after EXP. The expiry date refers to the last day of that month.

Bydureon BCise pen should be stored as follows:

• Store in a refrigerator (2 °C to 8 °C).
• The pen may be kept for up to 4 weeks below 30 °C prior to use.
• Store in the original package in order to protect from light.
• The pen must be stored flat.

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.

6. Contents of the pack and other information

What Bydureon BCise pen contains

• – 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.

What Bydureon looks like and contents of the pack

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.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Sodertalje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11	Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550
Efc^rapufl	Luxembourg/Lu­xemburg
Acmpa3eHeKa Etarapua EOOfl	AstraZeneca S.A./N.V.
Tea.: +359 (2) 44 55 000	Tel/Tel: +32 2 370 48 11
Česká republika	Magyarorszag
AstraZeneca Czech Republic s.r.o.	AstraZeneca Kft.
Tel: +420 222 807 111	Tel.: +36 1 883 6500
Danmark	Malta
AstraZeneca A/S	Associated Drug Co. Ltd
Tlf: +45 43 66 64 62	Tel: +356 2277 8000
Deutschland	Nederland
AstraZeneca GmbH	AstraZeneca BV
Tel: +49 41 03 7080	Tel: +31 79 363 2222
Eesti	Norge
AstraZeneca	AstraZeneca AS
Tel: +372 6549 600	Tlf: +47 21 00 64 00
EXXáSa	Österreich
AstraZeneca A.E.	AstraZeneca Österreich GmbH

Tql: +30 210 6871500	Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100	Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777
Italia AstraZeneca S.p.A. Tel: +39 02 9801 1	Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Kúnpog AXéKTop Oap^aKeuTiK^ At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000
Latvija SIA AstraZeneca Latvija Tel: +371 67377100	United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency

INSTRUCTIONS FOR THE USER

Your step by step guide

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

If you have questions about taking Bydureon

• Refer to the Common questions and answers

Helpful hints

• Take your time.
• Follow these instructions step by step.
• You will need enough time to complete all the steps without stopping.
• You will probably need less time as you get used to giving yourself injections.

IMPORTANT:

Read and follow each step in these instructions carefully every time you take Bydureon. Do not skip steps. Also read the Package Leaflet in your carton.

Your guide to the parts

Single-dose kit

Keep this flap open so you can refer to it as you go through the steps

Needle (monoject)

The single-dose kit has a spare needle (not shown) in case you need it.

Your guide to the parts

Single-dose kit

What’s inside

To take the correct dose, read each section so that you do every step in order.

This guide is divided into sections:

• 1 Getting started

• 2 Connecting the parts

• 3 Mixing the medicine and filling the syringe

• 4 Injecting the medicine

Common questions and answers.

• 1. Getting Started

1a Take a single-dose kit from the refrigerator.

Prepare to safely dispose of used needles and syringes. Have what you need ready in order to safely dispose of used needles and syringes.

1b Wash your hands.

Peel back the cover to open.

Remove the syringe. The liquid in the syringe should be clear and free of particles. It is okay if there are air bubbles.

Place the needle, vial connector package, vial, and syringe on a clean, flat surface.

Pick up the needle, and twist off the blue cap.

Put the covered needle down. The needle is now prepared. You will need it later.

There is a spare needle in case you need it.

Pick up the vial.

Tap the vial several times against a hard surface to loosen the powder.

Use your thumb to remove the green cap.

Put the vial down.

2. Connecting the parts

Pick up the vial connector package and peel off the paper cover. Do not touch the orange connector inside.

Hold the vial connector package.

In your other hand, hold the vial.

Press the top of the vial firmly into the orange connector.

Lift the vial with the orange connector now attached out of its package.

2e

This is what the vial should now look like.

Put it down for later.

Pick up the syringe.

Snap

2g

Break off the cap

Be careful not to push in the plunger.

Just like you might break a stick, you are breaking off the cap.

This is what the broken-off cap looks like.

You will not need the cap and can throw it away.

This is what the syringe should now look like.

Now, pick up the vial with the orange connector attached.

Twist the orange connector onto the syringe until snug. While twisting, be sure to hold the orange connector. Do not over tighten. Be careful not to push in the plunger.

This is how the parts should now look when they are connected.

• 3. Mixing the medicine and filling the syringe

IMPORTANT:

During these next steps, you will be mixing the medicine and filling the syringe. Once you mix the medicine, you must inject it immediately. You must not save the mixed medicine to inject at a later time.

With your thumb, push down the plunger until it stops and hold your thumb in place.

The plunger may feel like it is springing back a little.

Keep pushing down on the plunger with your thumb and shake vigorously . Keep shaking until the liquid and powder are mixed well.

Do not worry that the vial might come off. The orange connector will keep it attached to the syringe.

Shake vigorously like you would shake a bottle of oil-and-vinegar salad dressing.

When the medicine is mixed well, it should look cloudy.

If you see clumps of dry powder on the sides or bottom of the vial, the medicine is NOT mixed well.

Shake vigorously again until well mixed.

Keep pushing on the plunger with your thumb while shaking.

Now, hold the vial so the syringe is pointing up. Keep pushing on the plunger with your thumb until it stops, and hold it in place.

Gently tap the vial with the other hand. Keep pushing on the plunger with your thumb to keep the plunger in place.

The tapping helps the medicine drip down along the sides of the vial. It is okay if there are air bubbles.

Pull the plunger down beyond the black dashed Dose Line.

This draws the medicine from the vial into the syringe. You may see air bubbles. This is normal.

A little bit of liquid may cling to the sides of the vial. This is also normal.

With one hand, hold the plunger in place so it does not move.

With the other hand, twist the orange connector to remove.

After removing the connector be careful not to push in the plunger.

This is what the syringe should now look like.

• 4. Injecting the medicine

IMPORTANT:

Read the next steps carefully and look closely at the pictures.

This helps you get the correct dose of medicine.

Twist the needle onto the syringe until snug. Do not remove the needle cover yet. Be careful not to push in the plunger.

Slowly push

Top of plunger

4b

Slowly push in the plunger so the top of the plunger lines up with the black dashed Dose Line.

Then, take your thumb off the plunger.

It is important to stop pushing at this point, or you will waste your medicine and you will not get the correct dose.

The top of the plunger must stay lined up with the black dashed Dose Line as you go through the next steps. This will help you get the correct dose of medicine.

IMPORTANT:

It is normal to see a few air bubbles in the mixture.

The air bubbles will not harm you or affect your dose.

You can inject each dose of the medicine in your stomach area (abdomen), your thigh, or the back of your upper arm.

Each week you can use the same area of your body. But be sure to choose a different injection site in that area.

4e

Hold the syringe near the black dashed Dose Line.

4f

Pull the needle cover straight off .

Do not twist.

Be careful not to push in the plunger.

When you remove the cover, you may see 1 or 2 drops of liquid. This is normal.

Be sure to use the injection technique recommended by your doctor or diabetes nurse.

Remember: You must take your injection of Bydureon immediately after mixing it.

Insert the needle into your skin (subcutaneously). To inject your full dose, push down on the plunger with your thumb until it stops.

Withdraw the needle.

Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.

4h. Dispose of the syringe with the needle still attached as instructed by your doctor or diabetes nurse. DO NOT try to recap or reuse the needle.

You do not have to save any parts. Each single-dose kit has everything you need for your weekly dose of Bydureon.

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

When it is time for your next weekly dose, start again at step 1.

Common questions and answers

If your question is about:

How soon to inject after mixing

Mixing the medicine

Air bubbles in syringe

Attaching the needle

Removing the needle cover

Plunger not lining up with black dashed Dose Line

Being unable to push the plunger down when injecting

Common questions and answers

• 1. After I mix the medicine, how long can I wait before taking the injection?

You must take your injection of Bydureon immediately after mixing it. If you do not inject Bydureon immediately, the medicine will start to form small clumps in the syringe. These clumps could clog the needle when you take the injection (see question 7).

• 2. How do I know that the medicine is mixed well?

When the medicine is mixed well, it should look cloudy. There should not be any dry powder on the sides or bottom of the vial. If you do see any dry powder, shake vigorously while continuing to push down on the plunger with your thumb. (This question relates to the steps shown in sections 3a to 3d).

• 3. I’m ready to take the injection. What should I do if I see air bubbles in the syringe?

It is normal for air bubbles to be in the syringe. The air bubbles will not harm you or affect your dose. Bydureon is injected into your skin (subcutaneously). Air bubbles are not a problem with this type of injection.

• 4. What should I do if I have trouble attaching the needle?

First, be sure you have removed the blue cap. Then, twist the needle onto the syringe until snug. To prevent losing medicine, do not push in the plunger while attaching the needle. For more information on injection techniques talk with your health care professional.

(This question relates to step 4a.)

• 5. What should I do if I have trouble removing the needle cover?

With one hand, hold the syringe near the black dashed Dose Line. With your other hand, hold the needle cover. Pull the needle cover straight off Do not twist it. (This question relates to step 4f.)

• 6. I am at step 4c. What should I do if the top of the plunger has been pushed past the black dashed Dose Line?

The black dashed Dose Line shows the correct dose. If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection. Before your next injection in 1 week, carefully review the instructions for steps 3a to 4h.

• 7. When I inject, what should I do if I cannot push the plunger all the way down?

This means the needle has become clogged. Remove the needle and replace it with the spare needle from your kit. Then choose a different injection site and finish taking the injection.

To review how to:

• Remove the blue cap of the needle, see step 1d
• Attach the needle, see step 4a
• Remove the needle cover and give the injection, see steps 4e to 4g

If you still cannot push the plunger all the way down, withdraw the needle. Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.

To prevent a clogged needle, always mix the medicine very well, and inject immediately after mixing.

Bydureon only needs to be taken once a week.

Make a note that you have taken your Bydureon today and mark your calendar for when you are due for your next injection.

Where to learn more about Bydureon

• Talk with your doctor, pharmacist or diabetes nurse
• Read the Package Leaflet carefully

INSTRUCTIONS FOR THE USER

Read these instructions carefully before use

Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen

How to use Bydureon pre-filled pen

Prior to use of the pen, it is recommended that you should be trained by a doctor or diabetes nurse on its proper use.

Unless a trained person can help to inject this medicine it is not recommended for people who are blind or cannot see well.

Step 1: Prepare your pen

E. Attach the needle to the pen,

by pushing and screwing it onto the top of the pen until it is tight. DO NOT remove the needle cover yet.

DO NOT proceed unless needle is attached

Step 2: Mix your dose

• A. Combine the medicine.

While holding the pen upright with the needle cover uppermost, slowly turn the knob anticlockwise. STOP when you hear the click and the green label disappears.

• B. Firmly tap the pen to mix.

• Hold the pen by the end with the orange label and tap the pen firmly against the palm of your hand.
• WITHOUT twisting the knob, ROTATE the pen every few taps.
• Tap the prefilled pen firmly until a uniformly cloudy suspension with no clumps is obtained.
• You may need to tap 80 times or more.

• C. Check the suspension.

  
  

  ore

  
  

Hold the pen up to the light and look through both sides of the mixing window. The solution should have NO CLUMPS and be uniformly cloudy.

To get your full dose the medicine must be mixed well.

If it’s not mixed well, tap longer and more firmly.

DO NOT proceed unless your medicine is mixed well

To get your full dose the medicine must be mixed well. If it’s not mixed well, tap longer and more firmly. It’s normal if you see air bubbles in the liquid, and they will cause no harm.

• D. Compare both sides of the mixing window to the photos below,

by holding the pen against the page. Pay attention to the bottom surface. If you don’t see clumps you are ready to inject.

Step 3: Inject your dose

IMPORTANT Once the medicine is mixed well, you must inject the dose immediately. You cannot save it for later use.

• A. Choose your injection site,

in either your stomach, thigh, or back of the arm. Each week you can use the same area of your body but choose a different injection site in that area. Gently clean the area with soap and water or an alcohol swab.

• B. Twist knob to release injection button.

While holding the pen upright with the needle cover uppermost, twist the knob anticlockwise until the orange label disappears and the injection button is released. DO NOT push the injection button yet.

by pulling straight off. DO NOT twist. You may see a few drops of liquid on the needle or in the cover.

Insert the needle into your skin (subcutaneously). Press the injection button with your thumb until you hear a click.

Hold for 10 seconds to make sure you get the full dose.

with the needle attached, in a puncture-resistant container. DO NOT try to recap or reuse the needle.

Common Questions and Answers

• 1. How do I know that the medicine is mixed well?

The medicine is mixed well when the liquid looks cloudy from both sides of the window. You should not see any clumps in the liquid. It may help to hold the pen up to the light to see in the window. If you see clumps of any size keep tapping the pen firmly against the palm of your hand until mixed.

• 2. I am having trouble mixing my dose. What should I do?

Remember, before preparing your dose, leave the pen out of the refrigerator for at least 15 minutes. This will let the pen warm up to room temperature. It will be easier to mix the medicine if the pen is at room temperature.

Be sure you are holding the pen at the end with the knob and the orange label. This will help you grip the pen better and tap it more firmly against your palm.

It may also help to tap the mixing window on both sides against your palm. If you see any clumps, keep tapping.

• 3. After I mix the medicine, how long can I wait before taking the injection?

You must inject your dose right after mixing it. If you do not inject your dose right away, small clumps of medicine may form in the pen and you may not get your full dose.

• 4. I’m ready to inject my dose. What should I do if I see air bubbles in the pen?

It is normal for air bubbles to be in the pen. The medicine is injected into your skin (subcutaneously). Air bubbles will not harm you or affect your dose with this type of injection.

• 5. What should I do if I cannot push the injection button all the way in when trying to

inject my dose?

Check that you have fully screwed on the pen needle. Also be sure you twisted the knob until it stopped, the orange label disappeared, and the injection button appears.

If you still cannot push the button in, this may mean that the needle is clogged. Remove the needle from your skin and replace it with the spare needle from the carton. Review how to attach the needle. Then choose a different injection site and finish taking the injection.

If you still cannot push the button all the way in, remove the needle from your skin. Use a puncture-resistant container to throw away the pen with the needle still attached.

• 6. How do I know if I injected my full dose?

To be sure you get your full dose, press the injection button with your thumb until you hear a click. After the click, continue to hold the needle in your skin for 10 seconds. This will allow enough time for all the medicine to go from the pen to under your skin.

• 7. How do I dispose of my Bydureon pen?

You will need a puncture-resistant container that is large enough to hold the entire pen with a used needle attached. Be sure the container has a lid. You may use a biohazard container, another hard plastic container, or a metal container. A container is not included in the carton.

Ask your pharmacist how to safely throw away the container with used pens and needles. Do not throw the container in your household waste.

INSTRUCTIONS FOR THE USER

Read these instructions carefully before use

Read also the Package Leaflet in your carton

Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen exenatide

Once weekly

For subcutaneous use only

Single-dose pre-filled pen

BCise is the name of the pre-filled pen device used to inject your Bydureon medicine.

Before You Begin

The Bydureon BCise pen:

• – Is a single use, fixed dose pen that automatically injects your medicine.

• – Comes in the locked position before you use it. Do not unlock the pen until you are ready to inject it.

• – Needle is hidden. You do not see it before, during, or after using the pen.

• Do not use the pen if any parts look to be broken or damaged.
• Store flat in the refrigerator between 2 °C to 8 °C.
• Bydureon BCise pen should not be used by people who are blind or cannot see well, unless another person who is trained to use this device can help.
• Keep the pen, and all medicines, out of the reach of children.

Before Use

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

Figure A

Supplies needed to give your injection:

• Bydureon BCise pen Alcohol swab A clean, flat surface Puncture-resistant container (see “disposal” instructions at the end of these instructions)

STEP 1: Prepare for injection

• A. Let your pen come to room temperature.

Remove 1 pen from the refrigerator and rest it flat for 15 minutes. Bydureon BCise pen can be kept at room temperature for up to 4 weeks.

• B. Check the expiration date (labelled EXP) printed on the pen label. Do not use the pen past the expiration date.

  Figure B

  
  

  Figure C

  
  

• C. Wash your hands.

• D. Choose your injection site.

In either your stomach, thigh, or back of the upper arm, see Figure D.

Each week you can use the same area of your body, but choose a different injection site in that area of your body.

Clean the area with an alcohol swab.

Figure G

Figure H

Do not go to the next step unless your medicine is mixed well. To get a full dose, the medicine must be mixed well and look cloudy.

If not mixed well, continue to shake hard.

STEP 3: Prepare the Pen

Important: After the medicine is fully mixed, you must complete the preparation steps right away , and inject to get the full dose. Do not save it to use later.

Only unlock the pen when you are ready to inject.

• A. Unlock the pen.

Hold the pen up straight with the orange cap toward the ceiling. Turn the knob from the Lock to the Unlock position until you hear a click.

Figure I

Figure J

• B. While still holding the pen straight up, firmly unscrew the orange cap.

• You may need to turn the cap a few times before it loosens (if you hear clicking you are turning in the wrong direction).
• Continue holding the pen upright to prevent the medicine from accidently leaking.
• A green shield will pop up after the cap is removed. The green shield hides the needle.

It is normal to see a few drops of liquid inside the cap. Do not recap the pen.

Throw away the cap.

Hold upright & firmly unscrew

STEP 4: Inject the Dose

• A. Inject and hold:

• Push the pen against your skin. You will hear a “click” when the injection begins.
• Keep holding the pen against the skin for 15 seconds. This is to make sure you get the full

dose.

Figure O

• B. Make sure you received your full dose.

After you receive your injection, you will see an orange rod in the window. After you lift the pen from your skin, the green shield will move back up to lock over the needle. See the Common Questions & Answers for what to do if you do not see the orange rod in the window after injection.

• C. Disposal.

Properly dispose of your pen right away after use , as instructed by your doctor, pharmacist or diabetes nurse.

• You will need a puncture-resistant container that: is large enough to hold the entire pen, has a lid,
• does not leak,
• is properly labelled to warn of hazardous waste inside the container.

You may use a biohazard container, another hard plastic container, or a metal container.

Common Questions and Answers

• 1. Where is the needle?

The needle is attached to the pen and covered by the orange cap.

When you unscrew the orange cap, the green shield keeps the needle covered until you inject.

For more information, please see Figure N in Step 3B in the Instructions for the User.

• 2. How do I know if the medicine is fully mixed?

After shaking the pen, look through both sides of the window. You should not see any white medicine along the bottom, top, or sides. If you see white medicine, it is unmixed. To mix, shake the pen hard until the white medicine is no longer on the bottom, top, or sides. The medicine should look even throughout (see pictures in Figure G and Figure H, Step 2C).

• 3. Why do I need to hold the pen upright while removing the orange cap?

Holding the pen with the orange cap straight up helps prevent the medicine from leaking. It is normal to see a few drops of medicine inside the orange cap after you unscrew it.

• 4. Why should I inject my medicine right away after mixing it?

If you do not inject your medicine right away after mixing, the medicine may separate, and you will not get your full dose. You can re-mix your medicine if your pen is in the locked position. However, after you unlock it, you must complete the preparation steps right away and inject to get the full dose. You cannot save it for later use.

• 5. How do I know I gave myself the full dose of medicine?

To be sure you get your full dose, press and hold the pen against your skin.

You will feel the needle go into your skin. Hold the needle against your skin for 15 seconds. This will allow enough time for all the medicine to go from the pen to under your skin. After removing the needle, look for the orange rod in the window as a way to tell that the dose has been given. If the orange rod does not appear, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country).

• 6. Why should I store my pen flat in the refrigerator?

Pens stored vertically (with the needle up or down) are more difficult to mix. The medicine can still be fully mixed but it will take more shaking and more time.

• 7. How do I dispose of my Bydureon BCise pen?

Do not throw away the pen in your household waste. You will need a puncture-resistant container that is large enough to hold the entire pen. Be sure the container has a lid. You may use a biohazard container, another hard plastic container, or a metal container. A container is not included in the carton.

Do not recycle the container with used pens. Ask your pharmacist how to safely throw it away. Do not throw the container in your household waste.

• 8. What if the device malfunctions and I cannot unlock it?

Review the Instructions for the User Step 3 to confirm the order of operations, then contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country). Do not try to unlock with excessive force or tools.

• 9. What if the device malfunctions and I cannot remove the orange cap?

Review the Instructions for the User Step 3 to confirm the order of operations, also confirm that the knob is fully in the unlocked position, then contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country). Do not use tools or try to force the cap off.

• 10. Where to learn more about Bydureon BCise pen

• Talk with your doctor, pharmacist or diabetes nurse
• Read the Package Leaflet carefully.

How to Store Bydureon BCise pen

• Store flat in the refrigerator between 2 °C to 8 °C.
• Each pen can be kept at room temperature not to exceed 30 °C for no more than a total of 4 weeks, if needed.
• Store in packaging provided to protect from light until you are ready to prepare and use your dose.
• Do not use past the expiration date. The expiration date is labelled EXP.
• Keep the pen clean and away from spills.

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for exenatide, the scientific conclusions of CHMP are as follows:

In view of available data on delayed gastric emptying from clinical trials and in view of a plausible mechanism of action, the PRAC considers a causal relationship between exenatide and delayed gastric emptying is at least a reasonable possibility. The PRAC concluded that the product information of products containing exenatide should be amended accordingly.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for exenatide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing exenatide is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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