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

- 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 LAVENTAIR ELLIPTA is and what it is used for

• 2. What you need to know before you use LAVENTAIR ELLIPTA

• 3. How to use LAVENTAIR ELLIPTA

• 4. Possible side effects

• 5. How to store LAVENTAIR ELLIPTA

• 6. Contents of the pack and other information

Step-by-step instructions

1. What LAVENTAIR ELLIPTA is and what it is used for

What LAVENTAIR ELLIPTA is

LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators.

What LAVENTAIR ELLIPTA is used for

LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD ) in adults. COPD is a long-term condition characterised by breathing difficulties that slowly get worse.

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

LAVENTAIR 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 LAVENTAIR ELLIPTA

Do not use LAVENTAIR ELLIPTA:

• – if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).

If you think this 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 LAVENTAIR ELLIPTA to treat asthma)

• - if you have heart problems or high blood pressure

• - 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 suffer from epilepsy

• - if you have thyroid gland problems

• - if you have diabetes

• - 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 LAVENTAIR 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 LAVENTAIR 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 LAVENTAIR 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 LAVENTAIR 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.

Some medicines may affect how this medicine works, or make it more likely that you’ll have side effects. These include:

• - medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart

problems

• - ketoconazole or itraconazole, to treat fungal infections

• - clarithromycin or telithromycin, to treat bacterial infections

• - ritonavir, to treat HIV infection

• - medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids)

• - other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.

tiotropium, indacaterol. Don’t use LAVENTAIR ELLIPTA if you already use these medicines. Tell your doctor or pharmacist if you are taking any of these.

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. Don’t use this medicine if you are pregnant unless your doctor tells you that you can.

It is not known whether the ingredients of LAVENTAIR ELLIPTA can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use LAVENTAIR ELLIPTA. Don’t use this medicine if you are breast-feeding unless your doctor tells you that you can.

Driving and using machines

It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or use machines.

LAVENTAIR 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 LAVENTAIR 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.

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

Use LAVENTAIR ELLIPTA regularly

It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.

LAVENTAIR 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).

How to use the inhaler

See ‘Step-by-step instructions’ in this leaflet for full information.

LAVENTAIR ELLIPTA is for inhalation use. To use LAVENTAIR 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 LAVENTAIR 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 feel shaky, you have visual disturbances, have a dry mouth, or have a headache.

If you forget to use LAVENTAIR ELLIPTA

Don’t inhale an extra 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 reliever inhaler (such as salbutamol), then seek medical advice.

If you stop using LAVENTAIR ELLIPTA

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.

Allergic reactions

If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.

Uncommon side effects (may affect up to 1 in 100 people):

• skin rash (hives) or redness

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

• swelling, sometimes of the face or mouth (angioedema)
• becoming very wheezy, coughing or having difficulty in breathing
• suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)

Immediate breathing difficulties

Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare. If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine:

Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.

Common side effects

These may affect up to 1 in 10 people:

• painful and frequent urination (may be signs of a urinary tract infection)
• combination of sore throat and runny nose
• sore throat
• feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
• headache
• cough
• pain and irritation in the back of the mouth and throat
• constipation
• dry mouth
• infection of the upper airways.

Uncommon side effects

These may affect up to 1 in 100 people:

• irregular heart beat
• faster heart beat
• awareness of heart beat (palpitations)
• rash
• tremor
• taste disturbance
• hoarseness.

Rare side effects

These may affect up to 1 in 1,000 people:

• blurred vision
• increase of the measured eye pressure
• decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
• difficulty and pain when passing urine – these may be signs of a bladder obstruction or urinary retention.

Frequency not known

Frequency cannot be estimated from the available data:

• 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 LAVENTAIR 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 dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

What LAVENTAIR ELLIPTA contains

The active substances are umeclidinium bromide and vilanterol.

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).

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

What LAVENTAIR ELLIPTA looks like and contents of the pack

LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed.

The Ellipta inhaler consists of a light grey plastic body, a red 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 substances are present as a white powder in separate blisters 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 marketed.

Marketing Authorisation Holder:

GlaxoSmithKline (Ireland) 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:

Belgie/Belgiqu­e/Belgien

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0) 10 85 52 00

Efc^rapufl

Eep.iHH-XeviH/Ä. MeHapuHu

Etarapua” EOOfl

Tea.: +359 2 454 0950

Česká republika

GlaxoSmithKline, s.r.o.

Tel: + 420 222 001 111

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

Deutschland

BERLIN-CHEMIE AG

Tel.: + 49 (0) 30 67070

Eesti

OÜ Berlin-Chemie Menarini Eesti

Tel: +372 667 5001

EMáSa

Guidotti Hellas A.E.

Tql: + 30 210 8316111–13

España

FAES FARMA, S.A.

Tel: + 34 900 460 153	Tel.: + 48 (0)22 576 9000
France MENARINI France Tel: + 33 (0)1 45 60 77 20	Portugal BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 00
Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 361	Romania GlaxoSmithKline (Ireland) Limited Tel: +40 800672524
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000	Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160
Island Vistor hf. Simi: + 354 535 7000	Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730
Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39 (0)55 56801	Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30
Knnpog GlaxoSmithKline (Ireland) Limited Tql: +357 80070017	Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00
Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210	United Kingdom (Northern Ireland ) GlaxoSmithKline (Ireland) 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

What is the inhaler?

The first time you use LAVENTAIR 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 LAVENTAIR ELLIPTA inhaler carton contains

The inhaler is packaged in a tray. Don’t 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 – don’t open, eat or inhale it.

When you take the inhaler out of its tray, it will be in the ‘closed’ position. Don’t open the inhaler 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 open 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 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.

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

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. 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.

Your lips fit over the contoured shape of the mouthpiece for inhaling.

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.

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

• 4) Close the inhaler