fluticasone and vilanterol

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Pronunciation: floo TIK a sone and vye LAN ter ol

Brand: Breo Ellipta

What is the most important information I should know about fluticasone and vilanterol?

You should not use this medicine if you are allergic to fluticasone, vilanterol, or milk proteins.

Fluticasone and vilanterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known.

What is fluticasone and vilanterol?

Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Vilanterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Fluticasone and vilanterol is a once-daily combination medicine used in adults with asthma or COPD (chronic obstructive pulmonary disease), to improve symptoms and prevent bronchospasm or asthma attacks.

In people with COPD, fluticasone and vilanterol is for long-term treatment. In people with asthma, this medicine is for short-term treatment until symptoms are well-controlled with with other medicines.

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine.

Fluticasone and vilanterol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using fluticasone and vilanterol?

You should not use this medicine if you are allergic to fluticasone, vilanterol, or milk proteins.

Fluticasone and vilanterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if it seems like your asthma medications don't work as well.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure fluticasone and vilanterol is safe for you, tell your doctor if you have:

  • a weak immune system;
  • heart disease, high blood pressure;
  • liver disease;
  • glaucoma or cataracts;
  • a thyroid disorder;
  • seizures;
  • diabetes;
  • any type of infection, including tuberculosis or herpes infection of the eyes; or
  • a personal or family history of osteoporosis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether fluticasone and vilanterol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use fluticasone and vilanterol?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The usual dose of this medicine is 1 inhalation per day. Use the medicine at the same time each day, and not more than once in a 24-hour period.

Tell your doctor if any of your medicines seem to stop working as well in controlling your symptoms.

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

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using your inhaler. Do not swallow.

If you also use another steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

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.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

While using fluticasone and vilanterol, your vision and your bone mineral density may need to be checked often.

Your doctor will need to check your lung function on a regular basis. Once your asthma is under control, your doctor may want you to stop using fluticasone and vilanterol. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using fluticasone and vilanterol?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

What are the possible side effects of fluticasone and vilanterol?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medication;
  • chest pain, shortness of breath, tremors, nervousness;
  • feeling very weak or tired, nausea and vomiting, feeling like you might pass out;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • fever, chills, cough with yellow or green mucus;
  • sores or white patches in your mouth and throat, pain when swallowing;
  • low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling; or
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

  • headache; or
  • runny or stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect fluticasone and vilanterol?

Many drugs can interact with fluticasone and vilanterol. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with fluticasone and vilanterol, especially:

  • antifungal medicine such as ketoconazole;
  • ritonavir or other HIV/AIDS medicine; or
  • heart medication--atenolol, carvedilol, metoprolol, nebivolol, and others.

This list is not complete and many other drugs can interact with fluticasone and vilanterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about fluticasone and vilanterol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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