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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Spiriva HandiHaler?

Spiriva HandiHaler can help to treat symptoms of chronic obstructive pulmonary disease, also known as COPD. These symptoms include bronchitis and emphysema. By enlarging the airways Spiriva HandiHaler makes it easier for you to breathe. Spiriva HandiHaler may also be used for other conditions as determined by your doctor.

Key Facts About Spiriva HandiHaler

Spiriva HandiHaler is an anticholinergic agent, and it can help patients with COPD to breathe easier, because it opens and enlarges the airways.

Spiriva HandiHaler is in FDA pregnancy category C. It is not known whether Spiriva HandiHaler can be harmful to an unborn baby. You should tell your doctor if you are pregnant or plan to become pregnant before using Spiriva HandiHaler. Do not use Spiriva Handihaler if you are breast-feeding as it is not known if this medication passes into breast milk.

The Spiriva capsule is to be inhaled usi only in the HandiHaler device and then discarded. It is important that you use one capsule at a time, and not take the capsule by mouth.

Do not use Spiriva HandiHaler if you are having a bronchospasm attack. Spiriva HandiHaler is not for a bronchospasm attack that has already started. It will not work fast enough to reverse your symptoms. Use a fast-acting inhalation medication to treat a bronchospasm attack. Your doctor can help you obtain the right fast-acting inhaler to treat your individual symptoms

Before You Take Spiriva HandiHaler

You should not take Spiriva Handihaler if you are allergic to Tiotropium.

You should not use Spiriva HandiHaler if you are allergic to ipratropium (Atrovent, Combivent, DuoNeb).

Tell your doctor if you take other anticholinergics, such as ipratropium, because they may increase the risk of Spiriva HandiHaler’s side effects. Your doctor can identify if you take any anticholinergics if you are not sure.

You should talk to your doctor before taking Spiriva HandiHaler if you have an allergy to milk or milk proteins.

If you have narrow angle glaucoma you should tell your doctor before taking Spiriva HandiHaler.

You should not take Spiriva if you have an enlarged prostate, urination problems, bladder obstruction or kidney disease.

Spiriva HandiHaler Drug Interactions

You should inform your doctor if you are taking any of the following:

• belladonna (Donnatal)
• benztropine (Cogentin)
• cough, cold or allergy medications
• darifenacin (Enablex),
• dimenhydrinate (Dramamine, Gravol)
• flavoxate (Urispas)
• irritable bowel medications like dicyclomine (Bentyl), hyoscyamine (Hyomax) and propantheline (Pro Banthine)
• methscopolamine (Pamine)
• oxybutynin (Ditropan, Oxytrol)
• scopolamine (Transderm-Scop)
• solifenacin (Vesicare)
• steroid medications like prednisone (Deltasone, Sterapred), methylprednisolone (Medrol), fluticasone (Advair , Flonase, Flovent, Veramyst), beclomethasone (Qvar), budesonide (Pulmicort, Rhinocort, Symbicort), dexamethasone (Cortastat, Dexasone, Solurex, DexPak), mometasone (Asmanex, Nasonex) and triamcinolone (Nasacort)
• theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl)
• tolterodine (Detrol)
• tropine (Atreza, Sal-Tropine)
• ulcer medications like glycopyrrolate (Robinul) and omepenzolate (Cantil)

Other drugs you take that are not listed may interact with Spiriva HandiHaler. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Spiriva HandiHaler

Spiriva is used to prevent bronchospasm attacks. Do not use this medication to treat a bronchospasm attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an attack.

You should only use the Spiriva capsule in the HandiHaler device. Do not take the capsule by mouth

Use only one capsule at a time in the Spiriva HandiHaler device.

You should use Spiriva on a regular basis to get the most benefit from this medication. Be sure to refill your prescription early enough so you do not run out of medication completely.

You must keep each Spiriva capsule in its blister pack until you are ready to place the capsule into the HandiHaler and use the device. Be sure to throw away any capsule that is not used right after you have taken it out of the blister pack because any exposure to air can ruin the capsule.

Your doctor may have you complete lung function tests on a regular basis while you are being treated with Spiriva HandiHaler to be sure that your condition is getting better and not worse.

Use Spiriva as your doctor has prescribed. Do not use Spriva HandiHaler in larger or smaller amounts, or for shorter or longer than recommended. Follow the directions on your prescription label exactly.

Store Spiriva at room temperature away from moisture and direct sunlight. Spiriva HandiHaler should be stored at between 68 and 77 degrees F (20 and 25 degrees C).

Use all of your medications as directed by your doctor. Talk with your doctor if your Spiriva HandiHaler is not working well in treating or preventing your bronchospasm attacks.

If you miss a dose of Spiriva HandiHaler you should attempt to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose do not take the missed dose in addition to your regular dose.

Spiriva HandiHaler Side Effects

If you experience any of the following adverse effects you should stop taking Spiriva Handihaler and seek medical help immediately:

• Paradoxical bronchospasm; In rare cases the medication may cause a worsening of breathing. This may occur when starting a new box of Spiriva capsules. If this occurs or if you experience trouble breathing or wheezing discontinue using Spiriva Handihaler and seek medical assistance.
• allergic reaction such as difficult breathing, hives, or swelling of your face, lips, throat or tongue
• blurred vision, mis-colored images, eye pain or redness, or seeing halos around lights
• chest pain or tightness
• pain or burning when urinating, urinating less than normal or not at all
• rapid heart rate
• sores or white patches of your mouth, lips, or tongue

More common adverse effects of Spiriva HandiHaler may include:

• cold symptoms like a stuffy nose, sore throat or sneezing
• dry mouth
• inflamed sinus
• sore throat
• heartburn
• muscle pain
• nosebleeds
• upset stomach

It should be noted that this is not a complete list of possible side effects of Spiriva HandiHaler. You should contact your physician for a complete list and medical advice regarding these effects.

Spiriva HandiHaler Description and Dosing

Spiriva HandiHaler is indicated for indicated for the long-term, once-daily, and maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The typical dose of Spiriva is two inhalations of the powder contents of one Spiriva capsule, once as day, with the HandiHaler device. Your doctor will prescribe the dose that is right for you, and it is important that you follow your doctor’s instructions for taking Spiriva HandiHaler exactly as prescribed.

In the U.S. Spiriva HandiHaler is a combination of Spiriva capsules and a HandiHaler device. The Spiriva capsules contain 18 mcg of dry powder formulation, consisting of tiotropium, in a light green, hard gelatin capsule. The capsule has TI 01 printed on one side and the Boehringer Ingelheim company logo on the other side.

If you suspect that you have overdosed with Spiriva HandiHaler you should seek emergency help immediately.

Ingredients in Spiriva HandiHaler

Spiriva HandiHaler’s ingredients are tiotropium bromide and lactose monohydrate

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.