What is the most important information I should know about Spiriva?

Spiriva is not intended for use during acute bronchospastic attacks (sudden occurrence of difficulty breathing). It may not be able to open your airways and allow you to breath. Tiotropium is used to prevent attacks, it should not be used as a rescue medication.

It is very important that you use the tiotropium inhaler properly, so that the medicine gets into the lungs. Talk to your healthcare provider about proper inhaler use.

In rare cases, Spiriva has been associated with the development of narrow-angle glaucoma, an eye disorder. Contact your doctor immediately if you develop symptoms suggestive of narrow-angle glaucoma such as eye pain or discomfort, blurred vision, visual halos around objects, color distortion, or redness of the eyes. Do not allow the powder to come into contact with the eyes. This may cause blurring of vision and dilation of the pupils. If contact with the eyes occurs, flush with water and seek medical attention if side effects occur.

What is Spiriva?

Spiriva is an anticholinergic medication. Tiotropium prevents narrowing of the airways.

Spiriva is used in the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) such as chronic bronchitis and emphysema.

Spiriva may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using Spiriva?

Do not use Spiriva without first talking to your doctor if you have:

• an allergy to ipratropium (Atrovent, Combivent) or atropine;
• narrow-angle glaucoma;
• kidney disease;
• enlargement of the prostate; or
• difficulty urinating.

You may not be able to use Spiriva, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Spiriva is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use Spiriva without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether tiotropium passes into breast milk. Do not use Spiriva without first talking to your doctor if you are breast-feeding a baby.

How should I use Spiriva?

Use Spiriva exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Tiotropium capsules are intended for use in the inhaler provided. Do not swallow the capsules. Do not use the inhaler device to administer any medications other than tiotropium.

The tiotropium capsules should be stored in the sealed blisters and only removed immediately before use. The drug should be used immediately after the packaging over an individual capsule is opened, or else its effectiveness may be reduced. If additional capsules are accidentally exposed to air, they should be thrown away and not used.

Separate a blister card along the perforated line. Carefully peel back the aluminum foil using the tab until one capsule is fully visible. Peel back the foil only as far as the "STOP" line printed on the foil to prevent exposure of more than one capsule. After using the first capsule, the 2 remaining capsules in the blister strip should be used over the next 2 consecutive days.

To use the inhaler:

• Open the dust cap on the inhaler device by pulling it upwards. Then, open the mouthpiece. Insert the capsule in the center chamber. It does not matter which end of the capsule is placed in the chamber. Close the mouthpiece firmly until you hear a click, leaving the dust cap open.
• Hold the inhaler device with the mouthpiece upwards and press the piercing button completely in one time and release. This makes holes in the capsule and allows the medication to be released when you breathe in through the mouthpiece.
• Breathe out fully, away from the mouthpiece. Never breathe into the mouthpiece.
• Raise the inhaler to your mouth and close your lips tightly around the mouthpiece. Keep your head in an upright position and breathe in slowly and deeply but at a rate sufficient to hear the capsule vibrate. Breathe in until your lungs are full. Hold your breath as long as is comfortable and at the same time take the inhaler out of your mouth. Resume normal breathing.
• To ensure you get the full dose, breathe out once again, place the inhaler back in your mouth, and breathe in deeply again.
• After completing a dose, open the mouthpiece and tip out the used capsule and dispose. Close the mouthpiece and dust cap for storage of the inhaler.

Spiriva is usually used once a day. Follow your doctor's instructions. Do not use more of the medication or use it more often than is directed.

The tiotropium capsules contain only a small amount of powder and as a result the capsule is only partially filled. After using a dose, you may notice that a tiny amount of the powder is left in the capsule. This is normal.

It is very important that you use the tiotropium inhaler properly, so that the medicine gets into the lungs. Talk to your healthcare provider about proper inhaler use.

It is important to use Spiriva regularly to get the most benefit.

Spiriva is not intended for use during acute bronchospastic attacks (sudden occurrence of difficulty breathing). It may not be able to open your airways and allow you to breath. Tiotropium is used to prevent attacks, it should not be used as a rescue medication.

Your doctor may want you to have lung function tests or other medical evaluations during treatment with Spiriva to monitor progress and side effects.

Normally, during a one-month period of use, the inhaler device does not need to be cleaned. However, if cleaning is necessary, open the dust cap and mouth piece. Open the base by lifting the piercing button. Rinse the entire inhaler with warm water to remove any powder. Do not use cleaning agents or detergents. Tip out any water and air-dry, leaving the dust cap, mouthpiece and base open. It takes about 24 hours to air dry, so if cleaning is needed, do it immediately following a dose so it will be ready for the next dose. Do not use the inhaler if it is wet. The outside of the inhaler can be cleaned with a damp, not wet, tissue.

Store Spiriva at room temperature away from moisture and heat. Store the capsules, unopened, in the blister packaging. Do not store the capsules in the inhaler.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a tiotropium overdose may include altered mental status, shaking, abdominal pain, and constipation.

What should I avoid while using Spiriva?

Do not allow the powder to come into contact with the eyes. This may cause blurring of vision and dilation of the pupils. If contact with the eyes occurs, flush with water and seek medical attention if side effects occur.

What are the possible side effects of Spiriva?

In rare cases, Spiriva has been associated with the development of narrow-angle glaucoma, an eye disorder. Contact your doctor immediately if you develop symptoms suggestive of narrow-angle glaucoma such as eye pain or discomfort, blurred vision, visual halos around objects, color distortion, or redness of the eyes. If you experience either of the following serious side effects, stop using Spiriva and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
• increased difficulty breathing.

Other, less serious side effects may be more likely to occur. Continue to use Spiriva and talk to your doctor if you experience

• dry mouth;
• constipation;
• difficult or painful urination; or
• increased heart rate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Spiriva?

Before using Spiriva, talk to your doctor if you are taking any of the following medicines:

• ipratropium (Atrovent);
• albuterol and ipratropium (Combivent, DuoNeb);
• dicyclomine (Bentyl),
• propantheline (Pro-Banthine),
• mepenzolate (Cantil),
• methscopolamine (Pamine), and
• scopolamine (Transderm-Scop).

You may not be able to use Spiriva, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with Spiriva or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.