Budesonide; Formoterol Metered Dose Inhaler (MDI)

BUDESONIDE; FORMOTEROL (byoo DES oh nide; for MOH te rol) treats asthma and chronic obstructive pulmonary disease (COPD). It works by opening the airways of the lungs, making it easier to breathe. It is a combination of an inhaled steroid and a bronchodilator. It is often called a controller inhaler. Do not use it to treat a sudden asthma attack or COPD flare-up.

This medication is inhaled through the mouth. Shake well before using. Rinse your mouth with water after use. Make sure not to swallow the water. Take it as directed on the prescription label. Do not use it more often than directed. Keep taking it unless your care team tells you to stop.

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. While it may be prescribed to children as young as 6 years for selected conditions, precautions do apply.

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
• Flu-like symptoms—fever, chills, muscle pain, cough, headache, fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Muscle pain or cramps
• Pain, tingling, or numbness in the hands or feet
• Sinus pain or pressure around the face or forehead
• Thrush—white patches in the mouth
• Wheezing or trouble breathing that is worse after use

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in taste
• Cough
• Dry mouth
• Headache
• Hoarseness
• Sore throat
• Tremors or shaking
• Trouble sleeping

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. This medication is flammable. Avoid exposure to heat, fire, flame, and smoking. 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.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

They need to know if you have any of these conditions:

• Diabetes
• Eye disease, such as glaucoma, cataracts, or blurred vision
• Heart disease
• High blood pressure
• Immune system problems
• Infection
• Irregular heartbeat or rhythm
• Liver disease
• Osteoporosis, weak bones
• Pheochromocytoma
• Seizures
• Thyroid disease
• An unusual or allergic reaction to budesonide, formoterol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Do not take the medication with any of the following:

• Cisapride
• Dronedarone
• Other medications that contain long-acting beta agonists (LABAs), such as arformoterol, formoterol, indacaterol, olodaterol, salmeterol, vilanterol
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Certain antibiotics, such as clarithromycin or telithromycin
• Certain antivirals for HIV or hepatitis
• Certain heart medications, such as atenolol or metoprolol
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for depression, anxiety, or other mental health conditions
• Certain medications for fungal infections, such as ketoconazole or itraconazole
• Diuretics
• Grapefruit juice
• MAOIs, such as Marplan, Nardil, and Parnate
• Mifepristone
• Other medications that cause heart rhythm changes
• Some vaccines
• Steroid medications, such as prednisone or cortisone
• Stimulant medications for attention disorders, weight loss, or staying awake
• Theophylline

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

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.

Follow the plan from your care team for treating an acute asthma attack or bronchospasm (wheezing). If your symptoms get worse or do not get better, call your care team right away.

If you have asthma, you and your care team should develop an Asthma Action Plan that is just for you. Be sure to know what to do if you are in the yellow (asthma is getting worse) or red (medical alert) zones.

Do not treat yourself for coughs, colds or allergies without asking your care team for advice. Some nonprescription medications can affect this one.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your care team right away if you are around someone with these viruses.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

This medication may slow your child's growth if it is taken for a long time at high doses. Your care team will monitor your child's growth.