Umeclidinium (ue-mek-li-DIN-ee-um)

Treats chronic obstructive pulmonary disease (COPD).

Brand Name(s):

Incruse Ellipta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder

• Your doctor will tell you how much medicine to use. Do not use more than directed. Use this medicine at the same time each day.
• To use:
  • Open the cover of the inhaler until you hear a click. The inhaler is now ready to use. Do not close the cover until you have taken your dose. If you open and close the cover without inhaling the dose, you will lose the medicine. Do not take more than 1 puff per day.
  • Before you inhale your dose, breathe out fully. Try to empty your lungs as much as possible.
  • Place the mouthpiece of the inhaler in your mouth and breathe in a steady, deep breath. Do not breathe in through your nose.
  • Remove the inhaler from your mouth. Hold your breath for about 3 to 4 seconds, then breathe out slowly.
  • The inhaler has a window that shows the number of doses that are left. The counter will turn red when the inhaler has fewer than 10 doses left. This will remind you to refill your prescription.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in the foil tray. Do not open it until you are ready to use the inhaler for the first time. Throw away the medicine 6 weeks after it was opened or when the counter reads "0".

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how umeclidinium works. Tell your doctor if you are using an anticholinergic medicine, including aclidinium, atropine, ipratropium, or tiotropium.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have glaucoma, heart problems, trouble urinating, an enlarged prostate, or a bladder blockage.
• This medicine may cause the following problems:
  • Increased risk of paradoxical bronchospasm (trouble breathing right after use)
  • Glaucoma
  • Trouble urinating
• Do not use this medicine to treat a COPD attack. Your doctor may prescribe another medicine that you should use when you have a COPD flare-up.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much or how often you urinate, difficult or painful urination
• Eye pain, blurred vision, other vision changes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

• Joint pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088