Aclidinium Bromide (a-kli-DIN-ee-um BROE-mide), Formoterol Fumarate (for-MOE-ter-ol FUE-ma-rate)

Treats chronic obstructive pulmonary disease (COPD).

Brand Name(s):

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.
• This medicine is a powder that is used with its own inhaler device. Keep the medicine in the sealed bag until you are ready to use the inhaler. Do not press the orange button until you are ready to take a dose.
• Remove the cap by squeezing and pulling it off the mouthpiece. Check the mouthpiece to make sure it is clear.
• Hold the inhaler with the mouthpiece facing you and the orange button is on top. Press the orange button all the way down and release it. Do not tilt the inhaler.
• Check the control window to make sure your dose is ready for inhalation. Look if the colored control window changed from red to green. If it is still red, repeat the steps to prepare your dose.
• To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put your lips tightly around the mouthpiece and breathe in quickly and deeply until you hear a "click" sound. Keep breathing in, even after you hear the "click" sound to be sure you get the full dose. Do not hold the orange button while you are breathing in.
• Remove the inhaler from your mouth and hold your breath for as long as is comfortable, and then breathe out slowly through your nose. You may have a grainy feeling or a slightly sweet or bitter taste in your mouth after inhalation. Do not take an extra dose if you do not taste or feel anything after inhaling.
• Check the colored control window if it has turned to red. This means you have inhaled the full dose of this medicine. If it is still colored green, repeat the steps above. If you are unable to inhale correctly after several attempts, call your doctor.
• Once the window has turned red, place the cap back by pressing it back into the mouthpiece.
• To clean the inhaler, wipe the mouthpiece with a dry tissue or towel. Do not use water to clean it, as this may damage the medicine.
• The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. A red band will appear in the window to 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: If you miss a dose of this medicine, skip the missed dose, then go back to your regular dosing schedule. Do not take 2 doses at one time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not store this medicine on a vibrating surface. Throw away the inhaler 2 months after opening the bag, after a "0" with a red background shows, or when the device is empty and locks out.

Drugs and Foods to Avoid:

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

• Do not use this medicine together with similar inhaled medicines, including aclidinium, arformoterol, formoterol, glycopyrrolate, indacaterol, ipratropium, olodaterol, salmeterol, tiotropium, umeclidinium, or vilanterol.
• Some medicines can affect how aclidinium/formoterol works. Tell your doctor if you are using any of the following:
  • Aminophylline, caffeine, theophylline
  • Beta-blocker
  • Diuretic (water pill)
  • Medicine to treat depression (including MAO inhibitors, TCAs)
  • Steroid medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart disease, asthma, high blood pressure, heart rhythm problems, diabetes, seizures, thyroid problems, glaucoma, trouble urinating, an enlarged prostate, or bladder blockage.
• This medicine may cause the following problems:
  • Increased risk of paradoxical bronchospasm (trouble breathing right after use) and asthma-related death
  • High blood pressure
  • Changes in heart rhythm
  • Eye or vision problems
• Do not use this medicine to treat acute attacks. You should have another medicine to use for an acute asthma attack or COPD flare-up. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.
• 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
• Chest tightness, trouble breathing
• Difficulty passing urine, painful urination
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Eye pain, blurred vision or other changes in vision
• Fast, slow, pounding, or uneven heartbeat
• Lightheadedness, dizziness, or fainting

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

• Headache
• Nervousness, tremor

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