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Breo Ellipta is prescribed to manage and prevent symptoms (such as shortness of breath and wheezing) caused by chronic lung disease (chronic obstructive lung disease-COPD, including persistent bronchitis and emphysema). This inhaler contains 2 medical ingredients: fluticasone and vilanterol. Fluticasone is a part of a class of drugs known as corticosteroids. It functions by diminishing the inflammation of the airways in the lungs to make breathing more comfortable. Vilanterol is classified as a long-acting beta agonist. It opens airways to make breathing easier.
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Notice: The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Consult your doctor, nurse, or pharmacist before following any medical regiment to ensure it is safe and effective for you.
See also Precautions section. Headache, dry/irritated throat, hoarseness, runny nose, and 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, weakness, puffy face, unusual weight gain, slow wound healing, thinning skin, bone pain, menstrual period changes, mental/mood changes (such as depression, nervousness, mood swings, agitation), easy bruising/bleeding, increased thirst/urination, vision problems, muscle cramps, shaking (tremor), signs of infection (such as sore throat that doesn’t go away, fever, chills, cough). Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting, chest pain.
Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing, 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.
Before using this medication, tell your doctor or pharmacist if you are allergic to fluticasone or vilanterol; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, bone loss (osteoporosis), depression, diabetes, eye problems (such as cataracts, glaucoma), heart problems (such as angina, irregular heartbeat), any recent infection, liver problems, overactive thyroid (hyperthyroidism), seizures.
Fluticasone/vilanterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using fluticasone/vilanterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation.
This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluticasone/vilanterol safely. If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss.
This medication may slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Other medications can affect the removal of fluticasone from your body, which may affect how fluticasone works. Examples include boceprevir, HIV protease inhibitors (such as lopinavir, ritonavir), some azole antifungals (such as ketoconazole), among others.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets. Do not remove the inhaler from its original foil package until ready to use.
Discard the inhaler 6 weeks after you remove it from the original foil package or when the counter reads “0,” whichever is sooner. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
FLUTICASONE/VILANTEROL POWDER INHALER – ORAL