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Spiriva HandiHaler

Pronunciation

Generic Name: tiotropium (TYE-oh-TROE-pee-um)
Brand Name: Spiriva HandiHaler

Spiriva HandiHaler is used for:

Treating symptoms of chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.

Spiriva HandiHaler is an anticholinergic agent. It works by enlarging the airways to allow easier breathing.

Do NOT use Spiriva HandiHaler if:

  • you are allergic to any ingredient in Spiriva HandiHaler or to a related medicine (eg, ipratropium)
  • you are taking another anticholinergic (eg, ipratropium)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Spiriva HandiHaler:

Some medical conditions may interact with Spiriva HandiHaler. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (including milk proteins)
  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to atropine
  • if you have trouble urinating, an enlarged prostate, bladder blockage, glaucoma, or kidney problems
  • if you are having an asthma attack or increased difficulty breathing

Some MEDICINES MAY INTERACT with Spiriva HandiHaler. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticholinergics (eg, ipratropium) because they may increase the risk of Spiriva HandiHaler's side effects. Ask your doctor if you are unsure if any of your medicines are anticholinergics

This may not be a complete list of all interactions that may occur. Ask your health care provider if Spiriva HandiHaler may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Spiriva HandiHaler:

Use Spiriva HandiHaler as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Spiriva HandiHaler. Talk to your pharmacist if you have questions about this information.
  • Do not swallow the capsules. The capsules are used with the provided special inhaler.
  • Do not use any other medicines with the special inhaler device.
  • To remove the capsule from the packaging, peel back the foil and tip the capsule out. Do NOT cut the foil or use anything sharp to remove the capsule.
  • Do not remove a capsule from the packaging until you are ready to use it. If a second capsule is exposed to the air when you are removing a capsule for use, it must be discarded. Do not save the capsule for later.
  • Place the capsule in the special inhaler device right away as directed. Do NOT open the capsule before you place it in the device. Close the mouthpiece against the base until you hear a click. The device will puncture the capsule so that the medicine inside may be inhaled into the lungs through the mouthpiece.
  • Hold the device with the mouthpiece pointed up. Press the green button 1 time to pierce the capsule. Do NOT press the green button more than once. Do NOT shake the device.
  • Exhale slowly and deeply. Do not exhale into the mouthpiece of the inhaler. Position the inhaler mouthpiece between your lips and try to rest your tongue flat. Keep your head upright. Take a slow, deep breath. You should hear or feel the capsule vibrate inside the inhaler. Take the device out of your mouth and hold your breath for as long as it feels comfortable. Exhale slowly through pursed lips. Breathe out completely.
  • To be sure all of the medicine has been inhaled from the capsule, inhale from the mouthpiece a second time following the same process.
  • You may inhale small pieces of the capsule when you breathe in Spiriva HandiHaler. This is normal and should not harm you.
  • Ask your doctor or pharmacist if you are unclear on how to use this device or inhale the medicine.
  • Always use the new inhaler device provided with your medicine. Clean the device as needed according to the instructions in the patient leaflet.
  • Using Spiriva HandiHaler at the same time each day will help you remember to use it.
  • Use Spiriva HandiHaler on a regular schedule to get the most benefit from it.
  • If you miss a dose of Spiriva HandiHaler, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. Do not use Spiriva HandiHaler more often than 1 time every 24 hours.

Ask your health care provider any questions you may have about how to use Spiriva HandiHaler.

Important safety information:

  • Spiriva HandiHaler may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Spiriva HandiHaler with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Spiriva HandiHaler will not stop an asthma attack once it has started. If you are also using a rescue inhaler (eg, albuterol), be sure to always carry it with you to use during asthma attacks.
  • Avoid getting Spiriva HandiHaler in your eyes. If you get Spiriva HandiHaler in your eyes and eye pain, blurred vision, or other vision changes occur, contact your doctor immediately.
  • Spiriva HandiHaler may sometimes cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator inhaler. Contact your doctor or seek other medical care at once.
  • Use Spiriva HandiHaler with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, dry mouth, or urinary tract infections.
  • Spiriva HandiHaler should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Spiriva HandiHaler while you are pregnant. It is not known if Spiriva HandiHaler is found in breast milk. If you are or will be breast-feeding while you use Spiriva HandiHaler, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Spiriva HandiHaler:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dry mouth; indigestion; mild nosebleed; runny nose; sinus inflammation or infection; sore throat; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; chest pain; depression; difficult or painful urination; eye pain or discomfort; fast or irregular heartbeat; irritation, pain, or white patches in the mouth or on the tongue; mouth sores; new or worsened breathing problems; severe or persistent constipation; severe or persistent nosebleed; vision changes (eg, halos, colored images); wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include mental changes; severe constipation; stomach pain; tremors.

Proper storage of Spiriva HandiHaler:

Store Spiriva HandiHaler at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Spiriva HandiHaler out of the reach of children and away from pets.

General information:

  • If you have any questions about Spiriva HandiHaler, please talk with your doctor, pharmacist, or other health care provider.
  • Spiriva HandiHaler is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Spiriva HandiHaler or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Spiriva HandiHaler. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Spiriva HandiHaler. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Spiriva HandiHaler.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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