Budesonide, Formoterol Fumarate Pressurized inhalation, powder

What is this medicine?

BUDESONIDE; FORMOTEROL (byoo DES oh nide; for MOH te rol) inhalation is a combination of two medicines that decrease inflammation and help to open up the airways in your lungs. It is used to treat asthma. Do NOT use for an acute asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• heart disease or irregular heartbeat

• high blood pressure

• immune system problems

• infection

• liver disease

• worsening asthma

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

• pregnant or trying to get pregnant

• breast-feeding

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 12 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, use only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.

What may interact with this medicine?

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

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• mifepristone

• probucol

• procarbazine

• some other medicines for asthma like formoterol, salmeterol

This medicine may also interact with the following medications:

• antibiotics like clarithromycin, erythromycin

• cimetidine

• diuretics

• grapefruit juice

• itraconazole

• ketoconazole

• medicines for depression, anxiety, or psychotic disturbances

• medicines for irregular heartbeat

• methadone

• some heart medicines like atenolol, metoprolol

• some other medicines for breathing problems

• some vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not improve or get worse. If you need to use your short-acting inhalers more often, call your doctor right away. Do not use more than every 12 hours.

If you have asthma, be aware that using this medicine may increase your risk of dying from asthma related problems. Talk to your doctor about the risks and benefits of taking this medicine. NEVER use this medicine for an acute asthma attack.

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.

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 such as skin rash or itching, hives, swelling of the face, lips or tongue

• breathing problems

• changes in vision

• chest pain

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever

• high blood pressure

• nervousness

• tremors

• white patches or sores in mouth

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

• cough

• different taste in mouth

• headache

• sore throat

• stuffy nose

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.