Pulmicort Flexhaler is a steroid that is used to prevent asthma attacks.

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

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

Budesonide may also be used for purposes not listed in this medication guide.

Budesonide is not a rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Pulmicort Flexhaler is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use only the inhaler device that comes with Pulmicort Flexhaler. Do not place the device in water or try to take it apart.

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).

Rinse your mouth with water after using 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.

Your doctor will need to check your progress on a regular basis.

Call your doctor if your symptoms do not improve of if they get worse. If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

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.

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

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

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

• you have a severe allergy to milk proteins; or

• you are having an asthma attack.

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 Flexhaler 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: hives, rash, severe itching; chest pain, difficult breathing, feeling anxious; swelling of your face, lips, tongue, or throat.

Pulmicort Flexhaler may cause serious side effects. 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.

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

Common side effects of Pulmicort Flexhaler 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 your immune system;

• seizure medication; or

• other steroid medicine (flunisolide, fluticasone, mometasone, and others).

This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.