Stiolto Respimat 28 ACT

Stiolto Respimat 28 ACT is a combination medicine that helps prevent airflow blockage and decrease flare-ups in adults with COPD (chronic obstructive pulmonary disease), which includes bronchitis and emphysema.

Stiolto Respimat 28 ACT is intended only for people with COPD and should never be used to treat asthma.

Stiolto Respimat 28 ACT may also be used for other reasons not mentioned in this medication guide.

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

Stiolto Respimat 28 ACT is not a rescue medicine. It will not work quickly 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 Stiolto Respimat 28 ACT 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.

Stiolto Respimat 28 ACT 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; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stiolto Respimat 28 ACT may cause serious side effects. Call your doctor immediately if you have:

• pounding heartbeats or fluttering in your chest;
• wheezing, choking, or other breathing problems after using Stiolto Respimat 28 ACT;
• 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 feeling limp.

Common side effects of Stiolto Respimat 28 ACT 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.

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

Stiolto Respimat 28 ACT 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.

Use the medicine as soon as possible, but skip the missed dose if your next dose is coming up soon. Do not take two doses at once. Do not use it more than once in a 24-hour period.

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

Signs of overdose 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 Stiolto Respimat 28 ACT in your eyes.

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

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

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

This list is not complete. Other drugs might affect Stiolto Respimat 28 ACT, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.