Umeclidinium/Vilanterol, 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: anticholinergic/long-acting beta agonist; bronchodilator

Generic and brand names: umeclidinium/vilanterol, inhalation; Anoro Ellipta

What is this medicine used for?

This combination of two medicines is inhaled through the mouth. It helps control symptoms and prevent wheezing in people with COPD. This medicine is not used to treat or prevent asthma attacks.

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 proteins
• Diabetes
• Eye problems such as cataracts or glaucoma
• Heart disease or irregular heartbeat
• High blood pressure
• Liver disease
• Problems with potassium levels in the blood
• Seizures
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

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 your healthcare provider's approval.

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. Carefully follow the instructions in the medicine package for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Use this medicine exactly as your healthcare provider prescribes. Do not use more or less than prescribed. Use it every day at the same time. Do not stop taking this medicine without your healthcare provider's approval. Suddenly stopping this medicine may make your symptoms worse.

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

If your healthcare provider prescribes another medicine to be inhaled, ask how long you should wait between doses of the different medicines.

What if I miss a dose?

If you miss a dose, use 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 or take more than 1 inhalation per day. 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, fast or irregular heartbeat, seizures, tremors, nervousness, muscle cramps or weakness, headache, dry mouth, nausea, vomiting, dizziness, fainting, worsening shortness of breath.

What should I watch out for?

This medicine must not be the only medicine you use to treat COPD. 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.

Rarely, this medicine may cause vision problems. You need to have regular eye exams while taking this medicine. Talk with your healthcare provider about this.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. Always carry a form of identification stating that you take this medicine, such as a medical alert bracelet or ID card.

Diabetics: This medicine may affect blood sugar test results. Talk to your healthcare provider before you change your diet or dosage of diabetes 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; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Increased trouble breathing or coughing, increased sputum or change in sputum color, chest pain, fast or irregular heartbeat, unusual tiredness or weakness, severe dizziness or fainting, changes in vision, eye pain or irritation, seeing halos or bright colors around lights, severe nausea or vomiting, trouble urinating, increased urination, severe muscle cramps or weakness, tremors, severe nervousness, confusion, severe dizziness, extreme thirst or hunger.

Other: Headache, runny or stuffy nose, nausea, dry mouth, mild dizziness, sore throat, indigestion, diarrhea, constipation, neck pain.

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)
• Alzheimer's disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• 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), ofloxacin, pentamidine (NebuPent, Pentam), and telithromycin (Ketek)
• Anticholinergic medicines such as benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• 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
• Cancer medicines such as arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), dasatinib (Sprycel), degarelix (Firmagon), eribulin (Halaven), goserelin (Zoladex), histrelin (Vantas), idelalisib (Zydelig), lapatinib (Tykerb), nilotinib (Tasigna), panobinostat (Farydak), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cisapride
• Conivaptan (Vaprisol)
• Cyclobenzaprine (Amrix)
• Dextromethorphan/quinidine (Nuedexta)
• 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), and torsemide (Demadex)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Ephedrine
• Ezogabine (Potiga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Midodrine
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), granisetron (Sancuso), ondansetron (Zofran), and promethazine
• Other medicines to treat breathing or lung problems such as aclidinium (Tudorza), arformoterol (Brovana), budesonide/formoterol (Symbicort), formoterol (Perforomist), indacaterol (Arcapta), ipratropium (Atrovent), mometasone/formoterol (Dulera), salmeterol (Serevent), theophylline, and tiotropium (Spiriva)
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and oxycodone/acetaminophen (Percocet, Roxicet)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Phenylephrine (Neo-Synephrine, Sudafed PE)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Pseudoephedrine (Sudafed)
• Rasagiline (Azilect)
• Stimulants such as amphetamine/dextroamphetamine (Adderall), 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. Tell all healthcare providers who treat you about any other medicines you are taking by mouth, inhalation, or shots.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light. Do not open the cover of the inhaler until you are ready to use it. If you open and close the cover without inhaling the medicine, you will lose the dose.

Write the date you open the foil tray on the label on the inhaler. Discard the medicine 6 weeks after you open the foil tray or when the counter reads “0”, whichever comes first.

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This advisory includes selected information only and may not include all side effects of this medicine or 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.