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

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

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 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)

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.

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

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