Olodaterol and tiotropium

Olodaterol and tiotropium is a combination medicine that helps prevent airflow blockage and lowers the chances of flare-ups in adults with COPD (chronic obstructive pulmonary disease), which includes bronchitis and emphysema.

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

Olodaterol and tiotropium may also be used for other reasons not mentioned in this medication guide.

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.

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 a bronchospasm attack.

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

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.

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

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

• pounding heartbeats or fluttering in your chest;
• wheezing, choking, or other breathing issues after using olodaterol and tiotropium;
• painful or difficult urination, or needing to urinate more often;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar--more thirst, more urination, hunger, dry mouth, fruity breath odor; or
• low potassium level--leg cramps, constipation, irregular heartbeats, more thirst or urination, numbness or tingling, muscle weakness or feeling weak.

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 happen. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

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

-2 inhalations orally once a day, at the same timeMaximum dose: 2 inhalations every 24 hoursUse: Long-term treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

Use the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time. Do not use it 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 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.

Tell your doctor about all the other medicines you take, especially:

• atropine;
• medicine for depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (like Benadryl);
• medicine for Parkinson's disease;
• medicine for stomach issues, motion sickness, or irritable bowel syndrome;
• medicine for an overactive bladder; or
• other bronchodilator medication.

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