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Arnuity Ellipta

Generic Name: Fluticasone Inhalation Powder (floo TICK ah ZONE)
Brand Name: Arnuity Ellipta, Flovent Diskus

Uses of Arnuity Ellipta:

  • It is used to treat asthma.
  • Do not use Arnuity Ellipta (fluticasone inhalation powder) to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

What do I need to tell my doctor BEFORE I take Arnuity Ellipta?

  • If you have an allergy to fluticasone or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Arnuity Ellipta, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this medicine. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with Arnuity Ellipta.
  • If you have a milk allergy.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Arnuity Ellipta with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Arnuity Ellipta?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
  • It may take a few weeks to see the full effect.
  • If you have been taking Arnuity Ellipta for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like Arnuity Ellipta. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
  • When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
  • Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
  • Have your eye pressure checked if you are on this medicine for a long time. Talk with your doctor.
  • This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Arnuity Ellipta while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Arnuity Ellipta) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to use as you have been told by the doctor or read the package insert.
  • To gain the most benefit, do not miss doses.
  • Keep using Arnuity Ellipta (fluticasone inhalation powder) as you have been told by your doctor or other health care provider, even if you feel well.
  • Use this medicine at the same time of day.
  • For breathing in only.
  • Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
  • Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
  • If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
  • Do not prepare a dose until you need to take it. If you prepare a dose and close the inhaler without taking a dose, it will waste the drug and may damage the inhaler.
  • Do not breathe out into the puffer (inhaler). Close the inhaler after you use your dose.
  • Do not take the device apart or wash it. Do not use it with a spacer. Do not breathe out into the device.
  • Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
  • Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped Arnuity Ellipta.
  • Flushing.
  • Redness or white patches in mouth or throat.
  • Bone or joint pain.
  • Change in eyesight.
  • Trouble speaking.
  • This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using this medicine, use a rescue inhaler and get medical help right away.

What are some other side effects of Arnuity Ellipta?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Nose and throat irritation.
  • Flu-like signs.
  • Runny nose.
  • Nose stuffiness.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Arnuity Ellipta?

  • Store at room temperature. Do not freeze.
  • Store in foil until ready for use. Be sure you know how long this brand of Arnuity Ellipta is good for after opening the foil. Throw away the inhaler after this amount of time or when the indicator reads zero, whichever comes first.
  • Protect from heat.
  • Protect from light.
  • Protect from cold.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Arnuity Ellipta or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Arnuity Ellipta. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: December 6, 2017

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