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IMPORTANT SAFETY INFORMATION

Talk to your doctor to see if Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is right for you.

SPIRIVA HandiHaler is a prescription medicine used once every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis, emphysema, or both.

SPIRIVA HandiHaler also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations). A COPD exacerbation is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath, and wheezing that requires medicine beyond your rescue medicine.

Do not use SPIRIVA HandiHaler if you are allergic to tiotropium or ipratropium (Atrovent®). Allergic reactions may include itching, rash, or swelling of the lips, tongue, or throat.

SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled by mouth using the HandiHaler device.

Stop taking SPIRIVA and get medical help right away if your breathing suddenly worsens, your throat, lips, or tongue swells, you get hives, you have vision changes or eye pain, or you have difficulty passing urine or painful urination.

Tell your doctor if you have glaucoma, problems passing urine, or an enlarged prostate, as these may worsen with SPIRIVA. Tell your doctor if you have kidney problems or are allergic to milk proteins. Ask your doctor if you are not sure. Also discuss with your doctor all the medicines you take, including eye drops.

The most common side effect with SPIRIVA is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.

Do not get SPIRIVA powder in your eyes.

Read the Patient Information and the step-by-step Patient's Instructions for Use for SPIRIVA before you take your medicine.

The information provided on this site is for general information and educational purposes only. You should always consult a doctor for diagnosing and treating a health or fitness problem, and before using any drug product discussed on this site. Respiratory symptoms may be due to other diseases that might require different therapies.

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.

Click here for Full Prescribing Information and Patient's Instructions for Use.

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This information is for U.S. residents only. Products discussed herein may have different labeling in different countries.