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SPIRIVA® HandiHaler®
(speh REE vah)
(tiotropium bromide) inhalation powder

Do NOT swallow SPIRIVA capsules.

Important Information: Do not swallow SPIRIVA capsules. SPIRIVA capsules should only be used with the HandiHaler device and inhaled through your mouth (oral inhalation).

Read the information that comes with your SPIRIVA HandiHaler before you start using it and each time you refill your prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is SPIRIVA HandiHaler?

SPIRIVA HandiHaler is a prescription medicine that you use one time every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD). SPIRIVA HandiHaler helps make your lungs work better for 24 hours. SPIRIVA HandiHaler relaxes your airways and helps keep them open. You may start to feel like it is easier to breathe on the first day, but it may take longer for you to feel the full effects of the medicine. SPIRIVA HandiHaler works best and may help make it easier to breathe when you use it every day.

SPIRIVA HandiHaler also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations). A COPD exacerbation is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath, and wheezing that requires medicine beyond your rescue medicine.

SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA HandiHaler has not been studied in children.

Who should not take SPIRIVA HandiHaler?

Do not use SPIRIVA HandiHaler if you:

• are allergic to tiotropium. See the end of this leaflet for a complete list of ingredients.
• have had an allergic reaction to ipratropium (Atrovent®).

Allergic reactions may include itching, rash, or swelling of the lips, tongue, or throat (trouble swallowing).

What should I tell my doctor before using SPIRIVA HandiHaler?

Before taking SPIRIVA HandiHaler, tell your doctor about all your medical conditions, including if you:

• have kidney problems.
• have glaucoma. SPIRIVA HandiHaler may make your glaucoma worse.
• have an enlarged prostate, problems passing urine, or a blockage in your bladder. SPIRIVA HandiHaler may make these problems worse.
• are pregnant or plan to become pregnant. It is not known if SPIRIVA HandiHaler could harm your unborn baby.
• are breast-feeding or plan to breast-feed. It is not known if SPIRIVA HandiHaler passes into breast milk. You and your doctor will decide if SPIRIVA HandiHaler is right for you while you breast-feed.
• have a severe allergy to milk proteins. Ask your doctor if you are not sure.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and eye drops, vitamins, and herbal supplements. Some of your other medicines or supplements may affect the way SPIRIVA HandiHaler works. SPIRIVA HandiHaler is an anticholinergic medicine. You should not take other anticholinergic medicines while using SPIRIVA HandiHaler, including ipratropium. Ask your doctor or pharmacist if you are not sure if one of your medicines is an anticholinergic.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I take SPIRIVA HandiHaler?

• Use SPIRIVA HandiHaler exactly as prescribed. Use SPIRIVA HandiHaler one time every day.
• Read the “Instructions for Use” at the end of this leaflet before you use SPIRIVA HandiHaler. Talk with your doctor if you do not understand the instructions.
• Do not swallow SPIRIVA capsules.
• Only use SPIRIVA capsules with the HandiHaler device.
• Do not use the HandiHaler device to take any other medicine.
• SPIRIVA HandiHaler comes as a powder in a SPIRIVA capsule that fits the HandiHaler device. Each SPIRIVA capsule, containing only a small amount of SPIRIVA powder, is one full dose of medicine.
• Separate one blister from the blister card. Then take out one of the SPIRIVA capsules from the blister package right before you use it.
• After the capsule is pierced, take a complete dose of SPIRIVA HandiHaler by breathing in the powder by mouth two times, using the HandiHaler device (take 2 inhalations from one SPIRIVA capsule). See the “Instructions for Use” at the end of this leaflet.
• Throw away any SPIRIVA capsule that is not used right away after it is taken out of the blister package. Do not leave the SPIRIVA capsules open to air; they may not work as well.
• If you miss a dose, take it as soon as you remember. Do not use SPIRIVA HandiHaler more than one time every 24 hours.
• If you use more than your prescribed dose of SPIRIVA HandiHaler, call your doctor or a poison control center.

What should I avoid while using SPIRIVA HandiHaler?

Do not let the powder from the SPIRIVA capsule get into your eyes. Your vision may get blurry and the pupil in your eye may get larger (dilate). If this happens, call your doctor.

What are the possible side effects of SPIRIVA HandiHaler?

SPIRIVA HandiHaler can cause serious side effects. If you get any of the following side effects, stop taking SPIRIVA HandiHaler and get medical help right away.

• Allergic reaction. Symptoms may include: itching, rash, swelling of the lips, tongue, or throat (trouble swallowing).
• Sudden narrowing and blockage of the airways into the lungs (bronchospasm). Your breathing suddenly gets worse.
• New or worsened increased pressure in the eyes (acute narrow-angle glaucoma). Symptoms of acute narrow-angle glaucoma may include: eye pain, blurred vision, seeing halos (visual halos) or colored images along with red eyes.
• New or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include: difficulty passing urine, painful urination.

Other side effects with SPIRIVA HandiHaler 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
• blurred vision

These are not all the possible side effects with SPIRIVA HandiHaler. Tell your doctor if you have any side effect that bothers you or that does not go away.

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

How do I store SPIRIVA HandiHaler?

• Do not store SPIRIVA capsules in the HandiHaler device.
• Store SPIRIVA capsules in the sealed blister package at room temperature between 68oF–77oF (20o–25oC).
• Keep SPIRIVA capsules away from heat and cold (do not freeze).
• Store SPIRIVA capsules in a dry place. Throw away any unused SPIRIVA capsules that have been open to air.

Ask your doctor or pharmacist if you have any questions about storing your SPIRIVA capsules.

Keep SPIRIVA HandiHaler, SPIRIVA capsules, and all medicines out of the reach of children.

General information about SPIRIVA HandiHaler

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use SPIRIVA HandiHaler for a purpose for which it has not been prescribed. Do not give SPIRIVA HandiHaler to other people even if they have the same symptoms that you have. It may harm them.

For more information about SPIRIVA HandiHaler, talk with your doctor. You can ask your doctor or pharmacist for information about SPIRIVA HandiHaler that is written for health professionals.

For more information about SPIRIVA HandiHaler, you may call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.

What are the ingredients in SPIRIVA HandiHaler?

Active ingredient: tiotropium

Inactive ingredient: lactose monohydrate

What is COPD (Chronic Obstructive Pulmonary Disease)?

COPD is a serious lung disease that includes chronic bronchitis, emphysema, or both. Most COPD is caused by smoking. When you have COPD, your airways become narrow. So, air moves out of your lungs more slowly. This makes it hard to breathe.

Instructions for Use

SPIRIVA® HandiHaler®
(speh REE vah)
(tiotropium bromide inhalation powder)

Do not swallow SPIRIVA capsules.

Important Information about using your SPIRIVA HandiHaler

• Do not swallow SPIRIVA capsules.
• SPIRIVA capsules should only be used with the HandiHaler device and inhaled through your mouth (oral inhalation).
• Do not use your HandiHaler device to take any other medicine.

First read the Patient Information, then read these Instructions for Use before you start to use SPIRIVA HandiHaler and each time you refill your prescription. There may be new information.

Becoming familiar with your HandiHaler device and SPIRIVA capsules:

Your SPIRIVA HandiHaler comes with SPIRIVA capsules in blister packaging and a HandiHaler device. Use the new HandiHaler device provided with your medicine.

The parts of your HandiHaler device include: (See Figure A)

1. dust cap (lid)
2. mouthpiece
3. mouthpiece ridge
4. base
5. green piercing button
6. center chamber
7. air intake vents

Figure A

Each SPIRIVA capsule is packaged in a blister. (See Figure B)

Figure B

• Each SPIRIVA capsule contains only a small amount of powder. (See Figure C) This is 1 full dose.
• Do not open the SPIRIVA capsule or it may not work.

Figure C

Taking your full daily dose of medicine requires 4 main steps.

Step 1. Opening your HandiHaler device:

After removing your HandiHaler device from the pouch:

• Open the dust cap (lid) by pressing the green piercing button. (See Figure D)

Figure D

• Pull the dust cap (lid) upwards away from the base to expose the mouthpiece. (See Figure E)

Figure E

• Open the mouthpiece by pulling the mouthpiece ridge up and away from the base so the center chamber is showing. (See Figure F)

Figure F

Step 2. Inserting the SPIRIVA capsule into your HandiHaler device:

Each day, separate only 1 of the blisters from the blister card by tearing along the perforated line. (See Figure G)

Figure G

Remove the SPIRIVA capsule from the blister:

• Do not cut the foil or use sharp instruments to take out the SPIRIVA capsule from the blister.
• Bend 1 of the blister corners with an arrow and separate the aluminum foil layers.
• Peel back the printed foil until you see the whole SPIRIVA capsule. (See Figure H)
• If you have opened more than 1 blister to the air, the extra SPIRIVA capsule should not be used and should be thrown away

Figure H

Place the SPIRIVA capsule in the center chamber of your HandiHaler device. (See Figure I)

Figure I

Close the mouthpiece firmly against the gray base until you hear a click. Leave the dust cap (lid) open. (See Figure J)

Figure J

Step 3. Piercing the SPIRIVA capsule:

• Hold your HandiHaler device with the mouthpiece pointed up. (See Figure K)
• Press the green piercing button once until it is flat (flush) against the base, then release. This is how you make holes in the SPIRIVA capsule so that you get your medicine when you breathe in.
• Do not press the green button more than one time.
• Do not shake your HandiHaler device.
• The piercing of the SPIRIVA capsule may produce small gelatin pieces. Some of these small pieces may pass through the screen of your HandiHaler device into your mouth or throat when you breathe in your medicine. This is normal. The small pieces of gelatin should not harm you.

Figure K

Step 4. Taking your full daily dose (2 inhalations from the same SPIRIVA capsule):

Breathe out completely in 1 breath, emptying your lungs of any air. (See Figure L)

Important: Do not breathe into your HandiHaler device.

Figure L

With your next breath, take your medicine:

• Hold your head in an upright position while you are looking straight ahead. (See Figure M)
• Raise your HandiHaler device to your mouth in a horizontal position. Do not block the air intake vents.
• Close your lips tightly around the mouthpiece.
• Breathe in deeply until your lungs are full. You should hear or feel the SPIRIVA capsule vibrate (rattle). (See Figure M)
• Hold your breath for a few seconds and, at the same time, take your HandiHaler device out of your mouth.
• Breathe normally again.

The rattle tells you that you breathed in correctly. If you do not hear or feel a rattle, see the section, “If you do not hear or feel the SPIRIVA capsule rattle as you breathe in your medicine.”

Figure M

Figure N

To get your full daily dose, you must again, breathe out completely (See Figure N) and for a second time, breathe in (See Figure O) from the same SPIRIVA capsule.

Important: Do not press the green piercing button again.

Remember: To get your full medicine dose each day, you must breathe in 2 times from the same SPIRIVA capsule. Make sure you breathe out completely each time before you breathe in from your HandiHaler device.

Figure O

Caring for and storing your SPIRIVA HandiHaler:

• After taking your daily dose, open the mouthpiece and tip out the used SPIRIVA capsule into your trash can, without touching it.
• Remove any SPIRIVA capsule pieces or SPIRIVA powder buildup by turning your HandiHaler device upside down and gently, but firmly, tapping it. (See Figure P) Then, close the mouthpiece and dustcap for storage.
• Do not store your HandiHaler device and SPIRIVA capsules (blisters) in a damp moist place. Always store SPIRIVA capsules in the sealed blisters.

Figure P

If you do not hear or feel the SPIRIVA capsule rattle as you breathe in your medicine:

Do not press the green piercing button again.

Hold your HandiHaler device with the mouthpiece pointed up and tap your HandiHaler device gently on a table. (See Figure Q)

Check to see that the mouthpiece is completely closed. Breathe out completely before deeply breathing in again with the mouthpiece in your mouth. (See Figure O)

If you still do not hear or feel the SPIRIVA capsule rattle after repeating the above steps:

• Throw away the SPIRIVA capsule.
• Open the base by lifting the green piercing button and check the center chamber for pieces of the SPIRIVA capsule. SPIRIVA capsule pieces in the center chamber can cause a SPIRIVA capsule not to rattle.
• Turn your HandiHaler device upside down and gently, but firmly, tap to remove the SPIRIVA capsule pieces. Call your doctor for instructions.

Figure Q

Cleaning your HandiHaler device:

Clean your HandiHaler device as needed. (See Figure R)

• It takes 24 hours to air dry your HandiHaler device after you clean it.
• Do not use cleaning agents or detergents.
• Do not place your HandiHaler device in the dishwasher for cleaning.

Cleaning Steps:

• Open the dust cap and mouthpiece
• Open the base by lifting the green piercing button.
• Look in the center chamber for SPIRIVA capsule pieces or powder buildup. If seen, tap out.
• Rinse your HandiHaler device with warm water, pressing the green piercing button a few times so that the center chamber and the piercing needle is under the running water. Check that any powder buildup or SPIRIVA capsule pieces are removed.
• Dry your HandiHaler device well by tipping the excess water out on a paper towel. Air-dry afterwards, leaving the dust cap, mouthpiece, and base open by fully spreading it out so that it dries completely.
• Do not use a hair dryer to dry your HandiHaler device.
• Do not use your HandiHaler device when it is wet. If needed, you may clean the outside of the mouthpiece with a clean damp cloth.

Figure R

Helpful Hints to help ensure that you are properly taking your full daily dose of SPIRIVA HandiHaler:

• Press the green piercing button 1 time; Breathe in 2 times; Breathe out completely before each of the 2 inhalations.
• Always use the new HandiHaler device provided with your medicine.
• Keep your HandiHaler device with the mouthpiece pointed up when pressing the green piercing button.
• Press the green piercing button 1 time to pierce the SPIRIVA capsule.
• Do not breathe out into your HandiHaler device.
• Keep your HandiHaler device in a horizontal position and keep your head upright, looking straight ahead, when breathing in.
• Check the center chamber of your HandiHaler device for SPIRIVA capsule pieces or powder build-up. If pieces or powder are seen, tap out before use.
• Clean your HandiHaler as needed and dry thoroughly.

For more information, ask your doctor or pharmacist, or go to www.spiriva.com or call 1-800-XXX-XXX.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 9/7/2011
This monograph has been modified to include the generic and brand name in many instances.