TRELEGY ELLIPTA is a dry powder inhaler containing a combination of three active ingredients: fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate. Fluticasone furoate is an inhaled corticosteroid (ICS), umeclidinium is an anticholinergic, and vilanterol is a long-acting beta agonist (LABA). The device administers these substances orally via inhalation in specified dosages for each component. Lactose monohydrate and magnesium stearate are among the key inactive ingredients. This medication is designed to deliver precise doses of these respiratory agents to the lungs, which may benefit patients with certain lung conditions.

How should I use this medication?

This medication is inhaled through the mouth. Rinse your mouth with water after use. Make sure not to swallow the water. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat, cold or humidity. Throw away 6 weeks after removing it from the foil pouch, when the dose counter reads "0" or after the expiration date, whichever is first.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -Increase in blood pressure -Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness -Muscle pain or cramps -Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss -Thrush—white patches in the mouth -Trouble passing urine -Wheezing or trouble breathing that is worse after use Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Change in taste -Cough -Dry mouth -Headache -Hoarseness -Sore throat -Tremors or shaking -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Diabetes -Eye disease -Heart disease -High blood pressure -Immune system problems -Infection -Irregular heartbeat or rhythm -Kidney disease -Osteoporosis, weak bones -Pheochromocytoma -Prostate disease -Seizures -Thyroid disease -Vision problems -An unusual or allergic reaction to fluticasone, umeclidinium, vilanterol, lactose, milk proteins, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dofetilide -Dronedarone -MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate -Pimozide -Thioridazine -Ziprasidone This medication may also interact with the following: -Aclidinium -Antihistamines for allergy -Antiviral medications for HIV or AIDS -Atropine -Beta-blockers like metoprolol and propranolol -Certain antibiotics like clarithromycin and telithromycin -Certain medications for bladder problems like oxybutynin, tolterodine -Certain medications for depression, anxiety, or psychotic disturbances -Certain medications for fungal infections like ketoconazole, itraconazole, posaconazole, voriconazole -Certain medications for Parkinson's disease like benztropine, trihexyphenidyl -Certain medications for stomach problems like dicyclomine, hyoscyamine -Certain medications for travel sickness like scopolamine -Conivaptan -Diuretics -Ipratropium -Medications for colds -Other medications for breathing problems -Other medications that prolong the QT interval (cause an abnormal heart rhythm) -Nefazodone -Tiotropium

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. NEVER use this medication for an acute asthma attack. You should use your short-acting rescue inhaler for an acute attack. If your symptoms get worse or if you need your short-acting inhalers more often, call your care team right away. This medication can worsen breathing or cause wheezing right after you use it. Be sure you have a short-acting inhaler for acute attacks (wheezing) nearby. If this happens, stop using this medication right away and call your care team. This medication may increase the risk of serious asthma-related problems. Talk to your care team if you have questions. Do not treat yourself for coughs, colds or allergies without asking your care team for advice. Some nonprescription medications can affect this one. You and your care team should develop an Asthma Action Plan that is just for you. Be sure to know what to do if you are in the yellow (asthma is getting worse) or red (medical alert) zones. If you are going to need surgery or other procedure, tell your care team that you are using this medication. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team if changes in diet or medications are needed.