In the U.S.—

In Canada—

• Bronchodilator

Tiotropium ( ty-OH-tro-pee-um) is a medicine used to treat bronchospasm (wheezing or difficulty in breathing) that is associated with Chronic Obstructive Pulmonary Disease. Chronic obstructive pulmonary disease is a long-term lung disease. It is also called COPD. COPD also includes breathing problems like chronic bronchitis (swelling of the airways or tubes leading to the lungs) and emphysema (damage to the air sacs in the lungs).

Tiotropium is a bronchodilator. A bronchodilator is a medicine that opens up narrowed breathing passages. It is taken by inhalation (an inhaler) to help decrease coughing, wheezing, shortness of breath, and troubled breathing by increasing the flow of air into the lungs

This medicine is available only with your doctor's prescription, in the following dosage forms:

Inhalation
• Capsule for inhalation (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tiotropium, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tiotropium, ipratropium, atropine, or inhaled lactose. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has not been studied in pregnant women. Before taking this medicine, be sure your doctor knows if you are pregnant or planning to become pregnant.

Breast-feeding—It is not known whether inhaled tiotropium passes into breast milk. Mothers who are taking this medicine and wish to breast feed should discuss this with their doctor.

Children—Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of tiotropium in children with use in other age groups. The disease that this medicine treats does not normally occur in children.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using tiotropium, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Ipratropium (e.g., Atrovent) — using these medicines at the same time has not been studied and is not recommended

• Difficulty urinating (bladder problems) or
• Narrow angle glaucoma (eye condition) or
• Enlarged prostate — this medicine can make these conditions worse

Inhaled tiotropium is used with a special inhaler (HandiHaler) and usually comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. There are four main steps to take your medicine. Open the blister and the HandiHaler device, insert the tiotropium capsule, press the HandiHaler button and inhale your medication. Ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

The HandiHaler is an inhalation device (inhaler) that has been specially designed for use with tiotropium capsules for inhalation. The HandiHaler must not be used to take other medicines.

Capsules should always be stored in sealed blisters and only removed immediately before use. The blister strip should be carefully opened to expose only one capsule at a time. Open the blister foil as far as the STOP line to remove only one capsule at a time. The medicine should be used immediately after the packaging over an individual capsule is opened, or else it may not be as effective as it should be. After using the first capsule, the 2 remaining capsules should be used over the next 2 consecutive days. Capsules should always be stored in the blister and only removed immediately before use. Capsules that are accidently exposed to air and that are not intended for immediate use should be discarded.

Inhaled tiotropium is a once daily maintenance medicine that opens narrowed airways and keeps them open for 24 hours. This medicine should not be used for immediate relief of breathing problems, such as a rescue medication.

Tiotropium capsules are to be used for oral inhalation only. The capsules should not be swallowed.

Dosing—

Follow your doctor's orders or the directions on the label. Use this medicine exactly as prescribed by your doctor. Do not use more of it than prescribed by your doctor.

• For inhalation dosage form (capsules):
  • For bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD)
    • Adults— 1 capsule (18 micrograms [mcg]) inhaled once daily; capsules should only be used with the HandiHaler inhalation device (inhaler)
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.
• Do not store capsules in the HandiHaler.

Care must be taken not to allow powder from the capsules to get into your eyes. If the powder does get into your eye it can cause blurring of vision and pupil dilation (decreasing pupil size).

If symptoms of eye pain, eye discomfort, blurred vision, visual halos, or colored images in association with red eyes occur, contact a physician immediately.

It is very important that your doctor check you at regular visits.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Arm, back or jaw pain;  chest pain or discomfort;  chest tightness or heaviness;  fast or irregular heartbeat;  nausea ;  shortness of breath;  sweating 
  
  

• Less common
  • Cough;  difficulty swallowing;  dizziness;  hives;  itching;  painful blisters on trunk of body;  puffiness or swelling of the eyelids or around the eyes, face, lips or tongue;  skin rash;  tightness in chest;  unusual tiredness or weakness ;  wheezing 
  
  

• Rare
  • Fainting;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs;  palpitations;  pounding, or irregular heartbeat or pulse 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Acid or sour stomach;  belching;  bladder pain;  bloody or cloudy urine ;  body aches or pain;  chest pain;  chills;  congestion ;  cough;  difficult, burning, or painful urination;  difficulty in breathing;  dry mouth;  dryness of throat;  ear congestion;  fever;  frequent urge to urinate;  headache;  heartburn;  hoarseness;  indigestion;  loss of voice;  lower back or side pain;  nasal congestion ;  pain or tenderness around eyes and cheekbones ;  runny nose;  sneezing;  sore throat;  stomach discomfort, upset or pain;  stuffy nose;  tender, swollen glands in neck;  trouble in swallowing;  troubled breathing;  unusual tiredness or weakness;  voice changes 
  
  

• Less common
  • Abdominal pain;  bloody nose;  blurred vision;  burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings;  canker sores;  difficulty having a bowel movement (stool);  discouragement;  fatigue;  feeling sad or empty;  flushed, dry skin;  fruit-like breath odor;  increased hunger;  increased thirst;  increased urination;  irritability;  lack of appetite;  large amount of cholesterol in the blood;  leg pain;  loss of interest or pleasure;  muscle pain;  nausea;  painful or difficult urination ;  skeletal pain;  sore mouth or tongue;  sores, ulcers, or white spots on lips or tongue or inside the mouth;  sweating;  swelling;  swelling or inflammation of the mouth;  tiredness;  troubled breathing;  trouble concentrating;  trouble sleeping;  unexplained weight loss;  vomiting;  white patches in mouth and/or on tongue 
  
  

• Incidence rare
  • Painful or difficult urination 
  
  

• Incidence unknown
  • Hives or welts;  irregular heartbeat ;  itching;  itching skin ;  redness of skin;  skin rash 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.