Tiotropium belongs to the class of medications called bronchodilators. This medication is used once daily for the long-term relief of symptoms such as shortness of breath and wheezing associated with the lung disease known as chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. Tiotropium works by opening the airways to make breathing easier.

Tiotropium should not be used as a rescue medication to relieve sudden attacks of COPD symptoms such as wheezing or shortness of breath. Consult your doctor or pharmacist for advice about rescue medications that are appropriate for you.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

For adults and children 18 years of age and older, the recommended dosage of tiotropium is to inhale the contents of one 18 µg capsule once daily through the inhalation device.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Take this medication at the same time each morning. The capsule shell should be discarded after the medication has been taken. Do not swallow the capsule shell.

Your doctor or another health care professional, such as your pharmacist, should teach you how to use the inhalation device. If you are unsure of how to use the device, contact your doctor or pharmacist.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Tiotropium capsules are sensitive to the moisture in the air. Once the strip of 5 capsules has been opened, they may be used for a maximum of 5 days. Discard any capsules that remain after 5 days.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Spiriva

Capsule

Each light green, hard gelatin capsule printed "TI 01" on one side and the Boehringer Ingelheim company logo on the other side contains 18 µg of tiotropium. Nonmedicinal ingredients: lactose is used as a filler. Capsule shells are made of gelatin.

Inhalation device

The HandiHaler® inhalation device is a grey reusable plastic device that is especially designed for administering Spiriva® capsules.

Do not use this medication if you:

• are allergic to tiotropium or any ingredients of this medication
• are allergic to atropine or atropine-like medications (e.g., ipratropium)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bad taste in your mouth
• constipation
• cough
• dizziness
• dry mouth or throat
• dry skin
• hoarseness
• itching
• joint swelling
• nosebleed
• rash
• sinus infection (e.g., facial pain, congestion)
• sore throat
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision or other changes in vision
• difficulty passing urine
• heartburn
• rapid, pounding, or irregular heartbeat
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• skin sores or infection
• sores, ulcers, or white spots on lips or tongue or inside the mouth
• swelling or redness of the mouth, gums, or tongue
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• cough, wheezing, or breathlessness immediately after using the inhaler
• lack of bowel movements (bowel obstruction)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• trouble swallowing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Dizziness/blurred vision: Tiotropium may cause dizziness or blurred vision, affecting your ability to safely drive or operate machinery. Avoid these and other hazardous tasks until you know how this medication affects you.

Lactose: Tiotropium capsules are prepared with lactose. If you have a milk protein allergy, talk to your doctor about whether this medication is appropriate for you.

Glaucoma: People with eye conditions (e.g., glaucoma) are more likely to experience worsening of their conditions and symptoms such as eye pain and swelling, blurred vision, or other unusual changes in their vision. Take extra care to ensure that tiotropium powder does not come into contact with your eyes. If your eyes have been in contact with tiotropium powder or you have any of these symptoms, contact your doctor immediately.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways which make breathing difficult. If you experience this problem when using tiotropium, stop using this medication immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Kidney function: Reduced kidney function or kidney disease may cause tiotropium to build up in the body, causing side effects. For people with reduced kidney function, tiotropium should only be used if the potential benefits outweigh the risks.

If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Urinary tract problems: This medication can cause increased difficulty with urine flow and urinary retention. If you have an enlarged prostate gland or another condition that makes it difficult to pass urine, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience difficulty starting to urinate or have pain when you urinate, speak with your doctor as soon as possible.

Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening COPD):

• decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol or terbutaline (less than 4 hours of relief)
• need for more inhalations than usual of short-acting, inhaled bronchodilators

Pregnancy: No studies have been done on the use of tiotropium by pregnant women. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are breast-feeding and are using tiotropium, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication for children younger than 18 years of age have not been established.

There may be an interaction between tiotropium and any of the following:

• aclidinium
• antihistamines (e.g., azelastine, chlorpheniramine, diphenhydramine, doxylamine, fexofenadine, ketotifen)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, loxapine, olanzapine, quetiapine, risperidone)
• atropine
• belladonna
• benztropine
• beta-2 agonists (bronchodilators; e.g., salbutamol, salmeterol)
• botulinum toxin
• cannabis
• clidinium
• darifenacin
• disopyramide
• domperidone
• donepezil
• eluxadoline
• fesoterodine
• flavoxate
• galantamine
• glucagon
• glycopyrrolate
• ipratropium
• metoclopramide
• mirabegron
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, tranylcypromine)
• muscle relaxants (e.g., baclofen, cyclobenzaprine, orphenadrine)
• nabilone
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tramadol)
• nitroglycerin
• oxybutynin
• phenothiazines (e.g., perphenazine, thioridazine)
• potassium supplements
• rivastigmine
• quinidine
• scopolamine
• secretin
• solifenacin
• thiazide diuretics (e.g., chlorothiazide, hydrochlorothiazide, indapamide)
• tolterodine
• topiramate
• tricyclic antidepressants (e.g., amitriptyline, imipramine)
• trospium
• umeclidinium

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.