Tiotropium (tye-oh-TROE-pee-um)

Treats asthma and chronic obstructive pulmonary disease (COPD).

Brand Name(s):

Spiriva, Spiriva HandiHaler, Spiriva Respimat, Spiriva Respimat Institutional Pack 10ACT, Spiriva Respimat Institutional Pack 28ACT

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed. Use this medicine at the same time each day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Spiriva® HandiHaler®:
  • Spiriva® capsules should be used only with the HandiHaler® device. Do not swallow the capsule. Do not use the device with any other medicine.
  • Do not remove the capsule from the blister pack until you are ready to use it. Use the capsule right away once you have opened a blister pack.
  • Do not let the powder from the capsule get into your eyes.
  • After you have used a dose, remove the used capsule and throw it away.
• Spiriva® Respimat® inhaler:
  • Do not use the inhaler with any other medicine.
  • Do not turn the clear base before you insert the cartridge.
  • Do not remove the cartridge once it has been inserted in the inhaler.
  • When you use the inhaler for the first time, you will need to prime it to make sure it delivers the correct amount of medicine. To prime the inhaler, point it away from your face and press the dose release button until you see a spray of medicine. Then press the button 3 more times. The inhaler is now ready to use.
  • If you have not used your inhaler for more than 3 days, spray 1 dose of medicine away from your face to prime the inhaler. If you have not used your inhaler for more than 21 days, repeat the instructions for priming the inhaler for the first time.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not use this medicine more than once every 24 hours.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Spiriva® HandiHaler®: Leave the capsules in the blister pack until you are ready to use the medicine.
  • Spiriva® Respimat® inhaler: Throw away the inhaler 3 months after its first use.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tiotropium works. Tell your doctor if you are using ipratropium or other inhaled medicines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, glaucoma, prostate problems, or problems urinating. Tell your doctor if you are allergic to milk proteins.
• This medicine may cause the following problems:
  • Paradoxical bronchospasm (increased trouble breathing), which can be life-threatening
  • New or worsening narrow-angle glaucoma
  • New or worsening trouble urinating
• This medicine may cause dizziness or blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Tell your doctor right away if you use other medicines for your lung condition and they do not seem to be working as well as usual. Do not change your doses or stop using your medicines before you talk to your doctor.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful or difficult urination
• Eye pain or redness, vision problems, seeing halos around lights
• Increased trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Cough, fever, runny nose, or sore throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088