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SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray, 1.25 mcg, is a long-term, 1 time each day, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

When taken in 2 puffs, 1 time each day, SPIRIVA RESPIMAT helps you breathe better and may reduce the risk of asthma flare-ups (also called exacerbations) in adult patients.

SPIRIVA RESPIMAT helps to keep airways open for a full 24 hours.

In studies, an asthma flare-up was defined as an episode consisting of an increase of asthma symptoms (shortness of breath, cough, wheezing, or chest tightness), or trouble breathing that lasts for 2 or more consecutive days requiring treatment with additional medications for 3 or more days. An asthma flare-up may also be called an exacerbation by your doctor.

SPIRIVA RESPIMAT works by relaxing the tiny muscles in your airways, helping to get them open and keep them open for a full 24 hours.

Keep in mind, it may take up to 4 to 8 weeks of treatment with SPIRIVA RESPIMAT for your breathing to improve. It’s important to give SPIRIVA RESPIMAT time to work for you.

SPIRIVA RESPIMAT is a maintenance medicine. For SPIRIVA RESPIMAT to work, you need to take 2 puffs, 1 time each day. Keep in mind, it may take up to 4 to 8 weeks of treatment with SPIRIVA RESPIMAT for your breathing to improve. It’s important to give SPIRIVA RESPIMAT time to work for you.

SPIRIVA RESPIMAT is an asthma maintenance medicine taken 1 time each day. You should take 2 puffs 1 time each day, every day, as prescribed by your doctor. Asthma is a chronic condition, and persistent asthma requires long-term treatment.

The best way to know if you’re doing all you can to manage your asthma is to have an open and honest discussion with your doctor. We offer several tips on preparing for your next doctor's appointment on this site. Be sure to talk about all your asthma symptoms, even if they seem normal to you.

If your asthma is well managed, it should have little impact on your daily life. You should also have a relatively low risk of having a serious asthma attack (also known as an exacerbation).

INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, is a long-term, once-daily, prescription medicine used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT also reduces the likelihood of COPD flare-ups (COPD exacerbations).

SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older.

SPIRIVA RESPIMAT is not a treatment for sudden symptoms of asthma or COPD.

IMPORTANT SAFETY INFORMATION

Do not use SPIRIVA RESPIMAT if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines.

SPIRIVA RESPIMAT 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.

SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and get immediate medical care.

SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA RESPIMAT, and call your doctor right away or seek emergency medical care.

SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma), 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.

Dizziness and blurred vision may occur with SPIRIVA RESPIMAT. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or other machines.

SPIRIVA RESPIMAT can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

The most common side effects reported with SPIRIVA RESPIMAT in patients with COPD include sore throat, cough, dry mouth, and sinus infection.

The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA RESPIMAT can increase side effects.

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.

CL-SVR-100067 2.15.2017

Please see full Prescribing Information, including Instructions for Use, for SPIRIVA RESPIMAT.