Family Circle - October 2010

IMPORTANT PATIENT INFORMATION

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

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Do NOT swallow SPIRIVA capsules.

Important Information: Do not swallow SPIRIVA capsules. SPIRIVA capsules should only be used with the HandiHaler device. SPIRIVA HandiHaler should only be inhaled by 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 “Patient’s Instructions for Use” that comes with your prescription 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 “Patient’s Instructions for Use” that comes with your prescription.

• 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.

After putting the SPIRIVA capsule into the
HandiHaler device, breathe in your
medicine through your mouth.

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 common 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 (20oC-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.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, C T 06877 USA Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, C T 06877 USA and Pfizer Inc New York, N Y 10017 USA Licensed from: Boehringer Ingelheim International GmbH SPIRIVA® and HandiHaler® are registered trademarks and are used under license from Boehringer Ingelheim International GmbH.

©Copyright 2009 Boehringer Ingelheim International GmbH ALL RIGH TS RESERVED SPIRIVA® is covered by U.S. Patent Nos. RE38,912, RE39,820, 5,478,578, 6,777,423, 6,908,928, 7,070,800, and 7,309,707 with other patents pending. The HandiHaler® device is covered by U.S. Design Patent No. D355,029 with other patents pending.