Olodaterol (oh-loe-DA-ter-ol), Tiotropium Bromide (tye-oh-TROE-pee-um BROE-mide)

Treats chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema.

Brand Name(s):

Stiolto Respimat, Stiolto Respimat Institutional Pack 10ACT, Stiolto Respimat Institutional Pack 28ACT

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is used with a metered-dose inhaler. The inhaler fits on the medicine canister and turns the medicine into a fine spray that you breathe in through your mouth and into your lungs. Your caregiver will show you how to use your inhaler. Follow directions carefully so you get the full benefit from your medicine.
• Prime the inhaler before use. Point it toward the ground and press the dose release button until you see a cloud of medicine. Then press the button 3 more times. The inhaler is now ready to use.
  • If you have not used the inhaler for longer than 3 days, prime it again with 1 spray.
  • If you have not used the inhaler for longer than 21 days, prime it like you did with the first use (with 3 sprays).
• To inhale this medicine, breathe out slowly and fully to get as much air out of your lungs as possible. Close your lips around the mouthpiece without covering the air vents, then point the inhaler to the back of your throat. While taking a slow, deep breath through your mouth, press the dose-release button and continue to breathe in.
• Hold your breath for about 10 seconds or for as long as you can, then breathe out. Repeat for a second dose.
• Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least once a week.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not use more than 2 puffs every 24 hours.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away the inhaler 3 months after its first use or when the inhaler is locked.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tiotropium/olodaterol works. Tell your doctor if you are using any of the following:
  • Aclidinium, atropine, ipratropium, theophylline, umeclidinium
  • Diuretic (water pill)
  • Beta-blocker medicine
  • Medicine to treat depression (including an MAO inhibitor, TCAs)
  • Other asthma medicines
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, heart rhythm problems (including QT prolongation), high blood pressure, diabetes, glaucoma, thyroid problems, prostate problems, trouble urinating, electrolyte imbalance, or seizures. Tell your doctor if you are allergic to atropine.
• This medicine may cause the following problems:
  • Increased risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid
  • Paradoxical bronchospasm (increased trouble breathing), which can be life-threatening
  • High blood pressure
  • Heart rhythm problems
  • Eye or vision problems
  • High blood sugar levels
• Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use your other medicine only during a severe COPD attack.
• Do not use this medicine if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. Make sure you always have your rescue medicine with you to treat sudden symptoms.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, eye pain, seeing halos around objects
• Chest pain, fast, pounding, or uneven heartbeat
• Decrease in how much or how often you urinate, painful or difficult urination
• Dizziness, lightheadedness, or fainting
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Increased hunger or thirst, weight loss
• Increased trouble breathing
• Seizures or tremors

If you notice these less serious side effects, talk with your doctor:

• Runny or stuffy nose, cough, sore throat, body aches

If you notice other side effects that you think are caused by this medicine, tell your doctor

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