Arnuity Ellipta

Read the Patient Information Leaflet and the Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Inhale this medication by mouth as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.

Inhale each dose deeply to get the drug into your lungs. You may or may not taste/feel the drug when you inhale. Either is normal. Do not breathe out (exhale) into the inhaler device.

If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug (the corticosteroid) last.

To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.

Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same time each day. Do not increase your dose, use this drug more often, or stop using it without first consulting your doctor.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin using fluticasone. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.

It may take up to 2 weeks or longer before you get the full benefit of this drug. Tell your doctor if your symptoms do not improve or if they worsen.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

See also Precautions section.

Dry/irritated throat, hoarseness, or coughing may occur as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: white patches in your mouth or on your tongue, signs of infection (such as sore throat that doesn't go away, fever, chills), mental/mood changes (such as depression, mood swings, agitation), vision problems, increased thirst/urination, easy bruising/bleeding, bone pain.

Rarely, this medication may cause sudden severe wheezing/trouble breathing immediately after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.

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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using fluticasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), bone loss (osteoporosis), eye problems (such as cataracts, glaucoma), liver disease.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

This medication may temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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.

A product that may interact with this drug is: desmopressin.

Other medications can affect the removal of fluticasone from your body, which may affect how fluticasone works. Examples include some azole antifungals (such as ketoconazole), HIV protease inhibitors (such as lopinavir), ritonavir, among others.

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. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as cortisol levels, lung function, eye exams, bone density tests) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range or increased use of quick-relief inhalers).

Avoid allergens/irritants such as smoke, pollen, pet dander, dust, or molds that may worsen breathing problems. Because the flu virus can also worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

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. Use your next dose at the regular time. Do not double the dose to catch up.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not remove the inhaler from its original foil package until ready to use. Discard this product 6 weeks after opening the foil tray or when the dose counter reads zero, whichever comes first. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).