Umeclidinium

Umeclidinium helps prevent airflow blockage and lessen flare-ups in adults with COPD (chronic obstructive pulmonary disease), which includes bronchitis and emphysema.

umeclidinium is meant only for individuals with COPD and should not be used to treat asthma.

Umeclidinium may also be used for reasons not mentioned in this medication guide.

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

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.

Umeclidinium 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.

Do not stop using umeclidinium without your doctor's advice, even if you feel fine.

Do not try to clean or take apart the inhaler device. Always use the new inhaler device provided with your refill.

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 if you are allergic to umeclidinium or have a severe allergy to milk proteins.

Umeclidinium is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack. Use only a fast acting inhalation medicine for an attack.

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

You should not use umeclidinium if you are allergic to it, or if you have:

• a severe allergy to milk proteins.

Tell your doctor if you have ever had:

• glaucoma;
• heart disease;
• an enlarged prostate; or
• urination problems.

Tell your doctor if you are pregnant or breastfeeding.

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

Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching; difficulty breathing; swelling of your face, lips, tongue, or throat.

Umeclidinium may cause serious side effects. Call your doctor right away if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• blurred vision, nausea, vomiting, eye pain or redness, or seeing halos or bright colors around lights; or
• painful or difficult urination, or urinating more often.

Common side effects of umeclidinium may include:

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;
• fast or irregular heartbeats;
• bruising, darkened skin;
• mouth pain, tooth pain;
• muscle or joint pain;
• stomach pain; or
• altered sense of taste.

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

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

1 inhalation (62.5 mcg) orally once a dayMaximum dose: 1 inhalation every 24 hoursUse: Treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

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

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

Do not use another inhaled bronchodilator that contains aclidinium, arformoterol, indacaterol, olodaterol, salmeterol, tiotropium, or vilanterol.

Follow your doctor's instructions regarding any limitations on food, drinks, or activities.

Tell your doctor about all your other medicines, especially:

• atropine;
• 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, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.