STIOLTO RESPIMAT is an inhalation drug for respiratory use containing two active ingredients: tiotropium bromide monohydrate, an anticholinergic, and olodaterol hydrochloride, a long-acting beta-adrenergic agonist. It comes as a sterile aqueous solution in a cartridge for use with a hand-held inhaler, delivering a metered inhalation dose. Key inactive ingredients include benzalkonium chloride and edetate disodium.

How should I use this medication?

This medication is inhaled through the mouth. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep taking it unless your care team tells you to stop. A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time. The sheet may change often. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat, cold or humidity. Throw away 3 months after removing it from the foil pouch, when the dose counter reads "0" or after the expiration date, whichever is first.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -Muscle pain or cramps -Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss -Trouble passing urine -Wheezing or trouble breathing that is worse after use Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Constipation -Cough -Dry mouth -Headache -Sore throat -Tremors or shaking -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Asthma -Diabetes -Glaucoma -Heart disease -High blood pressure -Irregular heartbeat or rhythm -Kidney disease -Pheochromocytoma -Prostate disease -Seizures -Thyroid disease -An unusual or allergic reaction to tiotropium, olodaterol, ipratropium, atropine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate This medication may also interact with the following: -Atropine -Certain antibiotics like clarithromycin, erythromycin, levofloxacin, linezolid, and telithromycin -Certain medications for allergy, cough and cold -Certain medications for bladder problems like oxybutynin, tolterodine -Certain medications for depression, anxiety, or mental health conditions -Certain medications for fungal infections like ketoconazole -Certain medications for Parkinson's disease like benztropine, trihexyphenidyl -Certain medications for stomach problems like dicyclomine, hyoscyamine -Certain medications for the heart -Certain medications for travel sickness like scopolamine -Certain medications for weight loss including some herbal products -Diuretics -Ipratropium -Other medications that can cause heart rhythm changes -Procarbazine -Ritonavir -Steroid medications like prednisone or cortisone -Stimulant medications for attention disorders, weight loss, or to stay awake -Theophylline -Thyroid hormones

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. NEVER use this medication for an acute asthma attack. You should use your short-acting rescue inhaler for an acute attack. If your symptoms get worse or if you need your short-acting inhalers more often, call your care team right away. This medication can worsen breathing or cause wheezing right after you use it. Be sure you have a short-acting inhaler for acute attacks (wheezing) nearby. If this happens, stop using this medication right away and call your care team. This medication may increase the risk of serious asthma-related problems. Talk your care team if you have questions. Do not treat yourself for coughs, colds or allergies without asking your care team for advice. Some nonprescription medications can affect this one. You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.