Tiotropium/olodaterol (By breathing)

Stiolto Respimat, Stiolto Respimat Institutional Pack 28ACT

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

• Some foods and 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
  • MAO inhibitor
  • TCA medicine for depression
  • Other medicine that you inhale, especially medicine to treat asthma
  • Steroid (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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 to 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).
• 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.

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

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

Treats chronic obstructive pulmonary disease (COPD).

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
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Increased hunger or thirst
• Increased trouble breathing

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

• Runny or stuffy nose, cough, fever, sore throat
• Shaking, nervousness

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, asthma, diabetes, glaucoma, heart disease, heart rhythm problems (such as QT prolongation), high blood pressure, an overactive thyroid, prostate problems, trouble urinating, or seizures. Tell your doctor if you are allergic to atropine.
• This medicine may cause the following problems:
  • Paradoxical bronchospasm (increased trouble breathing), which can be life-threatening
  • Heart rhythm changes
  • Low potassium levels
  • High blood sugar
• Do not use this medicine for a sudden 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.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.