Important Safety Information Full Prescribing Information Instructions For Use Healthcare Professional Site

Indications of Use: DUAKLIR® PRESSAIR® is a prescription medicine to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema or both.

Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma. DUAKLIR PRESSAIR is not a rescue medicine and should not be used for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden breathing problems. Get emergency medical care if your breathing problems worsen quickly or you use your rescue inhaler, but it does not relieve your breathing problems. DUAKLIR PRESSAIR should not be used in children. It is not known if DUAKLIR PRESSAIR is safe and effective in children.

INDICATION AND USAGE

DUAKLIR® PRESSAIR® (aclidinium bromide/formoterol fumarate inhalation powder) is a prescription medicine that is used to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema or both.

Limitations of Use:

DUAKLIR PRESSAIR is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (short-acting beta2 agonist medicine) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

DUAKLIR PRESSAIR is not for the treatment of asthma. It is not known if DUAKLIR PRESSAIR is safe and effective in people with asthma.

DUAKLIR PRESSAIR should not be used in children. It is not known if DUAKLIR PRESSAIR is safe and effective in children.

IMPORTANT SAFETY INFORMATION

WHO SHOULD NOT USE DUAKLIR PRESSAIR?

Do not use DUAKLIR PRESSAIR if you have asthma without also using a medicine called an inhaled corticosteroid.

Do not use DUAKLIR PRESSAIR if you have a severe allergy to milk proteins, or are allergic to aclidinium bromide, formoterol fumarate, or any of the ingredients in DUAKLIR PRESSAIR. Ask your healthcare provider if you are not sure.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE USING DUAKLIR PRESSAIR?

Tell your healthcare provider about all your medical conditions, including heart problems, high blood pressure, seizures, thyroid problems, diabetes, eye problems (especially glaucoma, as DUAKLIR PRESSAIR can make it worse), prostate or bladder problems or problems passing urine, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements and eye drops. DUAKLIR PRESSAIR and certain other medicines may interact with each other and may cause serious side effects. Especially tell your healthcare provider if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate), other LABA (long-acting beta2-adrenergic agonist) medicines (including formoterol, arformoterol, salmeterol, vilanterol, indacaterol, olodaterol) or atropine.

HOW SHOULD I USE DUAKLIR PRESSAIR?

Use DUAKLIR PRESSAIR exactly as prescribed. Do not use DUAKLIR PRESSAIR more often than prescribed. Use 1 inhalation 2 times each day (one in the morning and one in the evening). If you miss a dose, skip the missed dose. Do not take 2 doses at one time.

Do not use other medicines that contain a LABA for any reason. Do not stop using DUAKLIR PRESSAIR unless told to do so by your healthcare provider because your symptoms might get worse. DUAKLIR PRESSAIR does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms.

Call your healthcare provider or get medical care right away if your breathing problems get worse, you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well to relieve your symptoms.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF DUAKLIR PRESSAIR?

DUAKLIR PRESSAIR can cause serious side effects including:

  • People with asthma who take LABA medicines, such as formoterol fumarate (one of the medicines in DUAKLIR PRESSAIR), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe or death.
  • COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of DUAKLIR PRESSAIR, call your healthcare provider.
  • Using too much of a LABA medicine may cause chest pain, fast and irregular heartbeat, headache, tremor, or nervousness.
  • Sudden breathing problems may occur immediately after use of DUAKLIR PRESSAIR and may be life-threatening. If you have sudden breathing problems immediately after inhaling DUAKLIR PRESSAIR, stop using DUAKLIR PRESSAIR and call your healthcare provider right away or go to the nearest hospital emergency room.
  • Serious allergic reactions including rash, swelling of the face, mouth and tongue, hives, or breathing problems. Call your doctor or get emergency medical care if you have these symptoms.
  • Effects on your heart, including chest pain, fast or irregular heartbeat, and increased blood pressure.
  • Changes in laboratory blood levels: high blood sugar (hyperglycemia) or low blood potassium (hypokalemia). Low blood potassium may cause muscle spasms, muscle weakness, or abnormal heart rhythm.
  • New or worsened increased pressure in your eyes (acute narrow-angle glaucoma) may occur after use of DUAKLIR PRESSAIR. 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 orvomiting, blurred vision, seeing halos or bright colors around lights, and red eyes. If you have these symptoms, stop using DUAKLIR PRESSAIR and call your healthcare provider 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, painful urination, and urination in a weak stream or drips. If you have these symptoms of urinary retention, stop using DUAKLIR PRESSAIR and call your doctor right away.

The most common side effects of DUAKLIR PRESSAIR include: upper respiratory tract infection, headache and back pain.

These are not all the possible side effects of DUAKLIR PRESSAIR. Call your healthcare provider for medical advice about side effects.

ADVERSE EVENTS

To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or at medinfoUS@covispharma.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please also see the Full Prescribing Information, including Patient Information.

INDICATION AND USAGE

DUAKLIR® PRESSAIR® (aclidinium bromide/formoterol fumarate inhalation powder) is a prescription medicine that is used to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema or both.

Limitations of Use:

DUAKLIR PRESSAIR is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (short-acting beta2 agonist medicine) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

DUAKLIR PRESSAIR is not for the treatment of asthma. It is not known if DUAKLIR PRESSAIR is safe and effective in people with asthma.

DUAKLIR PRESSAIR should not be used in children. It is not known if DUAKLIR PRESSAIR is safe and effective in children.

IMPORTANT SAFETY INFORMATION

WHO SHOULD NOT USE DUAKLIR PRESSAIR?

Do not use DUAKLIR PRESSAIR if you have asthma without also using a medicine called an inhaled corticosteroid.

Do not use DUAKLIR PRESSAIR if you have a severe allergy to milk proteins, or are allergic to aclidinium bromide, formoterol fumarate, or any of the ingredients in DUAKLIR PRESSAIR. Ask your healthcare provider if you are not sure.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE USING DUAKLIR PRESSAIR?

Tell your healthcare provider about all your medical conditions, including heart problems, high blood pressure, seizures, thyroid problems, diabetes, eye problems (especially glaucoma, as DUAKLIR PRESSAIR can make it worse), prostate or bladder problems or problems passing urine, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements and eye drops. DUAKLIR PRESSAIR and certain other medicines may interact with each other and may cause serious side effects. Especially tell your healthcare provider if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate), other LABA (long-acting beta2-adrenergic agonist) medicines (including formoterol, arformoterol, salmeterol, vilanterol, indacaterol, olodaterol) or atropine.

HOW SHOULD I USE DUAKLIR PRESSAIR?

Use DUAKLIR PRESSAIR exactly as prescribed. Do not use DUAKLIR PRESSAIR more often than prescribed. Use 1 inhalation 2 times each day (one in the morning and one in the evening). If you miss a dose, skip the missed dose. Do not take 2 doses at one time.

Do not use other medicines that contain a LABA for any reason. Do not stop using DUAKLIR PRESSAIR unless told to do so by your healthcare provider because your symptoms might get worse. DUAKLIR PRESSAIR does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms.

Call your healthcare provider or get medical care right away if your breathing problems get worse, you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well to relieve your symptoms.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF DUAKLIR PRESSAIR?

DUAKLIR PRESSAIR can cause serious side effects including:

  • People with asthma who take LABA medicines, such as formoterol fumarate (one of the medicines in DUAKLIR PRESSAIR), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe or death.
  • COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of DUAKLIR PRESSAIR, call your healthcare provider.
  • Using too much of a LABA medicine may cause chest pain, fast and irregular heartbeat, headache, tremor, or nervousness.
  • Sudden breathing problems may occur immediately after use of DUAKLIR PRESSAIR and may be life-threatening. If you have sudden breathing problems immediately after inhaling DUAKLIR PRESSAIR, stop using DUAKLIR PRESSAIR and call your healthcare provider right away or go to the nearest hospital emergency room.
  • Serious allergic reactions including rash, swelling of the face, mouth and tongue, hives, or breathing problems. Call your doctor or get emergency medical care if you have these symptoms.
  • Effects on your heart, including chest pain, fast or irregular heartbeat, and increased blood pressure.
  • Changes in laboratory blood levels: high blood sugar (hyperglycemia) or low blood potassium (hypokalemia). Low blood potassium may cause muscle spasms, muscle weakness, or abnormal heart rhythm.
  • New or worsened increased pressure in your eyes (acute narrow-angle glaucoma) may occur after use of DUAKLIR PRESSAIR. 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 orvomiting, blurred vision, seeing halos or bright colors around lights, and red eyes. If you have these symptoms, stop using DUAKLIR PRESSAIR and call your healthcare provider 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, painful urination, and urination in a weak stream or drips. If you have these symptoms of urinary retention, stop using DUAKLIR PRESSAIR and call your doctor right away.

The most common side effects of DUAKLIR PRESSAIR include: upper respiratory tract infection, headache and back pain.

These are not all the possible side effects of DUAKLIR PRESSAIR. Call your healthcare provider for medical advice about side effects.

ADVERSE EVENTS

To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or at medinfoUS@covispharma.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please also see the Full Prescribing Information, including Patient Information.

References

  1. Partridge MR, Karlsson N, Small lR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin. 2009;25(8):2043-2048.
  2. DUAKLIR® PRESSAIR® (aclidinium bromide/formoterol fumarate inhalation powder) [prescribing information]. Zug, Switzerland: Covis Pharma GmbH; August 2022.
  3. Sethi S, Kerwin E, et al, AMPLIFY: a randomized, Phase III study evaluating the efficacy and safety of aclidinium/formoterol vs monocomponents and tiotropium in patients with moderate-to-very severe symptomatic COPD. Int J Chron Obstruct Pulmon Dis. 2019; 14667- 682
DUAKLIR® and the logo are registered trademarks of Almirall, S.A., used under license by Covis Pharma. PRESSAIR® is a registered trademark of the AstraZeneca group of companies, used under license by Covis Pharma.
©2025 Covis Pharma GmbH. All rights Reserved. PP-DKR-US-00047 12/24

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