Fluticasone, umeclidinium, and vilanterol are used in combination to treat chronic obstructive pulmonary disease (COPD), a set of conditions that affect the lungs and airways and include chronic bronchitis and emphysema. COPD is characterized by wheezing, shortness of breath, coughing, and chest tightness. Adults can also take it to manage asthma-related chest tightness, coughing, wheezing, and shortness of breath. Fluticasone belongs to the group of drugs known as steroids. Anticholinergics are a class of drugs that includes umeclidinium. Vilanterol belongs to the group of drugs known as long-acting beta-agonists (LABAs). The interaction of fluticasone, umeclidinium, and vilanterol eases breathing by relaxing and widening airways in the lungs.

Fluticasone, umeclidinium, and vilanterol are available as a powder to be inhaled by mouth with a unique inhaler. Typically, it is breathed in once daily. At about the same time each day, inhale vilanterol, umeclidinium, and fluticasone. Ask your doctor or pharmacist to explain any instructions on your prescription label that you do not understand, and carefully follow their instructions. Use it only as directed by your doctor, neither more nor less often.

During a sudden COPD or asthma attack, avoid using the inhalation medications fluticasone, umeclidinium, and vilanterol. A short-acting (rescue) inhaler will be recommended by your doctor for usage during COPD or asthma attacks.

Inhaling fluticasone, umeclidinium, and vilanterol does not treat COPD or asthma; rather, it regulates it. Even if you feel fine, keep taking fluticasone, umeclidinium, and vilanterol. Without consulting your doctor, do not discontinue taking vilanterol, umeclidinium, or fluticasone. Your symptoms can come back if you stop using fluticasone, umeclidinium, and vilanterol inhalation.

Read the enclosed written instructions before using fluticasone, umeclidinium, and vilanterol inhalation for the first time. You should request instructions on using the inhaler from your physician, pharmacist, or respiratory therapist. While they are watching you, practice using your inhaler.

Do not swallow the water after rinsing your mouth with it after inhaling; instead, spit it out.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before using fluticasone, umeclidinium, and vilanterol,

• Inform your doctor and pharmacist if you have any allergies to fluticasone (Flonase, Flovent), umeclidinium (Incruse Ellipta, in Anoro Ellipta), vilanterol (in Anoro Ellipta, in Breo Ellipta), other medications, milk protein, or any other components of fluticasone, umeclidinium, and vilanterol oral inhalation. For a list of the ingredients, consult the Medication Guide or speak to your pharmacist.
• Indacaterol (Arcapta), formoterol (Perforomist, in Dulera), arformoterol (Brovana), or salmeterol (in Advair, Serevent) are a few examples of other LABAs that you should mention to your doctor if you use them. Fluticasone, umeclidinium, and vilanterol inhalation should not be taken with these drugs. Which medications you should take and which ones you should quit taking will be determined by your doctor.
• If you use another LABA, such as arformoterol (Brovana), formoterol (Perforomist, in Dulera), indacaterol (Arcapta), or salmeterol (Advair, Serevent), let your doctor know. The inhalation of fluticasone, umeclidinium, and vilanterol should not be combined with the usage of these drugs. The medications you should take and cease taking will be prescribed to you by your doctor.
• Inform your doctor and pharmacist about all of the vitamins, nutritional supplements, herbal items, and prescription and non-prescription medications you are using. Any of the following should be mentioned: antifungals as voriconazole (Vfend), ketoconazole (Nizoral), and itraconazole (Onmel, Sporanox); antihistamines; atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal, Innopran) are examples of beta-blockers. Atropine (in Lomotil, Motofen) is another; diuretics (‘water pills’); HIV protease inhibitors as indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); clarithromycin (Biaxin); conivaptan (Vaprisol); nefazodone; telithromycin (Ketek); additional COPD medications such as aclidinium (Tudorza Pressair), ipratropium (Atrovent HFA), and tiotropium (Spiriva); drugs for irritable bowel syndrome, motion sickness, Parkinson’s disease, ulcers, or urinary issues; as well as troleandomycin (TAO). Additionally, let your physician and pharmacist know if you are currently taking any of the following drugs or have recently stopped taking any of them: the use of antidepressants such amitriptyline, amoxapine, nortriptyline (Pamelor), protriptyline (Vivactil), imipramine (Tofranil), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors, such as tranylcypromine (Parnate), selegiline (Eldepryl, Emsam), phenelzine (Nardil), isocarboxazid (Marplan), and phenelzine. Fluticasone, umeclidinium, and vilanterol may also interact with numerous other drugs. As a result, it is important to inform your doctor about all of the drugs you are taking, even ones that are not on this list. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
• Inform your physician if you have or have ever had osteoporosis (a condition in which the bones become brittle and weak), high blood pressure, irregular heartbeat, seizures, hyperthyroidism (a condition in which the body produces too much thyroid hormone), diabetes, glaucoma (an eye disease), cataracts (clouding of the eyes’ lens), tuberculosis (TB), any condition that affects your immune system, prostate, or bladder. If you have pneumonia, herpes eye infection, or any other infection, let your doctor know as well.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while using fluticasone, umeclidinium, or vilanterol.
• Inform the surgeon or dentist that you are taking fluticasone, umeclidinium, and vilanterol if you are having surgery, including dental surgery.
• If you have never had chickenpox or measles and have not had a vaccination against these diseases, let your doctor know. Avoid sick people, especially those who have the measles or chickenpox. Call your doctor right once if you are exposed to these infections or if you start to experience their symptoms. To safeguard yourself against certain infections, you might need to receive a vaccine (shot).

Keep eating normally unless your doctor instructs you otherwise.

The missed dose should be taken as soon as you remember. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. Never use more than one dose per day, and never take two doses at once to make up for missing ones.

There could be negative effects from using fluticasone, umeclidinium, or vilanterol. If any of these symptoms are severe or do not go away, consult your doctor:

• Nervousness
• Shaking of a body part that you are unable to control
• Congestion or a sore throat
• Taste varies
• Backache

Some adverse effects can be very harmful. Call your doctor right away if you suffer any of the following adverse effects, or seek emergency medical attention:

• Hives
• Rash
• Face, throat, or tongue swelling
• Rapid heartbeat or erratic heartbeat
• Chest ache
• The onset of chest tightness, wheezing, or coughing after inhaling the medicine
• Experiencing fatigue, a loss of strength, nausea, vomiting, or energy
• Urinating with difficulty, in a feeble stream, or in drips
• Uncomfortable or frequent urination
• Throat or mouth white patches
• Fever, chills, or other infection-related symptoms
• Cough, breathing issues, or a change in the hue of sputum (the mucus you may cough up)

The use of fluticasone, umeclidinium, and vilanterol may make you more likely to develop cataracts or glaucoma. During the course of your treatment with fluticasone, umeclidinium, and vilanterol, you’ll probably need to have regular eye exams. Inform your doctor if you experience any of the following vision changes: blurred vision, seeing haloes or bright colors around lights; or eye pain, redness, or discomfort. During your course of fluticasone, umeclidinium, and vilanterol therapy, you’ll probably need to have routine bone assessments and eye examinations.

Your risk of developing osteoporosis may increase if you take fluticasone, umeclidinium, or vilanterol. Discuss the dangers of using this drug with your doctor.

Other side effects could be brought on by vilanterol, umeclidinium, and fluticasone. If you experience any strange issues while taking this drug, call your doctor right away.

Keep this medication out of children’s reach and tightly closed in the foil tray it was packaged in. It should not be kept in the bathroom. Store it at room temperature away from sunshine, excessive heat, and moisture. After removing the inhaler from the foil overwrap and after each blister has been used (when the dose indicator displays 0), or six weeks later, whichever comes first, dispose of it.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the best way to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

• Seizures
• Chest pain
• Breathing difficulty
• Dizziness
• Hammering, rapid, or erratic heartbeat
• Nervousness
• Headache
• Region of your body that you are unable to control shakes
• Weak or cramping muscles
• Mouth ache
• Nausea
• Extreme fatigue
• Having trouble falling or staying asleep

Keep all of your doctor’s appointments.

Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.