What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/06/362/002, EU/1/06/362/003, EU/1/06/362/001, EU/1/06/362/004.


Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen.

Package leaflet: Information for the patient

Byetta 5 micrograms solution for injection in pre-filled pen

Byetta 10 micrograms solution 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 Byetta is and what it is used for
2. What you need to know before you use Byetta
3. How to use Byetta
4. Possible side effects
5. How to store Byetta
6. Contents of the pack and other information

1. What Byetta is and what it is used for

Byetta contains the active substance exenatide. It is an injectable medicine used to improve blood sugar control in adults with type 2 (non insulin dependent) diabetes mellitus.

Byetta is used with other diabetic medicines called metformin, sulphonylureas, thiazolidinediones and basal or long acting insulins. Your doctor is now prescribing Byetta 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 if your body is not able to use the insulin properly. The medicine in Byetta helps your body to increase the production of insulin when your blood sugar is high.

2. What you need to know before you use Byetta

Do not use Byetta

  • 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 Byetta about the following:

  • Using this medicine in combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can occur. 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 (a dangerous condition that can occur in diabetes), as you should not use this medicine.
  • How to inject this medicine. It should be injected under the skin and not into a vein or into the muscle.
  • If you have severe problems with slow stomach emptying 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. There is little experience with this medicine in patients with kidney problems.

Byetta 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 Byetta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly:

  • medicines that are used to treat type 2 diabetes that work like Byetta (e.g. liraglutide and prolonged-release exenatide), as taking these medicines with Byetta 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.

Ask your doctor if the time at which you take any tablets should be changed because this medicine slows stomach emptying and can affect medicines that need to pass through the stomach quickly, e.g.

  • Stomach resistant tablets or capsules (e.g. medicines that reduce stomach acid (proton pump inhibitors)) that should not stay too long in your stomach, may need to be taken an hour before, or four hours after this medicine.
  • Some antibiotics may need to be taken an hour before your Byetta injection.
  • For tablets that you need to take with food, it may be best if they are taken at a meal at a time when this medicine is not being administered.

Byetta with food

Use this medicine at any time within the 60 minutes (1 hour) before your meal. (See section 3 “How to use Byetta”). Do not use this medicine after your meal.

Pregnancy and breast-feeding

It is not known if this medicine may harm your unborn child. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as it should not be used during pregnancy.

It is not known if exenatide passes into your milk. This medicine should not be used if breast-feeding.

Driving and using machines

If you use this medicine in combination with a sulphonylurea or insulin, 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).

Byetta contains metacresol

Metacresol may cause allergic reactions.

Byetta contains sodium

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

3. How to use Byetta

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.

Two strengths of Byetta are available: Byetta 5 micrograms and Byetta 10 micrograms. Your doctor may tell you to use Byetta 5 micrograms twice a day to start with. After using Byetta 5 micrograms twice a day for 30 days the doctor may increase your dose to Byetta 10 micrograms twice a day.

If you are over 70 years old or have problems with your kidneys it may take longer than 30 days to tolerate the Byetta 5 micrograms dose and so your doctor may not increase your dose.

One injection of your pre-filled pen will give you your dose. Do not change your dose unless your doctor has told you to.

You should inject this medicine at any time within the 60 minutes (1 hour) before your morning and evening meals, or before your two main meals of the day, which should be about 6 hours or more apart. Do not use this medicine after your meal.

You should inject this medicine under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm. If you are using Byetta and an insulin you must make two separate injections.

You will not need to test your sugar levels on a day-by-day basis to set the dose of Byetta. However, if you are also using a sulphonylurea or an insulin your doctor may tell you to check your blood sugar levels to adjust the dose of sulphonylurea or insulin. 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).

See the accompanying Pen User Manual for instructions for using the Byetta Pen.

Your doctor or nurse must teach you how to inject Byetta before you use it for the first time.

Becton, Dickinson and Company needles are suitable to use with the Byetta pen. Injection needles are not included.

Use a new injection needle for each injection and dispose of it after each use. This medicine is for you; never share a Byetta pen with others.

If you use more Byetta than you should

If you use more of this medicine than you should, talk to a doctor or go to a hospital right away. 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 Byetta

If you miss a dose of this medicine, skip that dose and use your next dose at the next prescribed time. Do not use an extra dose or increase the amount of your next dose to make up for the one you missed.

If you stop using Byetta

If you feel you should stop using this medicine 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)
  • Rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat
  • Difficulty to swallow
  • Hives and difficulties to breathe

Cases of inflammation of the pancreas (pancreatitis) have been reported (frequency not known) 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 your chance 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)
  • vomiting
  • diarrhoea
  • hypoglycaemia

When this medicine is used with a medicine that contains a sulphonylurea or an insulin, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur very commonly. The dose of your sulphonylurea or insulin 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):

  • dizziness
  • headache
  • feeling jittery
  • constipation
  • pain in the stomach area
  • bloating
  • indigestion
  • itching (with or without rash)
  • flatulence (passing gas)
  • increased sweating
  • loss of energy and strength
  • 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.

Uncommon side effects (may affect up to 1 in 100 people):

  • decreased in kidney function
  • dehydration, generally associated with nausea, vomiting and/or diarrhoea
  • unusual taste in the mouth
  • burping
  • injection site reactions (redness)
  • sleepiness
  • hair loss
  • weight decreased

Rare side effects (may affect up to 1 in 1,000 people):

  • intestinal obstruction (blockage in intestine)

In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data).

  • 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

Malta

ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Byetta

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 – 8°C). Once in use, keep your pen below 25°C for 30 days. Dispose of a used pen after 30 days, even if some medicine remains in the pen.

Replace the cap on the pen in order to protect from light. Do not freeze. Throw away any Byetta pen that has been frozen.

Do not use this medicine if you notice particles in the solution, or if it is cloudy or coloured.

Do not store the pen with the needle attached. If the needle is left on, medicine may leak from the pen or air bubbles may form in the cartridge.

Do not throw away any medicines via waste water 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 Byetta contains

  • The active substance is exenatide.
  • Two pre-filled pens are available. One to deliver doses of 5 micrograms and one 10 micrograms.
  • Each dose of Byetta 5 micrograms solution for injection (injection) contains 5 micrograms exenatide in 20 microlitre.
  • Each dose of Byetta 10 micrograms solution for injection (injection) contains 10 micrograms exenatide in 40 microlitre.
  • Each millilitre (ml) of the solution for injection contains 0.25 milligrams (mg) of exenatide.
  • The other ingredients are metacresol, (44 micrograms/dose in Byetta 5 micrograms solution for injection and 88 micrograms/dose in Byetta 10 micrograms solution for injection), mannitol, glacial acetic acid, sodium acetate trihydrate and water for injections (see section 2).

What Byetta looks like and contents of the pack

Byetta is a clear and colourless liquid (solution for injection) filled in a glass cartridge within a pen. When the pen is empty, you cannot use it again. Each pen has 60 doses to provide 30 days of twice–a–day injections.

Byetta is available in pack sizes of 1 and 3 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer

AstraZeneca AB
Global External Sourcing (GES)
Astraallén
Gärtunaporten (B 674:5)
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 contact the local representative of the Marketing Authorisation Holder:

United Kingdom
AstraZeneca UK Ltd
Tel: +44 1582 836 836

This leaflet was last revised in 04/2019

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

CV 19 0065