Umeclidinium and Vilanterol Oral Inhalation

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

The combination of umeclidinium and vilanterol comes as a powder to inhale by mouth using a special inhaler. It is usually inhaled once a day. Inhale 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 you do not understand. Use umeclidinium and vilanterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use umeclidinium and vilanterol inhalation to treat sudden attacks of COPD. Your doctor will prescribe a short-acting beta agonist medication such as albuterol (Accuneb, Proair, Proventil, Ventolin) to use during attacks. If you were using this type of medication on a regular basis before you began treatment with umeclidinium and vilanterol, your doctor will probably tell you to stop using it regularly but to continue to use it to treat attacks.

Umeclidinium and vilanterol inhalation should not be used to treat COPD that is quickly getting worse. Call your doctor or get emergency medical help if your breathing problems worsen, if you have to use your short-acting inhaler to treat attacks of COPD more often, or if your short-acting inhaler does not relieve your symptoms.

Umeclidinium and vilanterol inhalation controls COPD but does not cure it. Continue to use umeclidinium and vilanterol even if you feel well. Do not stop using umeclidinium and vilanterol without talking to your doctor. If you stop using umeclidinium and vilanterol inhalation, your symptoms may get worse.

Before you use umeclidinium and vilanterol inhalation for the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches.

To use the inhaler, follow these steps:

1. If you will be using a new inhaler for the first time, remove it from the box and the foil tray. Fill in the "Tray opened" and "Discard" blanks on the inhaler label with the date that you opened the tray and the date 6 weeks later when you must replace the inhaler.
2. When you are ready to inhale your dose, slide the cover down to expose the mouthpiece until it clicks. If you open and close the inhaler without using your dose, you will waste the medication.
3. The counter will count down by 1 each time you open the cover. If the counter does not count down, your inhaler will not provide the medicine. If your inhaler does not count down, call your pharmacist or doctor.
4. Hold the inhaler away from your mouth and breathe out as completely as possible through your mouth. Do not breathe out into the mouthpiece.
5. Put the mouthpiece between your lips, and close your lips firmly around it. Take a long, steady, deep breath in through your mouth. Do not breathe in through your nose. Be careful not to block the air vent with your fingers.
6. Remove the inhaler from your mouth, and hold your breath for about 3 to 4 seconds or as long as you comfortably can. Breathe out slowly.
7. You may or may not taste or feel the medicine released by the inhaler. Even if you do not, do not inhale another dose. If you are not sure you are getting your dose of umeclidinium and vilanterol, call your doctor or pharmacist.
8. You may clean the mouthpiece with a dry tissue, if needed. Slide the cover up over the mouthpiece as far as it will go to close the inhaler.

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

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

Before using umeclidinium and vilanterol,

• tell your doctor and pharmacist if you are allergic to umeclidinium, vilanterol, any other medications, milk protein, or any of the ingredients in umeclidinium and vilanterol inhalation. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have asthma. Your doctor will tell you not to use umeclidinium and vilanterol unless you are using it along with an inhaled steroid medication.
• tell your doctor if you have or have ever had high blood pressure, irregular heartbeat, QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), seizures, diabetes, glaucoma (an eye disease), urinary retention (difficulty urinating), prostate or bladder problems, or heart, thyroid, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using umeclidinium and vilanterol, call your doctor.
• you should know that umeclidinium and vilanterol inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, call your doctor right away. Do not use umeclidinium and vilanterol inhalation again unless your doctor tells you that you should.

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.

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

• shaking of a part of your body that you cannot control
• nervousness
• runny nose, sore throat
• constipation
• diarrhea
• pain in your arms or legs
• muscle spasms
• neck pain

Some side effects can be serious. If you experience any of these symptoms, stop using umeclidinium and vilanterol and call your doctor immediately or get emergency medical treatment:

• rash; hives; itching; trouble breathing; or swelling of the face, mouth, or tongue
• pounding, fast, or irregular heartbeat
• chest pain
• eye pain, redness, or discomfort; blurred vision; seeing halos or bright colors around lights, sometimes along with nausea and vomiting
• difficulty urinating or urinating in a weak stream or drips
• frequent or painful urination

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

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 tray or after every blister has been used (when the dose counter 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 (https://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. https://www.upandaway.org

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
• dry skin
• nausea
• dizziness
• excessive tiredness
• difficulty falling asleep or staying asleep
• blurred vision
• dilated pupils
• seeing things or hearing voices that do not exist (hallucinating)

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using umeclidinium and vilanterol.

Do not let anyone else take 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.

• Anoro Ellipta^® (containing umeclidinium, vilanterol)