Olodaterol and tiotropium is a combination medicine used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Olodaterol and tiotropium is for use only in people with COPD and should not be used to treat asthma.

Olodaterol and tiotropium may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to tiotropium, ipratropium, or olodaterol.

Olodaterol and tiotropium is not a rescue medicine. It will not work fast enough to treat an bronchospasm attack.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed.

Olodaterol and tiotropium is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Use only the inhaler device provided with your medicine or you may not get the correct dose. Use the new inhaler each time you get your prescription refilled.

Do not change your dose or stop using your medicine without your doctor's advice.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use the medicine at the same time each day, and not more than once in a 24-hour period.

Store at room temperature. Do not allow the medicine to freeze.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

-2 inhalations orally once a day, at the same time
Maximum dose: 2 inhalations every 24 hours

Use: Long-term treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

You should not use olodaterol and tiotropium if you are allergic to olodaterol, tiotropium, or ipratropium.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• seizures;

• a thyroid disorder;

• diabetes;

• glaucoma;

• kidney disease; or

• an enlarged prostate or urination problems.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Olodaterol and tiotropium is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time. Do not use more than once in a 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include include headache, chest pain, fast heart rate, tremor, and feeling shaky or nervous.

Do not use a second inhaled bronchodilator that contains formoterol, arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol.

Avoid getting olodaterol and tiotropium in your eyes.

Do not get this medicine in your eyes. If contact does occur, rinse with water.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Olodaterol and tiotropium may cause serious side effects. Call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• wheezing, choking, or other breathing problems after using olodaterol and tiotropium;

• painful or difficult urination, or urinating more often;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or

• low potassium level--leg cramps, constipation, irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of olodaterol and tiotropium may include:

• runny nose;

• cough; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• atropine;

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• other bronchodilator medication.

This list is not complete. Other drugs may affect olodaterol and tiotropium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.