Rolufta Ellipta 55 micrograms inhalation powder (single dose)
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Rolufta Ellipta 55 micrograms powder for inhalation (single dose) umeclidinium (umeclidinium)
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as yours, as it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Rolufta Ellipta is and what it is used for
- What you need to know before using Rolufta Ellipta
- How to use Rolufta Ellipta
- Possible side effects
- How to store Rolufta Ellipta
- 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
This medicine is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease that slowly worsens over time, in which the airways and air sacs in the lungs become obstructed or damaged, causing difficulty in breathing. This breathing difficulty is compounded by the tightening of the muscles surrounding the airways, causing them to narrow and restrict airflow.
This medicine prevents the tightening of these muscles in the lungs, making it easier for air to move in and out of the lungs. When used regularly, it helps control breathing difficulties and reduces the impact of COPD on your daily life.
Rolufta Ellipta must not be used to relieve a sudden attack of breathlessness or wheezing (whistling sounds when breathing).
If you experience such attacks, you should use a fast-acting "rescue" inhaler (such as salbutamol). If you do not have a fast-acting inhaler, contact your doctor.
2. What you need to know before starting to use 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 any of the above applies to you, do not use this 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 an eye condition called closed-angle glaucoma
- if you have an enlarged prostate, difficulty urinating, or a bladder obstruction
- if you have severe liver problems.
Talk to your doctor if you think any of the above conditions apply to you.
Immediate breathing difficulties If you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using your Rolufta Ellipta inhaler:
stop using this medicine and seek immediate medical attention, as you may be experiencing a serious condition called paradoxical bronchospasm.
Eye problems during treatment with Rolufta Ellipta
If you experience eye pain or discomfort, blurred vision, seeing halos or colored images around lights, or eye redness while being treated with Rolufta Ellipta, stop using this medicine and seek immediate medical help, as these symptoms may indicate an acute attack of closed-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 need to take any other medicines. If you are unsure what your medicine contains, consult your doctor or pharmacist.
In particular, inform your doctor or pharmacist if you are taking other long-acting medicines for respiratory problems similar to this one, for example, tiotropium. Do not use Rolufta Ellipta together with these medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. If you are pregnant, do not use this medicine unless your doctor has instructed you to do so.
It is unknown whether the components of Rolufta Ellipta are excreted in breast milk. If you are breastfeeding, you must consult your doctor before using Rolufta Ellipta.
If you are breastfeeding, do not use this medicine unless your doctor has instructed you to 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 your doctor has informed you that you have an intolerance to certain sugars, consult with them before using this medicine.
3. How to use Rolufta Ellipta
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one inhalation every day, at the same time each day. You only need one inhalation per day, as the effect of this medicine lasts for 24 hours.
Do not use more doses than your doctor has prescribed.
Use Rolufta Ellipta regularly
It is very important that you use Rolufta Ellipta every day, as directed by your doctor. This will help you to remain symptom-free throughout the day and night.
Do not use this medicine to relieve a sudden attack of breathlessness or wheezing. If you have such an attack, you must use a fast-acting "rescue" inhaler (such as salbutamol).
How to use the inhaler
For complete information, read the "Step-by-step instructions for use" at the end of this leaflet.
Administration of Rolufta Ellipta is by inhalation. To use Rolufta Ellipta, inhale it into your lungs through your mouth using the Ellipta inhaler.
If symptoms do not improve
If your COPD symptoms (breathlessness, wheezing, cough) 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 require medical attention. If possible, show them the inhaler, packaging, or this leaflet. You may notice your heart beating faster than normal, visual disturbances, or dry mouth.
If you forget to use Rolufta Ellipta
Do not inhale a double dose to make up for missed doses. Inhale the next dose at your usual time.
If you experience wheezing or breathlessness, use your fast-acting "rescue" inhaler (for example, salbutamol), and seek medical advice.
If you stop using Rolufta Ellipta
Use this medicine for the length of time recommended by your doctor. It will only be effective for as long as you continue to use it. Do not stop using it unless your doctor tells you to, even if you feel better, as your symptoms may worsen.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Allergic reactions
If you experience any of the following symptoms after using Rolufta Ellipta, stop using this medicine and inform your doctor immediately:
Uncommon (may affect up to 1 in 100 people):
- itching
- skin rash (hives) or redness
Rare (may affect up to 1 in 1,000 people):
- wheezing (a whistling sound when breathing), coughing, or difficulty breathing
- sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness)
Other adverse effects:
Common (may affect up to 1 in 10 people):
- faster heartbeat
- pain when urinating and increased frequency (may be signs 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 symptoms 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
- altered taste
- hoarseness
Rare (may affect up to 1 in 1,000 people):
- eye pain
Frequency not known (frequency cannot be estimated from available data):
- decreased vision or eye pain due to increased intraocular pressure (possible signs of glaucoma)
- blurred vision
- increased intraocular pressure
- difficulty and pain during urination, which may indicate bladder obstruction or urinary retention
- dizziness
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V.
By reporting adverse 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 stated on the packaging, tray, and inhaler, after EXP. The expiry date refers to the last day of the month indicated.
Keep the inhaler within the sealed tray to protect it from moisture, and only remove it immediately before first use. Once the tray has been opened, the inhaler may be used for a period of 6 weeks from the date the tray was opened. Write the date on which the inhaler should be discarded in the space provided for this purpose on the inhaler label. 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rolufta Ellipta
The active substance is umeclidinium (as bromide).
Each inhalation provides a delivered dose (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.
Nature and contents of the pack
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 aluminum tray sealed with a peelable aluminum foil lid. The tray contains a desiccant bag to reduce moisture within the package.
The active substance is presented as a white powder in a blister inside the inhaler.
Rolufta Ellipta is available in packs containing one inhaler with either 7 or 30 doses, and in multiple packs containing 90 doses (3 inhalers of 30 doses each). Some pack sizes may not be marketed.
Marketing Authorization 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 about this medicine, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Tel/Tel: + 32 (0) 10 85 52 00 | Lithuania UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947 | ||
| Luxembourg/Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgium/Belgium Tel/Tel: + 32 (0) 10 85 52 00 | ||
Czech Republic GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111 | Hungary Berlin-Chemie/A. Menarini Kft. Tel.: +36 23501301 | ||
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta GlaxoSmithKline Trading Services Limited Tel: +356 80065004 | ||
Germany BERLIN-CHEMIE AG Tel: +49 (0) 30 67070 | Netherlands GlaxoSmithKline BV Tel: + 31 (0) 33 208110030 | ||
Estonia OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 | ||
Greece GlaxoSmithKline Μονοπρόσωπη A.E.B.E. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 | ||
Spain FAES FARMA, S.A. Tel.: +34 900 460 153 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 | ||
France Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 | Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00 | ||
Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 361 | Romania GlaxoSmithKline Trading Services Limited Tel: +40 800672524 | ||
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 (0)1 300 2160 | ||
Iceland Vistor hf. Sími: + 354 535 7000 | Slovakia Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730 | ||
Italy
Tel: +39-055 56801 | Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 | ||
Cyprus GlaxoSmithKline Trading Services Limited Tel: +357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 | ||
Latvia SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210 | United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221441 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine 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 properly, as it contains pre-measured doses and is ready for immediate use.
Your Rolufta Ellipta inhaler pack 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 desiccant bag to reduce moisture. Discard the desiccant bag; do not open, 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 the medicine. When the tray is opened, record the “Discard after” date in the space provided on the inhaler label. The “Discard after” date is 6 weeks from the date the tray is opened. After this date, the inhaler must not be used. The tray may be discarded once opened.
If stored in the refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
The step-by-step instructions for using the Ellipta inhaler provided below apply to both the 30-dose inhaler (30 days of treatment) and the 7-dose inhaler (7 days of treatment).
- Read this information before starting
If the inhaler cap is opened and closed without inhaling the medicine, the dose will be lost. The lost dose will be safely retained inside the inhaler but will not be available for inhalation.
It is not possible to accidentally administer an extra or double dose by inhaling again.
- Prepare a dose
Wait to open the inhaler cap until you are ready to inhale a dose.
Do not shake the inhaler.
- Slide the cap down until you hear a ‘click’.
The medicine is now ready to inhale.
As confirmation, the dose counter decreases by 1 unit.
- If the dose counter does not decrease when you hear the ‘click’, the inhaler will not release the medicine dose.
Take it to your pharmacist and ask for assistance.
- Inhale your medicine
- While holding 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 vents with your fingers.
- Take a long, steady, and deep breath in. 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.
Before closing the cap, the inhaler mouthpiece may be cleaned using a dry tissue.
- Close the inhaler
- Slide the cap upward until it stops, to cover the mouthpiece.