About SPIRIVA RESPIMAT

SPIRIVA RESPIMAT is engineered to deliver your COPD maintenance medicine in a slow-moving mist without the use of propellants. Inhaling the mist deeply two times, once a day, helps relax your airways and keep them open for 24 hours.

After priming the inhaler, there are three simple steps to using SPIRIVA RESPIMAT. A helpful way to remember the steps for daily use is to think TOP:

T

TURN

the clear base

O

OPEN

the cap and close your lips around the mouthpiece

P

PRESS

the dose-release button and inhale

Once a day, repeat these steps twice to get your proper dose of SPIRIVA RESPIMAT.

For full instructions on using your inhaler, please see the complete Instructions for Use.

Taken once daily as directed, SPIRIVA RESPIMAT helps relax airways and keep them open for 24 hours. SPIRIVA RESPIMAT also reduces the chance of COPD flare-ups (or COPD exacerbations). SPIRIVA RESPIMAT does not treat sudden breathing problems and cannot be used in place of a rescue inhaler.

Additional features include:

  • Dose-release button that generates a metered amount of your COPD medicine in a slow-moving mist (1 dose = 2 puffs, once daily)
  • Slim profile and portable design that makes the inhaler easy to store and keep with you
  • Dose indicator to help keep track of approximately how much medicine is left, so you know when you need a refill
  • Protective cap that keeps the mouthpiece clean and prevents you from accidently pressing the dose-release button when closed

IMPORTANT SAFETY INFORMATION
for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER

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

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines 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 or SPIRIVA HANDIHALER 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 seek emergency medical care.

More Important Safety Information
IMPORTANT SAFETY INFORMATION for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER (continued)

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

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines 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 or SPIRIVA HANDIHALER 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 seek emergency medical care.

Before using SPIRIVA HANDIHALER, tell your doctor if you have a severe allergy to milk proteins.

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

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER 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 or SPIRIVA HANDIHALER. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or machinery.

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER 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.

The most common side effects reported with SPIRIVA HANDIHALER in patients with COPD include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate, and blurred vision.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HANDIHALER device.

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

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder.

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 can increase side effects. Do not use SPIRIVA RESPIMAT and SPIRIVA HANDIHALER together.

INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are long-term, once-daily, prescription maintenance medicines 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 and SPIRIVA HANDIHALER also reduce the likelihood of 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 is not a treatment for sudden symptoms of asthma or COPD.

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.

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

IMPORTANT SAFETY INFORMATION for SPIRIVA RESPIMAT and SPIRIVA HANDIHALER

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

SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines 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 or SPIRIVA HANDIHALER 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 seek emergency medical care.