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

How to Use This Medicine:
Spray

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• Before using the medicine, gently blow your nose to clear the nostrils.
• To use the spray:
  
  • Shake the bottle gently before each use.
  • When you use the spray for the first time, you must prime the bottle. Pump the bottle 8 times or until a fine spray comes out.
  • Insert the tip of the bottle into your nostril.
  • Close the opposite nostril with a finger and lean your head slightly forward.
  • Spray into your nostril and breathe gently inward. Lean your head backward for a few seconds.
  • If a second dose is needed in the same nostril, lean the head slightly forward and repeat the same steps.
  • Spray the opposite nostril using the same steps.
  • Do not blow your nose for 15 minutes after using the spray.
  • After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
  • If you do not use the bottle for 2 days, prime it again by releasing one spray.
  • If you do not use the bottle for more than 14 days, clean the spray tip and prime it again by releasing two sprays.
  • After you prime the bottle, there will only be 120 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 120 sprays even if some liquid remains in the bottle.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

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 taking medicine to treat HIV or AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, telithromycin, Biaxin®, Ketek®, Nizoral®, or Sporanox®), or medicine to treat depression (such as nefazodone, Serzone®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, tuberculosis (now or in the past), an infection (including a cold or the flu), a herpes simplex eye infection, a history of glaucoma or cataracts, or a recent exposure to chickenpox or measles.
• Make sure your doctor knows if you have had nose surgery, a nose injury, or sores or ulcers in the nose. You may need to stop using the medicine to allow the nose to heal.
• This medicine may increase your risk of having some unwanted effects in the nose. Check with your doctor right away if you or your child have bloody mucus; sores inside the nose; unexplained nosebleeds; or a whistling sound when you breathe while you are using this medicine.
• This medicine may cause thrush (a type of fungus infection) in the nose or throat. Tell your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• You may get infections more easily while you are using this medicine. Avoid close contact with anyone who has chickenpox or measles if you have never had these infections. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.
• 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 weight loss.
• Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• Call your doctor if your symptoms do not improve or if they get worse.
• This medicine may slow down a child's growth if it is used for a long time. Talk to your child's doctor if you think your child is not growing properly or if you have any questions about this.
• 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 or eye pain.
• Fever, chills, cough, sneezing, sore throat, and body aches.
• Heavy bleeding from your nose.
• Increased itching or pain in your nose.
• Red or white patches in your throat.
• Swelling of the face, throat, or lips.
• Unexplained tiredness.
• Wheezing, chest pain, or trouble breathing.

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

• Change in your menstrual period.
• Nosebleeds or dry mouth.
• Sore throat, hoarseness, or cough.
• Stinging or burning in the nose.

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