Tudorza Pressair is a bronchodilator.

Tudorza Pressair is used to prevent bronchospasm in adults with chronic bronchitis, emphysema, or other forms of COPD (chronic obstructive pulmonary disease).

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

Tudorza Pressair will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for a bronchospasm attack.

Call your doctor at once if you have painful or difficult urination, blurred vision, nausea, vomiting, eye pain or redness, or seeing halos or bright colors around lights;

Use Tudorza Pressair exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Tudorza Pressair is not a rescue medicine. Aclidinium will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for a bronchospasm attack.

Tudorza Pressair is a powder that comes with a special inhaler device preloaded with measured doses of this medicine. The device delivers a single dose each time you press a button on the inhaler.

Tudorza Pressair comes with patient instructions for using the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Tudorza Pressair should be used at evenly spaced intervals, usually every 12 hours.

Use Tudorza Pressair regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Call your doctor or seek medical attention if you think your fast-acting inhaler medications are not working as well.

Store Tudorza Pressair at room temperature away from moisture and heat. Keep this medicine in the sealed pouch until ready to use. Do not store the inhaler device on top of any surface that vibrates.

Throw the inhaler device away 45 days after you have taken it out of the sealed pouch, or if the dose indicator shows a zero or the device locks, whichever comes first. Each inhaler device contains 60 doses.

You should not use Tudorza Pressair if you are allergic to aclidinium or to milk proteins.

To make sure Tudorza Pressair is safe for you, tell your doctor if you have:

• narrow-angle glaucoma;

• enlarged prostate; or

• bladder obstruction or other urination problems.

It is not known whether Tudorza Pressair will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether aclidinium passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

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.

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

If this medication gets in your eyes, rinse with water.

Get emergency medical help if you have any signs of an allergic reaction to Tudorza Pressair: hives, itching, rash, wheezing, chest tightness, trouble 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, nausea, vomiting, eye pain or redness, or seeing halos or bright colors around lights;

• increased urination, painful or difficult urination;

• little or no urinating; or

• worsening or no improvement in your symptoms.

Common Tudorza Pressair side effects may include:

• stuffy nose, sore throat, sinus pain;

• cough; or

• headache.

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.

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

• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;

• bronchodilators such as ipratropium or tiotropium;

• cold or allergy medicine that contains an antihistamine;

• medication for Parkinson's disease; or

• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.

This list is not complete. Other drugs may interact with Tudorza Pressair, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.