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Budesonide/Formoterol/Glycopyrronium Metered Dose Inhaler (BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL - ORAL INHALATION)

For chronic lung disease (COPD).

Brand Name(s): Breztri

Generic Name: Budesonide/Formoterol/Glycopyrronium, Budesonide/Formoterol Fumarate/Glycopyrronium

Instructions

This medicine will work best if you take it at about the same time every day.

Keep this medicine at room temperature. Protect from moisture and high humidity.

Before using the inhaler, look at the counter for the number of doses remaining in the inhaler.

Ask your doctor, nurse or pharmacist to show you how to use this medicine correctly.

Keep the medicine in the foil pouch until you are ready to use it.

Each time you receive a new inhaler, you need to get it ready to use. Shake the inhaler for 5 seconds, point it away from you and then spray into the air. Repeat this 3 more times. This process is called priming the pump and removes any air from the medicine canister.

Repeat the priming process with each new inhaler or any time you drop the inhaler, take it apart for cleaning, or go more than one week without using the inhaler.

Shake the medicine well before use.

Rinse your mouth and throat with water after using the inhaler each time.

Do not swallow the water after rinsing.

If you are using more than one puff or more than one inhaled medicine, wait at least 1 minute between puffs.

If another inhaled medicine needs to be used, wait at least one minute before using the next medicine.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Keep track of how many times you use the inhaler. Do not use it more than the total number of doses shown on the package.

Throw away 3 months after removing from the pouch, or when the dose counter says zero, whichever comes first.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Cautions

If you are switching from an oral steroid medication to this medicine, it is important that your body adapts properly to this change. Please speak with your doctor or nurse for more information.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

Be very careful not to spray the medicine into your eyes. Wash your hands thoroughly before touching your eyes.

Avoid smoking while on this medicine. Smoking can worsen breathing problems and increase the risk of bone loss.

Contact your doctor if you develop any signs of a new infection such as fever, cough, sore throat, or chills.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

If this medicine causes more wheezing or makes it harder to breathe, stop the medicine. Get medical help right away.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

If you have any trouble using the medicine, please tell your doctor, nurse or pharmacist.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • coughing
  • dry mouth
  • hoarseness or throat irritation
  • high blood pressure

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bone pain
  • chest pain
  • eye pain or redness
  • fainting
  • fast or irregular heart beats
  • mouth sores or irritation
  • muscle cramps or weakness
  • nervousness
  • shakiness
  • excessive thirst
  • difficulty or discomfort urinating
  • increased urinary frequency
  • blurring or changes of vision
  • seeing halos or colors around lights
  • wheezing or difficulty breathing
  • worsening breathing symptoms
  • yeast infection in the mouth or throat

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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