Umeclidinium Oral Inhalation

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

Before using umeclidinium,

• tell your doctor and pharmacist if you are allergic to umeclidinium, any other medications, milk protein, or any of the ingredients in umeclidinium inhalation. Ask your pharmacist or check the Patient Information 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. Be sure to mention any of the following: antihistamines; atropine; other medications for COPD including aclidinium (Tudorza Pressair), ipratropium (Atrovent HFA), and tiotropium (Spiriva); or medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had glaucoma (an eye disease), prostate or bladder problems, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using umeclidinium, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using umeclidinium.

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

• joint or muscle pain
• runny nose, sore throat
• cough

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

• rash
• hives
• itching
• swelling of the face, mouth, or tongue
• coughing, wheezing, or chest tightness that begins after you inhale umeclidinium
• 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
• fast or irregular heartbeat

Umeclidinium 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• chest pain
• shortness of breath
• fast heartbeat
• shaking of a part of your body that you cannot control
• dry mouth
• hot, dry, flushed skin
• blurred vision
• dilated pupils
• seeing things or hearing voices that do not exist (hallucinating)

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.