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Rolufta (umeclidinium bromide) – Package leaflet - R03BB07

Updated on site: 10-Oct-2017

Medication nameRolufta
ATC CodeR03BB07
Substanceumeclidinium bromide
ManufacturerGlaxoSmithKline Trading Services Limited

Package leaflet: Information for the user

Rolufta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Rolufta is and what it is used for

2.What you need to know before you use Rolufta

3.How to use Rolufta

4.Possible side effects

5.How to store Rolufta

6.Contents of the pack and other information Step-by-step instructions for use

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

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

What Rolufta 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 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).

2. What you need to know before you use Rolufta

Do not use Rolufta:

-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, don’t 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 (Don’t use Rolufta 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 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

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:

Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.

Children and adolescents

This medicine should not be given to children or adolescents below the age of 18 years.

Other medicines and Rolufta

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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. You should not use Rolufta as well as these other medicines.

Pregnancy, breast-feeding and fertility

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

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

Driving and using machines

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

Rolufta 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

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.

Don’t use more than your doctor tells you to use.

Use Rolufta regularly

It is very important that you use Rolufta 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’ in this leaflet for full information.

To use Rolufta, 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 than you should

If you accidentally take 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

Don’t take an extra dose to make up for a missed dose. Just take 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

Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Don’t 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.

Common side effects

These 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.

Uncommon side effects

These may affect up to 1 in 100 people:

irregular heart beat

constipation

dry mouth

rash

taste disturbance.

Other side effects

Other side effects have occurred in a very small number of people but their exact frequency is unknown:

Decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).

Blurred vision

Difficulty and pain when passing urine – these may be signs of a bladder obstruction or urinary retention

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.

5.How to store Rolufta

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.

Store in the sealed tray in order to protect from moisture and do not open the foil lid until ready for 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 discarded 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 you store 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 dispose of medicines no longer required. This will help to protect the environment.

6.Contents of the pack and other information

What Rolufta contains

The active substance is umeclidinium 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 contains lactose’) and magnesium stearate.

What Rolufta looks like and contents of the pack

The Ellipta inhaler itself 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 strip inside the inhaler. Each inhaler contains either 7 or 30 doses. Multipacks containing 90 (3 inhalers of 30) doses are also available. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited

Currabinny

Carrigaline

County Cork

Ireland.

Manufacturer

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)

Priory Street

Ware

Hertfordshire

SG12 0DJ

United Kingdom

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

België/Belgique/Belgien

Lietuva

GlaxoSmithKline Pharmaceuticals s.a./n.v.

GlaxoSmithKline Lietuva UAB

Tél/Tel: + 32 (0) 10 85 52 00

Tel: + 370 5 264 90 00

 

info.lt@gsk.com

България

Luxembourg/Luxemburg

ГлаксоСмитКлайн ЕООД

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Teл.: + 359 2 953 10 34

Belgique/Belgien

 

Tél/Tel: + 32 (0) 10 85 52 00

Česká republika

Magyarország

GlaxoSmithKline, s.r.o.

GlaxoSmithKline Kft.

Tel: + 420 222 001 111

Tel.: + 36 1 225 5300

cz.info@gsk.com

 

Danmark

Malta

GlaxoSmithKline Pharma A/S

GlaxoSmithKline (Malta) Limited

Tlf: + 45 36 35 91 00

Tel: + 356 21 238131

dk-info@gsk.com

 

Deutschland

Nederland

GlaxoSmithKline GmbH & Co. KG

GlaxoSmithKline BV

Tel.: + 49 (0)89 36044 8701

Tel: + 31 (0)30 6938100

produkt.info@gsk.com

nlinfo@gsk.com

Eesti

Norge

GlaxoSmithKline Eesti OÜ

GlaxoSmithKline AS

Tel: + 372 6676 900

Tlf: + 47 22 70 20 00

estonia@gsk.com

firmapost@gsk.no

Ελλάδα

Österreich

GlaxoSmithKline A.E.B.E.

GlaxoSmithKline Pharma GmbH

Τηλ: + 30 210 68 82 100

Tel: + 43 (0)1 97075 0

 

at.info@gsk.com

España

Polska

GlaxoSmithKline, S.A.

GSK Services Sp. z o.o.

Tel: + 34 902 202 700

Tel.: + 48 (0)22 576 9000

es-ci@gsk.com

 

France

Portugal

Laboratoire GlaxoSmithKline

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tél: + 33 (0)1 39 17 84 44

Tel: + 351 21 412 95 00

diam@gsk.com

FI.PT@gsk.com

Hrvatska

România

GlaxoSmithKline d.o.o.

GlaxoSmithKline (GSK) S.R.L.

Tel: +385 1 6051999

Tel: + 4021 3028 208

Ireland

Slovenija

GlaxoSmithKline (Ireland) Limited

GlaxoSmithKline d.o.o.

Tel: + 353 (0)1 4955000

Tel: + 386 (0)1 280 25 00

 

medical.x.si@gsk.com

Ísland

Slovenská republika

Vistor hf.

GlaxoSmithKline Slovakia s. r. o.

Sími: + 354 535 7000

Tel: + 421 (0)2 48 26 11 11

 

recepcia.sk@gsk.com

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

Finland.tuoteinfo@gsk.com

Κύπρος

Sverige

GlaxoSmithKline (Cyprus) Ltd

GlaxoSmithKline AB

Τηλ: + 357 22 39 70 00

Tel: + 46 (0)8 638 93 00

gskcyprus@gsk.com

info.produkt@gsk.com

Latvija

United Kingdom

GlaxoSmithKline Latvia SIA

GlaxoSmithKline UK Ltd

Tel: + 371 67312687

Tel: + 44 (0)800 221441

lv-epasts@gsk.com

customercontactuk@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: http://www.ema.europa.eu.

Step-by-step instructions for use

What is the inhaler?

The first time you use Rolufta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.

The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. Throw this sachet away

– don’t eat or inhale it.

When you take the inhaler out of its box (sealed tray), it will be in the ‘closed’ position. Don’t open it until you are ready to inhale a dose of medicine. 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 inhaler provided below can be used for either the 30-dose or the 7-dose inhaler.

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.

1) Prepare a dose

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

Slide the cover down until you hear a “click”.

Your medicine is now ready to be inhaled.

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.

2)Inhale your medicine

While holding the inhaler away from your mouth, breathe out as far as is comfortable. Don’t breathe out into the inhaler.

Put the mouthpiece between your lips, and close your lips firmly around it. Don’t 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.

3)Close the inhaler

If you want to clean the mouthpiece, use a dry tissue, before you close the cover.

Slide the cover upwards as far as it will go, to cover the mouthpiece.

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