Anoro Ellipta
(Umeclidinium Bromide/Vilanterol Trifenatate)

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Anoro Ellipta 62.5/25mcg/Inh
Anoro Ellipta 62.5/25mcg/Inh Metered-Dose Powder for Inhalation

Umeclidinium Bromide/Vilanterol Trifenatate

Manufactured by GlaxoSmithKline Inc.

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Anoro Ellipta 62.5/25mcg/Inh
Anoro Ellipta 62.5/25mcg/Inh Metered-Dose Powder for Inhalation

Umeclidinium Bromide/Vilanterol Trifenatate

Manufactured by GlaxoSmithKline UK Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

* Anoro Ellipta 55/22mcg/Inh in the UK is equivalent to Anoro Ellipta 62.5/25mcg/Inh.

Prescription Required

Parallel Import

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No generic medication is available for Anoro Ellipta (Umeclidinium Bromide/Vilanterol Trifenatate)

What Anoro Ellipta is and what it is used for

What ANORO ELLIPTA is ANORO ELLIPTA contains two active substances called umeclidinium 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 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.ANORO 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 take Anoro 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 ANORO ELLIPTA regularly It is very important that you use ANORO ELLIPTA every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night. ANORO 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. To use ANORO 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. 4 If you use more ANORO 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 ANORO ELLIPTA Don’t take an extra dose to make up for a missed dose. Just take 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 ANORO 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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions to ANORO ELLIPTA are uncommon (they affect less than 1 person in 100). If you have any of the following symptoms after taking ANORO ELLIPTA stop taking this medicine and tell your doctor immediately.
• skin rash (hives) or redness
• 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 ANORO ELLIPTA are rare (they affect less than 1 person in 1000). 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. 5

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.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:; E-mail: [email protected] Malta ADR Reporting Website:

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 expiry date refers to the last day of that month. Store in the sealed tray in order to protect from moisture and do not open the foil lid until ready for 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 discarded 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 you store in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use. 6 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.

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