Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rolufta

Document Subject

Generated Narrative: MedicinalProductDefinition mp06bb7b199fc5a315ff3aceb8ab9ff2c8

identifier: http://ema.europa.eu/identifier/EU/1/17/1174/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-06bb7b199fc5a315ff3aceb8ab9ff2c8

identifier: http://ema.europa.eu/identifier/EU/1/17/1174/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rolufta

Attesters

Step-by-step instructions for use

What is in this leaflet

1. What Rolufta Ellipta is and what it is used for
2. What you need to know before you use 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

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 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.

This 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.

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 Rolufta Ellipta:

• 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. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can.

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.

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.

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

Allergic reactions

If you have any of the following symptoms after taking Rolufta Ellipta, stop using this medicine and tell 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, coughing or having difficulty in breathing suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness).

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
• mouth and throat pain.

Uncommon (may affect up to 1 in 100 people)

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

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

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.

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).

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. Rolufta Ellipta is available in packs of 1 inhaler containing either 7 or 30 doses and in multipacks containing 90 (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 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:

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC
Tel: +370 52 691 lt@berlin-chemie.com

• / .
  E
  Te .: +359 2 454 0bcsofia@berlin-chemie.com Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.:+36 23501bc-hu@berlin-chemie.com Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline Trading Services Limited Tel: +356 80065Deutschland BERLIN-CHEMIE AG Tel: +49 (0) 30 67Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti O Berlin-Chemie Menarini Eesti Tel: +372 667 5ee@berlin-chemie.com

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline
A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a FAES FARMA, S.A. Tel: +34 900 460 aweber@faes.es

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0)1 39 17 84 diam@gsk.com

Portugal GlaxoSmithKline Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 office-croatia@berlin-chemie.com

Rom nia GlaxoSmithKline Trading Services Limited Tel: +40 800672Ireland Slovenija

GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 (0)1 300 2slovenia@berlin-chemie.com

sland Vistor hf. S mi: + 354 535 7Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 slovakia@berlin-chemie.com

Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Tel: +39-055 56Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline Trading ServicesLimited : +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103lv@berlin-chemie.com

United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in

Other sources of information

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