Laventa Air Ellipta

Package leaflet: Information for the user

LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed

umeclidinium/vilanterol
Please read all of this leaflet carefully before you start taking 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 pass it on to other people, even if their symptoms are the same as yours, as it may 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 LAVENTAIR ELLIPTA is and what it is used for
2. What you need to know before using 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 is LAVENTAIR ELLIPTA and what is it used for

What is LAVENTAIR ELLIPTA
LAVENTAIR ELLIPTA contains two active substances: umeclidinium bromide and vilanterol. They belong to a group of medicines called bronchodilators.
What LAVENTAIR ELLIPTA is used for
It is used for the treatment of chronic obstructive pulmonary disease (COPD) in adults.
COPD is a chronic condition characterized by breathing difficulties that tend to worsen over time.
In COPD, the muscles surrounding the airways become constricted. This medicine blocks the tightening of the muscles in the lungs, making it easier for air to flow in and out of the lungs. When used regularly, it helps control breathing difficulties and reduces the impact of COPD on everyday life.
LAVENTAIR ELLIPTA must not be used to relieve a sudden attack of breathlessness or shortness of breath.
If such an attack occurs, you must use a fast-acting inhaler (such as salbutamol).
Contact your doctor if you do not have a fast-acting inhaler.

2. What you need to know before using 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, do not use this medicine before consulting your doctor.

Warnings and precautions
Talk to your doctor before using this medicine:

• if you have asthma (Do not use LAVENTAIR ELLIPTA to treat asthma)
• if you have heart problems or high blood pressure
• if you have an eye condition called narrow-angle glaucoma
• if you have an enlarged prostate , difficulty urinating , or urinary blockage
• if you have epilepsy
• if you have thyroid gland problems
• if you have low levels of potassium in your blood
• if you have diabetes
• if you have severe liver problems
  Talk to your doctor if you think any of these apply to you.

Immediate breathing difficulties
If immediately after using your LAVENTAIR ELLIPTA inhaler you experience chest tightness, cough, 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 LAVENTAIR ELLIPTA
If during treatment with LAVENTAIR ELLIPTA you experience eye pain or discomfort, temporary blurred vision, halos around lights, or colored images, together with redness of the 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 LAVENTAIR ELLIPTA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you are unsure what your medicine contains, consult your doctor or pharmacist.
Some medicines may affect how this medicine works, or may increase the likelihood of side effects.
These include:

• medicines called beta-blockers (such as propranolol), used to treat high blood pressure or other heart problems
• ketoconazole or itraconazole, used to treat fungal infections
• clarithromycin or telithromycin, used to treat bacterial infections
• ritonavir, used to treat HIV infection
• medicines that lower potassium levels in the blood, such as certain diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthines or steroids)
• other long-acting medicines similar to this one used to treat breathing problems, e.g. tiotropium, indacaterol. Do not use LAVENTAIR ELLIPTA if you are already using these medicines.
  Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may need to monitor you closely, as these medicines may increase the side effects of LAVENTAIR ELLIPTA.

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 it is safe to do so.
It is not known whether the components of LAVENTAIR ELLIPTA pass into breast milk. If you are breastfeeding , consult your doctor before using LAVENTAIR ELLIPTA. Do not use this medicine while breastfeeding unless your doctor tells you it is safe to do so.
Driving and using machines
It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or operate machinery.
LAVENTAIR ELLIPTA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use LAVENTAIR ELLIPTA

Use this medicine exactly as your doctor has told you. If you have any doubts, 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 amount your doctor has prescribed.
Use LAVENTAIR ELLIPTA regularly
It is very important that you use LAVENTAIR ELLIPTA every day as prescribed by your doctor. This will help keep you symptom-free throughout the day and night.
LAVENTAIR ELLIPTA must not be used to relieve symptoms of a sudden attack of breathlessness or wheezing. If such an attack occurs, you must use a fast-acting inhaler (such as salbutamol).
How to use the inhaler
For complete instructions, see the “Step-by-step instructions” at the end of this leaflet.
LAVENTAIR ELLIPTA is for inhalation only. To use LAVENTAIR ELLIPTA, inhale it into your lungs through your mouth using the ELLIPTA inhaler.
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 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 immediately, as you may require medical observation. If possible, show them the inhaler, the packaging, or this patient information leaflet. You may notice that your heart beats faster than usual, you may experience tremors, visual disturbances, dry mouth, or headache.
If you forget to use LAVENTAIR 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 become breathless or short of breath, use your fast-acting inhaler (such as salbutamol), and seek advice from your doctor.
If you stop using LAVENTAIR ELLIPTA
Use this medicine for the length of time prescribed by your doctor. It will remain effective only as long as you continue using it. Do not stop unless your doctor advises you to, even if you feel better, because your symptoms may worsen.
If you have any questions about how to use this medicine, speak with your doctor, pharmacist, or nurse.

4. Possible side effects

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

Allergic reactions
If you have experienced any of the following symptoms after taking LAVENTAIR ELLIPTA, stop using this medicine and contact your doctor immediately.

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

• Skin rash (urticaria) or redness

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

• Swelling, sometimes of the face or mouth (angioedema)
• If you become very wheezy, have a cough or experience breathing difficulties
• If you feel very weak or confused (this may lead to collapse or loss of consciousness)

Immediate breathing difficulties
Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare. If, immediately after using this medicine, you experience chest tightness, cough, wheezing or shortness of breath:
stop using this medicine and seek immediate medical assistance, as you may be experiencing a serious condition called paradoxical bronchospasm.

Other side effects

Common (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 at the back of the mouth and throat
• Constipation
• Dry mouth
• Upper respiratory tract infection

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat
• Rapid heartbeat
• Awareness of your heartbeat (palpitations)
• Muscle spasms
• Tremor
• Taste disturbances
• Hoarseness

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

• Blurred vision
• Increased measured intraocular pressure
• Decreased vision or eye pain (possible signs of glaucoma)
• Difficulty and pain when passing urine – these may be signs of bladder emptying obstruction or urinary retention

Not known (frequency cannot be estimated from the available data)

• Dizziness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 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 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 the medicine 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 LAVENTAIR ELLIPTA Contains
The active substances are umeclidinium bromide and vilanterol.
Each single inhalation delivers an inhaled dose (released from the mouthpiece) of 55 micrograms of
umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as
trifenate).
The other components are lactose monohydrate (see section 2, "LAVENTAIR ELLIPTA contains lactose") and magnesium stearate.

Description of the Appearance of LAVENTAIR ELLIPTA and Contents of the Package
LAVENTAIR ELLIPTA is a pre-dosed inhalation powder.
The Ellipta inhaler consists of a light grey body, a red mouthpiece cap, and a dose counter. It is packaged in an aluminium laminate tray with a removable lid. The tray contains a desiccant sachet to reduce moisture in the package.
The active substances are present as white powder in separate blisters inside the inhaler.
LAVENTAIR ELLIPTA is available in packages containing 1 inhaler with either 7 or 30 doses, and in multiple packs containing 90 doses (3 inhalers with 30 doses each).
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization 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 GlaxoSmithKline Pharmaceuticals s.a./n.v.
България” 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]

Österreich
Ελλάδα GlaxoSmithKline Pharma GmbH
Guidotti Hellas A.E. Tel: + 43 (0)1 97075 0
Τηλ: + 30 210 8316111-13 [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
MENARINI France BIAL, Portela & Ca. SA.
Tél: + 33 (0)1 45 60 77 20 Tel: + 351 22 986 61 00
[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 Trading Services 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
Sími: + 354 535 7000 Slovakia s.r.o.
Tel: +421 2 544 30 730
[email protected]

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

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

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210
[email protected]

Additional Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Step-by-Step Instructions

What is the ELLIPTA Inhaler?
When you use LAVENTAIR ELLIPTA for the first time, there is no need to check that the inhaler works correctly; it contains pre-measured doses and is ready for immediate use.

Your LAVENTAIR ELLIPTA Package 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 lid by pulling the tab.
The tray contains a desiccant sachet to reduce moisture. Discard this desiccant sachet – do not open, eat, or inhale it.

Desiccant
When you remove it from its box (sealed tray), the inhaler will be in the 'closed' position. Do not open the inhaler until you are ready to inhale a dose of the 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 is opened. After this date, the inhaler must not be used. The tray may be discarded after first opening.
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 30-dose inhaler (30-day supply) described below also apply to the 7-dose inhaler (7-day supply).

1) Read Before Starting
If you open and close the inhaler cap without inhaling the medicine, you will lose that dose.
The missed dose will be securely held inside the inhaler but will no longer be available.
You cannot accidentally inhale extra medicine or a double dose in a single inhalation.

2) Prepare a Dose
Wait to open the cap until you are ready to inhale the dose.
Do not shake the inhaler.

• Slide the cap down until you hear a 'click'.

“Click”
The medicine is now ready to inhale.
The dose counter will count down by 1 to confirm.

• 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 slowly, steadily, and deeply. 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 cap.

4) Close the Inhaler

• Slide the cap fully upwards to cover the mouthpiece.