When This Medicine Should Not Be Used:
You should not use this medicine if you or your child have had an allergic reaction to budesonide. This medicine is not to be used during an asthma attack.

How to Use This Medicine:
Liquid Under Pressure, Powder Under Pressure, Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Pulmicort Respules®:
  
  • This medicine is a liquid that is used in children who are 12 months to 8 years of age. The medicine is breathed in with a device called a nebulizer. The nebulizer turns the medicine into a fine mist that the child breathes in through the mouth and into the lungs. Your child's doctor will show you how to use a nebulizer.
  • Pulmicort Respules® is provided as a strip of five small plastic containers with sealed caps. Each container holds one dose. The strip of containers is sealed inside a foil pouch.
  • Wash your child's face after using the Pulmicort Respules® to avoid skin irritation.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Pulmicort Flexhaler™:
  
  • This medicine is a powder that is used in adults and children who are 6 years of age and older. It is breathed in with a special inhaler device that comes with the medicine. The powder is stored inside this inhaler. Before each use, you will turn the brown grip at the bottom of the inhaler to load a new dose of the powder into the air chamber. Do not use a spacer with the Pulmicort Flexhaler™.
  • When you use the Pulmicort Flexhaler™ for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it. Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip. Twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time. You do not have to prime it again after this, even if you have not used it for a long time.
  • The Pulmicort Flexhaler™ has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.
  • When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water after rinsing.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Keep the inhaler clean and dry at all times. Carefully follow the patient instructions about cleaning and caring for your inhaler.

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 cimetidine (Tagamet®), clarithromycin (Biaxin®), erythromycin (Eryc®, Ery-Tab®), itraconazole (Sporanox®), or ketoconazole (Nizoral®). Tell your doctor if you are also using other steroid medicines (such as dexamethasone, prednisolone, prednisone, or Medrol®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have bone problems (osteoporosis), cataracts, glaucoma, or any type of infection, especially a lung infection such as tuberculosis (TB) or a herpes infection in the eye.
• Tell your doctor if you or your child have an allergy to milk proteins. This medicine contains small amounts of lactose, which has milk sugar with milk proteins.
• 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.
• 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.
• 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 or your child have been exposed to someone with chickenpox or measles.
• If you or your child develop a skin rash, hives, or any allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.
• This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child notice any signs of a throat infection.
• 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 normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think this is a problem.
• This medicine may increase your risk of having an adrenal gland that is less active than normal. This is more likely for people who use steroids for a long time. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
• 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).
• Your doctor may want you to carry a medical identification card stating that you or your child are using this medicine and 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. Eye exams may be needed to check for unwanted effects.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Call your doctor if your symptoms do not improve or if they get worse.

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 or tightness.
• Fever, chills, sore throat, cough, runny or stuffy nose, and body aches.
• Lightheadedness, dizziness, or fainting.
• Sores or white patches in your mouth or throat.
• Unusual tiredness or weakness.
• Worsening of asthma symptoms.

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

• Dry mouth, hoarseness, or voice changes.
• Joint pain.
• Pain, redness, or swelling in the ear.
• Upset stomach, diarrhea, nausea, or vomiting.

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