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Fluticasone (Inhalation) (Aerosol Powder, Powder, Disk)

(ARNUITY ELLIPTA)
Fluticasone (By breathing)
Fluticasone (floo-TIK-a-sone)Prevents asthma attacks. This medicine is a corticosteroid.
Arnuity Ellipta , Flovent Diskus , Flovent HFA

When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to fluticasone or while you are having an asthma attack. Do not use Arnuity™ Ellipta® or Flovent® Diskus® if you are allergic to milk proteins.

How to Use This Medicine:
Powder Under Pressure, Powder, Disk

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions. Your doctor or pharmacist should also show you how to use the inhaler.
  • Do not breathe into the inhaler. To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright. Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down on the top of the canister once.
  • Hold your breath for about 5 to 10 seconds, and then breathe out slowly.
  • When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water.
  • Arnuity™ Ellipta®:
    • Do not shake the inhaler. When you are ready to use the medicine, open the cover of the inhaler. You should hear a click, and the dose counter number will change. This means the medicine is ready.
    • The dose counter will turn red when the inhaler has fewer than 10 doses. Stop using the inhaler when the counter reaches 0, or 6 weeks after you open the package, whichever comes first.
  • Flovent® HFA:
    • Before you use the inhaler for the first time, point it away from your face and test spray into the air 4 times. Shake the inhaler before each spray. Test spray 1 time if the inhaler has not been used for 7 days or if it has been dropped.
    • When the dose counter reaches 020, you will need a refill soon. Stop using the inhaler when it reaches 0.
  • Flovent® Diskus®:
    • To use the inhaler, hold it level and push the lever away from you. You should hear a click and see the mouthpiece. The dose counter number should change.
    • When you are finished, slide the lever back into place until it clicks. The dose counter will turn red when you have 5 or fewer doses left.
    • Do not use a spacer device with the inhaler. Do not wash the inhaler.
  • Missed dose:Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not use more than 1 dose of Arnuity™ Ellipta® in 1 day.
  • Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty. Store the medicine at room temperature in a dry place, away from heat, moisture, or light. Store the Flovent® HFA inhaler with the mouthpiece down.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Some foods and medicines can affect how fluticasone works. Tell your doctor if you are using clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, or voriconazole.

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, osteoporosis, cataracts, or glaucoma.
  • This medicine will not stop an asthma attack that has already started. You should have another medicine to use in case of an acute asthma attack.
  • This medicine may cause the following problems:
    • Increased trouble breathing right after use (paradoxical bronchospasm)
    • Low bone mineral density, which may lead to osteoporosis
    • Cataracts, glaucoma, or other vision problems
    • Slow growth in children
    • Problems with the adrenal glands
  • This medicine may weaken your immune system and increase your risk for infections, including fungus infection in the mouth (thrush). Tell your doctor if you have any immune system problems or infections, including herpes simplex in your eye or tuberculosis. Tell your doctor right away if you are exposed to measles or chickenpox.
  • If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
  • You may need to use this medicine for 1 to 2 weeks before your asthma starts to get better. Call your doctor if your symptoms do not improve or if they get worse.
  • Tell any doctor or dentist who treats you that you are using this medicine.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Color changes on the skin, dark freckles, easy bruising, muscle weakness, round or puffy face
  • Eye pain or vision changes
  • Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
  • Sores or white patches in your mouth or throat, pain when eating or swallowing
  • Tiredness, weakness, nausea and vomiting, dizziness
  • Worsening of breathing problems

If you notice these less serious side effects, talk with your doctor:

  • Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088