Umeclidinium and vilanterol

Umeclidinium and vilanterol is a combination medicine that helps prevent airflow blockage and decrease flare-ups in adults with COPD (chronic obstructive pulmonary disease), which includes bronchitis and emphysema.

Umeclidinium and vilanterol is only for people with COPD and should not be used for treating asthma.

Umeclidinium and vilanterol may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed.

Umeclidinium and vilanterol is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use the medicine at the same time each day, and not more than once in a 24-hour period.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the inhaler away 6 weeks after opening, or when the dose indicator shows a zero (whichever comes first).

You should not use umeclidinium and vilanterol if you are allergic to umeclidinium or vilanterol, or if you have a severe allergy to milk proteins.

Umeclidinium and vilanterol is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

You should not use this medicine if you are allergic to umeclidinium or vilanterol, or if you have a severe allergy to milk proteins.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• liver disease;
• glaucoma;
• diabetes;
• a thyroid disorder; or
• an enlarged prostate or urination problems.

Tell your doctor if you are pregnant or breastfeeding.

Umeclidinium and vilanterol is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Umeclidinium and vilanterol may lead to serious side effects. Contact your doctor immediately if you experience:

• wheezing, choking, or other breathing issues after using this medicine;
• painful or hard urination, or urinating more often;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• high blood sugar--increased thirst or urination, hunger, dry mouth, fruity breath odor; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or feeling limp.

Common side effects of umeclidinium and vilanterol may include:

• stuffy nose, sinus pain, sore throat;
• chest pain, cough;
• diarrhea, constipation;
• muscle spasms; or
• pain in your neck, arms, or legs.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

One inhalation (umeclidinium 62.5 mcg-vilanterol 25 mcg) orally once a dayMaximum dose: One inhalation every 24 hoursUse: Long term treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at the same time. Do not use more than once in a 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, chest pain, fast heart rate, tremor, and feeling shaky or nervous.

Do not use a second inhaled bronchodilator that contains formoterol, arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol.

Tell your doctor about all your other medicines, especially:

• atropine;
• antifungal or antiviral medicine;
• monoamine oxidase inhibitors, tricyclic antidepressants, drugs that prolong QT interval;
• beta-blockers;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• another bronchodilator medication.

This list is not complete. Other drugs may affect umeclidinium and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.