When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to budesonide or formoterol. You should not use this medicine if your asthma attack has already started, or if you are having a severe asthma attack or COPD flare-up.

How to Use This Medicine:
Liquid Under Pressure, Powder

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Test spray in the air before using for the first time or if the inhaler has not been used for a while.
• Shake well for 5 seconds before using. You must keep track of the number of puffs you use. Use the dose tracker card to do this. Throw away the inhaler after you have used the number of puffs allowed, or if it is 3 months since you opened the foil pouch.
• When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water after rinsing.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using clarithromycin (Biaxin®), erythromycin (PCE®), itraconazole (Sporanox®), ketoconazole (Nizoral®), telithromycin (Ketek®), medicine to treat HIV infection (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fotovase®, Invirase®, Norvir®, or Reyataz®), blood pressure medicines (such as atenolol, labetalol, Inderal®, Tenormin®, or Toprol®), or diuretics or "water pills" (such as furosemide, hydrochlorothiazide [HCTZ], or Lasix®). Tell your doctor if you are taking a medicine for depression or took a depression medicine in the past 2 weeks such as amitriptyline, doxepin, nefazodone, Elavil®, Eldepryl®, Marplan®, Nardil®, Pamelor®, Parnate®, or Sinequan®.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, bone problems (such as osteoporosis), heart or blood vessel disease, heart rhythm problems, high blood pressure, seizures, thyroid problems, diabetes, any kind of infection (especially tuberculosis or herpes infection of the eye), low potassium in the blood, or if you have a weakened immune system. Tell your doctor if you have eye problems (such as a cataract or glaucoma).
• Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur. Talk to your doctor about any questions or concerns that you have.
• This should not be the first and only medicine you use for asthma or COPD. This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma attack or an acute COPD flare-up. If the other medicine does not work as well, tell your doctor right away.
• Take all of your COPD medicines as your doctor ordered. If you use any type of corticosteroid medicine to control your breathing, keep using it as ordered by your doctor. Do not change your doses or stop using your medicines without asking your doctor.
• Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with arformoterol, formoterol, salmeterol, Brovana®, Perforomist™, or Serevent® inhalers.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• Call your doctor if your symptoms do not improve or if they get worse.
• You may get infections more easily while using this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.
• This medicine may cause a fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat; or pain when eating or swallowing.
• Patients with COPD may be more likely to have pneumonia when taking this medicine. Check with your doctor if you start having an increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.
• Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.
• This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.
• If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.
• This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.
• This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.
• Check with your doctor right away if you or your child have blurred vision, difficulty with reading, or any other change in vision while using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor). Be sure to keep all appointments.
• This medicine may affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.
• Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine. The card will say that you or your child may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in vision.
• Chest pain, shortness of breath, troubled breathing, tightness in the chest, or wheezing.
• Dry mouth, increased thirst, or muscle cramps.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Seizures or tremors.
• Sores or white patches on your lips, mouth, or throat.

If you notice these less serious side effects, talk with your doctor:

• Anxiety, nervousness, or restlessness.
• Headache.
• Nausea, vomiting, diarrhea, upset stomach, or stomach pain.
• Skin rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088