Tudorza Pressair Patient Package Insert

Patient Information

TUDORZAPRESSAIR™ (TU-door-za PRESS-air)

(aclidinium bromide inhalation powder)

FOR ORAL INHALATION ONLY

Read the Patient Information that comes with TUDORZA PRESSAIR before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your doctor about your medical condition or your treatment.

What is TUDORZA PRESSAIR?

TUDORZA PRESSAIR is a prescription medicine used long term, 2 times each day to treat symptoms of chronic 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 isnota 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 non-prescription medicines and eyedrops, vitamins, and herbal supplements.

TUDORZA PRESSAIR and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your doctor if you take:

  • anticholinergics (including Tiotropium, Ipratropium)
  • 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
    • nausea or vomiting
    • blurred vision
    • seeing halos or bright colors around lights
    • 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
    • painful urination
    • urinating frequently
    • urination in a weak stream or drips

    If you have these symptoms of urinary retention, stop taking TUDORZA PRESSAIR and call your doctor right away.

  • serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems.Call your doctor or get emergency medical care if you get any symptoms of a serious allergic reaction.

The most common side effects of TUDORZA PRESSAIR include:

  • headache
  • common cold symptoms
  • cough

If your COPD symptoms worsen over time do not increase your dose of TUDORZA PRESSAIR, instead call 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 1-800-FDA-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.(SeeFigure P),or

  • 45 days after you took the inhaler out of the sealed pouch, whichever comes first.
  • If your TUDORZA PRESSAIR inhaler appears to be damaged or if you lose the cap, your inhaler should be replaced.
  • Youdo not needto 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 notuse water to clean your TUDORZA PRESSAIR inhaler, as this may damage your medicine.
  • This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

    Distributed by:
    Forest Pharmaceuticals, Inc.
    Subsidiary of Forest Laboratories, Inc.
    St. Louis, MO 63045

    FOREST PHARMACEUTICALS, INC.
    Subsidiary of Forest Laboratories, Inc.
    St. Louis, Missouri 63045

    Under license of ALMIRALL, S.A.

    Almirall

    TUDORZA™andPRESSAIR™are trademarks of ALMIRALL, S.A.

    Approved July 2012

    Revised September 2012

    Tudorza Pressair Overview

    Overall Rating
    Medication Type
    Prescription
    Approval Date
    Jul 23, 2012
    DEA Schedule
    Not Classified

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