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AstraZeneca

Incruse Ellipta (previously Incruse)
umeclidinium bromide

Package leaflet: Information for the user


Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed

umeclidinium (umeclidinium bromide)


imageThis medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.


If you think the above applies to you, don’t use this medicine until you have checked with your doctor.


Warnings and precautions

Talk to your doctor before using this medicine:

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 Incruse 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 Incruse Ellipta

If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with Incruse Ellipta:


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


Children and adolescents

Do not give this medicine to children or adolescents below the age of 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 talk to your doctor or pharmacist.


In particular, tell your doctor or pharmacist if you are taking other long-acting medicines similar to this medicine for breathing problems, e.g. tiotropium. Don’t use Incruse Ellipta as well as these other medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist.


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 using this medicine. Don’t use this medicine if you are pregnant unless your doctor tells you so.


It is not known whether the ingredients of Incruse Ellipta can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use Incruse Ellipta.


Driving and using machines

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


Incruse 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.

  1. How to use Incruse Ellipta


    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.

    Don’t use more than your doctor tells you to use. Use Incruse Ellipta regularly

    It is very important that you use Incruse Ellipta every day, as instructed by your doctor. This will help

    to keep you free of symptoms throughout the day and night.


    Do not use this medicine 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 for usein this leaflet for full information.


    Incruse Ellipta is for inhalation use. To use Incruse Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.


    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 Incruse 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 have visual disturbances or have a dry mouth.


    If you forget to use Incruse Ellipta

    Don’t inhale an extra 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 Incruse Ellipta

    Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Don’t 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.


  2. Possible side effects


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


    Allergic reactions

    Allergic reactions are uncommon (may affect up to 1 in 100 people).

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

    • itching

    • skin rash (hives) or redness

      Common side effects

      These may affect up to 1 in 10 people:

      • faster heart beat

      • painful and frequent urination (may be signs of a urinary tract infection)

      • common cold

      • infection of nose and throat

      • cough

      • feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)

      • headache

      • constipation.


        Uncommon side effects

        These may affect up to 1 in 100 people:

      • irregular heart beat

      • sore throat

      • dry mouth

      • rash

      • taste disturbance.


        Rare side effects

        These may affect up to 1 in 1,000 people:

      • eye pain


        Other side effects

        Other side effects have occurred in a very small number of people but their exact frequency is unknown (cannot be estimated from the available data):


        • Decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).

        • Blurred vision

        • Increase of the measured eye pressure

        • Difficulty and pain when passing urine – these may be signs of a bladder obstruction or urinary retention

        • Dizziness


          Reporting of side effects

          image

          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.


  3. How to store 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 carton, tray and inhaler after ‘EXP’. The expiry date refers to the last day of that month.


    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.


    Do not store above 30°C.

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


    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.


  4. Contents of the pack and other information What Incruse Ellipta contains

The active substance is umeclidinium bromide.


Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).


The other ingredients are lactose monohydrate (see section 2 under ‘Incruse Ellipta contains lactose’) and magnesium stearate.


What Incruse Ellipta looks like and contents of the pack

Incruse Ellipta is an inhalation powder, pre-dispensed.

The Ellipta inhaler consists of a grey plastic body, a light green mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant packet, to reduce moisture in the packaging.


The active substance is present as a white powder in a blister inside the inhaler. Each inhaler contains either 7 or 30 doses. Multipacks containing 90 (3 inhalers of 30) doses are also available. Not all pack sizes may be marketed.


Marketing Authorisation Holder


GlaxoSmithKline (Ireland) Limited 12 Riverwalk

Citywest Business Campus

Dublin 24 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:


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

lt@berlin-chemie.com

България

Берлин-Хеми/А. Менарини България” EООД Teл.: +359 2 454 0950

bcsofia@berlin-chemie.com

Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien

Tél/Tel: + 32 (0) 10 85 52 00


Česká republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111

cz.info@gsk.com

Magyarország

Berlin-Chemie/A. Menarini Kft.

Tel.: +36 23501301

bc-hu@berlin-chemie.com


Danmark

GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00

dk-info@gsk.com

Malta

GlaxoSmithKline (Ireland) Limited Tel: +356 80065004


Deutschland

GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701

produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0) 33 2081100


Eesti

OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001

ee@berlin-chemie.com

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00


Ελλάδα

Menarini Hellas A.E.

Τηλ: +30 210 83161 11-13

Österreich

GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0

at.info@gsk.com


España GlaxoSmithKline, S.A. Tel: + 34 900 202 700

es-ci@gsk.com

Polska

GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000


France

Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44

diam@gsk.com

Portugal

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com


Hrvatska

Berlin-Chemie Menarini Hrvatska d.o.o.

Tel: +385 1 4821 361

office-croatia@berlin-chemie.com

România

GlaxoSmithKline (Ireland) Limited Tel: +40 800672524


Ireland

GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000

Slovenija

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

Tel: +386 01 300 2160

slovenia@berlin-chemie.com


Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika

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

Tel: +421 2 544 30 730

slovakia@berlin-chemie.com


Italia

GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741111

Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30

Finland.tuoteinfo@gsk.com


Κύπρος

GlaxoSmithKline (Ireland) Limited Τηλ: +357 80070017

Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00

info.produkt@gsk.com


Latvija

SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210

lv@berlin-chemie.com

United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221441

customercontactuk@gsk.com


This leaflet was last revised in

.

Step-by-step instructions for use


What is the inhaler?

The first time you use Incruse Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.


image

Your Incruse Ellipta inhaler carton contains


Tray lid



Inhaler

Carton


This leaflet


Desiccant Tray


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 your inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw this desiccant sachet away – don’t open, eat or inhale it.


Desiccant


image

When you take the inhaler out of its tray, it will be in the ‘closed’ position. Don’t open the inhaler until you are ready to inhale a dose of medicine. When the tray is opened, write the “Discard by” date on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date you opened the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.

The instructions for use of the Ellipta inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).


  1. Read this before you start


    If you open and close the cover without inhaling the medicine, you will lose the dose.

    The lost dose will be securely held inside the inhaler, but it will no longer be available. It is not possible to accidentally take extra medicine or a double dose in one inhalation.


    image


  2. Prepare a dose


    Wait to open the cover until you are ready to inhale your dose. Do not shake the inhaler.


    • Slide the cover down until you hear a “click”.


      image

      Your medicine is now ready to be inhaled.


      The dose counter counts down by 1 to confirm.


    • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.

      Take it back to your pharmacist for advice.


  3. Inhale your medicine


    • While holding the inhaler away from your mouth, breathe out as far as is comfortable.

      Don’t breathe out into the inhaler.


    • Put the mouthpiece between your lips, and close your lips firmly around it.

      Don’t block the air vent with your fingers.


      image


    • Take one long, steady, deep breath in. Hold this breath in for as long as possible (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 you are using the inhaler correctly. If you want to clean the mouthpiece, use a dry tissue, before you close the cover.

  4. Close the inhaler


image

Slide the cover upwards as far as it will go, to cover the mouthpiece.