Incruse Ellipta

Incruse Ellipta is an anticholinergic that works by relaxing muscles in the airways to improve breathing.

Incruse Ellipta is used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease, including bronchitis and emphysema.

Incruse Ellipta is for use only in people with COPD and should not be used to treat asthma.

Use Incruse Ellipta exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Incruse Ellipta is a powder that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister of powdered medicine each time you use the inhaler. Follow the patient instructions provided with the inhaler device.

The usual dose is 1 inhalation per day. Use the medicine at the same time each day, and not more than once in a 24-hour period.

Incruse Ellipta 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. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.

Do not stop using this medicine 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 Incruse Ellipta if you are allergic to umeclidinium or have a severe allergy to milk proteins.

Incruse Ellipta 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 Incruse Ellipta if you are allergic to umeclidinium, or if you have:

• a severe allergy to milk proteins.

To make sure Incruse Ellipta is safe for you, tell your doctor if you have:

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

Tell your doctor if you are pregnant or breastfeeding.

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

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

Call your doctor at once 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 Incruse Ellipta side effects 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 day Maximum dose: 1 inhalation every 24 hours Use: Treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one 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.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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 interact with umeclidinium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.