Budesonide/Formoterol, Inhalation Aerosol

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KEY POINTS

• This medicine is inhaled through the mouth to prevent asthma attacks or to treat COPD. Use it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects, especially breathing symptoms, 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: corticosteroid; long-acting beta agonist; bronchodilator

Generic and brand names: budesonide/formoterol, inhalation aerosol; Symbicort

What is this medicine used for?

This is a combination of two medicines. Budesonide is a steroid that reduces inflammation in the lungs. Formoterol is a long-acting medicine that helps open up the airways. This medicine is inhaled through the mouth to:

• Prevent asthma attacks (It does not stop asthma attacks that have already started.)
• Treat COPD

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
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Adrenal or thyroid gland problems
• Diabetes
• Eye problems such as glaucoma or cataracts
• Heart disease, heart failure, or heart rhythm problems
• High blood pressure
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Liver problems
• Osteoporosis
• Problems with low levels of potassium in your blood
• Seizures
• Tuberculosis (TB)

Also, tell your provider if you are taking prednisone or other steroid medicines, or if you take other medicines for asthma, including nonprescription products. Tell your provider if you have any kind of infection.

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. 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 12.

Use this medicine exactly as your healthcare provider prescribes. Do NOT take more of this medicine than prescribed. Do not stop using this medicine or any other medicine without your healthcare provider's approval.

Do not spray this medicine in your eyes. If you get some medicine in your eyes, flush them with cool water and contact your healthcare provider.

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: chest pain, fast irregular heartbeat, muscle cramps, nausea, nervousness, seizures, severe dizziness, tremors.

What should I watch out for?

This medicine must not be the only medicine you use to treat asthma or 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 have any injury, surgery, infection, severe asthma attacks, or periods of stress, you may need to take more steroids by mouth. Report any of these problems to your healthcare provider right away.

This medicine may cause an increase in wheezing or trouble breathing right after using the medicine. You should always have a fast-acting inhaled bronchodilator medicine with you to treat sudden wheezing. Talk with your healthcare provider about this.

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.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. If you are exposed to an infectious disease, contact your healthcare provider right away. Chickenpox or measles may be more serious than usual while you are using this medicine. Also, do not have any vaccines without getting your healthcare provider's approval first.

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.

Treatment with this medicine may affect bone density. Your healthcare provider may order tests to check if this medicine is affecting your bones.

This medicine may affect growth in children. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or wear a medical ID bracelet or necklace that says you have asthma or COPD and are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

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, tremor, seizures, nervousness, fever, chills, cough, sore throat, runny nose, white patches in or around your mouth, muscle aches and pains, vision changes, unexplained weakness or tiredness, severe nausea or vomiting, fainting or severe dizziness, numbness in your arms or legs; sinus swelling and pain, rash.

Other: Nausea, dizziness, trouble sleeping, headache, muscle cramps, back pain, stomach pain, hoarseness.

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:

• Aldesleukin (Proleukin)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), and trazodone
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), prochlorperazine (Compro), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Artemether/lumefantrine (Coartem)
• Atomoxetine (Strattera)
• 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), ceritinib (Zykadia), crizotinib (Xalkori), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Dextromethorphan/quinidine (Nuedexta)
• 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)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), and quinidine
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• 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.)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), and ondansetron (Zofran)
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)
• Other medicines to treat breathing or lung problems such as aminophylline, arformoterol (Brovana), fluticasone/salmeterol (Advair), formoterol (Perforomist), salmeterol (Serevent), and theophylline
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• St. John's wort
• Stimulants such as caffeine, dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and pseudoephedrine (Sudafed)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

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 with the mouthpiece down. Do not wash the inhaler. Keep it away from heat and moisture. Discard the inhaler when the counter reaches 0, or 3 months after you take it out of the foil pouch, whichever comes first.

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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.