Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - elebrato

Document Subject

Generated Narrative: MedicinalProductDefinition mp07dfba600182595cfe2f36d89c5d2642

identifier: http://ema.europa.eu/identifier/EU/1/17/1237/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed

type: Full name

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part: nan

type: Invented name part

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-07dfba600182595cfe2f36d89c5d2642

identifier: http://ema.europa.eu/identifier/EU/1/17/1237/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - elebrato

Attesters

Step-by-step instructions

What is in this leaflet

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

What Elebrato Ellipta is

Elebrato Ellipta contains three active substances called fluticasone furoate, umeclidinium bromide and vilanterol. Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators.

What Elebrato Ellipta is used for

Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long- term condition characterised by breathing difficulties that slowly get worse.

In COPD the muscles around the airways tighten, making breathing difficult. This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.

Elebrato Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD. It should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.

Do not use Elebrato Ellipta:

• if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Elebrato Ellipta

• if you have asthma (Do not use Elebrato Ellipta to treat asthma)
• if you have heart problems or high blood pressure
• if you have liver problems
• if you have tuberculosis (TB) of the lung, or any long standing or untreated infections
• if you have an eye problem called narrow-angle glaucoma
• if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder
• if you suffer from epilepsy
• if you have thyroid gland problems
• if you have low potassium in your blood
• if you have a history of diabetes
• if you experience blurred vision or other visual disturbances

Check with your doctor if you think any of these may apply to you.

Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Elebrato Ellipta inhaler: stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.

Eye problems during treatment with Elebrato Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Elebrato Ellipta:

stop using this medicine and seek medical help immediately. These may be signs of an acute attack of narrow-angle glaucoma.

Infection of the lung Because you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia. See section 4 Possible side effects for information on symptoms to look out for while you are using this medicine.

Tell your doctor as soon as possible if you develop any of these symptoms.

Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.

Other medicines and Elebrato Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist.

Some medicines may affect how this medicine works, or make it more likely to have side effects. These include:

• medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems

• ketoconazole or itraconazole, to treat fungal infections

• clarithromycin or telithromycin, to treat bacterial infections

• ritonavir or cobicistat, to treat HIV infection

• medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat COPD and asthma (such as methylxanthine or steroids)

• other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol. Do not use Elebrato Ellipta if you already use these medicines. Tell your doctor or pharmacist if you are taking any of these. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Elebrato Ellipta.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not use this medicine if you are pregnant unless your doctor tells you that you can.

It is not known whether the ingredients of this medicine can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use Elebrato Ellipta. Do not use this medicine if you are breast- feeding unless your doctor tells you that you can.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.

Elebrato Ellipta contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.

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

The recommended dose is one inhalation every day at the same time of day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours.

Do not use more than your doctor tells you to use.

Use Elebrato Ellipta regularly It is very important that you use Elebrato Ellipta every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.

Elebrato Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).

How to use the inhaler See Step-by-step instructions at the end of this leaflet for full information.

Elebrato Ellipta is for inhalation use.

Once the tray is opened Elebrato Ellipta is ready to use.

If your symptoms do not improve
If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:

contact your doctor as soon as possible.

If you use more Elebrato Ellipta than you should
If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache. If you forget to use Elebrato Ellipta
Do not inhale a double dose to make up for a forgotten dose. Just inhale your next dose at the usual time. If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.

If you stop using Elebrato Ellipta
Use this medicine for as long as your doctor recommends. Do not stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.

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

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

Allergic reactions Allergic reactions to Elebrato Ellipta are rare (they may affect up to 1 in 1 000 people). If you have any of the following symptoms after taking Elebrato Ellipta, stop using it and tell your doctor immediately:

• skin rash or redness, hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema)
• wheezing, coughing or having difficulty in breathing
• suddenly feeling weak or light headed (may lead to collapse or loss of consciousness)

Immediate breathing difficulties If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.

Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Elebrato Ellipta these could be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus colour
• increased cough or increased breathing difficulties

Other side effects

Common (may affect up to 1 in 10 people)

• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth out with water immediately after using Elebrato Ellipta may help prevent this side effect.
• infection of the nose, sinuses or throat
• infection of the upper airways
• itchy, runny or blocked nose
• pain in the back of the mouth and throat
• inflammation of the sinuses
• inflammation of the lungs (bronchitis)
• flu (influenza)
• common cold
• headache
• cough
• painful and frequent urination (may be signs of a urinary tract infection)
• joint pain
• back pain
• constipation. Uncommon (may affect up to 1 in 100 people)
• irregular heart beat
• faster heart beat
• hoarseness
• weakening of the bones, leading to fractures
• dry mouth
• taste disturbance
• blurred vision
• increased eye pressure
• eye pain.

Rare (may affect up to 1 in 1 000 people)

• allergic reactions (see earlier in Section 4)
• difficulties passing urine (urinary retention)
• pain or discomfort passing urine (dysuria)
• awareness of heart beat (palpitations)
• anxiety
• tremor
• muscle spasms
• increase in blood sugar (hyperglycaemia).

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 carton, tray and inhaler after EXP . The expiry date refers to the last day of that month.

Do not store above 30 C.

Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.

If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.

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 Elebrato Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate). The other ingredients are lactose monohydrate (see section 2 under Elebrato Ellipta contains lactose ) and magnesium stearate.

What Elebrato Ellipta looks like and contents of the pack Elebrato Ellipta is an inhalation powder, pre-dispensed. The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant sachet, to reduce moisture in the packaging.

The active substances are present as a white powder in separate blister strips inside the inhaler.
Elebrato Ellipta is available in packs of 1 inhaler containing either 14 or 30 doses (14 or 30 day supply) and in multipacks containing 90 (3 inhalers of 30) doses (90 day supply). Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin Ireland

Manufacturer
Glaxo Wellcome Production Zone Industrielle No.2 23 Rue Lavoisier 27000 Evreux
France

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

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC
Tel: + 370 52 691 lt@berlin-chemie.com

• / .
  E
  Te .: + 359 2 454 0bcsofia@berlin-chemie.com

Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com

Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: + 36 23501bc-hu@berlin-chemie.com

Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline Trading Services Limited
Tel: + 356 80065Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti O Berlin-Chemie Menarini Eesti
Tel: + 372 667 5ee@berlin-chemie.com

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
Guidotti Hellas A.E. : + 30 210 8316111- sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a FAES FARMA, S.A. Tel: + 34 900 460 aweber@faes.es Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Menarini France T l: + 33 (0)1 45 60 77 Portugal BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 info@bial.com

Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 office-croatia@berlin-chemie.com

Rom nia GlaxoSmithKline Trading Services Limited
Tel: + 40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: + 386 (0)1 300 2slovenia@berlin-chemie.com

sland Vistor hf. S mi: +354 535 7Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: + 421 2 544 30 slovakia@berlin-chemie.com

Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39 (0)55 56Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline Trading Services Limited : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija SIA Berlin-Chemie/Menarini Baltic
Tel: + 371 67103lv@berlin-chemie.com United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in .

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