Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lyxumia

Document Subject

Generated Narrative: MedicinalProductDefinition mp88465ebc29d8e476ad0a83f9574d1c59

identifier: http://ema.europa.eu/identifier/EU/1/12/811/001 (1 pre-filled pen)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lyxumia 10 micrograms solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-88465ebc29d8e476ad0a83f9574d1c59

identifier: http://ema.europa.eu/identifier/EU/1/12/811/001 (1 pre-filled pen)

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - lyxumia

Attesters

What is in this leaflet

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

Lyxumia contains the active substance lixisenatide. It is an injectable medicine used to help your body to control your blood sugar level when it is too high. It is used in adults with type 2 diabetes.

Lyxumia is used with other medicines for diabetes when they are not enough to control your blood sugar levels. These may include:

• oral antidiabetics (such as metformin, pioglitazone, sulphonylurea medicines) and/or,
• a basal insulin, a type of insulin which works all day.

Do not use Lyxumia

• if you are allergic to lixisenatide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lyxumia if:

• you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin) since this medicine will not be right for you

• you have or have had inflammation of the pancreas (pancreatitis)

• you have a severe stomach or gut problem such as a disease of the muscles of the stomach called gastroparesis which results in delayed stomach emptying

• you have severe kidney disease, or you are on dialysis as the use of this medicine will not be recommended

• you are also taking a sulphonylurea or a basal insulin. This is because low blood sugar (hypoglycaemia) can occur. Your doctor may want to control your blood sugar level and then, decide to reduce your dose of basal insulin or sulphonylurea. Lyxumia should not be used with a combination of both basal insulin and sulphonylurea

• you are taking other medicines, as there are other medicines such as antibiotics or stomach resistant tablets or capsules that should not stay too long in your stomach (see section Other medicines and Lyxumia)

• you experience loss of fluids/dehydration,e.g., in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids, especially when starting treatment with Lyxumia

• you suffer from heart problems which can cause shortness of breath or ankle swelling, since there is limited experience in this population.

Children and adolescents There is no experience with Lyxumia in children and adolescents less than 18 years and therefore, the use of Lyxumia is not recommended in this age group.

Other medicines and Lyxumia Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. The effect of some medicines you swallow might be affected by Lyxumia. Some medicines such as antibiotics or stomach resistant tablets or capsules that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Lyxumia injection.

Pregnancy and breast-feeding
Lyxumia should not be used during pregnancy. It is not known if Lyxumia may harm your unborn child.
Lyxumia should not be used if breast-feeding. It is not known if Lyxumia passes into your milk.
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 advice before taking this medicine.

Driving and using machines
If you use Lyxumia with a sulphonylurea or a basal insulin, you may get low blood sugar (hypoglycaemia). This may make it difficult to concentrate and you may feel dizzy or sleepy. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of Lyxumia This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially sodium-free . This medicine contains metacresol which may cause allergic reactions.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to inject

• The starting dose is 10 micrograms once a day for the first 14 days injected using the green pen.
• The dose from then onwards will be 20 micrograms once a day -using the purple pen.

When to inject Inject Lyxumia in the hour before any meal of the day. Preferably inject Lyxumia before the same meal every day, when you have chosen the most convenient meal for your injection. Where to inject Inject Lyxumia into the skin (subcutaneously) of your stomach area (abdomen), upper leg (thigh) or upper arm.

Learning how to use the pre-filled pens Before you use the pen for the first time, your doctor or nurse will show how to inject Lyxumia.

Always read the "Instructions for Use" provided in the box. Always use the pen as described in the Instructions for Use .

Other important information about using the pre-filled pens There is more information on how to use the pens in the Instructions for Use . The most important points are:

• Always use a new needle for each injection. You must dispose of the needle after each use, in an appropriate sharp s container, following local recommendations. Speak to your doctor, nurse or pharmacist about how to dispose of sharps.
• Only use needles that are compatible for use with Lyxumia pen (see Instructions for Use ).
• You must activate your Lyxumia pen before you use it for the first time. This is to make sure that it is working correctly and that the dose for your first injection is correct.
• If you think your Lyxumia pen may be damaged, do not use it. Get a new one. Do not try to repair the pen.

If you use more Lyxumia than you should
If you use more Lyxumia than you should, talk to your doctor immediately. Too much Lyxumia can make you feel sick or be sick.

If you forget to use Lyxumia
If you miss a dose of Lyxumia, you can inject it in the hour before your next meal. Do not take two doses at the same time to make up for a forgotten injection.

If you stop using Lyxumia
Do not stop using Lyxumia without talking with your doctor. If you stop using Lyxumia, your blood sugar levels can increase.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some severe allergic reactions (such as anaphylaxis) have been reported uncommonly in patients receiving Lyxumia. You should seek immediate medical attention if you experience symptoms like swelling of the face, tongue or throat which causes difficulty with breathing.

Stop taking Lyxumia and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis). The most frequent side effects reported with Lyxumia that may affect more than 1 in 10 users (frequency very common) were nausea (feeling sick) and vomiting. These side effects were mostly mild and usually go away over time.

Other side effects include Very common side effects: may affect more than 1 in 10 people

• Diarrhoea
• Headache
• Low blood sugar (hypoglycaemia ( hypo ) especially when Lyxumia is used with insulin or a sulphonylurea
  The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weak, dizzy, confused or irritable, feeling hungry, fast heartbeat and feeling jittery. Your doctor will tell you what to do if you get a low blood sugar. This is more likely to happen if you also take a sulphonylurea or a basal insulin. Your doctor may reduce your dose of these medicines before you start using Lyxumia.

Common side effects: may affect up to 1 in 10 people

• Flu (influenza)
• Cold (upper respiratory tract infection)
• Feeling dizzy
• Indigestion (dyspepsia)
• Back pain
• Cystitis
• Viral infection
• Low blood sugar (when Lyxumia is taken with metformin)
• Drowsiness (somnolence)
• Injection site reactions (such as itching).

Uncommon side effect: may affect up to 1 in 100 people

• Hives (urticaria)
• Gallstones
• Inflamed gallbladder

Rare side effect: may affect up to 1 in 1,000 people

• A delay in the emptying of the stomach

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or 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 pen label and on the carton after EXP. The expiry date refers to the last day of the month.

Before first use
Store in a refrigerator (2 C-8 C). Do not freeze. Keep away from the freezer compartment.

During use of the pen The pen can be used for 14 days when stored at a temperature below 30 C. Do not freeze. Do not store with a needle attached. When you are not using the pen, keep the cap on the pen in order to protect from light.

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 Lyxumia contains

• The active substance is lixisenatide.
• Lyxumia 10 micrograms solution for injection: Each dose contains 10 micrograms of lixisenatide (50 micrograms per ml).
• Lyxumia 20 micrograms solution for injection: Each dose contains 20 micrograms of lixisenatide (100 micrograms per ml).
• The other ingredients are glycerol 85 %, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid (for pH adjustment), sodium hydroxide solution (for pH adjustment) and water for injections.

What Lyxumia looks like and contents of the pack Lyxumia is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen.

Each green pen of Lyxumia 10 micrograms solution for injection contains 3 ml of solution, delivering 14 doses of 10 micrograms. Pack size of 1 pre-filled pen.

Each purple pen of Lyxumia 20 micrograms solution for injection contains 3 ml of solution, delivering 14 doses of 20 micrograms. Pack sizes of 1, 2 or 6 pre-filled pens. Not all pack sizes may be available in your country.

A treatment initiation pack is also available for use during the first 28 days of treatment. The treatment initiation pack contains one green pen of Lyxumia 10 micrograms solution for injection and one purple pen of Lyxumia 20 micrograms solution for injection.

Marketing Authorisation Holder Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France

Manufacturer Sanofi-Aventis Deutschland GmbH Industriepark H chst - 65926 Frankfurt am Main Germany

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

Belgi /Belgique/ Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB
Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l.
Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 Tel. aus dem Ausland: +49 69 305 21 Nederland Sanofi B.V.
Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis
: +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop Industrie T l : 0 800 222 Appel depuis l tranger: +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda. Tel: +351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l.
Tel: 800 536Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: