Incruse Ellipta

Patient Information Leaflet

Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed

umeclidinium
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

What Incruse Ellipta is
Incruse Ellipta contains the active substance umeclidinium (as bromide), which belongs to a group of
medicines called bronchodilators.
What Incruse Ellipta is used for
It is used for the treatment of chronic obstructive pulmonary disease (COPD) in adults.
COPD is a chronic condition in which the airways and air sacs in the lungs gradually become blocked or damaged, leading to breathing difficulties that slowly worsen over time.
Breathing difficulties are compounded by the tightening of muscles in the lungs, which narrows the airways and thereby reduces airflow.
This medicine, by blocking the tightening of these muscles, makes it easier for air to flow into and out of the lungs.
When used regularly, it helps control breathing problems and reduces the impact of COPD on daily life.
Incruse Ellipta must not be used to relieve sudden breathing difficulties or wheezing.
If such an attack occurs, a fast-acting inhaler (such as salbutamol) should be used.
Contact your doctor if you do not have a fast-acting inhaler.

2. What you need to know before using Incruse Ellipta

Do not use Incruse Ellipta:

• If you are allergic to umeclidinium or to any of the other ingredients of this medicine (listed in section 6). If you think this applies to you, do not use this medicine before consulting your doctor.

Warnings and precautions
Talk to your doctor before using Incruse Ellipta:

• if you have asthma (Do not use Incruse Ellipta to treat asthma)
• if you have heart problems
• if you have a condition called narrow-angle glaucoma
• if you have an enlarged prostate, difficulty urinating, or kidney blockage.
• if you have severe liver problems. Talk to your doctor if you think any of these conditions apply to you.

Immediate breathing difficulties
If immediately after using your Incruse Ellipta inhaler you experience chest tightness,
coughing, wheezing, or shortness of breath:
stop using this medicine and seek immediate medical help, as you may be experiencing
a serious condition called paradoxical bronchospasm.

Eye problems during treatment with Incruse Ellipta
If during treatment with Incruse Ellipta you experience eye pain or discomfort, temporary blurred vision, halos around lights, or colored images associated with red eyes:
stop using this medicine and seek immediate medical help, as these may be symptoms of an acute attack of narrow-angle glaucoma.

Children and adolescents
Do not administer this medicine to children or adolescents under 18 years of age.

Other medicines and Incruse Ellipta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you are unsure about the ingredients of your medication, consult your doctor or pharmacist.
In particular, inform your doctor or pharmacist if you are taking other long-acting medicines similar to this one for breathing problems, such as tiotropium. Do not use Incruse Ellipta together with these medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding:
ask your doctor for advice before taking this medicine.
Do not use this medicine during pregnancy unless your doctor tells you to do so.
It is not known whether the components of Incruse Ellipta pass into breast milk. If you are breastfeeding, consult your doctor before using Incruse Ellipta. Do not use this medicine while breastfeeding unless your doctor tells you it is safe to do so.

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

Incruse Ellipta contains lactose
If you have been diagnosed with an intolerance to certain sugars, talk to your doctor before using this medicine.

3. How to use Incruse Ellipta

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one inhalation every day at the same time. You need to inhale it only once daily because the effect of this medicine lasts for 24 hours.
Do not use more than the amount prescribed by your doctor.
Use Incruse Ellipta regularly
It is very important that you use Incruse Ellipta every day as prescribed by your doctor. This will help keep your symptoms under control throughout the day and night.
Do not use this medicine to relieve a sudden attack of breathlessness or wheezing. If such an attack occurs, you must use a fast-acting inhaler (such as salbutamol).
How to use the inhaler
For complete information, see the “Step-by-step instructions for use” at the end of this leaflet.
Incruse Ellipta is for inhalation use only. To use Incruse Ellipta, breathe in through your mouth using the Ellipta inhaler until your lungs are full.
If your symptoms do not improve
If your COPD symptoms (shortness of breath, wheezing, cough) do not improve or worsen, or if you are using your fast-acting inhaler too 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 immediately, as you may need medical assistance. If possible, show them the inhaler, the packaging, or this leaflet. You may notice that your heart beats faster than usual, blurred vision, or dry mouth.
If you forget to use Incruse Ellipta
Do not inhale a double dose to make up for a forgotten dose. Simply take the next dose at your usual time.
If you become breathless or short of breath, use your fast-acting inhaler (such as salbutamol), and consult your doctor.
If you stop using Incruse Ellipta
Use this medicine for the period recommended by your doctor. It will remain effective only as long as you continue using it. Do not stop using it unless your doctor advises you to, even if you feel better, because your symptoms may worsen.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
Stop using this medicine and contact your doctor immediately if, after taking Incruse Ellipta, you experience any of the following symptoms:
Uncommon (may affect up to 1 in 100 people):

• itching
• skin rash (urticaria) or redness

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

• wheezing, coughing, or breathing difficulties
• sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness)

Other side effects

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

• fast heartbeat
• painful and frequent urination (could be symptoms of a urinary tract infection)
• common cold
• infection of the 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
• mouth and throat pain

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

• irregular heartbeat
• sore throat
• dry mouth
• taste disturbances
• hoarseness

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

• eye pain

Not known (frequency cannot be estimated from available data):

• reduced vision or eye pain caused by increased eye pressure (possible signs of glaucoma)
• blurred vision
• increased eye pressure
• difficulty and pain when passing urine – these may be signs of bladder obstruction or urinary retention
• dizziness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. 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 pack, tray, and inhaler after
Exp. The expiry date refers to the last day of that month.
Keep the inhaler in the sealed tray to protect it from moisture, and remove it from the tray only immediately before
first use.
Once the tray has been opened, the inhaler may be used for 6 weeks, starting from the date the tray was opened.
Write the date on which the inhaler should be discarded on the label in the space provided. This date should be
recorded as soon as the inhaler is removed from the tray.
Do not store above 30°C.
If stored in a refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Incruse Ellipta contains
The active substance is umeclidinium (as bromide).
Each single inhalation delivers an inhaled dose (released from the mouthpiece) of 55 micrograms of
umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
The other components are lactose monohydrate (see section 2 under "Incruse Ellipta contains lactose") and
magnesium stearate.

Description of the appearance of Incruse Ellipta and package contents
Incruse Ellipta is a pre-dosed inhalation powder.
The Ellipta inhaler consists of a light grey body, a light green mouthpiece cap, and a dose counter. It is packaged in an aluminium foil tray with a removable lid. The tray contains a desiccant sachet to reduce moisture in the package.
The active substance is present as a white powder in a blister inside the inhaler. Incruse Ellipta is available in packages containing 1 inhaler with 7 or 30 doses, and in multiple packs containing 90 doses (3 inhalers with 30 doses each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tél/Tel: + 32 (0) 10 85 52 00 Tel: +370 52 691 947
[email protected]

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” EООД GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: +359 2 454 0950 Belgique/Belgien
[email protected] Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. Berlin-Chemie/A. Menarini Kft.
Tel: + 420 222 001 111 Tel.: +36 23501301
[email protected] [email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti GlaxoSmithKline AS
Tel: +372 667 5001 Tlf: + 47 22 70 20 00
[email protected]

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. GlaxoSmithKline Trading Services Limited
Tel: +385 1 4821 361 Tel: +40 800672524
[email protected]

Ireland Slovenija
GlaxoSmithKline Trading Services Limited Berlin-Chemie / A. Menarini Distribution
Tel: + 353 (0)1 4955000 Ljubljana d.o.o.
Tel: +386 (0)1 300 2160
[email protected]

Ísland Slovenská republika
Vistor hf. Berlin-Chemie / A. Menarini Distribution
Sími: + 354 5357000 Slovakia s.r.o.
Tel: +421 2 544 30 730
[email protected]

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Step-by-step instructions for use

What is the Ellipta inhaler?
When you use Incruse Ellipta for the first time, there is no need to check whether the inhaler is working correctly; it contains pre-measured doses and is ready for immediate use.
Your Incruse Ellipta package contains:

The inhaler is packaged in a tray. Do not open the tray until you are ready to start using the new inhaler.
When you are ready to use the inhaler, open the cover by pulling the tab. The tray contains a sachet of desiccant to reduce moisture. Discard this sachet – without opening, eating, or inhaling it.

Desiccant
When removed from its box (sealed tray), the inhaler will be in the 'closed' position. Do not open the inhaler until you are ready to inhale a dose of medicine. After opening the tray, write the “Discard by” date on the label of the inhaler in the designated space. The “Discard by” date is 6 weeks from the date the tray was opened. After this date, the inhaler must no longer be used. The tray may be discarded after first opening.
If stored in the refrigerator, allow the inhaler to return to room temperature for at least one hour before use.
The step-by-step instructions for using the 30-dose Ellipta inhaler (30-day supply) described below also apply to the 7-dose inhaler (7-day supply).

1) Read before starting
If you open and close the inhaler cover without inhaling the medicine, you will lose the dose.
The missed dose will be securely held within the inhaler but will no longer be available.
It is not possible to accidentally inhale more than one or a double dose in a single inhalation.

2) Prepare a dose
Wait to open the cover until you are ready to inhale the dose.
Do not shake the inhaler.

• Slide the cover down until you hear a 'click'.

“Click”
The medicine is now ready to be inhaled.
The dose counter will count down by 1 as confirmation.

• If the dose counter does not count down when you hear the 'click', the inhaler will not release the medicine. Return it to your pharmacist for advice.

3) Inhale the medicine

• With the inhaler away from your mouth, breathe out as far as possible. Do not breathe out into the inhaler.
• Place the mouthpiece between your lips and close your lips firmly around it. Do not block the air inlets with your fingers.

• Breathe in slowly, steadily, and deeply. Hold this breath 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 using the inhaler correctly.
If you wish to clean the mouthpiece, use a dry cloth, before closing the cover.

4) Close the inhaler

Slide the cover fully upwards to cover the mouthpiece.