Patient Information Leaflet
Contents
1. a BMI body mass index lt 25 There is little experience with Byetta in patients with kidney problems The use of Byetta is not recommended if you have severe kidney disease or you are on dialysis Children and adolescents There is no experience with Byetta in children and adolescents less than 18 years and therefore use of Byetta is not recommended 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 Ask your doctor if the time at which you take any tablets should be changed because Byetta slows stomach emptying and can affect medicines that need to pass through the stomach quickly Stomach resistant tablets or capsules for example proton pump inhibitors that should not stay too long in your stomach may need to be taken an hour before or four hours after Byetta 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 Byetta is not being administered The use of Byetta with other medicines that are used to treat type 2 diabetes that work like Byetta for example liraglutide and Bydureon exenatide once weekly is not recommended Byetta with food and drink Use Byetta at any time within the 60 minutes 1 hour before your meal See 3 How to use Byetta Do not use Byetta after your meal Pregna2. 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 your Byetta pen should be kept below 25 C for 30 days Replace the cap on the pen in order to protect from light Do not freeze Throw away any Byetta pen that has been frozen Use a Byetta pen for only 30 days Dispose of a used Byetta pen after 30 days even if some medicine remains in the pen Do not use Byetta if you notice particles in the solution or if it is cloudy or coloured Do not store the Byetta pen with the needle attached If the needle is left on medicine may leak from the Byetta 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 i
3. 58 10 23 010 Sverige AstraZeneca AB Tel 46 8 553 26 000 United Kingdom AstraZeneca UK Ltd Tel 44 1582 836 836 Detailed information on this medicine is available on the website of the European Medicines Agency http www ema europa eu CV 15 0059
4. Patient Information Leaflet PACKAGE LEAFLET INFORMATION FOR THE USER Byetta 5 micrograms solution for injection pre filled pen Byetta 10 micrograms solution for injection 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 suga
5. eneca A S TIf 45 43 66 64 62 Deutschland AstraZeneca GmbH Tel 49 41 03 7080 Eesti AstraZeneca Tel 372 6549 600 FAAG6a AstraZeneca A E Tra 30 2 106871500 Espana AstraZeneca Farmac utica Spain S A Tel 34 91 301 91 00 France AstraZeneca T l 33 1 41 29 40 00 Hrvatska AstraZeneca d o o Tel 385 1 4628 000 Lietuva UAB AstraZeneca Lietuva Tel 370 5 2660550 Luxembourg Luxemburg AstraZeneca S A N V T l Tel 432 2 370 48 11 Magyarorsz g AstraZeneca Kft Tel 436 1 883 6500 Malta Associated Drug Co Ltd Tel 356 2277 8000 Nederland AstraZeneca BV Tel 31 79 363 2222 Norge AstraZeneca AS Tlf 47 21 00 64 00 sterreich _ AstraZeneca Osterreich GmbH Tel 43 1711310 Polska AstraZeneca Pharma Poland Sp z 0 0 Tel 48 22 874 35 00 Portugal AstraZeneca Produtos Farmac uticos Lda Tel 351 21 434 61 00 Romania AstraZeneca Pharma SRL Tel 40 21 317 60 41 Patient Information Leaflet Ireland AstraZeneca Pharmaceuticals Ireland Ltd Tel 353 1609 7100 Island Vistor hf Simi 354 535 7000 Italia AstraZeneca S p A Tel 39 02 9801 1 Konpoc Ak xtop Papuaksvtik At Tn 357 22490305 Latvija SIA AstraZeneca Latvija Tel 371 67377100 This leaflet was last approved in 02 2015 Slovenija AstraZeneca UK Limited Tel 386 1 51 35 600 Slovenska republika AstraZeneca AB o z Tel 421 2 5737 7777 Suomi Finland AstraZeneca Oy Puh Tel 3
6. f you use too much Byetta you may need medical treatment right away Too much Byetta 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 Byetta skip that dose and take your next dose at the next prescribed time Do not take an extra dose or increase the amount of your next dose to make up for the one you missed Patient Information Leaflet If you stop using Byetta If you feel you should stop using Byetta consult your doctor If you stop using Byetta 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 very rarely may affect up to 1 in 10 000 people You should see your doctor immediately if you experience symptoms such as Swollen face tongue or throat e Difficulty to swallow e Hives and difficulties to breathe Cases of inflammation of the pancreas pancreatitis have been reported rarely may affect up to 1 in 1 000 people in patients receiving Byetta 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 you
7. n 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 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 S dert lje Sweden Patient Information Leaflet 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 Treland For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder Belgi Belgique Belgien AstraZeneca S A N V Tel 32 2 370 48 11 Bbsrapua Actpa3eneka bsrapus EOOJI Tex 359 2 44 55 000 Cesk republika AstraZeneca Czech Republic s r o Tel 420 222 807 111 Danmark AstraZ
8. ncy and breast feeding It is not known if Byetta may harm your unborn child 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 advise before taking this medicine as Byetta should not be used during pregnancy It is not known if the medicine in Byetta passes into your milk Byetta should not be used if breast feeding Driving and using machines If you use Byetta 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 Patient Information Leaflet 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 o
9. r 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 When using Byetta 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 Byetta should not be used if you have type 1 diabetes or diabetic ketoacidosis a dangerous condition that can occur in diabetes Byetta should be injected under the skin and not into a vein or into the muscle Patient Information Leaflet If you have severe problems with your stomach emptying including gastroparesis or food digestion the use of Byetta is not recommended Byetta slows stomach emptying so food passes more slowly through your stomach Tell your doctor if you have ever had inflammation of the pancreas pancreatitis see section 4 There is little experience with Byetta in patients with
10. r chance of getting pancreatitis or getting it again whether or not you are taking Byetta STOP taking Byetta 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 of Byetta may affect more than 1 in 10 people e nausea nausea is most common when first starting Byetta but decreases over time in most patients e vomiting e diarrhoea e hypoglycaemia When Byetta 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 Byetta 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 of Byetta may affect up to 1 in 10 people dizziness headache feeling jittery pain in the stomach area bloating indigestion increased sweating Patient Information Leaflet loss of energy and strength heartburn injection site reactions redness weight decreased e reduced appetite Byetta may reduce your appetite the amount of food you eat and your weight If you lose weight too quickly more than 1 5 kg pe
11. r week talk to your doctor about it since this may not be good for you Uncommon side effects of Byetta may affect up to 1 in 100 people e unusual taste in the mouth e burping e constipation e gas flatulence Rare side effects of Byetta e intestinal obstruction blockage in intestine e angiodema swelling of the face and throat e hypersensitivity rashes itching and rapid swelling of the tissues of the neck face mouth or throat decrease in kidney function dehydration sometimes with a decrease in kidney function drowsiness hair loss In addition some other side effects have been reported frequency not known cannot be estimated from the available data e 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 Ireland HPRAPharmacovigilance Earlsfort Terrace IRL Dublin 2 Tel 353 1 6764971 Fax 353 1 6762517 Website www hpra ie e mail medsafety hpra ie Malta ADR Reporting Website www medicinesauthority gov mt adrportal Patient Information Leaflet
12. ver 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 Byetta should be injected 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 Byetta after your meal Byetta is injected 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 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 I
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