55 micrograms / 22 micrograms inhalation powder , divided dose of 
umeclidinium / vilanterol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
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

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. These belong to a group of medicines called bronchodilators.

What ANORO ELLIPTA is used for

ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease ( COPD ) in adults. COPD is a chronic disease that is characterized by difficulty breathing and that slowly worsens.

In COPD, the muscles around the airways contract. This medicine prevents the muscles in the lungs from contracting so that the air can pass more easily. When used regularly, it can help control your breathing difficulties and reduce the effects of COPD on your daily life.

ANORO ELLIPTA should not be used to treat a sudden attack of shortness of breath or wheezing.

If you get such an attack, you must use a fast-acting inhaler (eg salbutamol ). Contact your doctor if you do not have a fast-acting inhaler.

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 until you have talked to your doctor.

Warnings and cautions

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 disease called narrow-angle glaucoma
  • if you have an enlarged prostate, difficulty urinating, or an obstruction in the bladder
  • if you suffer from epilepsy
  • if you have thyroid problems
  • if you have diabetes
  • if you have severe liver problems.

Talk to your doctor if you think any of these may apply to you.

Acute breathing difficulties

If you get a chest tightness, cough, wheeze, or shortness of breath immediately after using the ANORO ELLIPTA inhaler:

Stop using this medicine and seek medical attention immediately. It can be a serious condition called paradoxical bronchospasm

Eye problems during treatment with ANORO ELLIPTA

If you experience pain or discomfort in the eyes, temporarily blurred vision, see light rings or colored dots in combination with red eyes during treatment with ANORO ELLIPTA.

Stop using this medicine and seek medical attention immediately. This may be a sign of acute narrow-angle glaucoma.

Children and young people

Do not give this medicine to children and 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 your medicine contains, talk to your doctor or pharmacist.

Some medicines may affect the way this medicine works, or increase the risk of side effects. These are:

  • so-called beta-blockers (such as propanol) used to treat high blood pressure and other heart problems
  • ketoconazole and itraconazole used to treat fungal infections
  • clarithromycin and telithromycin used to treat bacterial infections
  • ritonavir used to treat HIV – infection
  • drugs that lower the amount of potassium in the blood e.g. diuretics ( diuretic tablets) or medicines used to treat asthma (eg methylxanthines or steroids ).
  • other long-acting drugs that are similar to this drug and are used for breathing problems, e.g. tiotropium and indacaterol. Do not use ANORO ELLIPTA if you are already taking these medicines.

Tell your doctor or pharmacist if you are taking any of these medicines.

Pregnancy and breastfeeding

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. Do not use this medicine during pregnancy unless your doctor tells you to.

It is not known whether the ingredients in ANORO ELLIPTA can pass into breast milk. If you are breast-feeding, you must consult your doctor before using ANORO ELLIPTA. Do not use this medicine while breast-feeding unless your doctor advises you to do so.

Driving and using machines

ANORO ELLIPTA is likely to have no effect on your ability to drive or use machines.

ANORO ELLIPTA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use ANORO ELLIPTA

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one inhalation (inhalation) at the same time each day. You only need to inhale once a day as the effect of this medicine lasts for 24 hours.

Do not use more medicines than your doctor tells you to.

Use ANORO ELLIPTA regularly

It is very important that you use ANORO ELLIPTA every day according to your doctor’s instructions. That way, you can be helped to be symptom-free all day and night.

ANORO ELLIPTA should not be taken to treat a sudden attack of shortness of breath or wheezing. If you get such an attack, you must use a fast-acting inhaler (eg salbutamol ).

How to use the inhaler

For complete information, see “ Step-by-Step Instructions for Use ” after section 6 of this leaflet.

ANORO ELLIPTA is for inhalation only . To use ANORO ELLIPTA, inhale the medicine into your lungs through your mouth with the ELLIPTA inhaler.

If your symptoms do not get better

If your COPD symptoms (shortness of breath, wheezing, coughing) do not improve or get worse, or if you use your fast-acting inhaler more often than before:

Contact your doctor as soon as possible.

If you use more ANORO ELLIPTA than you should

If you happen to take too much of this medicine, contact your doctor or pharmacist immediately for advice, as you may need medical attention. If possible, show the inhaler, package, or package leaflet. Your heart may beat faster than normal, you may feel shaky, have visual disturbances, have a dry mouth, or a headache.

If you forget to use ANORO ELLIPTA

Do not inhale any extra dose to make up for a forgotten dose. Only inhale the next dose at the usual time.

If you experience wheezing or shortness of breath, use your fast-acting inhaler (eg salbutamol ), then seek medical attention.

If you stop using ANORO ELLIPTA

Use this medicine for as long as your doctor prescribes it. This medicine will only work as long as you use it. Do not stop using it unless your doctor advises you to do so, not even if you feel better, as your symptoms may worsen.

If you have any further questions on the use of this product, 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 get any of the following symptoms while taking ANORO 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 are (may affect up to 1 in 1000 people)

  • swelling, sometimes in the face or mouth ( angioedema )
  • severe wheezing/wheezing, coughing, or difficulty breathing
  • a sudden feeling of weakness or dizziness (which may lead to collapse or unconsciousness)

Acute breathing difficulties

Acute breathing difficulties after using ANORO ELLIPTA are rare. If you get a chest tightness, cough, wheeze, or shortness of breath immediately after using this medicine:

Stop using ANORO ELLIPTA and seek medical attention immediately, as you may have a serious condition called paradoxical bronchospasm.

Common side effects are

These can occur in up to 1 in 10 people:

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

Uncommon side effects are

These can occur in up to 1 in 100 people:

  • irregular heartbeats
  • faster heartbeat
  • palpitations ( palpitation )
  • rash
  • shaking/trembling
  • changed taste experience
  • huskiness.

Rare side effects are

These can occur in up to 1 in 1,000 people:

  • dimsyn
  • increase in the measured pressure in the eye
  • impaired vision or pain in your eyes due to high pressure (possible signs of glaucoma )
  • difficulty and pain when urinating – this may be a sign of bladder obstruction or urinary retention.

Has been reported

The frequency can not be calculated 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 carton, tray, and inhaler after “EXP”. The expiration date is the last day of the specified month.

Store the inhaler in the sealed trough and remove it immediately before using it for the first time. Moisture sensitive. Once the foil package has been opened, the inhaler can be used for up to 6 weeks, starting from the day the foil package has been opened. Write the date on which the inhaler is to be disposed of in the space provided on the label. The date should be written as soon as the inhaler has been removed from the foil package.

Do not store above 30 ° C.

If the inhaler is stored in a refrigerator, allow it to reach room temperature for at least one hour before use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

What ANORO ELLIPTA contains

The active substances are umeclidinium bromide and vilanterol.

Each inhalation delivers a dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms vilanterol (as triphenate).

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

What ANORO ELLIPTA looks like and contents of the pack

ANORO ELLIPTA is an inhalation powder, divided dose .

The Ellipta inhaler consists of a light gray plastic body with a red protective cap over the mouthpiece and a dose counter. It is packed in a foil-laminated tray with a peel-off foil lid. The tray contains a bag of desiccant to reduce the moisture in the package.

The active substances consist of a white powder in separate blisters inside the inhaler. Each inhaler contains either 7 or 30 doses. Multipacks of 90 doses (3 inhalers x 30) 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 Operations UK Limited (operating under the name Glaxo Wellcome Operations)

Priory Street

Ware

Hertfordshire

SG12 0DJ

UK

Glaxo Operations UK Ltd. (operating under the name Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle,

County Durham DL12 8DT 
United Kingdom

Glaxo Wellcome Production

Industrial Zone No.2,

23 Rue Lavoisier,

27000 Evreux

France

Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 (0) 10 85 52 00 Luxembourg / LuxemburgGlaxoSmithKline Pharmaceuticals sa / nvBelgium / BelgiumTel: + 32 (0) 10 85 52 00
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Muhammad Nadeem

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