Pulmicort contains budesonide, a corticosteroid that prevents the release of substances in the body that cause inflammation.

Pulmicort is used to prevent asthma attacks.

Pulmicort Flexhaler is for use in adults and children at least 6 years old.

Pulmicort Respules are for use in children 12 months to 8 years old.

Do not use Pulmicort to treat an asthma attack that has already begun. Budesonide is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast-acting inhalation medicine to treat an asthma attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Your dosage of Pulmicort may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely.

Before taking this medicine

You should not use Pulmicort if you are allergic to budesonide, or if:

• you have a severe allergy to milk proteins; or

• you are having an asthma attack.

To make sure Pulmicort is safe for you, tell your doctor if you have ever had:

• food or drug allergies;

• liver disease;

• osteoporosis, or low bone mineral density;

• glaucoma, cataracts, or herpes infection of the eyes;

• tuberculosis; or

• any type of infection caused by bacteria, fungus, virus, or parasite.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, if you have a family history of osteoporosis, or if you are a woman going through menopause.

Tell your doctor if you are pregnant or breast-feeding.

Use Pulmicort exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pulmicort is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

Use only the inhaler device that comes with Pulmicort Flexhaler. Do not place the device in water or try to take it apart. The Flexhaler device has a dose counter that shows how many doses are left inside. The dose-counter indicator may not appear to move until about 5 doses have been used. Do not use an extra dose just because the Flexhaler indicator has not moved to a lower number after just one use.

Always rinse your mouth with water after using the Pulmicort Flexhaler, to help prevent thrush (a fungal infection in the mouth or throat). If you are using a nebulizer with a face mask, wash the mask area of your face after each use.

Do not allow a young child to use Pulmicort Flexhaler without help from an adult.

Pulmicort Respules should be used only with a standard jet nebulizer connected to an air compressor. Do not mix with other medicines in the nebulizer cup (reservoir).

Your doctor will need to check your progress on a regular basis. Your vision or bone mineral density may also need to be checked.

Using a steroid can weaken your immune system. This can make it easier for you to get sick from being around others who are ill.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

Call your doctor if your symptoms do not improve after the first week of treatment, or if you think your asthma medications are not working as well. If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Store at room temperature, away from moisture, light, and heat. Keep the cover on your inhaler device while not in use.

Store Pulmicort Respules upright in the foil envelope. When you are ready to use the medicine, remove an ampule and put the strip back in the envelope. Once you have opened an envelope, you must use the ampules within 2 weeks.

In case of emergency, wear or carry medical identification to let others know you use a steroid medication.

You should not use Pulmicort if you are allergic to budesonide, or if:

• you have a severe allergy to milk proteins; or

• you are having an asthma attack.

To make sure Pulmicort is safe for you, tell your doctor if you have ever had:

• food or drug allergies;

• liver disease;

• osteoporosis, or low bone mineral density;

• glaucoma, cataracts, or herpes infection of the eyes;

• tuberculosis; or

• any type of infection caused by bacteria, fungus, virus, or parasite.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, if you have a family history of osteoporosis, or if you are a woman going through menopause.

Tell your doctor if you are pregnant or breast-feeding.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

High doses or long-term use of budesonide can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid getting Pulmicort in your eyes.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Get emergency medical help if you have signs of an allergic reaction to Pulmicort: hives, rash, severe itching; chest pain, difficult breathing, feeling anxious; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening asthma symptoms;

• wheezing, choking, or other breathing problems after using this medication;

• white patches or sores inside your mouth or on your lips;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• signs of infection - fever, chills, body aches, ear pain, nausea, vomiting; or

• signs of low adrenal gland hormones - worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Budesonide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Pulmicort side effects may include:

• runny or stuffy nose, sneezing;

• red, itchy, and watery eyes;

• fever, sore throat, cough;

• nausea, vomiting, diarrhea, stomach pain, loss of appetite;

• nosebleed; or

• headache, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• antifungal medicine (such as ketoconazole

• drugs that weaken the immune system such as cancer medicine, or medicines to prevent organ transplant rejection;

• seizure medication; or

• other steroid medicine (fluticasone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.