September 1, 2015
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Tudorza Pressair

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Tudorza Pressair

PATIENT INFORMATION

TUDORZA® PRESSAIR®
(TU-door-za PRESS-air)
(aclidinium bromide) Inhalation Powder

What is TUDORZA PRESSAIR?

TUDORZA PRESSAIR is a prescription medicine used long term, 2 times each day to treat symptoms ofchronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. You may start to feel like it is easier to breathe on the first day, but it may take longer for you to feel the full effects of the medicine. TUDORZA PRESSAIR works best and may help make it easier to breathe when you use it every day.

TUDORZA PRESSAIR is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

It is not known if TUDORZA PRESSAIR is safe and effective in children.

What should I tell my doctor before using TUDORZA PRESSAIR?

Before you use TUDORZA PRESSAIR, tell your doctor about all your medical conditions, including if you:

  • have eye problems, especially glaucoma. TUDORZA PRESSAIR may make your glaucoma worse.
  • have prostate or bladder problems, or problems passing urine. TUDORZA PRESSAIR may make these problems worse.
  • have a severe allergy to milk proteins. Ask your doctor if you are not sure.
  • are pregnant or plan to become pregnant. It is not known if TUDORZA PRESSAIR can harm your unborn baby.
  • are breast-feeding or plan to breast-feed. TUDORZA PRESSAIR may pass into your breast milk. You and your doctor should decide if you will take TUDORZA PRESSAIR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines and eyedrops, vitamins, and herbal supplements.

TUDORZA PRESSAIR and certain other medicines may interact with each other causing serious side effects. Especially tell your doctor if you take anticholinergics (including Tiotropium, Ipratropium) or atropine. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine.

How should I use TUDORZA PRESSAIR?

  • See the step-by-step instructions for using TUDORZA PRESSAIR at the end of this Patient Information.
  • Use TUDORZA PRESSAIR exactly as prescribed.
  • The usual dose of TUDORZA PRESSAIR is one oral inhalation 2 times a day. Each dose should be about 12 hours apart.
  • If you miss a dose, just skip the dose.Take your next dose at your usual time. Do not take 2 doses at one time.

TUDORZA PRESSAIR does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your doctor to have one prescribed for you.

Do not use TUDORZA PRESSAIR more often than prescribed or take more medicine than prescribed for you.

  • Call your doctor or get emergency medical care right away if:
    • your breathing problems worsen with TUDORZA PRESSAIR
    • you need to use your rescue inhaler medicine more often than usual
    • your rescue inhaler medicine does not work as well for you at relieving symptoms

What are the possible side effects of TUDORZA PRESSAIR?

TUDORZA PRESSAIR can cause serious side effects including:

  • sudden shortness of breath immediately after use of TUDORZA PRESSAIR. If you have this symptom, stop taking TUDORZA PRESSAIR and call your doctor right away or go to the nearest hospital emergency room.
  • new or worsened increased pressure in your eyes (acute narrow-angle glaucoma). Acute narrow-angle glaucoma can lead to permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
    • eye pain or discomfort
    • seeing halos or bright colors around lights
    • blurred vision
    • nausea or vomiting
    • red eyes
      Using only eyedrops to treat these symptoms may not work. If you have these symptoms, stop taking TUDORZA PRESSAIR and call your doctor right away.
  • new or worsened urinary retention. Urinary retention can be caused by blockage in your bladder or, if you are a male, a larger than normal prostate. Symptoms of urinary retention may include:
    • difficulty urinating
    • urinating frequently
    • urination in a weak stream or drips
    • painful urination
      If you have these symptoms of urinary retention, stop taking TUDORZA PRESSAIR and call your doctor right away.
  • serious allergic reactions. Symptoms of a serious allergic reaction may include:
    • swelling of the face, lips, tongue, or throat
    • hives
    • breathing problems
    • rash
    • itching

If you have these symptoms, stop taking TUDORZA PRESSAIR and call your doctor or go to the nearest hospital emergency room right away.

The most common side effects of TUDORZA PRESSAIR include headache, common cold symptoms, or cough.

If your COPD symptoms worsen over time do not increase your dose of TUDORZA PRESSAIR, insteadcall your doctor.

Tell your doctor if you get any side effect that bothers you or does not go away. These are not all the possible side effects with TUDORZA PRESSAIR. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.

How should I store TUDORZA PRESSAIR?

  • Store TUDORZA PRESSAIR at room temperature between 68°F to 77°F (20° to 25°C) in the protective pouch. Do not open the sealed pouch until you are ready to use a dose of TUDORZA PRESSAIR. Once a sealed pouch is opened, start using your TUDORZA PRESSAIR. Discard the PRESSAIR inhaler 45 days after opening the pouch, after the marking “0” with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.
  • Keep TUDORZA PRESSAIR in a dry place.
  • Do not store the inhaler on a vibrating surface.

Keep TUDORZA PRESSAIR and all medicines out of the reach of children.

General information about the safe and effective use of TUDORZA PRESSAIR

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use TUDORZA PRESSAIR for a condition for which it was not prescribed. Do not give TUDORZA PRESSAIR to other people even if they have the same symptoms that you have. It may harm them.

This patient leaflet summarizes the most important information about TUDORZA PRESSAIR. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TUDORZA PRESSAIR that is written for health professionals.

For more information, go to www.tudorza.com, or call 1-800-678-1605.

What are the ingredients in TUDORZA PRESSAIR?

Active ingredient: aclidinium bromide Inactive ingredient: lactose monohydrate

Instructions for Use

TUDORZA® PRESSAIR®
(TU-door-za PRESS-air)
(aclidinium bromide inhalation powder)

FOR ORAL INHALATION ONLY

Read this Instructions for Use before you start using TUDORZA PRESSAIR and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Your TUDORZA PRESSAIR INHALER:

When you are ready to use TUDORZA PRESSAIR for the first time, remove the TUDORZA PRESSAIR inhaler from the pouch. To remove the inhaler from the pouch, tear along the “notch.” The pouch may then be discarded.

Look at the parts of the inhaler so you become familiar with them. (See Figure A)

Figure A

Parts of the inhaler - Illustration

Taking a dose from the TUDORZA PRESSAIR Inhaler requires you to press, release, and inhale. See the step-by-step instructions for using TUDORZA PRESSAIR below.

How to prepare and use your TUDORZA PRESSAIR Inhaler

Step 1. Remove the protective cap by lightly squeezing the arrows marked on each side of the cap and pulling outwards. (See Figure B)

Figure B

Remove the protective cap - Illustration

  • Look to see that nothing is blocking the mouthpiece.

Step 2. Hold the TUDORZA PRESSAIR inhaler with the mouthpiece facing you, but not inside your mouth. The green button should be facing straight up. (See Figure C)

Figure C

Holding the TUDORZA PRESSAIR inhaler - Illustration

Step 3. Before you put the inhaler into your mouth, press the green button all the way down. (See Figure D)

  • Then release the green button. (See Figure E)
  • Do not continue to hold the green button down.

Figure D and Figure E

press the green button all the way down - Illustration

Step 4. Stop and Check the Control Window to make sure your dose is ready for inhalation. Look to see if the colored control window has changed from red (See Figure F), to green (See Figure G)

  • The green control window tells you that your medicine is ready for inhalation. (See Figure G)

Figure F and Figure G

Check the Control Window - Illustration

 

  • If the control window stays red (See Figure F), repeat the Press and Release actions in Step 3 until the control window is green.

Now the dose is ready to be inhaled.

Step 5. Before you put the inhaler into your mouth, breathe out completely. Do not breathe out into the inhaler.

  • Put your lips tightly around the mouthpiece of the TUDORZA PRESSAIR inhaler. Breathe in quickly and deeply through your mouth. (See Figure H). This quick, deep breath makes sure that you get enough of the medication from the inhaler into your lungs.
  • Breathe in until you hear a “click” sound. Keep breathing in, even after you have heard the inhaler “click” to be sure you get the full dose.

Figure H and Figure I

Correct breathing - Illustration

  • Do not hold down the green button while you are breathing in. (See Figure I)

Step 6. Remove the TUDORZA PRESSAIR inhaler from your mouth and hold your breath for as long as is comfortable (See Figure J), then breathe out slowly through your nose.

Figure J

Hold your breath - Illustration

Some people may taste the medicine during their inhalation. Do not take an extra dose even if you do not taste anything after inhaling.

Step 7. Stop and Check the Control Window. Make sure you have used your TUDORZA PRESSAIRinhaler correctly.

  • Look at the control window to see if it has turned to red (See Figure K) from green (See Figure L). If the window is red you have inhaled your full dose of medicine correctly.

Figure K and L

Check the Control Window - Illustration

If the colored control window is still green, repeat Step 5.

  • If the window still does not change to red, you may have forgotten to release the green button before inhaling or may not have inhaled correctly. If that happens repeat Step 5 again.
  • Make sure you have released the green button and take a quick and deep breath in through the mouthpiece.
  • If you are unable to inhale correctly after several attempts, call your doctor.

Step 8. Once the window has turned red, place the protective cap back onto the inhaler by pressing it back onto the mouthpiece. (See Figure M)

Figure M

Place the protective cap back - Illustration

Additional information about the safe and effective use of TUDORZA PRESSAIR inhaler

The “click” sound and colored control window:

  • The “click” that you hear while inhaling tells you that you are using the TUDORZA PRESSAIR inhaler correctly.
  • When you use the inhaler correctly the colored control window changes from green to red.
  • Each time you are ready to use the TUDORZA PRESSAIR inhaler again, you will need to make sure the inhaler is ready by pressing and releasing the green button as seen in Step 3. When you press and release the green button the colored control window will change from red to green.

Helpful Tips for Using Tudorza Pressair

The Tudorza Pressair inhaler comes ready-to-use with 3 steps for twice-daily dosing. Remember to Press, Release and Inhale every time you use Tudorza.

PRESS the green button all the way down

RELEASE the green button completely

INHALE quickly and deeply keeping a tight seal with your lips around the mouthpiece You know you are getting the full dose of medicine when you hear the click while inhaling and see the inhaler's window change colors from green to red.

For more information about TUDORZA PRESSAIR and a video demonstration on how to use TUDORZA PRESSAIR, go to www.tudorza.com.

When should you get a new TUDORZA PRESSAIR inhaler?

  • The TUDORZA PRESSAIR inhaler has a dose indicator to show you how many doses are left in your inhaler. Each TUDORZA PRESSAIR inhaler has 60 doses of medicine.
    • When you start using the inhaler for the first time you will see the number 60 in the dose indicator.
    • You will see the number of doses count down in the dose indicator as you use the inhaler. The dose indicator moves down slowly, displaying intervals of 10 (60, 50, 40, 30, 20, 10, 0).
    • When a red band begins to appear in the dose indicator (See Figure N), this means you are nearing your last dose and should obtain a new PRESSAIR inhaler.

Figure N

Nearing your last dose - Illustration

  • You should discard the inhaler and start a new one when
    • the marking “0” with the red background shows in the middle of the dose indicator (See Figure O), or
    • the device locks out (See Figure P), or
    • 45 days after you took the inhaler out of the sealed pouch, whichever comes first.

Figure O

Empty dose indicator - Illustration

Figure P

Device locked - Illustration

  • If your TUDORZA PRESSAIR inhaler appears to be damaged or if you lose the cap, your inhaler should be replaced.
  • You do not need to clean your TUDORZA PRESSAIR inhaler. If you wish to clean it, wipe the outside of the mouthpiece with a dry tissue or paper towel. Do not use water to clean your TUDORZA PRESSAIR inhaler, as this may damage your medicine.

Questions and Answers about your TUDORZA PRESSAIR Inhaler

Question Answer
Do I need to take extra steps to prepare the inhaler before first use? TUDORZA PRESSAIR comes preloaded with medicine and is ready to use. Remove the inhaler from the pouch and follow the step-by-step instructions for use.
How do I know if the PRESSAIR inhaler is ready to use before taking each dose? The PRESSAIR inhaler is ready to use when the window on the front of the inhaler is green. (See Figure G)
  • If the window is red, press and release the green button completely. (See Step 3). This will change the color of the window from red to green, indicating the medicine is ready to inhale.
What if the PRESSAIR inhaler window doesn’t change from red to green? Check that you have pressed the green button down fully and then completely let go of the button. (See Step 3)
  • If the green button is locked, you have used all the medicine in your inhaler and should get a new TUDORZA PRESSAIR inhaler. (See Figure P)
How do I know that I used TUDORZA PRESSAIR correctly? The PRESSAIR inhaler has helpful features to let you know that you are getting the full dose of medicine.
  • Listen for the “click” sound as you are inhaling and keep breathing in after you hear the “click” to be sure you get the full dose. (See Step 5)
  • Look at the control window to see if it has turned to red after you have inhaled fully through the mouthpiece. If the window is red you have inhaled your full dose of medicine correctly. (See Step 7)
What if the TUDORZA PRESSAIR inhaler window does not change colors from green back to red after I inhale? This means you have not inhaled the medicine correctly. Review the checklist below and try inhaling again. (See Step 7)
  • Did you let go of the green button before inhaling?
  • Did you form a tight seal with your lips around the inhaler’s mouthpiece?
  • Are you breathing in quickly and deeply?
What if I do not see the dose counter move after I inhaled? The PRESSAIR dose indicator counts down in intervals of 10. The numbers change slowly with each dose; you will not see a change in the number after each dose. (See Figure N) As long as you hear the click and see the window change from green to red, you have successfully inhaled the full dose.
Can the PRESSAIR inhaler release too much medicine or lose doses of medicine from the inhaler? No. The PRESSAIR inhaler only releases 1 dose of medicine with each inhalation. Pressing and releasing the green button more than one time before inhaling does not increase the dose you will receive or cause any medicine to be lost.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/20/2015
This monograph has been modified to include the generic and brand name in many instances.

Additional Tudorza Pressair Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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