ANORO 55 MICROGRAMS/22 MICROGRAMS Proszek do inhalacji

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1. ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-metered dose
   1. What is ANORO ELLIPTA 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

ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-metered dose

umeclidinium/vilanterol

Read this leaflet carefully before taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is ANORO ELLIPTA and what it is used for

What is ANORO ELLIPTA
ANORO ELLIPTA contains two active ingredients: 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 around the airways narrow. This medicine blocks the narrowing
of the muscles in the lungs, making it easier for air to enter and leave the lungs. When used
regularly, it helps control breathing difficulties and reduces the effects of COPD on daily
life.

ANORO ELLIPTA should not be used to relieve a sudden attack of shortness
of breath or wheezing.
If this type of attack occurs, you should 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 allergicto umeclidinium, vilanterol or any of the other ingredients of this medicine ( listed in section 6). If you think this may apply to you, do not usethis 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 problemsor high blood pressure
• if you have an eye problem called acute narrow-angle glaucoma
• if you have an enlarged prostate, difficulty urinatingor a blockage in your urinary flow.
• if you suffer from epilepsy
• if you have thyroid problems
• if you have low levels of potassiumin your blood
• if you have diabetes
• if you have serious liver problemsTalk to your doctorif you think any of these apply to you.

Immediate breathing difficulties
If immediately after using your ANORO ELLIPTA inhaler you experience a feeling of chest tightness,
coughing, wheezing or shortness of breath:

stop using this medicineandseekimmediate medical help,as you may have 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, visual halos or colored images associated with redness of the eyes:

stop using this medicineandseekimmediate 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 ANORO 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 a medicine contains, ask your doctor or pharmacist.
Some medicines can affect how this medicine works, or make it more likely that you
will have side effects.
These include:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advicebefore taking this medicine. Do not use this medicine if you are
pregnant unless your doctor tells you that you can.
It is not known whether the ingredients of ANORO ELLIPTA pass into breast milk. If you are breastfeeding
, consult your doctorbefore using ANORO ELLIPTA. Do not use this medicine if you are
breastfeeding unless your doctor tells you that you can.

Driving and using machines
It is unlikely that ANORO ELLIPTA will affect your ability to drive or use machines.

ANORO ELLIPTA contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to use ANORO ELLIPTA

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor
or pharmacist.

The recommended doseis one inhalation per day, every day at the same time. You need to inhale it once
a day because the effect of this medicine lasts 24 hours.

Do not use more than your doctor has told you to.
Use ANORO ELLIPTA regularly
It is very important that you use ANORO ELLIPTA every day, as prescribed by your doctor. This
will help you to be free from symptoms throughout the day and all night. ANORO ELLIPTA must notbe used to relieve the symptoms of a sudden attack of shortness of
breath or wheezing. If this type of attack occurs, you should use a fast-acting inhaler (such as salbutamol).

How to use the inhaler
For complete information, see “Step-by-step instructions”at the end of this leaflet.
ANORO ELLIPTA is for inhalation use 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 (shortness of breath, wheezing, cough) do not improve or worsen, or if you are
using the fast-acting inhaler too often:

contact your doctor as soon as possible.
If you use more ANORO ELLIPTA than you should
If you accidentally use an excessive amount of this medicine, seek immediate medical attentionbecause
medical observation may be required. If possible, show them the inhaler, you may experience tremors, you may
experience blurred vision, dry mouth, or headache.

If you forget to use ANORO ELLIPTA
Do not inhale a double dose to make up for a missed dose. Simply inhale the next dose
at the usual time.
If your breathing becomes labored or you are short of breath, use a fast-acting inhaler (such as
salbutamol), and ask your doctor for advice.

If you stop using ANORO ELLIPTA
Use this medicine for the time recommended by your doctor. It will be effective as long as you use it.
Do not stop unless your doctor tells you to, even if you feel better, because your symptoms
may worsen.
If you have any questions about using 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 experience any of the following symptoms after taking ANORO ELLIPTA stop using
this medicine and inform 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 short of breath, have a cough or difficulty breathing
• If you feel very weak or confused (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 a feeling of tightness in the chest, coughing, wheezing or shortness of breath:

stop using this medicineandseekimmediate 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 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
• upper respiratory tract infection.

Uncommon(may affect up to 1 in 100 people)

• irregular heartbeat
• fast heartbeat
• feeling of heartbeat (palpitations)
• muscle spasms
• tremor
• altered taste
• hoarseness.

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

• blurred vision
• increased eye pressure measured
• decreased vision or eye pain (possible signs of glaucoma)
• difficulty and pain when passing urine - these may be signs of obstruction to bladder emptying or urinary retention.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, 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 only remove it
immediately before first use.
Once the tray is opened, the inhaler can be used for 6 weeks, starting from the date of opening the
tray. Write the date on which the inhaler must be discarded on the label in the appropriate space. The date
must be written as soon as the inhaler has been removed from the tray.
Do not store at a temperature above 30°C.
If stored in a refrigerator, leave the inhaler at room temperature for at least one hour before use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ANORO ELLIPTA contains
The active ingredients are umeclidinium bromide and vilanterol.
Each single inhalation provides 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
triphenate).
The other ingredients are lactose monohydrate (see section 2 under “ANORO ELLIPTA contains
lactose”) and magnesium stearate.

Description of the appearance of ANORO ELLIPTA and contents of the pack
ANORO ELLIPTA is a powder for inhalation, pre-dosed.
The Ellipta inhaler consists of a light grey body, a red mouthpiece cover and a dose counter. It is packaged in a
laminated aluminium tray with a removable lid. The tray contains a desiccant sachet, to reduce humidity in the
pack.
The active ingredients are present in the form of a white powder in separate blisters inside the inhaler.
ANORO ELLIPTA is available in packs of 1 inhaler containing 7 or 30 doses and in multi-packs containing 90 (3
inhalers of 30) doses.
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 on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00

Lietuva
UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tel: +370 52 691 947
[email protected]

България
Берлин-Хеми/А. Менарини
България” EООД
Teл.: +359 2 454 0950
[email protected]

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301
[email protected]

Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Trading Services Limited
Tel: +356 80065004

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001
[email protected]

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
Menarini Hellas A.E.
Τηλ: +30 210 83161 11-13

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44
[email protected]

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: +385 1 4821 361
[email protected]

România
GlaxoSmithKline Trading Services Limited
Tel: +40 800672524

Ireland
GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000

Slovenija
Berlin-Chemie / A. Menarini Distribution
Ljubljana d.o.o.
Tel: +386 (0)1 300 2160
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Berlin-Chemie / A. Menarini Distribution
Slovakia s.r.o.
Tel: +421 2 544 30 730
[email protected]

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 774 1111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Trading Services Limited
Τηλ: +357 80070017

Sverige
GlaxoSmithKline AB
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 medicine 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 is working
correctly; it contains doses that have already been pre-measured and is ready to be used immediately

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 sachet of desiccant, to reduce humidity. Discard this desiccant sachet –

do notopen it, eat it or inhale it.
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 appropriate space. The “Discard by” date is 6 weeks from the
date the tray is opened. After this date the inhaler should no longer be used. The tray can be discarded after
the first opening.
If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before
use.
The step-by-step instructions for using the 30-dose inhaler (supply for 30 days) described below also apply
to the 7-dose inhaler (supply for 7 days).

Desiccant

• 1)Read before starting

If you open and close the inhaler cover without inhaling the medicine, you will lose the dose.
The missed dose will be held firmly inside the inhaler safely, but will no longer be available.
It is not possible to accidentally take extra medicine or a double dose in a single inhalation.

• 2)Prepare a dose

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

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

“Click”
The medicine is now ready to be inhaled.
The dose counter counts down by 1for confirmation.

• If the dose counter does not count down when you hear the 'click', the inhaler will not release themedicine. Return it to your pharmacist for advice.
• 3)Inhale the medicine
• With the inhaler away from your mouth, exhale as far as you can. Do notexhale into the inhaler.
• Put your lips around the mouthpiece and close your lips tightly around it. Do notcover the air holes with your fingers.

• Inhale slowly, steadily, and deeply. Hold your breath for as long as possible (at least 3-4 seconds).
• Remove the inhaler from your mouth.
• Exhale slowly and gently.

You may not be able to taste or feel the medicine, even when using the inhaler correctly.
If you want to clean the mouthpiece, use a dry cloth, beforeclosing the cover.

• 4)Close the inhaler

Slide the cover up all the way to cover the mouthpiece.