Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation

The combination of fluticasone, umeclidinium, and vilanterol is used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Fluticasone is in a class of medications called steroids. Umeclidinium is in a class of medication called anticholinergics. Vilanterol is in a class of medications called long-acting beta-agonists (LABAs). The combination of fluticasone, umeclidinium, and vilanterol works by relaxing and opening air passages in the lungs, making it easier to breathe.

Unless your doctor tells you otherwise, continue your normal diet.

Inhale the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use more than one dose in a day and do not inhale a double dose to make up for a missed one.

Fluticasone, umeclidinium, and vilanterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nervousness
• shaking of a part of your body that you cannot control
• runny nose, sore throat
• taste changes
• back pain

Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• swelling of the face, throat, or tongue
• pounding fast, or irregular heartbeat
• chest pain
• coughing, wheezing, or chest tightness that begins after you inhale the medication
• feeling tired, weakness, nausea, vomiting, or lack of energy
• eye pain, redness, or discomfort, blurred vision, or seeing halos or bright colors around lights
• difficulty urinating or urinating in a weak stream or drips
• frequent or painful urination
• white patches in the mouth or throat
• fever, chills, or other signs of infection
• cough, difficulty breathing, or change in the color of sputum (the mucus you may cough up)

Fluticasone, umeclidinium, and vilanterol may increase the risk that you will develop glaucoma, cataracts, or osteoporosis. You will probably need to have regular eye exams and bone tests during your treatment with fluticasone, umeclidinium, and vilanterol.

Fluticasone, umeclidinium, and vilanterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Keep this medication in the foil tray it came in, tightly closed, and out of reach of children. Store it at room temperature and away from sunlight, excess heat and moisture (not in the bathroom). Dispose of the inhaler 6 weeks after you remove it from the foil overwrap or after every blister has been used (when the dose indicator reads 0), whichever comes first.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

• Trelegy Ellipta^®(as a combination product containing Fluticasone, Umeclidinium, Vilanterol)