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Fluticasone and Vilanterol

Generic Name: Fluticasone and Vilanterol (floo TIK a sone & VYE lan ter ol)
Brand Name: Breo Ellipta

  • In people with asthma, long-acting puffers (inhalers) like fluticasone and vilanterol raise the chance of asthma-related deaths. Talk with the doctor.
  • Long-acting puffers (inhalers) like this medicine may raise the chance of asthma-related hospital stays in children and teens. Talk with the doctor.
  • Do not use fluticasone and vilanterol to treat asthma if your asthma is well controlled by a long-term asthma-control drug alone.

Uses of Fluticasone and Vilanterol:

  • It is used to treat COPD (chronic obstructive pulmonary disease).
  • It is used to treat asthma.
  • This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Fluticasone and Vilanterol?

  • If you have an allergy to fluticasone, vilanterol, 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 are allergic to milk, talk with the doctor.
  • If you are using another drug like this one.

This is not a list of all drugs or health problems that interact with fluticasone and vilanterol.

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 this medicine 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 Fluticasone and Vilanterol?

  • Tell all of your health care providers that you take fluticasone and vilanterol. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have high blood sugar (diabetes), this medicine may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
  • 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.
  • There may be a higher chance of very bad and sometimes deadly heart problems like a heartbeat that does not feel normal with high doses of fluticasone and vilanterol. Do not take more than you are told.
  • Some people who take this medicine may have a higher chance of getting pneumonia. The chance of having to go to the hospital for pneumonia may also be higher. Some cases have been deadly. Talk with the 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 an eye exam as you have been told by 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.
  • 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 fluticasone and vilanterol. 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.
  • This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • This medicine is not approved for use in children. 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 this medicine 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 (Fluticasone and Vilanterol) best taken?

Use fluticasone and vilanterol 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.
  • For breathing in only.
  • Take this medicine at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Keep using fluticasone and vilanterol as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not take out the inhaler from the foil tray until right before first use.
  • Close the device after each dose. Do not open the device unless a dose is being used.
  • Do not take the device apart or wash it. Do not use it with a spacer. Do not breathe out into the device.
  • If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
  • 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.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.

See also: Dosage Information (in more detail)

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 high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Bone pain.
  • Very upset stomach or throwing up.
  • Feeling nervous and excitable.
  • Shakiness.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Redness or white patches in mouth or throat.
  • Feeling very tired or weak.
  • 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 Fluticasone and Vilanterol?

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.
  • Runny nose.
  • Nose or throat irritation.
  • Mouth irritation.
  • Signs of a common cold.
  • Flu-like signs.
  • Change in voice.
  • Back pain.
  • Joint pain.

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.

See also: Side effects (in more detail)

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 Fluticasone and Vilanterol?

  • Store at room temperature.
  • Protect from heat.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • After opening, throw away any part not used after 6 weeks or when the indicator reads zero, whichever comes first.
  • 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.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time fluticasone and vilanterol is refilled. If you have any questions about this medicine, please talk with the doctor, 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 fluticasone and vilanterol 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 fluticasone and vilanterol. 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: September 6, 2017

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