Incruse Ellipta

umeclidinium
Chemical Name: umeclidinium (as bromide)
Drug Type: anticholinergic bronchodilators

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.

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

Umeclidinium is used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).

Umeclidinium may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to umeclidinium or milk proteins.

To make sure this medicine is safe for you, tell your doctor if you have:

  • narrow-angle glaucoma;
  • heart disease;
  • enlarged prostate; or
  • bladder obstruction or other urination problems.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether umeclidinium passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

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

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Umeclidinium 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 umeclidinium each time you use the inhaler. Follow the patient instructions provided with the inhaler device.

The usual dose of umeclidinium is 1 inhalation per day. 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. 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.

You should not stop using umeclidinium suddenly. Stopping suddenly may make your condition worse.

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

Do not try to clean or take apart the inhaler device. Get your prescription refilled before you run out of medicine completely. 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 device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. Do not use more than 1 inhalation in a single day.

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

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

Get emergency medical help if you have signs of an allergic reaction: 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 medication;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • rapid heartbeats;
  • painful or difficult urination; or
  • little or no urinating.

Common side effects may include:

  • stuffy or runny nose, sinus pain, sneezing;
  • sore throat, cough;
  • bruising or skin discoloration;
  • mouth pain, tooth pain;
  • 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.

Using umeclidinium with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with umeclidinium, especially:

  • atropine;
  • cold or allergy medicine that contains an antihistamine (Benadryl and others);
  • medicine to treat Parkinson's disease;
  • medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
  • bladder or urinary medicines--darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or
  • bronchodilators--aclidinium, ipratropium, tiotropium.

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 interactions are listed in this medication guide.

Your pharmacist can provide more information about umeclidinium.