Important Safety Information

Indications and Usage

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.

DUAKLIR is not for the treatment of asthma.

DUAKLIR 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.

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 health care provider about all your medical conditions, including heart problems, high blood pressure, seizures, thyroid problems, diabetes, eye problems (especially glaucoma), prostate or bladder problems or problems passing urine, are pregnant or plan to become pregnant, or are breast feeding or plan to breast feed.
  • Tell your health care provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements and eyedrops. DUAKLIR PRESSAIR and certain other medicines may interact with each other and may cause serious side effects. Especially tell your health care provider if you take anticholinergics, other LABA (long-acting beta2-adrenergic agonist) medicines, xanthine derivatives, steroids, diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, beta-blockers or atropine.
  • Use DUAKLIR PRESSAIR exactly as prescribed. Do not use DUAKLIR more often than prescribed or take more medicine than prescribed for you.

WHAT ARE THE POSSIBLE SIDE EFFECT OF DUAKLIR PRESSAIR?

  • Using too much of a LABA medicine may cause chest pain, increased blood pressure, 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.
  • Call your doctor or get emergency medical care if you have any symptoms of a serious allergic reaction including rash, swelling of the face and tongue, hives, or breathing problems.
  • You may experience high blood sugar (hyperglycemia) or low blood potassium (hypokalemia). Low blood potassium may cause muscle spasms, muscle weakness, or abnormal heart rhythm.
  • These are not all the possible side effects of DUAKLIR PRESSAIR. Please see full Prescribing Information.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.