Olodaterol/Tiotropium, Inhalation

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KEY POINTS

• This medicine is inhaled through your mouth to control symptoms and prevent wheezing in people with COPD. This medicine is not used to treat or prevent asthma attacks. Use it exactly as directed.
• Do not use this medicine for sudden breathing problems.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: long-acting beta-agonist/anticholinergic; bronchodilator

Generic and brand names: olodaterol/tiotropium, inhalation; Stiolto Respimat

What is this medicine used for?

This medicine is inhaled through your mouth to treat breathing problems caused by COPD. This medicine should NOT be used to treat asthma.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to milk products
• An enlarged prostate gland or trouble urinating
• Asthma
• Diabetes
• Glaucoma
• Heart disease
• High blood pressure
• Kidney disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with low levels of potassium in your blood
• Seizures
• Thyroid problems

Tell your healthcare provider about all other medicines you are taking or using for your breathing problem.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without discussing with your healthcare provider.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill. Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Take this medicine exactly as your healthcare provider prescribes. Do not take more than 1 dose in 24 hours. Do not stop using this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Follow instructions in the medicine package about how to prepare and prime the inhaler and how to use the inhaler. Be careful not to get this medicine in your eyes.

If you are using other inhaled medicines, ask your healthcare provider or pharmacist which you should use first. Use inhaled medicines 10 minutes apart from each other. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. Do not use more than 1 dose in 24 hours. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: chest pain, nervousness, tremors, fast or irregular heartbeat, weakness, dizziness, headache, dry mouth, nausea, drowsiness, seizures.

What should I watch out for?

Do not use this medicine for sudden breathing problems. Your healthcare provider may also prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem. Use all medicines as directed by your healthcare provider. Talk with your healthcare provider if you have any questions.

In people with asthma, long-acting beta2-adrenergic agonists increase the risk of asthma-related hospitalization or death. Talk with your healthcare provider about this. If you have any of these symptoms, call your healthcare provider right away:

• You need to use more puffs than usual of your short-acting inhaler or use it more often.
• You have severe breathing trouble that does not improve, such as persistent wheezing, coughing, or shortness of breath.
• You have a bluish color in your lips or fingernails or cannot speak.
• You have any breathing symptoms that are getting worse.

If you use this medicine for a long time, your healthcare provider will want to see you regularly to see how this medicine is affecting you. Keep all appointments.

This medicine may increase your heart rate or blood pressure. Talk with your healthcare provider about this.

Contact your healthcare provider if your breathing does not improve with use of this medicine or if it gets worse.

If this medicine gets in your eyes it can cause pain, large pupils, and blurred vision. If this happens, flush your eyes with water and contact your healthcare provider right away.

This medicine may make you dizzy or cause blurred vision. Do not drive or operate machinery unless you are fully alert and can see clearly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, swelling of your tongue or throat, tightness in your chest, increased trouble breathing).

Serious (Report these to your healthcare provider right away.): Chest pain; fast or irregular heartbeat; severe dizziness or fainting; worsening breathing or coughing; blurred vision, vision changes, vision halos, or eye pain; severe muscle cramps or weakness; severe nervousness; trouble urinating or burning on urination; confusion; severe headache; unusual drowsiness; dry mouth or increased thirst; unusual hunger; tremors.

Other: Dizziness, constipation, dry mouth, mild nausea, heartburn, back or joint pain, sore throat, runny or stuffy nose, hoarseness, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Anagrelide (Agrylin)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), tedizolid (Sivextro), and telithromycin (Ketek)
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, amoxapine, citalopram (Celexa), clomipramine, desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as brompheniramine, chlorpheniramine (Chlor-Trimeton), cyproheptadine, diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, haloperidol (Haldol), iloperidone (Fanapt), loxapine, olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Apomorphine (Apokyn)
• Atomoxetine (Strattera)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bladder control medicines such as darifenacin (Enablex), fesoterodine (Toviaz), mirabegron (Myrbetriq), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), tolterodine (Detrol), and trospium
• Caffeine in food, drinks, or medicines
• Cancer medicines such as arsenic trioxide (Trisenox), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Diet pills such as diethylpropion (Tenuate), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), chlorthalidone, ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), methyclothiazide (Enduron), and torsemide (Demadex)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), and quinidine
• HIV medicines such as lopinavir/ritonavir (Kaletra) and saquinavir (Invirase)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), aminophylline, arformoterol (Brovana), budesonide/formoterol (Symbicort), fluticasone/vilanterol (Breo Ellipta), glycopyrrolate (Seebri), indacaterol (Arcapta), ipratropium (Atrovent), mometasone/formoterol (Dulera), oxtriphylline (Choledyl), salmeterol (Serevent), theophylline, tiotropium (Spiriva), and umeclidinium (Incruse Ellipta)
• Methadone (Dolophine, Methadose)
• Midodrine
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet), metoclopramide (Metozolv, Reglan), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Stimulants such as armodafinil (Nuvigil), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and modafinil (Provigil)
• Tetrabenazine (Xenazine)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the medicine at room temperature. Do not remove the cartridge once it has been inserted into the inhaler. Protect the medicine from heat, high humidity, and bright light. Discard the inhaler no later than 3 months after you insert the cartridge into the inhaler.

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This advisory includes selected information only and may not include all side effects of this medicine or drug interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.