INDICATIONS AND USAGE

TUDORZA 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.

TUDORZA 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.

IMPORTANT SAFETY INFORMATION

Who should not use TUDORZA PRESSAIR?

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

What should I tell my doctor before using TUDORZA?

Before you use TUDORZA, tell your doctor about all your medical conditions, including if you have eye problems (especially glaucoma), prostate or bladder problems, or problems passing urine. TUDORZA may make these problems worse.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and eyedrops. Especially tell your doctor if you take anticholinergics (including tiotropium, ipratropium) or atropine.

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

Seek immediate medical help if your breathing problems worsen with TUDORZA, you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well for you.

What are the possible side effects of TUDORZA?

TUDORZA can cause serious side effects. Stop taking TUDORZA and seek medical help right away if you experience:

Sudden shortness of breath immediately after use of TUDORZA

New or worsened symptoms of increased pressure in your eyes (acute narrow-angle glaucoma), which may include eye pain, nausea or vomiting, blurred vision, seeing halos or bright colors around lights, or red eyes. Using only eyedrops to treat these symptoms may not work and if not treated, this could lead to permanent loss of vision

Symptoms of new or worsened urinary retention (difficult, painful, or frequent urination, or urination in a weak stream or drips)

Serious allergic reactions including rash, hives, swelling of the face, lips, tongue, or throat; breathing problems; and itching

What are the most common side effects of TUDORZA?

The most common side effects of TUDORZA include headache, common cold symptoms, and cough. In a long-term cardiovascular safety trial of up to 3 years, the adverse reactions (occurring at a rate of ≥2% and more common than placebo) were nausea, back pain, cough, high blood pressure, sinusitis, constipation, joint pain, anemia, muscle spasms, congestive heart failure, cellulitis (skin infection), and gastroesophageal reflux disease. These are not all the possible side effects with TUDORZA.

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