Spiriva Respimat 10 ACT is a bronchodilator that is used to prevent bronchospasm (narrowing of the airways in the lungs) in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Spiriva Respimat 10 ACT is also used to prevent asthma attacks in adults and children who are at least 6 years old.

Spiriva Respimat 10 ACT may also be used for purposes not listed in this medication guide.

A tiotropium capsule is for use only in the HandiHaler device. Do not take the capsule by mouth. Use only one capsule at a time.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Spiriva Respimat 10 ACT is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Spiriva Respimat 10 ACT powder is packaged in capsules that are for use only with a special inhaler device (Spiriva HandiHaler). Do not take the capsule by mouth.

Spiriva Respimat 10 ACT aerosol is a cartridge that is inserted into a special inhaler device (Spiriva Respimat). Turning the base of the Respimat device until it clicks will release the medicine into the inhaler chamber.

Any child using Spiriva Respimat 10 ACT should be supervised by an adult while using this medicine.

You may need frequent lung function tests.

Store this medicine at room temperature away from moisture and heat. Do not freeze.

Do not remove a tiotropium capsule from its blister pack until you are ready to place the capsule into the HandiHaler and use the device.

You should not use Spiriva Respimat 10 ACT if you are allergic to tiotropium or ipratropium (Atrovent, Combivent, DuoNeb).

Tell your doctor if you have ever had:

• narrow-angle glaucoma;

• kidney disease;

• a milk allergy; or

• an enlarged prostate or urination problems.

Tell your doctor if you are pregnant. It is not known whether tiotropium will harm an unborn baby. However, having uncontrolled asthma during pregnancy may cause premature birth, a low birth weight baby, or complications such as eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Spiriva Respimat 10 ACT is not approved for use by anyone younger than 6 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Do not use more than two times in a 24-hour period.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dry mouth, eye redness, constipation, stomach pain, and confusion or drowsiness.

Avoid getting the powder from a tiotropium capsule in your eyes. If this does happen, call your doctor.

Avoid driving or hazardous activity until you know how Spiriva Respimat 10 ACT will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Spiriva Respimat 10 ACT may cause serious side effects. Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using Spiriva Respimat 10 ACT;

• blurred vision, eye pain or redness, seeing halos around lights;

• sores or white patches on your mouth, lips, or tongue;

• pain or burning when you urinate; or

• little or no urinating.

Common side effects of Spiriva Respimat 10 ACT may include:

• dry mouth;

• blurred vision;

• constipation, painful urination;

• upset stomach;

• chest pain, fast heart rate; or

• cold symptoms such as stuffy or runny nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• bronchodilator asthma medication.

This list is not complete. Other drugs may affect tiotropium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.