Stiolto Respimat (Tiotropium/Olodaterol)

STIOLTO RESPIMAT is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Olodaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Use only the prescribed dose of this medicine, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use.

You should not use this medicine if you are allergic to olodaterol, tiotropium, or ipratropium (Atrovent, Combivent, DuoNeb). STIOLTO RESPIMAT is for use only in people with COPD and should not be used to treat asthma.

Olodaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine.

To make sure STIOLTO RESPIMAT is safe for you, tell your doctor if you have:

• heart disease, coronary artery disease, or high blood pressure;
• epilepsy or other seizure disorder;
• a thyroid disorder;
• glaucoma;
• enlarged prostate;
• kidney disease;
• a food allergy; or
• bladder obstruction or other 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 is not known whether STIOLTO RESPIMAT passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

STIOLTO RESPIMAT 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; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• new or worsening COPD symptoms;
• painful or difficult urination;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe headache, pounding in your neck or ears;
• fast or irregular heartbeats; or
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

• stuffy nose, sinus pain;
• 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.

Avoid getting this medicine in your eyes.

Do not use a second long-acting inhaled bronchodilator such as arformoterol (Brovana), albuterol (Combivent, DuoNeb), formoterol (Foradil, Perforomist, Symbicort), olodaterol (Striverdi), or salmeterol (Serevent, Advair) unless your doctor has told you to.

This medicine may cause dizziness and blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• atropine;
• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
• cold or allergy medicine that contains an antihistamine;
• medication for Parkinson's disease;
• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome; or
• other bronchodilators such as aclidinium (Tudorza), ipratropium (Atrovent, Combivent), tiotropium (Spiriva), or umeclidinium (Incruse Ellipta).

This list is not complete. Other drugs may interact with STIOLTO RESPIMAT, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

The usual dose of this medicine is 2 inhalations once per day. Use the medicine at the same time each day, and not more than once in a 24-hour period. Using too much of this medicine can cause life-threatening side effects.

STIOLTO RESPIMAT is not a rescue medicine. It will not work fast enough to treat a COPD flare-up. Your doctor may prescribe a fast-acting inhalation medicine to treat a bronchospasm attack.

Tell your doctor if any of your medicines seem to stop working as well in controlling your symptoms.

This medicine comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if you think you need to use more than usual. An increased need for medication could be an early sign that your condition is getting worse.

COPD is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture and heat. Do not allow the medicine to freeze.

Seek emergency medical attention or call the Poison Help line.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use more than two inhalations every 24 hours.