Aclidinium Bromide (a-kli-DIN-ee-um BROE-mide)

Treats COPD.

Brand Name(s):

Tudorza Pressair

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder Under Pressure

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You will use the medicine with an inhaler device called Pressair®. The inhaler holds the powder medicine. Your doctor will show you how to use your inhaler. Make sure you understand all instructions.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• After you use a dose, check the colored control window to make sure it has changed back to red. If the control window is still green, you did not get the full dose. Try to use another dose. If you cannot get the full dose of medicine after you have tried several times, call your doctor.
• Do not use water to clean your inhaler. This will damage the medicine.
• Missed dose: Skip the missed dose and take your next dose at the regular time. Do not use 2 doses to make up for a missed dose.
• Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used medicine container and any leftover medicine. You will also need to throw away old medicine after the expiration date has passed. Throw away the inhaler 45 days after you open the pouch, when there is a "0" with a red background on the dose counter, or when the device locks and you cannot press the green button.

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 aclidinium works. Tell your doctor if you are using atropine, ipratropium, or tiotropium.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have glaucoma, prostate problems, or trouble urinating.
• This medicine will not stop breathing problems that have already started. Your doctor may prescribe another medicine to use in case of an acute attack.
• This medicine may cause the following problems:
  • Paradoxical bronchospasm (increased trouble breathing right after use)
  • Glaucoma
  • Urination problems
• Call your doctor right away if you use other medicines for your COPD and they do not seem to be working as well as usual. Do not change your doses or stop using your other medicines.
• Call your doctor if your symptoms do not improve or if they get worse.
• 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, vision changes, seeing halos around lights
• New or worsening cough, increased trouble breathing

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