Byetta 10micrograms/0.04ml solution for injection 2.4ml pre-filled disposable devices

Byetta is used in combination with other medicines to treat type 2 diabetes. It works by increasing the amount of insulin produced by the body. Insulin is a hormone that helps the body to use the sugar in the blood properly and it helps to prevent the blood sugar level from becoming too high.

In diabetes, the body may not be able to produce enough insulin or the insulin that it produces may not have the full effect. In some instances, the body may not be able to produce any insulin at all. These can all lead to problems controlling the blood sugar level.

It is very important that your blood sugar level is well controlled. Blood sugar levels which are too high or too low can be dangerous. Your prescriber or a member of your diabetes team will be able to give you information on how to recognise the warning signs of high and low blood sugar levels. They will also be able to tell you what to do if either of these occurs.

Warning signs can vary from person to person. If the usual warning signs of poorly controlled blood sugar levels change or disappear, you should contact your prescriber or a member of your diabetes team.

Your prescriber or your diabetes team may advise you to measure your blood sugar regularly – they will show you how to do this. If you are having problems controlling or measuring your blood sugar, you should contact your prescriber or a member of your diabetes team.

Other information about Byetta:

Byetta needs to be injected. Your prescriber will show you how to inject this medicine yourself.

There should also be instructions on how to inject this medicine in the Patient Information Leaflet that comes with this medicine or on the pharmacy label.

The pharmacy label on your medicine tells you how much medicine you should use. It also tells you how often you should use your medicine. This is the dose that you and your prescriber have agreed you should use. You should not change the dose of your medicine unless you are told to do so by your prescriber.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

This medicine needs to be used at specific times of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Byetta:

This medicine needs to be injected. Your medical team will train you how to inject the medicine yourself. For more information see the Patient Information Leaflet or contact one of your medical team.

If you have any concerns about this medicine or are having problems using it you should discuss these difficulties with your prescriber, diabetes nurse or pharmacist.

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

Make sure that you do not take any extra doses as this could cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex and it is therefore essential that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

If you are having any problems using your medicine you must speak to your prescriber. If you are not having any problems using this medicine then do not stop using it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

If you are injecting this medicine yourself, read the pharmacy label to find out how you should look after your medicine. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions.

Do not use the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Specific information about how to look after Byetta can be found in the Patient Information Leaflet that comes with this medicine. Make sure that the medicine is out of the sight and reach of children.

In the case of Byetta:

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Byetta is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone under the age of 18 years.

Over time it is possible that Byetta can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Byetta has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

As part of treatment, this medicine may be used in combination with other medicines. There is no information available about the side-effects of Byetta when it is taken on its own. The information included here relates to the side-effects caused by the combination of this medicine with other medicines that it is usually given with. There may be more information on the side-effects of Byetta in the Patient Information Leaflet for Byetta.

Very common: More than 1 in 10 people who use Byetta:

• decreased blood sugar levels when Byetta is used with a sulphonylurea very low blood sugar levels may lead to loss of consciousness, impairment of brain function, convulsions or death. If your blood sugar levels are low or you are having warning signs of low blood sugar levels you will need to have some sugar. Suitable foods include dextrose tablets, sweets, biscuits, sugary fruit juice or sugar. Your prescriber may have also prescribed you glucagon. Glucagon is an emergency treatment for people with very low blood sugar levels. If you have been prescribed glucagon, make sure you or your carer knows when to use it, where it is stored and how to use it
• diarrhoea
• nausea
• vomiting

Common: More than 1 in 100 people who use Byetta:

• distension of the stomach
• feeling dizzy
• feeling jittery
• gastro-oesophageal reflux
• headaches
• increased sweating
• indigestion
• injection site problems such as itching or redness of the skin
• loss of appetite
• stomach pain
• weakness
• weight loss

Uncommon: More than 1 in 1000 people who use Byetta:

• belching
• constipation
• flatulence
• taste changes

Rare: More than 1 in 10,000 people who use Byetta:

• abnormal laboratory test results
• angioedema
• dehydration
• hair loss
• kidney problems or worsening of kidney problems
• pancreatitis - this may be fatal. Seek medical advice if you develop symptoms such as stomach pain
• skin rash or rashes
• sleepiness
• urticaria

Very rare: Fewer than 1 in 10,000 people who use Byetta:

• anaphylactic reactions

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Byetta:

The following types of medicine may interact with Byetta:

If you are taking Byetta and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Other important information about interactions with Byetta:

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Byetta.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Byetta:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Byetta:

For more advice speak to your prescriber, nutritionist or pharmacist.

Alcohol can interact with certain medicines.

In the case of Byetta:

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Byetta:

People with diabetes may start to have insulin instead of Byetta to control their blood sugar during pregnancy. If you are taking Byetta and are planning to become pregnant, become pregnant or think that you are pregnant, talk to a member of your diabetes team. For more information on managing your diet and your diabetes during your pregnancy, talk to your prescriber or a member of your diabetes or antenatal team.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Byetta:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Byetta contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Byetta before, do not use Byetta. Talk to your prescriber, pharmacist or nurse as soon as possible.