ROLUFTA ELLIPTA 55 micrograms powder for inhalation (single dose)

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

Do not use Rolufta Ellipta

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

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

Warnings and precautions

Talk to your doctor before starting to use Rolufta Ellipta:

• if you have asthma(do not use Rolufta Ellipta to treat asthma)
• if you have heart problems
• if you have a type of 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.

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

Immediate breathing difficultiesIf you experience chest tightness, coughing, wheezing, or difficulty breathing immediately after using your Rolufta Ellipta inhaler:

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

Eye problems during treatment with Rolufta Ellipta

If you experience eye pain or discomfort, blurred vision for a while, halos, or colored images associated with redness of the eyes during treatment with Rolufta Ellipta, stop using this medicine and seek medical help immediatelyas 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 of age.

Other medicines and Rolufta 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 to treat similar respiratory problems to this medicine, such as tiotropium. Do not use Rolufta 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, ask your doctorfor advice before taking this medicine. If you are pregnant, do not use this medicine unless your doctor tells you to.

It is not known whether the components of Rolufta Ellipta can be excreted in breast milk. If you are breastfeeding, talk to your doctorbefore using Rolufta Ellipta.

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

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Rolufta Ellipta contains lactose

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

3. How to use Rolufta Ellipta

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, talk to your doctor or pharmacist again.

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

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

Use Rolufta Ellipta regularly

It is very important that you use Rolufta 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 instructions, read the "Step-by-step instructions for use" at the end of this leaflet.

The administration of Rolufta Ellipta is by inhalation. To use Rolufta 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 Rolufta 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 this 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 Rolufta 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 Rolufta Ellipta

Use this medicine for as long as your doctor recommends. It will only be effective for as long as you continue to 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.

4. Possible side effects

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

Allergic reactions

If after using Rolufta Ellipta you have any of the following symptoms, stop using this medicine 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 collapse 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
• cough
• feeling of pressure or pain in the cheeks and forehead (may be symptoms of sinusitis, an inflammation of the sinuses)
• 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, which 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. 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.

5. Storage of Rolufta 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 in 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 stored in a refrigerator, let the inhaler return to room temperature for 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

Composition of Rolufta Ellipta

The active substance 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 “Rolufta Ellipta contains lactose” in section 2) and magnesium stearate.

Appearance of the product and container contents

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

The Ellipta inhaler consists of a grey plastic body, a light green mouthpiece cover, and a dose counter. It is packaged in a laminated aluminium foil blister pack with a foldable aluminium foil lid. The blister pack contains a desiccant sachet to reduce moisture in the container.

The active substance is presented as a white powder in a blister pack inside the inhalator.

Rolufta Ellipta is available in packs of one inhaler containing 7 or 30 doses and in multipacks of 90 doses (3 inhalers of 30 doses). Not all pack sizes may be marketed.

Marketing authorisation holder:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer:

Glaxo Wellcome Production

Zone Industrielle No.2

23 Rue Lavoisier

27000 Evreux

France

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicinal product 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 Rolufta 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 Rolufta Ellipta inhaler contains:

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 desiccantsachet, to reduce moisture. Discard the desiccant sachet, do notopen, ingest or inhale it.

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, write the “Discard by” date 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 a refrigerator, allow the inhaler to reach room temperature for at least one hour before use.

The step-by-step instructions for 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 cover 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 extra dose or a double dose through a single inhalation.

1. Prepare a dose

Wait until you are ready to inhale a dose before opening the inhaler cover.

Do not shake the inhaler.

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

Now the medicine is ready to inhale.

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 your pharmacist and ask for help.

1. Inhale your medicine

• Hold the inhaler away from your mouth and breathe out as much as you can.

Do notbreathe out into the inhaler.

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

Do notblock the ventilation slots with your fingers.

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

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

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

1. Close the inhaler

• Slide the cover up, until it clicks, to cover the mouthpiece.