Rolufta Ellipta

Package leaflet: Information for the patient

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

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

What Rolufta Ellipta is
Rolufta Ellipta contains the active substance umeclidinium (as bromide), which belongs to a group of
medicines called bronchodilators.
What Rolufta 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 the small air spaces (alveoli) in the lungs gradually become blocked or damaged, leading to breathing difficulties that slowly worsen over time.
Breathing difficulties are compounded by the contraction of muscles in the lungs, which narrows the airways and thereby reduces airflow.
This medicine works by blocking the contraction of these muscles, making it easier for air to flow into and out of the lungs.
When used regularly, Rolufta Ellipta helps control breathing problems and reduces the impact of COPD in daily life.
Rolufta Ellipta must not be used to relieve a sudden attack of breathlessness or wheezing.
If such an attack occurs, you must use a fast-acting inhaler (such as salbutamol). If you do not have a fast-acting inhaler, contact your doctor.

2. What you need to know before using Rolufta Ellipta

Do not use Rolufta 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 Rolufta Ellipta:

• if you have asthma (do not use Rolufta Ellipta to treat asthma)
• if you have heart problems
• if you have a condition in the eyes called narrow-angle glaucoma
• if you have an enlarged prostate , difficulty passing urine , or kidney obstruction .
• 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 the Rolufta 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 Rolufta Ellipta
If during treatment with Rolufta 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 . These may
be symptoms of 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 unsure what is contained in your medicine, ask 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 Rolufta Ellipta together with these
other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are 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 Rolufta Ellipta pass into breast milk. If you are breastfeeding ,
consult your doctor before using Rolufta Ellipta. Do not use this medicine while breastfeeding unless your doctor tells you that you may do so.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
Rolufta Ellipta contains lactose
If you have been diagnosed with an intolerance to certain sugars or to milk proteins, talk to your doctor
before using this medicine.

3. How to use Rolufta 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 each day. You need to inhale it only once daily because the effect of this medicine lasts for 24 hours.
Do not use more than the dose prescribed by your doctor.
Use Rolufta Ellipta regularly
It is very important that you use Rolufta Ellipta every day as prescribed by your doctor. This will help keep you symptom-free throughout the day and night.
Do not use this medicine to relieve a sudden attack of breathlessness or wheezing. If you experience such an attack, use a fast-acting inhaler (such as salbutamol).
How to use the inhaler
For complete instructions, see the “Step-by-step Instructions for Use” at the end of this leaflet.
Rolufta Ellipta is for inhalation use only. To use Rolufta 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 do not improve (shortness of breath, wheezing, cough) or worsen, or if you are using your fast-acting inhaler too frequently:
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 immediately, as medical assistance may be needed. If possible, show them the inhaler, the packaging, or this leaflet. You may notice that your heart beats faster than usual, experience 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. Simply take the next dose at your usual time.
If you start to become breathless or short of breath, use your fast-acting inhaler (such as salbutamol), and consult your doctor.
If you stop using Rolufta Ellipta
Use this medicine for the period recommended by your doctor. It will remain effective as long as you continue using it. Do not stop using it unless your doctor advises you to do so, even if you feel better, because your symptoms may worsen.
If you have any doubts about how to use this medicine, consult 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 taking Rolufta Ellipta, you experience any of the following symptoms, stop using this medicine and
contact your doctor immediately:
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):

• shortness of breath, cough 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 (may be a sign of a urinary tract infection)
• common cold
• nose and throat infection
• cough
• feeling of pressure or pain in cheeks and forehead (may be a sign 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 the available data):

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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through 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 Rolufta Ellipta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 only immediately before
first use.
Once the tray has been opened, the inhaler can 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 designated space. 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Rolufta Ellipta contains
The active substance is umeclidinium (as bromide).
Each single inhalation delivers a 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, “Rolufta Ellipta contains lactose”) and
magnesium stearate.

Description of the appearance of Rolufta Ellipta and contents of the pack
Rolufta Ellipta is a pre-measured inhaled 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. Rolufta Ellipta is available
in packs containing 1 inhaler with either 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

Manufacturer:
Glaxo Wellcome Production
Zone Industrielle No.2,
23 Rue Lavoisier,
27000 Evreux,
France

For further information on 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” GlaxoSmithKline Pharmaceuticals s.a./n.v.
EООД Belgique/Belgien
Teл.: +359 2 454 0950 Tél/Tel: + 32 (0) 10 85 52 00
[email protected]

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
BERLIN-CHEMIE AG GlaxoSmithKline BV
Tel: +49 (0) 30 67070 Tel: + 31 (0) 33 2081100

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
FAES FARMA, S.A. GSK Services Sp. z o.o.
Tel.: +34 900 460 153 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 (Ireland) 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 Slovakia
Sími: + 354 535 7000 s.r.o.
Tel: +421 2 544 30 730
[email protected]

Italia Suomi/Finland
A. Menarini Industrie Farmaceutiche Riunite GlaxoSmithKline Oy
s.r.l. Puh/Tel: + 358 (0)10 30 30 30
Tel: +39-055 56801

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

Latvija United Kingdom (Northern Ireland)
SIA Berlin-Chemie/Menarini Baltic GlaxoSmithKline Trading Services Limited
Tel: +371 67103210 Tel: + 44 (0)800 221441
[email protected] [email protected]

Other sources of information
More 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?
When you first use Rolufta Ellipta, there is no need to check whether the inhaler
is working properly; it contains pre-measured doses and is ready for immediate use.
Your Rolufta Ellipta pack contains:

The inhaler is packaged in a tray. Do not open the tray until you are ready to start using the new inhaler.
When 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, ingesting, or inhaling it.

Desiccant
When removed from the 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. The
inhaler must not be used after this date. 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 below for using the 30-dose Ellipta inhaler (30-day supply) 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 a dose.
The missed dose will be securely held inside the inhaler but will no longer be available.
It is not possible to accidentally inhale extra or double medicine 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 inhale.
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 fully 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 steadily, deeply, and slowly through your mouth. Hold your breath as long as possible (at least 3–4 seconds).
• Remove the inhaler from your mouth.
• Breathe out slowly and gently.

You may not 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.
Annex IV
Scientific conclusions and grounds for the variation of the terms of the marketing authorisation(s)
Scientific conclusions
Taking into account the PRAC assessment report on the final report of the non-interventional PASS study
mandated for the above-mentioned medicines, the CHMP’s scientific conclusions are as follows:
Rolufta Ellipta, Incruse Ellipta, Anoro Ellipta and Laventair Ellipta (umeclidinium bromide, umeclidinium
bromide/vilanterol) are being removed from the additional monitoring list, as the condition for marketing
authorisation has been fulfilled. This refers to the conduct of an observational cohort study on post-
authorisation safety to quantify the incidence and comparative safety of selected cardiovascular and
cerebrovascular events (myocardial infarction, stroke, heart failure or sudden cardiac death) in patients with
COPD using inhaled UMEC/VI or inhaled UMEC compared to tiotropium (Study 201038), which was imposed
as a condition for marketing authorisation (Category 1 PASS), due to cardiovascular and cerebrovascular
safety concerns. According to the protocol, the HR (95% CI) was calculated for each treatment comparison;
the non-inferiority criterion was the upper limit of the 95% confidence interval (CI) around the hazard ratio
not exceeding 2.0 and the lower limit of the 95% CI not exceeding 1.0. Other secondary safety endpoints
were studied. Efficacy outcomes such as drug persistence and frequency of exacerbations were also assessed.
The adjusted HR (95% CI) for the composite outcome was 1.254 (0.830, 1.896) for UMEC vs. TIO cohorts
and 1.352 (0.952, 1.922) for UMEC/VI vs. TIO. The adjusted HR for UMEC/VI vs. TIO was not statistically
significant but close to the predefined limits. An increased risk of myocardial infarction was observed in the
UMEC/VI cohort compared to tiotropium: adjusted HR of 2.195 (1.053, 4.575). The risk of myocardial
infarction was lower between UMEC and TIO (adjusted HR (95% CI) of 1.754 (0.748, 4.115)). It is
recognised that the study was powered to test differences between cohorts only for the primary composite
endpoint and not to test non-inferiority for secondary endpoints; however, this difference in myocardial
infarction risk should be noted.
COPD, pneumonia, and lower respiratory tract infection were the most frequently reported events in patients
who had received UMEC/VI for more than one year. Most serious events were attributed to exacerbation
complicating advanced-stage COPD in most cases; excluding a potential relationship with UMEC/VI
treatment.
In conclusion, the PRAC considered that the benefit-risk balance of the medicines in question remains
unchanged.
This PASS study was a condition for the marketing authorisations of medicines containing the active
substances umeclidinium bromide, umeclidinium bromide/vilanterol. This condition is now considered to
have been fulfilled, and therefore it is recommended that the conditions or restrictions in Annex II be
updated to remove this requirement, as well as the deletion of further monitoring statements in Annexes I and
IIIB.
Having reviewed the PRAC recommendation, the CHMP agrees with the general conclusions and the
reasons for the recommendation.
Grounds for the variation of the terms of the marketing authorisation(s)
Based on the scientific conclusions regarding umeclidinium bromide, umeclidinium bromide/vilanterol, the
CHMP considers that the benefit-risk balance of the medicine(s) containing umeclidinium bromide,
umeclidinium bromide/vilanterol remains unchanged, subject to the proposed changes to the product
information.
The CHMP recommends that the terms of the marketing authorisation(s) be amended.