Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation

WHY is this medicine prescribed?

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). It is also used in adults to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma. 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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of fluticasone, umeclidinium, and vilanterol comes as a powder to inhale by mouth using a special inhaler. It is usually inhaled once a day. Inhale fluticasone, umeclidinium, and vilanterol at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part that you do not understand. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use fluticasone, umeclidinium, and vilanterol inhalation during a sudden COPD or asthma attack. Your doctor will prescribe a short acting (rescue) inhaler to use during COPD or asthma attacks.

Fluticasone, umeclidinium, and vilanterol inhalation controls COPD or asthma but does not cure it. Continue to use fluticasone, umeclidinium, and vilanterol even if you feel well. Do not stop using fluticasone, umeclidinium, and vilanterol without talking to your doctor. If you stop using fluticasone, umeclidinium, and vilanterol inhalation, your symptoms may return.

Before you use fluticasone, umeclidinium, and vilanterol inhalation for the first time, read the written instructions that come with it. Ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while they watch you.

After inhalation, rinse your mouth with water and spit the water out; do not swallow the water.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using fluticasone, umeclidinium, and vilanterol,

• tell your doctor and pharmacist if you are allergic to fluticasone (Flonase, Flovent), umeclidinium (Incruse Ellipta, in Anoro Ellipta), vilanterol (in Anoro Ellipta, in Breo Ellipta), any other medications, milk protein, or any other ingredients in fluticasone, umeclidinium, and vilanterol oral inhalation. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you use another LABA such as arformoterol (Brovana), formoterol (Perforomist, in Dulera), indacaterol (Arcapta), or salmeterol (in Advair, Serevent). These medications should not be used along with fluticasone, umeclidinium, and vilanterol inhalation. Your doctor will tell you which medication you should use and which medication you should stop using.

• tell your doctor if you use another LABA such as arformoterol (Brovana), formoterol (Perforomist, in Dulera), indacaterol (Arcapta), or salmeterol (in Advair, Serevent). These medications should not be used along with fluticasone, umeclidinium, and vilanterol inhalation. Your doctor will tell you which medication you should use and which medication you should stop using.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); antihistamines; atropine (in Lomotil, Motofen); beta-blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal, Innopran); clarithromycin (Biaxin); conivaptan (Vaprisol); diuretics ('water pills'); HIV protease inhibitors such as indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); other medications for COPD including aclidinium (Tudorza Pressair), ipratropium (Atrovent HFA), and tiotropium (Spiriva); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; nefazodone; telithromycin (Ketek; no longer available in U.S.); and troleandomycin (TAO; no longer available in the U.S.). Also tell your doctor and pharmacist if you are taking the following medications or have stopped taking them during the past 2 weeks: antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate). Many other medications may also interact with fluticasone, umeclidinium, and vilanterol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become weak and fragile), and if you have or have ever had high blood pressure, irregular heartbeat, seizures, hyperthyroidism (condition in which there is too much thyroid hormone in the body), diabetes, glaucoma (an eye disease), cataracts (clouding of the lens of the eyes), tuberculosis (TB), any condition that affects your immune system, prostate or bladder problems, or heart or liver disease. Also tell your doctor if you have a herpes eye infection, pneumonia, or any other type of infection.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using fluticasone, umeclidinium, and vilanterol, call your doctor.

• tell your doctor if you have never had chickenpox or measles and have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to these infections or if you develop symptoms of these infections, call your doctor immediately. You may need to get a vaccine (shot) to protect you from these infections.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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 or 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
• 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 or cataracts. You will probably need to have regular eye exams during your treatment with fluticasone, umeclidinium, and vilanterol. Tell your doctor if you have any of the following: pain, redness, or discomfort of the eyes; blurred vision; seeing halos or bright colors around lights; or any other changes in vision. 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 increase your risk of developing osteoporosis. Talk to your doctor about the risks of using this medication.

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

What should I know about STORAGE and DISPOSAL of 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.

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

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• seizures
• chest pain
• shortness of breath
• dizziness
• fast, pounding, or irregular heartbeat
• nervousness
• headache
• shaking of a part of your body that you cannot control
• muscle cramps or weakness
• dry mouth
• nausea
• excessive tiredness
• difficulty falling asleep or staying asleep

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.