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INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE

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About the medicine

How to use INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Incruse Ellipta 55microgramspowder forinhalation (single dose)

umeclidinium (umeclidinium)

Read this package leaflet carefully before you start using this medicine, because it containsimportant information for you.

  • Keep this package leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

  1. What is Incruse Ellipta and what is it used for
  2. What you need to know before you start using Incruse Ellipta
  3. How to use Incruse Ellipta
  4. Possible side effects
  5. Storage of Incruse Ellipta
  6. Contents of the pack and further information

Step-by-step instructions for use

1. What is Incruse Ellipta and what is it used for

What is Incruse Ellipta

Incruse Ellipta contains the active substance umeclidinium (as bromide), which belongs to a group of medicines called bronchodilators.

What is Incruse Ellipta used for

This medicine is used to treat chronic obstructive pulmonary disease (COPD)(COPD)in adults. COPD is a long-term disease that gradually worsens, and the airways and air sacs in the lungs become obstructed or damaged, making it difficult to breathe. This difficulty breathing is added to the contraction of the muscles surrounding the airways, making them narrower and more difficult for air to flow through.

This medicine prevents the contraction of these muscles in the lungs, making it easier for air to enter and leave the lungs. When used regularly, it helps control breathing difficulties and reduces the effects of COPD on daily life.

Incruse Ellipta should not be used to relieve a sudden attack of shortness of breath or wheezing.

If you have this type of attack, you should use a fast-acting "rescue" inhaler (such as salbutamol). If you do not have a fast-acting inhaler, contact your doctor.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you start using Incruse Ellipta

Do not use Incruse Ellipta

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

If you think the above applies to you, do not usethis medicine until you have consulted your doctor.

Warnings and precautions

Consult your doctor before starting to use Incruse Ellipta:

  • if you have asthma(do not use Incruse Ellipta to treat asthma)
  • if you have heart problems
  • if you have an eye problem called narrow-angle glaucoma
  • if you have enlarged prostate, difficulty urinating, or a blockage in the bladder
  • if you have severe liver problems.

Consult your doctorif you think any of the above conditions apply to you.

Immediate breathing difficulties

If you experience chest tightness, coughing, wheezing, or difficulty breathing immediately after using your Incruse Ellipta inhaler:

stop using this medicine and seek medical attention immediately, as you may have a serious condition called paradoxical bronchospasm.

Eye problems during treatment with Incruse Ellipta

If you experience eye pain or discomfort, blurred vision for a time, halos, or colored images associated with redness of the eyes during treatment with Incruse Ellipta:

stop using this medicine and seek medical help immediately, as these signs may be due to an acute attack of narrow-angle glaucoma.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years.

Other medicines and Incruse 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, consult your doctor or pharmacist.

In particular, tell your doctor or pharmacist if you are taking other long-acting medicines to treat similar respiratory problems to this medicine, such as tiotropium. Do not use Incruse Ellipta with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctorbefore using this medicine. If you are pregnant, do not use this medicine unless your doctor tells you to.

It is not known if the components of Incruse Ellipta can be excreted in breast milk. If you are breastfeeding, consult your doctorbefore using Incruse Ellipta.

If you are breastfeeding, do not use this medicine unless your doctor tells you to.

Driving and using machines

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

Incruse Ellipta contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before using this medicine.

3. How to use Incruse Ellipta

Follow the instructions for administration of this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist again.

The recommended doseis one inhalation every day, at the same time each day. You only need one inhalation per day, as the effect of this medicine lasts for 24 hours.

Do not use more doses than your doctor has told you to.

Use Incruse Elliptaregularly

It is very important that you use Incruse Ellipta every day, as your doctor has told you. This will help you not to have symptoms throughout the day and night.

Do notuse this medicine to relieve a sudden attack of shortness of breath or wheezing. If you have this type of attack, you should use a fast-acting "rescue" inhaler (such as salbutamol).

How to use the inhaler

To get the full information, read the "Step-by-step instructions for use" at the end of this package leaflet.

The administration of Incruse Ellipta is by inhalation. To use Incruse Ellipta, breathe it into your lungs through your mouth using the Ellipta inhaler.

If your symptoms do not improve

If your COPD symptoms (shortness of breath, wheezing, coughing) do not improve or worsen, or if you are using your fast-acting "rescue" inhaler more often than usual:

contact your doctor as soon as possible.

If you use more Incruse Ellipta than you should

If you accidentally use too much medicine, contact your doctor or pharmacist immediately, as you may need medical attention. If possible, show them the inhaler, packaging, or package leaflet. You may notice that your heart beats faster than normal, you have vision changes, or your mouth is dry.

If you forget to use Incruse Ellipta

Do not inhale a double dose to make up for forgotten doses.Inhale the next dose at the usual time.

If you have wheezing or shortness of breath, use your fast-acting "rescue" inhaler (such as salbutamol) and seek medical advice.

If you stop using Incruse Ellipta

Use this medicine for as long as your doctor recommends. It will only be effective for as long as you use it. Do not stop using it until your doctor tells you to, even if you feel better, as your symptoms may worsen.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Allergic reactions

If after using Incruse Ellipta you have any of the following symptoms, stop using thismedicine and tell your doctor immediately:

Uncommon(may affect up to 1 in 100people):

  • itching
  • rash (hives) or redness.

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

  • wheezing (a whistling sound when breathing), coughing, or difficulty breathing
  • a sudden feeling of weakness or dizziness (which may cause fainting or loss of consciousness)

Other side effects:

Common(may affect up to 1 in 10people):

  • fast heart rate
  • pain when urinating and increased frequency (may be signs of a urinary tract infection)
  • common cold
  • nose and throat infection
  • coughing
  • feeling of pressure or pain in the cheeks and forehead (may be symptoms of sinusitis, an inflammation of the nasal passages)
  • headache
  • constipation
  • mouth and throat pain.

Uncommon(may affect up to 1 in 100people):

  • irregular heartbeat
  • sore throat
  • dry mouth
  • change in taste
  • hoarseness.

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

  • eye pain.

Frequency not known(frequency cannot be estimated from the available data):

  • decreased vision or eye pain due to increased eye pressure (possible signs of glaucoma)
  • blurred vision
  • increased eye pressure
  • difficulty and pain when urinating, this may be a sign of bladder obstruction or urinary retention
  • dizziness.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package 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.

5. Storage of Incruse Ellipta

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 packaging, tray, and inhaler, after EXP. The expiry date is the last day of the month stated.

Keep the inhaler in the sealed tray to protect it from moisture and only remove it immediately before the first use. Once the tray is opened, the inhaler can be used for a period of 6 weeks, counting from the date of opening of the tray. Write the date when the inhaler should be discarded on the space provided on the inhaler label. The date should be noted as soon as the inhaler is removed from the tray.

Do not store above 30 °C.

If you store it in the refrigerator, let the inhaler return to room temperature at least one hour before use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Incruse Ellipta composition

The active ingredient is umeclidinium (as bromide).

Each inhalation provides a delivered dose (dose that comes out of the mouthpiece) of 55 micrograms of umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).

The other ingredients are lactose monohydrate (see section “Incruse Ellipta contains lactose” in section 2) and magnesium stearate.

Appearance of the product and container contents

Incruse Ellipta is a powder for inhalation (single-dose).

The Ellipta inhaler consists of a gray plastic body, a light green mouthpiece cover, and a dose counter. It is packaged in a laminated aluminum tray with a foldable aluminum foil. The tray contains a bag with a desiccant to reduce moisture in the container.

The active ingredient is presented as a white powder in a blister inside the inhaler. Incruse Ellipta is available in packs of one inhaler containing 7 or 30 doses and in multipacks of 90 doses (3 inhalers of 30 doses). Only some pack sizes may be marketed.

Marketing authorization holder:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

D24 YK11

Manufacturer:

Glaxo Wellcome Production

Zone Industrielle No.2

23 Rue Lavoisier

27000 Evreux

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

België/Belgique/Belgien

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0) 10 85 52 00

Lietuva

UAB “BERLIN-CHEMIE MENARINI BALTIC”

Tel: +370 52 691 947

[email protected]

Text in Bulgarian language with contact information of “Berlin-Chemie/A Menarini Bulgaria” including phone and email

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien

Tél/Tel: + 32 (0) 10 85 52 00

Ceská republika

GlaxoSmithKline, s.r.o.

Tel: + 420 222 001 111

[email protected]

Magyarország

Berlin-Chemie/A. Menarini Kft.

Tel.: +36 23501301

[email protected]

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

[email protected]

Malta

GlaxoSmithKline Trading Services Limited

Tel: +356 80065004

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

[email protected]

Nederland

GlaxoSmithKline BV

Tel: + 31 (0) 33 2081100

Eesti

OÜ Berlin-Chemie Menarini Eesti

Tel: +372 667 5001

[email protected]

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Ελλáδα

Menarini Hellas A.E.

Τηλ: +30 210 83161 11-13

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

[email protected]

España

GlaxoSmithKline, S.A.

Tel: + 34 900 202 700

[email protected]

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000

France

Laboratoire GlaxoSmithKline

Tél: + 33 (0)1 39 17 84 44

[email protected]

Portugal

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

[email protected]

Hrvatska

Berlin-Chemie Menarini Hrvatska d.o.o.

Tel: +385 1 4821 361

[email protected]

România

GlaxoSmithKline Trading Services Limited

Tel: +40 800672524

Ireland

GlaxoSmithKline Trading Services Limited

Tel: + 353 (0)1 4955000

Slovenija

Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.

Tel: +386 (0)1 300 2160

[email protected]

Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika

Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.

Tel: +421 2 544 30 730

[email protected]

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 7741 111

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Κúπρος

GlaxoSmithKline Trading Services Limited

Τηλ: +357 80070017

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

[email protected]

Latvija

SIA Berlin-Chemie/Menarini Baltic

Tel: +371 67103210

[email protected]

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Step-by-step instructions for use

What is the Ellipta inhaler?

The first time you use Incruse Ellipta, you do not need to check that the inhaler is working correctly, as it contains pre-measured doses and is ready to use directly.

Your Incruse Ellipta inhaler pack contains:

Open box with inhaler, leaflet, tray, desiccant, and tray lid shown individually

The inhaler is packaged in a tray. Do not open the tray until you are ready to start using your new inhaler. When you are ready to use the inhaler, remove the lid to open the tray. The tray contains a bag with a desiccantto reduce moisture. Discard the desiccant bag, do notopen it, ingest it, or inhale it.

Hand disposing of empty blister and desiccant in a trash can with arrows indicating direction

When you remove the inhaler from its tray, it will be in the “closed” position. Do not open the inhaler until you are ready to inhale a dose of medicine.When the tray is opened, the “Discard by” date should be noted on the space provided on the inhaler label. The “Discard by” date is 6 weeks from the date of opening the tray. After this date, the inhaler should not be used. The tray can be discarded once it is opened.

If stored in the refrigerator, let the inhaler reach room temperature for at least one hour before use.

The step-by-step instructions for using the Ellipta inhaler provided below can be used for both the 30-dose inhaler (30 days of treatment) and the 7-dose inhaler (7 days of treatment).

  1. Read this information before starting

If the inhaler cap is opened and closed without inhaling the medicine, the dose will be lost.The lost dose will be retained safely inside the inhaler, but it will not be available for inhalation.

It is not possible to accidentally administer an additional dose or a double dose through an inhalation.

Inhaler with dose counter showing number 30 and arrows indicating cap and decreasing units when used

  1. Prepare a dose

Wait to open the inhaler cap until you are ready to inhale a dose.

Do not shake the inhaler.

  • Slide the cap down until you hear a ‘click’.

Device with mouthpiece and ventilation slots, arrow indicating rotation with ‘click’ sound and number 29 on the base

Now, the medicine is ready to be inhaled.

As confirmation, the dose counter decreases by 1unit.

  • If the dose counter does not decrease when you hear the ‘click’, the inhaler will not release the dose of medicine.

Take it to the pharmacist and ask for help.

  1. Inhale your medicine
  • While holding the inhaler away from your mouth, breathe out as much as you can.

Do notbreathe out into the inhaler.

  • Place the mouthpiece between your lips, and close them firmly around the mouthpiece.

Do notblock the ventilation slots with your fingers.

Female face profile with oral inhaler in hands holding mouthpiece near lips

  • Take a long, steady, and deep breath in. Hold your breath for as long as you can (at least 3-4 seconds).
  • Remove the inhaler from your mouth.
  • Breathe out slowly and gently.

You may not be able to taste or feel the medicine, even when using the inhaler correctly.

Beforeclosing the cap, the inhaler mouthpiece can be cleaned using a dry cloth.

  1. Close the inhaler

Inhaler device with partially open protective cover showing number 29 and arrow indicating direction of opening

  • Slide the cap up, to the top, to cover the mouthpiece.

Online doctors for INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE

Discuss questions about INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

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If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

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Frequently Asked Questions

Is a prescription required for INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE?
INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE?
The active ingredient in INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE is umeclidinium bromide. This information helps identify medicines with the same composition but different brand names.
How much does INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE cost in pharmacies?
The average pharmacy price for INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE is around 45.27 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE?
INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE is manufactured by Glaxosmithkline (Ireland) Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to INCRUSE ELLIPTA 55 mcg INHALATION POWDER, SINGLE-DOSE?
Other medicines with the same active substance (umeclidinium bromide) include ROLUFTA ELLIPTA 55 micrograms powder for inhalation (single dose), ATROALDO 20 micrograms/PUFF pressurized inhalation solution, ATROVENT 20 micrograms PRESSURIZED INHALATION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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