Rolufta Ellipta (previously Rolufta) - patient leaflet, side effects, dosage

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

What Rolufta Ellipta is

Rolufta Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.

What Rolufta Ellipta is used for

his medicine is used to treat chronic obstructive pulmonary disease (COPD ) in adults. COPD is a long-term condition in which the airways and air-sacs in the lungs gradually become blocked or damaged, leading to breathing difficulties that slowly get worse. Difficulties in breathing is added to by tightening of the muscles around the airways, which narrows the airways and so restricts the flow of air.

his medicine blocks the tightening of these muscles, making it easier for air to get in and out of the lungs. When used regularly, it can help control your breathing difficulties and reduce the effects of COPD on your everyday life.

Rolufta 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). If you do not have a quick-acting inhaler contact your doctor.

2. What you need to know before you use Rolufta Ellipta

Do not use Rolufta 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 use this medicine until you have checked with your doctor.

Warnings and precautions

Talk to your doctor before using this medicine:

• - if you have asthma (Do not use Rolufta Ellipta to treat asthma)

• - if you have heart problems

• - 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 have severe liver problems

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 Rolufta 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 Rolufta 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 Rolufta 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 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 similar to this medicine for breathing problems, e.g. tiotropium. Do not use Rolufta Ellipta together with these other medicines.

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. Do not use this medicine if you are pregnant unless your doctor tells you so.

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

Driving and using machines

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

Rolufta 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.

3. How to use Rolufta 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.

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

Use Rolufta Ellipta regularly

It is very important that you use Rolufta 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 use’ at the end of this leaflet for full information.

Rolufta Ellipta is for inhalation use. To use Rolufta 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 Rolufta 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 Rolufta 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 Rolufta Ellipta

Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. 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.

4. 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 Rolufta Ellipta, stop using this medicine and tell your doctor immediately:

• itching
• skin rash (hives) or redness.

Other side effects:

Common (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 (may affect up to 1 in 100 people)

• irregular heart beat
• sore throat
• dry mouth
• rash
• taste disturbance.

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

• eye pain.

Not known (frequency 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

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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 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 throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rolufta Ellipta contains

The active substance is umeclidinium (as bromide).

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). This corresponds to a metered dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.

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

What Rolufta Ellipta looks like and contents of the pack

Rolufta 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.

Rolufta Ellipta is available in packs containing 1 inhaler and in multipacks comprising 3 cartons, each containing 1 inhaler 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

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

Kûnpoç

GlaxoSmithKline Trading Services Limited

Tql: +357 80070017

United Kingdom (Northern Ireland)

GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221441

This leaflet was last revised in

Other sources of information

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

Step-by-step instructions for use

What is the inhaler?

The first time you use Rolufta 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.

Your Rolufta Ellipta inhaler carton 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 your inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw this desiccant sachet away – do not open, eat or inhale it.

When you take the inhaler out of its tray, it will be in the ‘closed’ position. 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.

Cover

Dose counter _____________­______

This shows how many doses of medicine are left in the inhaler.

Before the inhaler has been used, it shows exactly 30 doses.

It counts down by 1 each time you open the cover.

When fewer than 10 doses are left, half of the dose counter shows red.

After you have used the last dose, half of the dose counter shows red and the number 0 is displayed. Your inhaler is now empty.

If you open the cover after this, the dose counter will change from half red to completely red.

• 2) Prepare a dose

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

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.

Do not breathe out into the inhaler.

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

Do not block the air vent with your fingers.

• 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