Anoro Ellipta (Umeclidinium bromide and vilanterol trifenatate)

GlaxoSmithKline LLC

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Bronchodilator Combinations

Lung Diseases

This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: umeclidinium and vilanterol. Both drugs work by relaxing the muscles around the airways in the lungs so they open up to make breathing easier. Umeclidinium belongs to a class of drugs known as anticholinergics, and vilanterol is a LABA medication (see also Warning section). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed.

Read the Medication Guide and the product instructions provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Inhale this medication by mouth as directed by your doctor, usually once daily. Do not open the cover of the inhaler until you are ready to use it. Each time you open the cover, you prepare a dose of the medication. If you open and close the cover without inhaling the medication, you will lose the dose. To avoid wasting a dose, do not close the cover until after you have inhaled the medication. You may or may not taste/feel the drug when you inhale. Do not exhale into the device. Use this medication regularly to get the most benefit from it. Use it at the same time every day. Do not use it more than one time each day. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication. If you have been using a quick-relief inhaler (such as albuterol, also called salbutamol in some countries) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath. Consult your doctor for details.

Tell your doctor right away if you have any serious side effects, including: shaking (tremor), nervousness, difficult/painful urination, muscle cramps/weakness, increased thirst/urination. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Infrequently, this medication may cause sudden, severe wheezing/trouble breathing immediately after you use it. If this happens, use your quick-relief inhaler and get medical help right away. Get medical help right away if you have any very serious side effects, including: chest pain, fast/irregular heartbeat, severe dizziness, fainting, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Do not use other anticholinergic drugs (such as ipratropium, tiotropium) or LABA drugs (such as formoterol, salmeterol) while using this medication.

Symptoms of overdose may include: shaking (tremor), chest pain, fast/irregular heartbeat, seizures. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Do not use more than one dose each day.

Store at room temperature away from light, heat, and moisture. Do not store in the bathroom. Do not open the sealed tray that the inhaler comes in until you are ready to use the new inhaler. Throw away the inhaler 6 weeks after first removing it from the tray or when the dose counter reads zero, whichever comes first. Keep all medications away from children and pets.