Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - byetta

Document Subject

Generated Narrative: MedicinalProductDefinition mp9367ad7779ef7d59f46d4f6cb649b03e

identifier: http://ema.europa.eu/identifier/EU/1/06/362/001 –4

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Byetta 5 micrograms solution for injection in pre-filled pen

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9367ad7779ef7d59f46d4f6cb649b03e

identifier: http://ema.europa.eu/identifier/EU/1/06/362/001 –4

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - byetta

Attesters

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

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.

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 .

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.

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,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

a delay in the emptying of the stomach

inflamed gallbladder

gallstones 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. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 S dert lje Sweden Manufacturer AstraZeneca AB Karlebyhusentr n Astraall n SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 79 363 2Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: