Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier.

This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Use Arnuity Ellipta exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Arnuity Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

Arnuity Ellipta is a powder form of fluticasone that come with a special inhaler device preloaded with blister packs containing measured doses of fluticasone. The device opens and loads a blister of fluticasone each time you use the inhaler. The disk device is not to be used with a spacer. Follow the patient instructions provided with your medicine.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

To reduce the chance of developing a yeast infection in your mouth, rinse with water (but do not swallow) after using this medicine. Pay special attention to your dental hygiene. Fluticasone can cause cavities or tooth discoloration.

If you switched to Arnuity Ellipta from an oral (taken by mouth) steroid, you should not stop using the steroid suddenly. Follow your doctor's instructions about tapering your dose. You may need to restart the oral steroid medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

Seek medical attention if you think any of your asthma medications are not working as well as usual.

Your doctor will need to check your progress while you are using Arnuity Ellipta. Your vision may also need to be checked at regular intervals.

Call your doctor if your symptoms do not improve after 2 weeks of treatment, or if symptoms get worse. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

You should not stop using Arnuity Ellipta suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture, heat, and light.

Store Arnuity Ellipta in the unopened foil tray until ready to use. Throw away any unused medicine 6 weeks after you open the foil tray or when the counter on your inhaler device shows "0", whichever comes first.

Arnuity Ellipta is not a rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

You should not use the inhalation powder if you are allergic to milk proteins.

Before taking this medicine

• You should not use Arnuity Ellipta if you are allergic to fluticasone or to milk proteins.
• Do not use Arnuity Ellipta to treat an asthma attack that has already begun.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• any type of infection (bacterial, viral, or fungal);
• glaucoma or cataracts;
• an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);
• tuberculosis;
• herpes infection of the eyes;
• liver disease;
• low bone mineral density; or
• a weak immune system.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether fluticasone will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using fluticasone inhalation. Ask your doctor about any risk.

Arnuity Ellipta is not approved for anyone younger than 5 years old.

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

Remember that your doctor has prescribed this medication because he or she 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 fever, chills, persistent sore throat), mental/mood changes (such as depression, mood swings, agitation), vision problems, increased thirst/urination, easy bruising/bleeding, bone pain.

Infrequently, 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.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bone problems
• eye disease, vision problems
• immune system problems
• infection, like chickenpox, tuberculosis, herpes, or fungal infection
• recent surgery or injury of mouth or throat
• taking corticosteroids by mouth
• an unusual or allergic reaction to fluticasone, steroids, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use Arnuity Ellipta?

This medicine is for inhalation through the mouth. Rinse your mouth with water after use. Make sure not to swallow the water. Follow the directions on your prescription label. Do not use with a spacer device. Do not use more often than directed. Make sure that you are using your inhaler correctly. Ask you doctor or health care provider if you have any questions.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, use only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.

What may interact with Arnuity Ellipta?

• antiviral medicines for HIV or AIDS
• certain antibiotics like clarithromycin and telithromycin
• certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, voriconazole
• conivaptan
• ketoconazole
• nefazodone