Budesonide and formoterol is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.

Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

Inhaled formoterol belongs to the family of medicines known as bronchodilators. It works by helping the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath. This increases the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Inhaled fluticasone and salmeterol is used to prevent asthma attacks and treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

This medicine is used with a special inhaler and usually comes with a patient information leaflet or patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor first. To do so may increase the chance of side effects. The full benefit of this medicine may take 1 to 2 weeks or longer to achieve.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

When you use the inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first inhalation. Therefore, before using the inhaler, prime it by spraying the medicine 2 times into the air away from the face, and shaking it well for 5 seconds before each spray.

How to use this medicine:

Take the inhaler out of the moisture-protective foil pouch before you use it for the first time.
Do not use the inhaler for this medicine with any other medicine.
Prime the inhaler before use by shaking the inhaler well for 5 seconds and then releasing a test spray. Once again, shake the inhaler and release a second test spray.
Breathe out to the end of a normal breath (exhale). Do not breathe into the inhaler.
Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath for as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
Release your finger from the grey top and then turn your head away from the inhaler. Breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
Shake the inhaler again for 5 seconds and take the second inhalation following exactly the same steps you used for the first inhalation.
Replace the mouthpiece cover after using the medicine.
Gargle and rinse your mouth with water after each dose. This will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.
The dose counter at the top of the inhaler will turn yellow when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.

Clean the inhaler every 7 days by wiping the mouthpiece with a dry cloth. Do not put the inhaler into water or try to take it apart. However, you must use a new inhaler with each refill of your medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough

difficulty with breathing

ear congestion

fever

headache

loss of voice

muscle aches

pain or tenderness around the eyes and cheekbones

sneezing

sore throat

stuffy or runny nose

tightness of the chest

unusual tiredness or weakness

Less common

Bladder pain

bloody or cloudy urine

congestion

cough producing mucus

diarrhea

difficult, burning, or painful urination

dryness of the throat

fast, irregular, pounding, or racing heartbeat or pulse

frequent urge to urinate

general feeling of discomfort or illness

hoarseness

joint pain

loss of appetite

lower back or side pain

nausea

noisy breathing

shakiness in the legs, arms, hands, or feet

shivering

sore mouth or tongue

stomach pain

sweating

tender, swollen glands in the neck

trembling or shaking of the hands or feet

trouble with sleeping

trouble with swallowing

voice changes

vomiting

white patches in the mouth or on the tongue

Rare

Blurred vision

confusion

decreased urine

dizziness or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

enlarged pupils

fainting

flushed, dry skin

fruit-like breath odor

increased hunger

increased sensitivity of the eyes to light

increased sweating, possibly with fever or cold, clammy skin

increased thirst

increased urination

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle cramps

nervousness

numbness or tingling in the hands, feet, or lips

pounding in the ears

seizures

severe chest pain

severe headache

slow, fast, pounding, or irregular heartbeat or pulse

stiff or sore neck

unexplained weight loss

Incidence not known

Blindness

decreased vision

eye pain

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Arm, back, or jaw pain

chest pain or discomfort

darkening of the skin

drowsiness

mental depression

rapid, deep breathing

restlessness

skin rash

stomach cramps

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Stomach discomfort

Less common

Belching

difficulty with moving

heartburn

indigestion

muscle spasms or stiffness

pain in the arms or legs

stomach upset

swollen joints

Rare

Bad, unusual, or unpleasant (after) taste

change in taste

deep or fast breathing with dizziness

fear

hives or welts, itching skin

irritability

large, flat, blue, or purplish patches in the skin

numbness in the feet, hands, and around the mouth

redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly and to check for any unwanted effects. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma attack when they do occur. Be sure to read about these risks in the patient information leaflet and 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. It 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 first asking your doctor.

You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with salmeterol (Serevent®), formoterol (Perforomist™), or arformoterol (Brovana®) inhalers.

Talk to your doctor or get medical care right away if:

Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.
Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
You or your child have a significant decrease in your peak flow when measured as directed by your doctor.
Do not change your dose or stop using your medicine without first asking your doctor.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child 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 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 or your child 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 may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, or wheezing.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.

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.

This medicine may affect blood sugar and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.