Formoterol Fumarate/Glycopyrrolate, Inhalation

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KEY POINTS

• This medicine is inhaled through the mouth to treat COPD. Use it exactly as directed.
• Do not use this medicine for sudden breathing problems. Your healthcare provider can prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem.
• 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: formoterol fumarate/glycopyrrolate, inhalation; Bevespi Aerosphere

What is this medicine used for?

This long-acting medicine is inhaled through the mouth to treat COPD. It should not be used to treat asthma attacks.

This medicine is usually prescribed along with steroids or other medicines to improve breathing.

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
• Asthma
• Diabetes
• Glaucoma
• Heart disease
• High blood pressure
• Kidney or liver disease
• Problems with low levels of potassium in your blood
• Seizures
• Thyroid disease
• Trouble urinating or an enlarged prostate gland

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. Do not use more or less than prescribed. Do not stop using this medicine or any other medicine without your healthcare provider's approval.

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

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

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.

What if I miss a dose?

If you miss a dose, skip the missed dose and use the next one as directed. Do not use double doses. 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: dizziness, nausea, vomiting, lightheadedness, nervousness, tremors, fast irregular heartbeat, weakness, seizures.

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.

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 for checkups and eye exams.

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

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

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, cough, vision changes, trouble urinating or decreased urination, muscle spasms or unusual weakness.

Other: Nausea, dizziness, tremor, trouble sleeping, nervousness, headache, hoarseness, dry mouth, cough, sore throat, runny or stuffy nose.

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:

• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Anagrelide (Agrylin)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), and telithromycin (Ketek)
• Anticholinergic medicines such as amantadine (Symmetrel), atropine/diphenoxylate (Lomotil), belladonna, benztropine (Cogentin), bethanechol (Urecholine), cevimeline (Evoxac), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), pilocarpine (Salagen), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), and sertraline (Zoloft)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and meclizine (Dramamine)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), prochlorperazine (Compro), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Apomorphine (Apokyn)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), 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)
• Dextromethorphan/quinidine (Nuedexta)
• Digoxin (Lanoxin)
• 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)
• Ephedrine, epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen), phenylephrine (Neo-Synephrine, Sudafed PE), or pseudoephedrine (Sudafed)
• 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 atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Linezolid (Zyvox)
• 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.)
• Metformin (Fortamet, Glucophage, Riomet)
• Methadone (Dolophine, Methadose)
• Metoclopramide (Metozolv, Reglan)
• Mifepristone (Korlym, Mifeprex)
• Narcotic pain medicines such as codeine, hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), morphine (Kadian, MS Contin), and oxycodone (OxyContin, Roxicodone)
• Nausea medicines such as dronabinol (Marinol), nabilone (Cesamet), prochlorperazine (Compro), and promethazine
• Other medicines to treat breathing or lung problems such as aclidinium (Tudorza), aminophylline, arformoterol (Brovana), budesonide/formoterol (Symbicort), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), indacaterol (Arcapta), ipratropium (Atrovent), mometasone/formoterol (Dulera), olodaterol (Striverdi Respimat), oxtriphylline (Choledyl), salmeterol (Serevent), theophylline, tiotropium (Spiriva), and umeclidinium (Incruse Ellipta)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Potassium supplements
• Pramlintide (Symlin)
• Propranolol (Hemangeol, Inderal, InnoPran)
• 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 this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Dispose of the canister 3 months after you open the foil pouch, or when the dose indicator shows zero.

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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.