Budesonide; Formoterol Inhalation

What is this medicine?

BUDESONIDE; FORMOTEROL (byoo DES oh nide; for MOH te rol) inhalation is a combination of 2 medicines that decrease inflammation and help to open up the airways in your lungs. It is used to treat asthma. It is also used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema. Do NOT use for an acute asthma or COPD attack.

How should I use this medicine?

This medicine is inhaled through the mouth. Rinse your mouth with water after use. Make sure not to swallow the water. Follow the directions on your prescription label. Do not use more often than directed. Do not stop taking except on your doctor's advice. Make sure that you are using your inhaler correctly. Ask your doctor or health care provider if you have any questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years of age for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• anxious

• breathing problems

• changes in vision, eye pain

• muscle cramps or muscle pain

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision

• signs and symptoms of infection like fever; chills; cough; sore throat; pain or trouble passing urine

• tremors

• unusually weak or tired

• white patches in the mouth or mouth sores

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

• back pain

• changes in taste

• cough

• diarrhea

• runny or stuffy nose

• upset stomach

What may interact with this medicine?

Do not take the medicine with any of the following medications:

• cisapride

• dofetilide

• dronedarone

• MAOIs like Marplan, Nardil, and Parnate

• other medicines that contain long-acting beta-2 agonists (LABAs) like arfomoterol, formoterol, indacaterol, olodaterol, salmeterol, vilanterol

• pimozide

• procarbazine

• thioridazine

This medicine may also interact with the following medications:

• certain antibiotics like clarithromycin, telithromycin

• certain antivirals for HIV or hepatitis

• certain heart medicines like atenolol, metoprolol

• certain medicines for blood pressure, heart disease, irregular heartbeat

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for fungal infections like ketoconazole, itraconazole

• diuretics

• grapefruit juice

• mifepristone

• other medicines that prolong the QT interval (an abnormal heart rhythm)

• some vaccines

• steroid medicines like prednisone or cortisone

• stimulant medicines for attention disorders, weight loss, or to stay awake

• theophylline

What if I miss a dose?

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a dry place at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not get the inhaler wet. Keep track of the number of doses used. Throw away the inhaler after using the marked number of inhalations or after the expiration date, whichever comes first. Do not burn or puncture canister.

What should I tell my health care provider before I take this medicine?

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

• bone problems

• diabetes

• eye disease, vision problems

• heart disease

• high blood pressure

• history of irregular heartbeat

• immune system problems

• infection

• liver disease

• pheochromocytoma

• seizures

• thyroid disease

• an unusual or allergic reaction to budesonide, formoterol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse.

If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away.

This medicine may increase your risk of getting an infection. Tell your doctor or health care professional if you are around anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.