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INDICATION

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

STIOLTO contains the anticholinergic, tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.

IMPORTANT SAFETY INFORMATION

People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), have an increased risk of death from asthma problems.

More Important Safety Information

INDICATION

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

STIOLTO contains the anticholinergic, tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.

 

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION (continued)

People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), have an increased risk of death from asthma problems. It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO), increase the risk of death in people with COPD. STIOLTO has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO is NOT to be used in asthma.

Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Symptoms of a serious allergic reaction may include rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use STIOLTO more often or at higher doses than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO.

Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines (including eye drops), vitamins, and herbal supplements. STIOLTO may interact with other medicines which may cause serious side effects.

STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, high blood sugar, or low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help.

STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Do not spray STIOLTO into your eyes.

The most common side effects of STIOLTO are runny nose, cough, and back pain.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler.

Please see accompanying Medication Guide, Instructions for Use, and Full Prescribing Information, including boxed WARNING.