Anoro Ellipta

Patient Information Leaflet: Instructions for the User

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

umeclidinium/vilanterol
Please read this leaflet carefully before 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What ANORO ELLIPTA is and what it is used for
2. What you need to know before using ANORO ELLIPTA
3. How to use ANORO ELLIPTA
4. Possible side effects
5. How to store ANORO ELLIPTA
6. Contents of the pack and other information
   Step-by-step instructions

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

What ANORO ELLIPTA is
ANORO ELLIPTA contains two active substances: umeclidinium bromide and vilanterol. They belong to a
group of medicines called bronchodilators.
What ANORO 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 tighten. This medicine blocks the tightening of the muscles in the lungs, making it easier for air to flow into and out of the lungs. When used regularly, it helps control breathing difficulties and reduces the impact of COPD on daily life.
ANORO 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 ANORO ELLIPTA

Do not use ANORO 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 ANORO 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 in urination , or urinary blockage
• if you have epilepsy
• if you have thyroid 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 conditions apply to you.

Immediate breathing difficulties
If immediately after using your ANORO ELLIPTA inhaler you experience a feeling of 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 ANORO ELLIPTA
If during treatment with ANORO ELLIPTA you experience eye pain or discomfort, temporary blurred vision, seeing halos around lights, colored images, or eye redness:
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 administer this medicine to children or adolescents under 18 years of age .
Other medicines and ANORO ELLIPTA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you are unsure about the ingredients of your medication, consult your doctor or pharmacist.
Some medicines may affect how this medicine works or make it more likely that you will experience 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 reduce potassium levels in the blood, such as certain diuretics (water tablets) or certain 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 ANORO ELLIPTA if you are already taking these medicines. Inform 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 ANORO ELLIPTA.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. Do not use this medicine during pregnancy unless your doctor tells you that you may do so.
It is not known whether the components of ANORO ELLIPTA pass into breast milk. If you are breastfeeding , consult your doctor before using ANORO ELLIPTA. Do not use this medicine while breastfeeding unless your doctor tells you that you may do so.
Driving and using machines
It is unlikely that ANORO ELLIPTA will affect your ability to drive or operate machinery.
ANORO ELLIPTA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to use ANORO ELLIPTA

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one inhalation daily, every day, at the same time. You need to inhale it only once a day because the effect of this medicine lasts for 24 hours.
Do not use more than your doctor has prescribed.
Use ANORO ELLIPTA regularly
It is very important that you use ANORO ELLIPTA every day as prescribed by your doctor. This will help keep you symptom-free throughout the day and night.
ANORO 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 information, see the “Step-by-step instructions” at the end of this leaflet.
ANORO ELLIPTA is for inhalation only. To use ANORO 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, coughing) or worsen, or if you are using your fast-acting inhaler too frequently:
contact your doctor as soon as possible.
If you use more ANORO 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 leaflet. You may notice your heart beating faster than usual, feel tremors, experience visual disturbances, dry mouth, or headache.
If you forget to use ANORO 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 experience breathlessness or shortness of breath, use your fast-acting inhaler (such as salbutamol) and consult your doctor.
If you stop using ANORO ELLIPTA
Use this medicine for the length of time recommended by your doctor. It will remain effective 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 doubts about how to use 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 experienced any of the following symptoms after taking ANORO ELLIPTA, stop using this medicine
and contact your doctor immediately.

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

• 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 difficulty breathing
• If you feel very weak or confused (this may lead to collapse or loss of consciousness)

Immediate breathing difficulties
Immediate breathing difficulties after using ANORO 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 have 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
• Fast 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 eye 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 ANORO 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 its sealed tray to protect the medicine from moisture, and remove it only
immediately before first use.
Once the tray has been opened, the inhaler may 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
must 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 ANORO 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
trifenilate).
The other ingredients are lactose monohydrate (see section 2, “ANORO ELLIPTA contains lactose”) and magnesium stearate.

Description of the appearance of ANORO ELLIPTA and contents of the pack
ANORO ELLIPTA is a pre-dosed powder for inhalation.
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.
ANORO ELLIPTA is available in packs containing 1 inhaler with 7 or 30 doses, and multiple packs containing 90 doses (3 inhalers with 30 doses each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Authorisation 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
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Norge
Eesti GlaxoSmithKline AS
OÜ Berlin-Chemie Menarini Eesti Tlf: + 47 22 70 20 00
Tel: +372 667 5001
[email protected]

Österreich
Ελλάδα GlaxoSmithKline Pharma GmbH
Menarini Hellas A.E. Tel: + 43 (0)1 97075 0
Τηλ: +30 210 83161 11-13 [email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [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
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 774 1111 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]

Other 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 ANORO ELLIPTA for the first time, there is no need to check that the inhaler works properly; it contains pre-measured doses and is ready for immediate use.

Your ANORO ELLIPTA pack contains

The inhaler is packaged in a tray. Do not open the tray until you are ready to start using the new inhaler. When you are 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, swallow, 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 inhaler label in the designated space. The “Discard by” date is 6 weeks from the date the tray was opened. The inhaler must not be used after this date. 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 downwards until you hear a 'click'.

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

• 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.